885: Force Majeur

Adam Curry & John C. Dvorak

2h 51m
December 11th, 2016
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Mediaite's 2016 Most Influential in News Media | Mediaite
Thu, 08 Dec 2016 21:13
CNN's Chief political correspondent Dana Bash had a banner year. She gave aggressive '‹pushback to every single '‹candidate fighting for the presidency and was able to net interviews using a combination of natural approachability and dogged determination'‹.'‹ She '‹seemed to be constantly on the road at campaign events, doing live shots and conducting interviews for broader pieces almost daily'‹.'‹ '‹Very often as the slogan goes, it felt she -was- CNN. '‹As she mentioned in CNN's Girls on the Bus series, this was the campaign of a lifetime'‹ and along with her producer Abigail Crutchfield she became one of the breakout stars'‹ of 2016.
As many conservative pundit'‹s'‹ recanted their opposition to Trump, captain of TheBlaze Glenn Beck never wavered in his conviction that the candidate and the ''alt-right'' movement he empowered were the wrong choice'‹s'‹. In withholding his support for the GOP nominee, the Never Trump stalwart courted the outrage '‹of '‹conservative allies and the admiration of onetime rivals, who praised him for his open-mindedness to Clinton and his belated admission of respect for Obama. The problem, a sober Beck said on election night, is ''we don't listen to each other and we don't trust each other.'' '‹Beck has become surprisingly unpredictable'‹ which makes him that much more influential if you can get him on your side.
Eric Bolling, has long been a fixture on Mediaite but this year he became a national star. Why? Because he became just one of a tiny handful of media leaders who can now say ''I was right about Donald Trump.'' He was panned for his spirited defenses of the mogul who became a candidate, then a nominee, and now the President-elect, but he has reason to gloat now... which he does. Oh just occasionally. The Five, which he moderates along with other big Fox names Kimberly Guilfoyle, Juan Williams, Dana Perino, Greg Gutfeld and occasional others has become a cable news ratings monster but with talk of a spot for him in the new administration, who knows what is next for Bolling.
The mere mention of Breitbart always guarantees an immediate reaction, whether it be positive or negative. There's a reason Steve Bannon's White House appointment spawned all that cable news coverage. Breitbart has expanded its success '‹and influence '‹under the direction of Joel Pollak and Alexander Marlow. Marlow in particular has been viewed as a young rising media star, having placed in Forbes' 30 Under 30 in media in 2015 and being the subject of a CNN profile just months ago, Breitbart has, of course, been controversial due to its association with the alt-right''''a connection that Pollak strongly disputed during a CNN appearance this year. Nevertheless, that association has led to companies like Kellogg's to pull ads from the site. But Breitbart retaliated by calling for a boycott, and the fact that #DumpKelloggs ended up being a top Twitter trend is a testament to the size and influence of Breitbart and its audience.
You may know Neil Cavuto as the anchor of Your World on weekdays and Cavuto on Business on Sundays, but what makes him even more influential is '‹that he is also a top manager. '‹Unlike other on-air stars, Cavuto is '‹also '‹a senior vice president and managing editor '‹for'‹ '‹Fox News Channel and '‹Fox Business Network. Despite numerous health problems- he's a cancer survivor, was diagnosed with Multiple Sclerosis, and had open-heart surgery earlier this year, he's remained a '‹powerful '‹fixture on his network, including moderating a GOP debate in January and '‹offering pointed (generally conservative) commentaries throughout the election. He made enough of an impact that even being absent for a chunk of this year, he signed a contract extension with FOX- '‹they like him there both on and off the air'‹.'‹ '‹His influence is not to be underestimated.
If CNN was one of the most pivotal homes for political media during the 2016 election cycle, then the host of '360' is one of its most critical and influential figures. To be sure, Anderson Cooper's nightly work on the network made for must-see TV, as the season vet grilled lawmakers and newsmakers alike while moderating panels that would frequently lead to on-air brawls. But Cooper knows when to toss out the script and speak from the gut. He frequently tore into campaign surrogates when he saw right through their nonsense, and famously remarked right to Donald Trump's face, ''With all due respect, sir, that's the argument of a 5-year-old.'' He moderated a litany of panels and town hall events for CNN this political season, scoring a sit-down with President Obama on gun control before being named by the Commission on Presidential Debates as one of the co-moderators for the general election. Cooper is, without a doubt, one of the single biggest names of our industry, and his crossover appeal to programs like 60 Minutes and LIVE with Kelly (where he was been long rumored to become the new daily fixture) on ABC demonstrate his continuing influence.
Abigail Crutchfield is CNN's Dana Bash's all-star producer. Bash interviewed nine presidential candidates in 2016, including multiple interviews with President-Elect Donald Trump and Crutchfield is the mastermind who made it all happen. At CNN's presidential debates, Bash was a questioner and Crutchfield was behind the scenes, working with her to prepare. During presidential conventions, Crutchfield and Bash reported from 3:00pm to 11:00pm daily, which led to Bash's interview with Trump's adult children- the first one they did after their father officially became the Republican nominee. Without Crutchfield, Bash would have had a lot fewer guests.
Kurt Eichenwald -- of Newsweek and Vanity Fair, of course -- was one of those media figures who had a long, successful career in the pre-Trump world, but whose star rose ever higher as the campaign season wore on. Just days before the election, Eichenwald generated headlines with his exclusive report about the root of Putin's love for Trump. Whether it was his groundbreaking and assertive pieces or his unique online presence, he seemed to be cropping up in conversation all throughout the worlds of politics and media. Of course, he wouldn't have been nearly as influential this year had he not laid the groundwork for his credibility by working tirelessly for years as a journalist for CBS News, the New York Times, Portfolio, and more. It was his bona fides in the field coupled with his no-nonsense takes on the election that cemented him as one of this year's most influential and someone political reporters can look up to for years to come.
Arden Farhi serves as CBS's White House Producer and spent much of 2016 following Donald Trump and providing first-hand accounts of the campaign and contributing to dozens of reports. (And will, obviously, be involved in covering President Trump in 2017 in his role.) Farhi was present during the chaotic Reno rally days prior to Election Day when Trump was rushed off stage by the Secret Service after it was thought someone in the crowd had a gun and was on hand during a rowdy anti-Trump protest outside a June rally in San Jose.'‹ His CBS News peers consistently named him among the first when asked to laud a person critical to their 2016 election coverage. A classic behind the scenes star who deserves to be recognized this year.
By her own admission, this 'Barrons of the Beltway' author never intended to become a part of the story this year, instead assuming her original reporting would suffice for a solid turn covering the election. Of course, that all changed one fateful night in Florida when she accused Trump's campaign manager Corey Lewandowski of assaulting her during a rally'‹. Fields soon found herself at the center of a political media firestorm whose implications rippled on. That's hardly the sole reason we've included Michelle Fields here on our list however; she left Breitbart this year to begin her work for The Huffington Post, and continued a healthy level of sharply-aimed'‹,'‹ '‹and widely shared, '‹criticism against the Trump candidacy in her new role. 2016 was a hallmark year for this young journalist, and we're looking forward to seeing what the new year will bring.
Paul Gigot oversees editorials at the Wall Street Journal and often set the tone for how the larger media would see the election through the lens of the right of center media. Recently, the Journal changed the public discourse after the editorial board penned a scathing op-ed that ripped President-elect Donald Trump over the deal he negotiated with Carrier that would enable a plant to keep additional jobs in the United States. This week, the board published a piece that suggested Trump's decision to talk to the Taiwanese president may in fact turn out to be a good thing. On top of his editorial duties, Gigot hosts ''The Journal Editorial Report'' on Fox News. The Journal and Fox News are the two most influential right of center entities in the mainstream media and Gigot was a major player in both in 2016.
Fin Gomez of Fox News Channel became integral for the network behind the scenes in large part thanks to solid connections within the Hillary Clinton campaign. Where other hosts on the channel found the campaign's lack of participation in its own coverage frustrating, Gomez worked tirelessly securing statements and critical interviews. One can imagine that it can't always have been easy being the Fox News producer responsible for Hillary Clinton but according to those inside Fox, Serafin used that challenge to become a critical player this election season.
NBC's Today Show has a place in the heart of many Americans, which is certainly due to in part to co-host and legal correspondent, Savannah Guthrie. Viewers across the country saw Guthrie spend hours on air covering the 2016 election along with her star co-anchor Matt Lauer. In a recent profile piece in the Hollywood Reporter, her boss, Andy Lack, praised the host for having a ''very good bullshit'' detector. In June, Guthrie pushed back on Trump calling it ''unseemly'' when he offered himself congratulations for forecasting there would be another terrorist attack. '‹Guthrie has handled everything from political interviews, to lighter segments, and the payoff is evident in the third quarter ratings boost that placed Today ahead of the competition at ABC and CBS in certain metrics. More can certainly be expected of her once she returns from maternity leave and Mediaite congratulates her as she prepares to give birth to her second child.
To successfully hold your own as one of the top voices in cable news is one thing. But to demonstrate that you have enough crossover appeal to also play to the TODAY Show crowd is a talent set all its own. NBC's Tamron Hall showed this year that she knows how to hit the sweet spot. It would be enough to highlight Hall's personal work to be a force for good, fighting on behalf of domestic abuse victims but a whole other thing altogether to spotlight her political interviews that often led to headlines everywhere. This summer during the Republican National Convention in Cleveland, Hall left Trump surrogate Scott Baio absolutely stuttering and sputtering for air when she slammed him on MSNBC for cheap shots aimed at Hillary Clinton.
On top of the two shows, and his managerial duties, Halperin was also a regular Morning Joe guest where his insights consistently made headlines during the 2016 election. Last month, he didn't hold back ripping The New York Times for 'anti-Trump' bias following the election. ''It's amazing,'' Halperin said referring to a recent Times headline about Trump's victory. ''It's The Onion.'' Some have critiqued him for being ''too favorable'' to Donald Trump but make no mistake in most of those cases Halperin ended up being right. And, just this week, he questioned the president-elect's decision to have a phone call with the Taiwanese President. "There's an improvisational quality to how they're dealing with everything," he noted about the transition team and quickly-assembling cabinet. "And that's a little bit dangerous," he said. Agree with him or not, when Halperin offers up his analysis, the political world listens.
John Heilemann was one pundit who could be counted on to tell it like it was and predict how it would be, no matter what outrageous things were going on in the campaign cycle. He and co-host Mark Halperin kept a busy schedule this election season with their show, With All Due Respect, his continuing duties as co-managing editor of Bloomberg politics, and his new Showtime feature, With The Circus: Inside the Greatest Show on Earth. Heilemann brought viewers an inside look at what really goes in during a presidential campaign, providing the sort of first-hand account that will be heavily valued by historians in the years to come.
There was little surprise or uproar when the Commission on Presidential Debates announced that NBC News' Lester Holt was tapped to moderate the first general election debate between Hillary Clinton and Donald Trump. After all, the unflappable veteran had been firm but fair in previous interviews with candidates, and was widely regarded as a ''no-brainer'' choice for the Commission. Since assuming the NBC Nightly News desk, Holt has repeatedly shown why he is deserving of consideration on our most influential in news media list. In fact, the Holt-helmed Nightly News reeled off 14 consecutive weeks in the top ratings spot earlier this year, going up against stiff competition in the form of ABC's World News Tonight. NBC Nightly News was the most watched program for the 36th consecutive sweep period in 2016 as well, proving that Holt can pack a jolt.
Few people sparked as many fierce debates this year as CNN's liberal commentator Van Jones. Until the bitter end of the election, he was '‹creating the talking points and coining phrases like ''whitelash,'''‹ as he became one of the best known Trump critics. '‹H'‹e '‹eventually '‹took on The Messy Truth, a project that involved him spending time talking to Donald Trump's voters and trying to better understand them. His commitment to his beliefs coupled with his willingness to hear other sides of the story made him an unstoppable force this year.'‹ You know you have made it when just saying the name "Van Jones" evokes a visceral reaction. . . one way or another. '‹
As Chief White House Correspondent for ABC News, Jonathan Karl '‹has become one of the most recognizable and influential reporters in the nation's Capitol.'‹ Whether he was asking Donald Trump about his attacks on primary opponents and their wives or prodding President Barack Obama about his pre-election statements about Trump being unfit for the presidency, Karl '‹was often '‹ask'‹ing'‹ the '‹toughest questions at press conferences. '‹Beloved and despised'‹ on both sides of the political aisle, Karl proved to be precisely what a White House reporter ought to be: dogged, non-partisan and well-respected.
Without a doubt, Brianna Keilar has been one of the 2016 election's biggest breakout stars, regularly filling in for network stalwart Wolf Blitzer on the Situation Room and asking crucial political '‹questions every step of the way. Keilar was also one of the featured correspondents on CNN's ''Girls on the Bus'' series, a twist on the decades-old book by Timothy Crouse about the male reporters covering the 1972 election. But times have changed, and CNN's strong female coalition has featured Brianna Keilar as much as anyone else. Who could forget one of the moments of pure viral gold that she delivered during an on-air interview with Trump surrogate Michael Cohen? Despite the outcome of the election, Keilar's deadpan delivery and rebuke of Cohen's argument was viewed by millions of people within mere hours, earning widespread praise from CNN personalities and rival network figures alike.
If it's ever been said on the record, count on the KFile Team to find it, no matter how old, how arcane, or how overlooked. The tireless team led by Andrew Kaczynski, which includes Kyle Blaine, Christopher Massie, and Nate McDermott, moved its operation from Buzzfeed to CNN this year without missing a step, and single-handedly propelled countless news cycles with their hard-earned scoops. Kaczynski and company scoured America's content landfills to unearth gems from old interviews, graduation speeches, forgotten press clips, and more. '‹'‹Nobody worked harder this year to try to make public figures accountable for what they said '-- even if they never remember saying it.
CNN's Chief National Correspondent was a political superstar in the game once again '‹this year, anchoring Inside Politics and providing a steady hand of veteran prowess to the network's coverage of the race. If there is a crucial panel or heated conversation going on somewhere on CNN, chances are that John King is standing nearby at his Magic Wall: cable news' very best visual descriptor of all things that live inside the Venn diagram of ''politics'' and ''cool on-screen graphics.'' But that doesn't mean that King's contributions are only on the objective side; he would routinely call out candidates in the race for their poor performances (''He might call himself low energy there to borrow a term from the primaries,'' he said of Trump) and added commentary important to the discussion. For example, when the trove of hacked emails from John Podesta were ma'‹de'‹ public, King weighed in bluntly, telling the CNN viewers at home, ''It shows you the secrecy'' some would say paranoia'' of Hillary Clinton and her inner circle.'' It's impossible to imagine the CNN political apparatus without associating the name John King..
If ever there was a need for crystal-clear explanations and easy-to-follow news, it was the 2016 election. This campaign season had innumerable twists and turns, which is why news consumers are lucky Vox founder Ezra Klein is no stranger to pulling back the curtain and letting interested parties see what really goes on behind the scenes. In fact, he's really good at it, as evidenced by the popularity of his old Washington Post blog and newsletter, which aimed to illuminate policymaking for the uninitiated. Years later, he's still doing it and his work is as vital as ever.
'‹MSNBC's Steve Kornacki had a big year in part, thanks to his use of huge, interactive boards to illustrate the often complex electoral college or other statistical points. His mastery of technology, innovation, and production made him a break-out geek heartthrob this election season. As likely to have a nerdy political analyst or niche expert on his show as he is to have an opinionated pundit, Kornacki developed a niche, a major following and a big future.
The breakout star of TheBlaze and one of the youngest conservative firebrands, 24-year-old Tomi Lahren became one of the most beloved and loathed pundits of the year '-- even inspiring multiple petitions to have her sacked. Lahren came to national prominence this year via a series of incendiary monologues, riffing freely and fearlessly on the subjects of race and political correctness. Her bold style and unalloyed praise for Donald Trump earned her a spot on the president-elect's soft launch for Trump TV. That project may have been put on hold for a few years, but Lahren isn't slowing down and expect her to be a major conservative force in the years to come'‹.
With Jon Stewart's tenure at the Daily Show firmly in the rearview, HBO's Bill Maher occupied the steady lane of the angsty unapologetic smart-ass (mostly) liberal in the 2016 cycle. His Real Time was the stuff of must-watch-TV every Friday night. He welcomed candidates, spokespeople, and network pundits from all ideologies onto his show in 2016. He's far less fluffy than many others in the late night game who dominate the other weeknights, and often gets the first crack as the weeks-end storylines even before John Oliver can get his hands on them. His ''New Rules'' segment alone is worth the price of admission, and his unique ability to volley a panel conversation with top notch guests is a refreshing take on the endless punditry we're otherwise bombarded with. Bill Maher is still a top dog in the game, and time will only tell how he contributes his voice to the Trump presidency.
If you're a regular connoisseur of the liberal blogosphere, then you're already more than'‹ familiar with TalkingPointsMemo and Josh Marshall. He was influential in 2016 and 2015 and 2014 and will be again in 2017. Posts from TPM get shared all across the net and help drive conversation on the American left. TPM has been an online mainstay for many years now and there's no doubt that it will continue to thrive under a Donald Trump presidency.
If it seems as if every presidential election puts the skewering comedy of Saturday Night Live front and center into the American consciousness, you largely have '-- ironically '-- a Canadian to thank. SNL's head honcho Lorne Michaels, who launched the venerable late night program and continues to this day to have an active role in its production, delivered another year for the ages in 2016; supported by a talented and hilarious cast that presented the week's must-see election parody cold open and sketches every week, Michaels proved yet again that Saturday Night Live is still beyond relevant: it's downright crucial. The show took square aim at not only the circus behind the presidential candidates themselves, but also the cable news pundits who nitpicked, debated, and screamed their points of view into our living rooms nightly. Yes its comedy but everyone now understands how long lasting, and perilous, the best of those political parodies can be.
'‹2016 was '‹ABC News' David Muir'‹'s break out year. The anchor for World News Tonight '‹became a major player '‹in the ABC News landscape'‹ and beyond. Muir secured major interviews at the most competitive times that significantly drove the politics and news media cycles; it was Muir, for instance, who lured an apology out of former Secretary of State Hillary Clinton for her use of a private email server. Muir also accompanied President Barack Obama on his historic trip to Cuba, earning the exclusive with the Commander in Chief as he normalized relations with that nation for the first time in decades. Under Muir's careful watch, World News Tonight became a formidable player and '‹neck and neck rival to the NBC Nightly News. He also masterfully co-moderated the third and final Democratic presidential debate along with his cohort Martha Raddatz, securing his '‹place as a leader in this year's news media landscape.
The Daily Beast's Olivia Nuzzi had a stand-out year that solidified her place among the top ranks of political journalists. Her election reporting was informative and dependable, but it was her tweets from the front lines of event after event that really illuminated the campaigning process for countless readers and followers. From expressing frustration and disgust to cracking jokes, she did her part to humanize an unorthodox period in American history. Speaking of humanizing, her GQ profiles on Hope Hicks and Scottie Nell Hughes brought much-needed dimension to two of Donald Trump's most ardent supporters. '‹The 23-year old '‹Nuzzi seems able to make any information digestible, which is a skill that will take her far in the coming years.
Outside of the cable news bubble, many networks news anchors did excellent work in 2016 but few rival Norah O'Donnell of CBS This Morning. When the Democratic primary process was anything but a sure bet for for Secretary of State Hillary Clinton, O'Donnell made headlines by grilling fan-favorite Senator Elizabeth Warren about her unannounced support, who a'‹t'‹ the time seemed to waver between Clinton and Bernie Sanders. One of O'Donnell's most noteworthy contributions to CBS in 2016 came in the form of a controversial undercover segment for 60 Minutes spotlighting the call centers that American Congressman use to raise untold sums of money. Although cameras were strictly forbidden inside the call center, O'Donnell and show producers defended the decision to air the footage, saying it benefitted the American people to know the truth. ''I'm a reporter who covered Capitol Hill for many years,'' O'Donnell later recounted. ''I didn't realize those call centers existed. So I'm sure many people in the American public don't realize that that's how many lawmakers are spending a lot of their time.'' Now we do thanks to Norah's terrific work in 2016.
From his perch high in the ratings, Fox News Channel's Bill O'Reilly remains the cable king. Throughout the election, O'Reilly was an increasingly unpredictable political commentator thereby making his views that much more influential. He became one of the few cable hosts who regularly secured interviews with President-elect Donald Trump. And, O'Reilly wasn't afraid to tell the presidential-elect what he really thought either. After the last presidential debate, O'Reilly opined ''I don't know if he can recover from that.'' He did and so did O'Reilly whose empire of historical books also continued to grow throughout 2016.
Aside from having one of the best Snapchat accounts in all of political media (see it for yourself for her famous arm pump of victory), Liz Plank took her talents to Vox earlier in 2016 to serve as the Senior Correspondent after an impressive tenure at Mic. She appears regularly all over cable news, often spotlighting the newest fight for women's rights. Her memorable turn earlier this year with newly-named Canadian Prime Minister Justin Trudeau was the stuff of viral glory, hilariously spotlighting (in a tongue-in-cheek way) the public's fascination with moving northwards after the election.
Remaining THE newsletter to read '‹in the political media during 2016 was no easy feat. But every morning, it was '‹required reading to know what would matter to the movers and shakers in Washington, especially with a historic and unprecedented presidential election hanging over everything. Senior writer Jake Sherman brought his expertise as a congressional reporter to the mix, helping explain how decisions are made in the actual rooms where they meet. Senior Washington correspondent Anna Palmer added her experience as co-author of POLITICO Influence, which was long considered a necessary read on K Street. Reporter Daniel Lippman rounded it all out by tossing in his overseas and environment reporting expertise, giving us the compulsory Playbook.
Mark Preston juggled quite a few key roles during the 2016 election as both the executive editor for CNN Politics and the co-host of Politics Inside Out on SiriusXM. '‹ What makes Preston unique is his ability to seamlessly transfer between his managerial duties, providing live analysis, and helping to nail down 2016 election scoops. Just this month, he had the inside details about a Trump meeting with Mitt Romney to discuss a possible Cabinet position. If you don't think that's enough he also helped coordinate debates and other political events sponsored by CNN this year. Yes he is a solid fixture on tv, but what you don't see is arguably far more valuable.
'‹He has the job mix that every aspiring journalist wishes they had and the veteran journalist and talk show host enjoyed another banner year in 2016. The CBS This Morning co-anchor won the ICFJ Founders Award for Excellence in Journalism in November, describing the morning program as ''the best show on morning television and one of the best shows in the industry.'' He also found time to cameo in the mega-blockbuster Batman V Superman: Dawn of Justice. Rose is perhaps best known, however, for his long-running self-named interview series. Charlie Rose gave us some of the best conversations of the year and delivered insightful and informative discussions with guests as varied as Bernie Sanders, Chris Christie, Ruth Bader Ginsburg, Bill Clinton, Lin-Manuel Miranda, Donald Rumsfeld, Helen Mirren and President Barack Obama. '‹He may have the best job in television, and he has earned it.
With a soft tone and a sharp wit, Fox News Channel's Shepard Smith delivers every broadcast in a unique way that keeps viewers coming back for more. Smith continues to show unpredictable remarkable candor in assessing the political news of the day, whether it be about Republicans or Democrats. Smith also has a strong sense of what is fit to air and what is not. For example, he made headlines this year when he refused to air the images of horror from the Nice attack. But what makes Smith stand out in the world of cable news again this year is for the more lighthearted moments he brings to our screens. In just the past few months, he was hilariously transfixed by a giant blob of foam, did the mannequin challenge, and got into a ridiculous riff with Chris Wallace about chapstick. Shep Smith would be a star at any news network, he just happens to have been at one for a long time now.
The Buzzfeed Editor-in-Chief helmed the media giant during one of the biggest year's on record, covering every aspect of the 2016 election. At times, he was responsible for keeping the ship on a straight and narrow path reminding his full Buzzfeed editorial staff, ''Readers are entitled to trust you less if they think you're in the tank.'' But he wasn't afraid to defend his home turf either, engaging in a war of words of sorts with CNN President Jeff Zucker for calling out Buzzfeed and at other times defending the site from conservative critics. To those who questioned Ben's decision to leave Politico in 2011 for a gig at some site that does lists. . well we know who got the last laugh. '‹
At first glance, you may wonder why this bad boy shock jock made the list for 2016. But upon closer review, it immediately becomes clear that his years of radio interviews with a certain controversial presidential candidate became the stuff of news headlines again and again during this cycle. Largely spearheaded by the efforts of the KFILE team at Buzzfeed/CNN, journalists spent hours combing through Stern's old footage of every imaginable interview he did with Trump in order to dig up the newest spat of controversies to rock the campaign trail. Rarely, did Stern fall short of delivering an impact, even decades after his interviews originally aired. Without a doubt, Stern is one of the public figures who knows Trump the best, and his lengthy sit-downs with the then-real estate mogul shed an important light onto the character, temperament, and personality of the man who will soon become our 45th President. In a bizarre twist of fate that absolutely no one saw coming, Howard Stern became, by default, a wildly influential figure in political media in 2016.
As Managing Director of United Talent Agency'‹ (which purchased news agency N.S. Bienstock), Jay Sures'‹,'‹ '‹and his company now represent many of the most prominent people on this list. '‹Their client roster includes Anderson Cooper, Bill O'Reilly, Jake Tapper, '‹Chuck Todd, Norah O'Donnell, Glenn Beck, '‹David Muir, (and Mediaite founder and ABC News' Dan Abrams)'‹ just to name a few. It's not just his company either. Sures personally oversees the careers of the biggest and brightest in the news business. Sures, who was inducted into the Broadcasting and Cable Hall of Fame this year, also hosted the hottest party at the White House Correspondents Dinner where he was a guest of his client, event host Larry Wilmore.
With anti-establishment sentiments pulsing through the heart of the body politic this year, Cenk Uygur was able to tap into the progressive dissatisfaction with the status quo like few others in 2016. The Young Turks founder and host used his nightly web program to promote progressive and liberal values while taking a no-holds-barred approach to political commentary when it came to this historic and contentious election. The Young Turks boasts over 3 million YouTube subscribers and TYT Network is a veritable online empire, featuring a whole host of shows such as Pop Trigger, TYT Sports, Think Tank and What the Flick?! With an upcoming Trump administration, expect Cenk to be more vocal, and influential, than ever'‹.
At the intersection of money and the power players who generate it lies The Hive, the newest effort from Vanity Fair '‹which launched this year. Jon Kelly has been leading The Hive since its launch in June, focusing on everything from the financial sectors to the Beltway and even Silicon Valley. Mike Hogan has been serving as the Digital Director this year, teaming up with Vanity Fair editor Matt Lynch in the process. Covering the self-described ''drama behind the U.S. power corridors,'' Kelly, Hogan, and Lynch have have brought an influential voice to important landscapes of public interest. Featuring an array of high-profile writers '-- along with an impressive list of sponsors '-- the launch of this vertical proved its value right out of the gate.
CNN's anchors and staff gets all of their facts from somewhere, and the one most responsible for that would be this man. As CNN's Director of Political Research for the last fourteen years, Yoon's influence could be felt through the network's coverage for 2016. As a veteran of five presidential election cycles, Yoon has become a leading authority on subjects like money in politics and the nomination process. While he says that clowns got in the way of other things he wanted to do, Yoon's efforts have still netted him an assortment of journalistic awards and honorable mentions. His briefing books have been a guiding force for years of CNN coverage, and he has contributed heavily to the network's news articles and presidential debate questions.
Shirley Zilberstein is the Executive Producer and Senior Editor of MSNBC, and her contributions behind-the-scenes for the Peacock were instrumental in the success that the network had in 2016. Zilberstein created and led a unit this year that drove information-gathering, research and fact-checking throughout the entire election. From a managerial '‹point of view,'‹ Zilberstein discovered new ways to optimize teams of Production Assistants, Associate Producers, Pages and NBC interns. This was an election cycle unlike no other where the never-ending flood of information came into newsrooms at a dizzying rate; thanks to Zilberstein and her team '-- affectionately referred to around Rockefeller Center as ''Shirley's Army'' '-- that work proved crucial to the success of the network during this unprecedented year.
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The Time That Reality Forked Right in Front of You
Sun, 11 Dec 2016 03:25
Posted December 10th, 2016 @ 9:33am in #Trump
We're living in one of the most interesting times in human history. We just witnessed reality forking into two separate paths right in front of us.
As regular readers of this blog know, my background in hypnosis and persuasion has erased my belief that some people can see reality for what it is and some cannot. My worldview is that the human brain did not evolve to understand reality on any deep level because we don't need that ability to survive and reproduce. If your illusion keeps you alive, it's good enough. And that brings me to today.
The election of Donald Trump to the Presidency of the United States has effectively forked reality into two versions that are running in parallel. Clinton's supporters believe they are living in a world that is a repeat of 1930s Germany, with Trump playing the part of Adolf Hitler. See this reaction for a typical example.
Meanwhile, the other half of the country believes we elected a highly-capable populist who will ''drain the swamp'' and bring a business approach to government along with greater prosperity.
So how do you know which reality is the real one? The fast answer is that you can't know. As I said, the human brain did not evolve to understand reality. But just for fun and education, I'll tell you the best way dig down to the next layer of truth: Look for the Cognitive Dissonance trigger.
In this case, Clinton supporters were persuaded to believe that Trump is OBVIOUSLY the next coming of Hitler. Or maybe worse because Trump is also rude and sexist. If that version of reality is true, Trump could not have been elected president. But he was. That's the trigger for cognitive dissonance: two observations that don't fit together.
How can it simultaneously be true that Trump is OBVIOUSLY the next Hitler while it is also true that half the country didn't notice? There are at least three ways to explain-away this dissonance. Maybe'...
Half the country are sexist, racist monsters too, so they like Trump.or'...
Half the country is stupid and can't identify a Hitler that is right in front of them.or'...
Clinton supporters have been duped into believing something ridiculous about Trump.Given this set-up, most normal human minds would assume the problem was with other people. That's how cognitive dissonance works. We like to think we are rational while others are not. So you would expect in this situation that Clinton supporters would enter a type of dream state in which they interpret their reality as being surrounded by racist-sexist-stupid citizens who just elected a genocidal dictator. They have to enter this dream because the only alternative involves believing that they themselves are gullible and deluded.
Trump supporters have no such trigger for cognitive dissonance in this particular case because their candidate won. Their worldview is consistent. They think Trump is the most capable candidate and enough people recognized that fact to make him president. Most of these people believe Trump is not a racist and they believe they are not racists either (or not much anyway). Nothing about a Trump-supporter's experience would trigger cognitive dissonance. But Clinton supporters have a huge trigger for cognitive dissonance, so it is more likely they entered a new illusion in this particular case.
For further evidence that the anti-Trumpers are living in an illusion, consider that the street protests against Trump fizzled out. That means the illusion of Trump-as-Hitler is already starting to fade. You also see it in the surging stock market and in the sharp uptick in citizen confidence in the economy.
The Hitler illusion will continue to fade. But for now the citizens of the United States live in two separate realities. As a hypnotist, I doubt any of us can see reality for what it is. My worldview is that we were in one kind of illusion before and some of us moved to another. When it comes to understanding reality, the best we can do is pick a version that does a good job predicting.
My view of reality predicts that the Hitler illusion will wear off in time because Trump keeps refusing to do Hitler-like things. Check my prediction at the end of Trump's term. I think you'll see his popularity continue to improve from here.
'--
You might enjoy my book because it works across every reality.
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And EMP might not be a bad idea to stop the MSM
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Punching Down
Hey Adam,
Don't know if anyone told you about this yet, but "Punching Down" is a social justice comedy term.
It refers (in a very patronizing way) to mocking the disenfranchised.
For example: Mocking someones handicap is considered punching down.
Most people appreciate humour, but it makes rich white kids upset so we need to rethink the way we tell jokes.
PS: Tell John i would give him this type of info if he hadn't blocked me on twitter :)
Thanks for the show,
Curtis
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F-Russia
Trump, Mocking Claim That Russia Hacked Election, at Odds with G.O.P. - The New York Times
Sat, 10 Dec 2016 23:22
At this point in a transition, a president-elect is usually delving into intelligence he has never before seen and learning about C.I.A. and National Security Agency abilities. But Mr. Trump, who has taken intelligence briefings only sporadically, is questioning not only analytic conclusions, but also their underlying facts.
''To have the president-elect of the United States simply reject the fact-based narrative that the intelligence community puts together because it conflicts with his a priori assumptions '-- wow,'' said Michael V. Hayden, who was the director of the N.S.A. and later the C.I.A. under President George W. Bush.
With the partisan emotions on both sides '-- Mr. Trump's supporters see a plot to undermine his presidency, and Hillary Clinton's supporters see a conspiracy to keep her from the presidency '-- the result is an environment in which even those basic facts become the basis for dispute.
Mr. Trump's team lashed out at the agencies after The Washington Post reported that the C.I.A. believed that Russia had intervened to undercut Mrs. Clinton and lift Mr. Trump, and The New York Times reported that Russia had broken into Republican National Committee computer networks just as they had broken into Democratic ones, but had released documents only on the Democrats.
The president-elect finds himself in a bind after strenuously rejecting for months all assertions that Russia was working to help him, though he did at one point invite Russia to find thousands of Mrs. Clinton's emails.
While there is no evidence that the Russian meddling affected the outcome of the election or the legitimacy of the vote, Mr. Trump and his aides want to shut the door on any such notion, including the idea that President Vladimir V. Putin schemed to put him in office.
Instead, Mr. Trump casts the issue as an unknowable mystery. ''It could be Russia,'' he recently told Time magazine. ''And it could be China. And it could be some guy in his home in New Jersey.''
The Republicans who lead the congressional committees overseeing intelligence, the Pentagon and the Department of Homeland Security take the opposite view. They say that Russia was behind the election meddling, but that the scope and intent of the operation need deep investigation, hearings and public reports.
One question they may want to explore is why the intelligence agencies believe that the Republican networks were compromised while the F.B.I., which leads domestic cyberinvestigations, has apparently told Republicans that it has not seen evidence of that breach. Senior officials say the intelligence agencies' conclusions are not being widely shared, even with law enforcement.
''We cannot allow foreign governments to interfere in our democracy,'' Representative Michael McCaul, a Texas Republican who is the chairman of the Homeland Security Committee and was considered by Mr. Trump for secretary of Homeland Security, said at the conservative Heritage Foundation. ''When they do, we must respond forcefully, publicly and decisively.''
He has promised hearings, saying the Russian activity was ''a call to action,'' as has Senator John McCain of Arizona, one of the few senators left from the Cold War era, when the Republican Party made opposition to the Soviet Union '-- and later deep suspicion of Russia '-- the centerpiece of its foreign policy.
Representative Peter T. King, Republican of New York and a member of the House Intelligence Committee, said there was little doubt that the Russian government was involved in hacking the D.N.C. ''All of the intelligence analysts who looked at it came to the conclusion that the tradecraft was very similar to the Russians,'' he said.
Even one of Mr. Trump's most enthusiastic supporters, Representative Devin Nunes, a California Republican, said on Friday that he had no doubt about Russia's culpability. His complaint was with the intelligence agencies, which he said had ''repeatedly'' failed ''to anticipate Putin's hostile actions,'' and with the Obama administration's lack of a punitive response.
Mr. Nunes, the chairman of the House Intelligence Committee, said that the intelligence agencies had ''ignored pleas by numerous Intelligence Committee members to take more forceful action against the Kremlin's aggression.'' He added that the Obama administration had ''suddenly awoken to the threat.''
Like many Republicans, Mr. Nunes is threading a needle. His statement puts him in opposition to the position taken by Mr. Trump and his incoming national security adviser, Michael Flynn, who has traveled to Russia as a private citizen for RT, the state-controlled news operation, and attended a dinner with Mr. Putin.
Mr. Nunes's contention that Mr. Obama was captivated by a desire to ''reset'' relations with Russia is also notable, because Mr. Trump has said he is trying to do the same '-- though he is avoiding that term, which was made popular by Mrs. Clinton in her failed effort as secretary of state in 2009.
A president must sort out how to evaluate the evidence presented to him each day in the Presidential Daily Brief.
Mr. Obama, for example, came to question the C.I.A.'s analytic skills after being briefed not long after the 2010 uprising in Tunisia.
Mr. Obama asked what the chance was that the street protests would spread to Egypt; he was told ''less than 20 percent.'' Tahrir Square erupted within days.
Intelligence can get politicized, of course, and one of the running debates about the disastrously mistaken assessments of Iraq that Mr. Trump often cites is whether the intelligence itself was tainted or whether the Bush White House read it selectively to support its march to war in 2003.
But what is unfolding in the argument over the Russian hacking is more complex, because tracking the origin of cyberattacks is complicated. It is made all the harder by the fact that the C.I.A. and the N.S.A. do not want to reveal human sources or technical abilities, including American software implants in Russian computer networks.
This much is known: In mid-2015, a hacking group long associated with the F.S.B. '-- the successor to the old Soviet K.G.B. '-- got inside the Democratic National Committee's computer systems. The intelligence gathering appeared to be fairly routine, and it was unsurprising: The Chinese, for instance, penetrated Mr. Obama's and Mr. McCain's presidential campaign communications in 2008.
In the spring of 2016, a second group of Russian hackers, long associated with the G.R.U., a military intelligence agency, attacked the D.N.C. again, along with the private email accounts of prominent Washington figures like John D. Podesta, the chairman of Mrs. Clinton's campaign. Those emails were ultimately published '-- a step the Russians had never taken before in the United States, though the tactic has been used often in former Soviet states and elsewhere in Europe. That moved the issue from espionage to an ''information operation'' with a political motive.
One person who attended a classified briefing on the intelligence said that the investigators had explained that the malware used in the cyberattack on the D.N.C. matched tools previously used by hackers with proven ties to the Russian government. That sort of ''pattern analysis'' is common in cyberinvestigations, though it is not conclusive.
But the intelligence agencies had more: They had managed to identify the individuals from the G.R.U. who oversaw the hacking efforts. That may have come from intercepted conversations, spying efforts, or implants in computer systems that allow the tracking of emails and text messages.
In briefings to Mr. Obama and on Capitol Hill, intelligence agencies have said they now believe that what began as an effort to undermine the credibility of American elections morphed over time into a much more targeted effort to harm Mrs. Clinton, whom Mr. Putin has long accused of interfering in Russian parliamentary elections in 2011.
But to hedge their bets before the election, according to the briefings, the Russians also targeted the Republican National Committee, Republican operatives and prominent members of the Republican establishment, like former Secretary of State Colin L. Powell.
But few of those emails have ever surfaced, save for Mr. Powell's, which were critical of Mrs. Clinton's campaign for trying to draw him into a defense of her use of a private computer server.
A spokesman for the Republican National Committee, Sean Spicer, disputed the report in The Times that the intelligence community had concluded that the R.N.C. had been hacked.
''The RNC was not 'hacked,' '' he said on Twitter. ''The @nytimes was told and chose to ignore.'' On Friday night, before The Times published its report, the committee had refused to comment.
Scott Shane and Eric Lipton contributed reporting.
Get politics and Washington news updates via Facebook, Twitter and in the Morning Briefing newsletter.
A version of this article appears in print on December 11, 2016, on page A1 of the New York edition with the headline: Scoffing at C.I.A., Trump Dismisses Data on Hacking.
Continue reading the main story
Anonymous Leaks to the WashPost About the CIA's Russia Beliefs Are No Substitute for Evidence
Sun, 11 Dec 2016 03:38
The Washington Post late Friday night published an explosive story that, in many ways, is classic American journalism of the worst sort: The key claims are based exclusively on the unverified assertions of anonymous officials, who in turn are disseminating their own claims about what the CIA purportedly believes, all based on evidence that remains completely secret.
These unnamed sources told the Post that ''the CIA has concluded in a secret assessment that Russia intervened in the 2016 election to help Donald Trump win the presidency, rather than just to undermine confidence in the U.S. electoral system.'' The anonymous officials also claim that ''intelligence agencies have identified individuals with connections to the Russian government who provided WikiLeaks with thousands of hacked emails'' from both the DNC and John Podesta's email account. Critically, none of the actual evidence for these claims is disclosed; indeed, the CIA's ''secret assessment'' itself remains concealed.
A second leak from last night, this one given to the New York Times, cites other anonymous officials as asserting that ''the Russians hacked the Republican National Committee's computer systems in addition to their attacks on Democratic organizations, but did not release whatever information they gleaned from the Republican networks.'' But that NYT story says that ''it is also far from clear that Russia's original intent was to support Mr. Trump, and many intelligence officials '-- and former officials in Mrs. Clinton's campaign '-- believe that the primary motive of the Russians was to simply disrupt the campaign and undercut confidence in the integrity of the vote.''
Deep down in its article, the Post notes '-- rather critically '-- that ''there were minor disagreements among intelligence officials about the agency's assessment, in part because some questions remain unanswered.'' Most importantly, the Post adds that ''intelligence agencies do not have specific intelligence showing officials in the Kremlin 'directing' the identified individuals to pass the Democratic emails to WikiLeaks.'' But the purpose of both anonymous leaks is to finger the Russian government for these hacks, acting with the motive to defeat Hillary Clinton.
Needless to say, Democrats '-- still eager to make sense of their election loss and to find causes for it other than themselves '-- immediately declared these anonymous claims about what the CIA believes to be true, and, with a somewhat sweet, religious-type faith, treated these anonymous assertions as proof of what they wanted to believe all along: that Vladimir Putin was rooting for Donald Trump to win and Hillary Clinton to lose and used nefarious means to ensure that outcome. That Democrats are now venerating unverified, anonymous CIA leaks as sacred is par for the course for them this year, but it's also a good indication of how confused and lost U.S. political culture has become in the wake of Trump's victory.
Given the obvious significance of this story '-- it is certain to shape how people understand the 2016 election and probably foreign policy debates for months if not years to come '-- it is critical to keep in mind some basic facts about what is known and, more importantly, what is not known:
(1) Nobody has ever opposed investigations to determine if Russia hacked these emails, nor has anyone ever denied the possibility that Russia did that. The source of contention has been quite simple: No accusations should be accepted until there is actual convincing evidence to substantiate those accusations.There is still no such evidence for any of these claims. What we have instead are assertions, disseminated by anonymous people, completely unaccompanied by any evidence, let alone proof. As a result, none of the purported evidence '-- still '-- can be publicly seen, reviewed, or discussed. Anonymous claims leaked to newspapers about what the CIA believes do not constitute proof, and certainly do not constitute reliable evidence that substitutes for actual evidence that can be reviewed. Have we really not learned this lesson yet?
(2) The reasons no rational person should blindly believe anonymous claims of this sort '-- even if it is pleasing to believe such claims '-- should be obvious by now.To begin with, CIA officials are professional, systematic liars; they lie constantly, by design, and with great skill, and have for many decades, as have intelligence officials in other agencies.
Many of those incidents demonstrate, as hurtful as it is to accept, that these agencies even lie when there's a Democrat overseeing the executive branch. Even in those cases when they are not deliberately lying, they are often gravely mistaken. Intelligence is not a science, and attributing hacks to specific sources is a particularly difficult task, almost impossible to carry out with precision and certainty.
Beyond that, what makes claims from anonymous sources so especially dubious is that their motives cannot be assessed. Who are the people summarizing these claims to the Washington Post? What motives do they have for skewing the assertions one way or the other? Who are the people inside the intelligence community who fully ratify these assertions and who are the ones who dissent? It's impossible to answer any of these questions because everyone is masked by the shield of anonymity, which is why reports of this sort demand high levels of skepticism, not blind belief.
Most important of all, the more serious the claim is '-- and accusing a nuclear-armed power of directly and deliberately interfering in the U.S. election in order to help the winning candidate is about as serious as a claim can get '-- the more important it is to demand evidence before believing it. Wars have started over far less serious claims than this one. People like Lindsey Graham are already beating their chest, demanding that the U.S. do everything in its power to punish Russia and ''Putin personally.''
Nobody should need an explainer about why it's dangerous in the extreme to accept such inflammatory accusations on faith or, worse, based on the anonymous assurances of intelligence officials, in lieu of seeing the actual evidence.
(3) An important part of this story, quite clearly, is inter-agency feuding between, at the very least, the CIA and the FBI.Recall that the top echelon of the CIA was firmly behind Clinton and vehemently against Trump, while at least some powerful factions within the FBI had the opposite position.
Former acting CIA Director Michael Morell not only endorsed Clinton in the New York Times but claimed that ''Mr. Putin had recruited Mr. Trump as an unwitting agent of the Russian Federation.'' George W. Bush's CIA and NSA director, Gen. Michael Hayden, pronounced Trump a ''clear and present danger'' to U.S. national security and then, less than a week before the election, went to the Washington Post to warn that ''Donald Trump really does sound a lot like Vladimir Putin'' and said Trump is ''the useful fool, some naif, manipulated by Moscow, secretly held in contempt, but whose blind support is happily accepted and exploited.''
Meanwhile, key factions in the FBI were furious that Hillary Clinton was not criminally charged for her handling of classified information; pressured FBI Director James Comey into writing a letter that was pretty clearly harmful to Clinton about further investigating the case; and seemed to be improperly communicating with close Trump ally Rudy Giuliani. And while we are now being treated to anonymous leaks about how the CIA believes Putin helped Trump, recall that the FBI, just weeks ago, was shoveling anonymous claims to the New York Times that had the opposite goal:
One can choose to believe whatever anonymous claims from these agencies with a long history of lying and error one wants to believe, based on whatever agenda one has. Or one can wait to review the actual evidence before forming beliefs about what really happened. It should take little effort to realize that the latter option is the only rational path.
(4) Even just within the leaks of the last 24 hours, there are multiple grounds of confusion, contradictions, and uncertainty.The always-observant Marcy Wheeler last night documented many of those; anyone interested in this story should read her analysis as soon as possible. I want to highlight just a few of these vital contradictions and questions.
To start with, the timing of these leaks is so striking. Even as Democrats have spent months issuing one hysterical claim after the next about Russian interference, the White House, and Obama specifically, have been very muted about all of this. Perhaps that's because he did not want to appear partisan or be inflammatory, but perhaps it's because he does not believe there is sufficient proof to accuse the Russian government; after all, if he really believed the Russians did even half of what Democrats claim, wouldn't he (as some Democrats have argued) be duty-bound to take aggressive action in retaliation?
It was announced yesterday afternoon that Obama had ordered a full review of hacking allegations: a perfectly sensible step that makes clear that an investigation is needed, and evidence disclosed, before any definitive conclusions can be reached. It was right on the heels of that announcement that this CIA leak emerged: short-cutting the actual, deliberative investigative process Obama had ordered in order to lead the public to believe that all the answers were already known and, before the investigation even starts, that Russia was guilty of all charges.
More important is what the Post buries in its story: namely, what are the so-called ''minor disagreements among intelligence officials about the agency's assessment''? How ''minor'' are they? And what do these conclusions really mean if, as the Post's sources admit, the CIA is not even able to link the hack to the actual Russian government, but only to people outside the government (from the Post: ''Those actors, according to the official, were 'one step' removed from the Russian government, rather than government employees'')?
This is why it's such a shoddy and unreliable practice to conduct critical debates through conflicting anonymous leaks. Newspapers like the Post have the obvious incentive to hype the flashy, flamboyant claims while downplaying and burying the caveats and conflicting evidence. None of these questions can be asked, let alone answered, because the people who are making these claims are hidden and the evidence is concealed.
(5) Contrary to the declarations of self-vindication by supremely smug Democrats, none of this even relates to, let alone negates, the concerns over their election-year McCarthyite behavior and tactics.Contrary to the blatant straw man many Democrats are railing against, nobody ever said it was McCarthyite to want to investigate claims of Russian hacking. To the contrary, critics of Clinton supporters have been arguing for exactly that: that these accusations should not be believed in the absence of meaningful inquiry and evidence, which has thus far been lacking.
What critics have said is McCarthyite '-- and, as one of those critics, I fully stand by this '-- is the lowly tactic of accusing anyone questioning these accusations, or criticizing the Clinton campaign, of being Kremlin stooges or Putin agents. Back in August, after Democrats decided to smear Jill Stein as a Putin stooge, here's how I defined the McCarthyite atmosphere that Democrats have deliberately cultivated this year:
So that's the Democratic Party's approach to the 2016 election. Those who question, criticize or are perceived to impede Hillary Clinton's smooth, entitled path to the White House are vilified as stooges, sympathizers and/or agents of Russia: Trump, WikiLeaks, Sanders, The Intercept, Jill Stein. Other than loyal Clinton supporters, is there anyone left who is not covertly controlled by or in service to The Ruskies?
Concerns over Democrats' McCarthyism never had anything to do with a desire for an investigation into the source of the DNC and Podesta hacking; everyone favored such investigations. Indeed, accusations that Democrats were behaving in a McCarthyite manner were predicated '-- and still are '-- on their disgusting smearing as Kremlin agents anyone who wanted evidence and proof before believing these inflammatory accusations about Russia.
To see the true face of this neo-McCarthyism, watch this amazing interview from this week with Democratic Rep. Adam Schiff, one of the party's leading Russia hawks (he's quoted in the Post article attacking Obama for not retaliating against Putin). When Schiff is repeatedly asked by the interviewer, Tucker Carlson, for evidence to support his allegation that Putin ordered the hacking of Podesta's emails, Schiff provides none.
What he does instead is accuse Carlson of being a Kremlin stooge and finally tells him he should put his program on RT. That '-- which has become very typical Democratic rhetoric '-- is the vile face of neo-McCarthyism that Democrats have adopted this year, and nothing in this CIA leak remotely vindicates or justifies it:
Needless to say, questions about who hacked the DNC and Podesta email accounts are serious and important ones. The answers have widespread implications on many levels. That's all the more reason these debates should be based on publicly disclosed evidence, not competing, unverifiable anonymous leaks from professional liars inside government agencies, cheered by drooling, lost partisans anxious to embrace whatever claims make them feel good, all conducted without the slightest regard for rational faculties or evidentiary requirements.
Secret CIA assessment says Russia was trying to help Trump win White House - The Washington Post
Sat, 10 Dec 2016 06:30
The CIA has concluded in a secret assessment that Russia intervened in the 2016 election to help Donald Trump win the presidency, rather than just to undermine confidence in the U.S. electoral system, according to officials briefed on the matter.
Intelligence agencies have identified individuals with connections to the Russian government who provided WikiLeaks with thousands of hacked emails from the Democratic National Committee and others, including Hillary Clinton's campaign chairman, according to U.S. officials. Those officials described the individuals as actors known to the intelligence community and part of a wider Russian operation to boost Trump and hurt Clinton's chances.
''It is the assessment of the intelligence community that Russia's goal here was to favor one candidate over the other, to help Trump get elected,'' said a senior U.S. official briefed on an intelligence presentation made to U.S. senators. ''That's the consensus view.''
The Post's Ellen Nakashima goes over the events and discusses the hacker groups responsible. (Jhaan Elker/The Washington Post)
The Obama administration has been debating for months how to respond to the alleged Russian intrusions, with White House officials concerned about escalating tensions with Moscow and being accused of trying to boost Clinton's campaign.
[U.S. government officially accuses Russia of hacking campaign to interfere with elections]
In September, during a secret briefing for congressional leaders, Senate Majority Leader Mitch McConnell (R-Ky.) voiced doubts about the veracity of the intelligence, according to officials present.
The Trump transition team dismissed the findings in a short statement issued Friday evening. ''These are the same people that said Saddam Hussein had weapons of mass destruction. The election ended a long time ago in one of the biggest Electoral College victories in history. It's now time to move on and 'Make America Great Again,''‰'' the statement read.
Trump has consistently dismissed the intelligence community's findings about Russian hacking.
''I don't believe they interfered'' in the election, he told Time magazine this week. The hacking, he said, ''could be Russia. And it could be China. And it could be some guy in his home in New Jersey.''
The CIA shared its latest assessment with key senators in a closed-door briefing on Capitol Hill last week, in which agency officials cited a growing body of intelligence from multiple sources. Agency briefers told the senators it was now ''quite clear'' that electing Trump was Russia's goal, according to the officials, who spoke on the condition of anonymity to discuss intelligence matters.
Sen. Lindsey O. Graham (R-S.C.) says he wants to investigate whether Russia interfered with the 2016 U.S. election, among claims that Donald Trump's rhetoric on Russia and Vladimir Putin is too soft. (Peter Stevenson/The Washington Post)
The CIA presentation to senators about Russia's intentions fell short of a formal U.S. assessment produced by all 17 intelligence agencies. A senior U.S. official said there were minor disagreements among intelligence officials about the agency's assessment, in part because some questions remain unanswered.
For example, intelligence agencies do not have specific intelligence showing officials in the Kremlin ''directing'' the identified individuals to pass the Democratic emails to WikiLeaks, a second senior U.S. official said. Those actors, according to the official, were ''one step'' removed from the Russian government, rather than government employees. Moscow has in the past used middlemen to participate in sensitive intelligence operations so it has plausible deniability.
Julian Assange, the founder of WikiLeaks, has said in a television interview that the ''Russian government is not the source.''
The White House and CIA officials declined to comment.
On Friday, the White House said President Obama had ordered a ''full review'' of Russian hacking during the election campaign, as pressure from Congress has grown for greater public understanding of exactly what Moscow did to influence the electoral process.
''We may have crossed into a new threshold, and it is incumbent upon us to take stock of that, to review, to conduct some after-action, to understand what has happened and to impart some lessons learned,'' Obama's counterterrorism and homeland security adviser, Lisa Monaco, told reporters at a breakfast hosted by the Christian Science Monitor.
Obama wants the report before he leaves office Jan. 20, Monaco said. The review will be led by James Clapper, the outgoing director of national intelligence, officials said.
During her remarks, Monaco didn't address the latest CIA assessment, which hasn't been previously disclosed.
Seven Democratic senators last week asked Obama to declassify details about the intrusions and why officials believe that the Kremlin was behind the operation. Officials said Friday that the senators specifically were asking the White House to release portions of the CIA's presentation.
This week, top Democratic lawmakers in the House also sent a letter to Obama, asking for briefings on Russian interference in the election.
U.S. intelligence agencies have been cautious for months in characterizing Russia's motivations, reflecting the United States' long-standing struggle to collect reliable intelligence on President Vladi­mir Putin and those closest to him.
In previous assessments, the CIA and other intelligence agencies told the White House and congressional leaders that they believed Moscow's aim was to undermine confidence in the U.S. electoral system. The assessments stopped short of saying the goal was to help elect Trump.
On Oct. 7, the intelligence community officially accused Moscow of seeking to interfere in the election through the hacking of ''political organizations.'' Though the statement never specified which party, it was clear that officials were referring to cyber-intrusions into the computers of the DNC and other Democratic groups and individuals.
Some key Republican lawmakers have continued to question the quality of evidence supporting Russian involvement.
''I'll be the first one to come out and point at Russia if there's clear evidence, but there is no clear evidence '-- even now,'' said Rep. Devin Nunes (R-Calif.), the chairman of the House Intelligence Committee and a member of the Trump transition team. ''There's a lot of innuendo, lots of circumstantial evidence, that's it.''
[U.S. investigating potential covert Russian plan to disrupt elections]
Though Russia has long conducted cyberspying on U.S. agencies, companies and organizations, this presidential campaign marks the first time Moscow has attempted through cyber-means to interfere in, if not actively influence, the outcome of an election, the officials said.
The reluctance of the Obama White House to respond to the alleged Russian intrusions before Election Day upset Democrats on the Hill as well as members of the Clinton campaign.
Within the administration, top officials from different agencies sparred over whether and how to respond. White House officials were concerned that covert retaliatory measures might risk an escalation in which Russia, with sophisticated cyber-capabilities, might have less to lose than the United States, with its vast and vulnerable digital infrastructure.
The White House's reluctance to take that risk left Washington weighing more-limited measures, including the ''naming and shaming'' approach of publicly blaming Moscow.
By mid-September, White House officials had decided it was time to take that step, but they worried that doing so unilaterally and without bipartisan congressional backing just weeks before the election would make Obama vulnerable to charges that he was using intelligence for political purposes.
Instead, officials devised a plan to seek bipartisan support from top lawmakers and set up a secret meeting with the Gang of 12 '-- a group that includes House and Senate leaders, as well as the chairmen and ranking members of both chambers' committees on intelligence and homeland security.
Obama dispatched Monaco, FBI Director James B. Comey and Homeland Security Secretary Jeh Johnson to make the pitch for a ''show of solidarity and bipartisan unity'' against Russian interference in the election, according to a senior administration official.
Specifically, the White House wanted congressional leaders to sign off on a bipartisan statement urging state and local officials to take federal help in protecting their voting-registration and balloting machines from Russian cyber-intrusions.
Though U.S. intelligence agencies were skeptical that hackers would be able to manipulate the election results in a systematic way, the White House feared that Russia would attempt to do so, sowing doubt about the fundamental mechanisms of democracy and potentially forcing a more dangerous confrontation between Washington and Moscow.
[Putin denies that Russia hacked the DNC but says it was for the public good]
In a secure room in the Capitol used for briefings involving classified information, administration officials broadly laid out the evidence U.S. spy agencies had collected, showing Russia's role in cyber-intrusions in at least two states and in hacking the emails of the Democratic organizations and individuals.
And they made a case for a united, bipartisan front in response to what one official described as ''the threat posed by unprecedented meddling by a foreign power in our election process.''
The Democratic leaders in the room unanimously agreed on the need to take the threat seriously. Republicans, however, were divided, with at least two GOP lawmakers reluctant to accede to the White House requests.
According to several officials, McConnell raised doubts about the underlying intelligence and made clear to the administration that he would consider any effort by the White House to challenge the Russians publicly an act of partisan politics.
Some of the Republicans in the briefing also seemed opposed to the idea of going public with such explosive allegations in the final stages of an election, a move that they argued would only rattle public confidence and play into Moscow's hands.
McConnell's office did not respond to a request for comment. After the election, Trump chose McConnell's wife, Elaine Chao, as his nominee for transportation secretary.
Some Clinton supporters saw the White House's reluctance to act without bipartisan support as further evidence of an excessive caution in facing adversaries.
''The lack of an administration response on the Russian hacking cannot be attributed to Congress,'' said Rep. Adam B. Schiff (Calif.), the ranking Democrat on the House Intelligence Committee, who was at the September meeting. ''The administration has all the tools it needs to respond. They have the ability to impose sanctions. They have the ability to take clandestine means. The administration has decided not to utilize them in a way that would deter the Russians, and I think that's a problem.''
Philip Rucker contributed to this report.
Read more:
Putin wants revenge and respect, and hacking the U.S. is his way of getting it
Trump and Putin are using the same tactic to deflect questions about the DNC hack
Russia's anti-American fever goes beyond the Soviet era's
Russia Hacked Republican Committee but Kept Data, U.S. Concludes - NYTimes.com
Sat, 10 Dec 2016 07:32
WASHINGTON '-- American intelligence agencies have concluded with ''high confidence'' that Russia acted covertly in the latter stages of the presidential campaign to harm Hillary Clinton's chances and promote Donald J. Trump, according to senior administration officials.
They based that conclusion, in part, on another finding '-- which they say was also reached with high confidence '-- that the Russians hacked the Republican National Committee's computer systems in addition to their attacks on Democratic organizations, but did not release whatever information they gleaned from the Republican networks.
In the months before the election, it was largely documents from Democratic Party systems that were leaked to the public. Intelligence agencies have concluded that the Russians gave the Democrats' documents to WikiLeaks.
Republicans have a different explanation for why no documents from their networks were ever released. Over the past several months, officials from the Republican committee have consistently said that their networks were not compromised, asserting that only the accounts of individual Republicans were attacked. On Friday, a senior committee official said he had no comment.
Mr. Trump's transition office issued a statement Friday evening reflecting the deep divisions that emerged between his campaign and the intelligence agencies over Russian meddling in the election. ''These are the same people that said Saddam Hussein had weapons of mass destruction,'' the statement said. ''The election ended a long time ago in one of the biggest Electoral College victories in history. It's now time to move on and 'Make America Great Again.'''
One senior government official, who had been briefed on an F.B.I. investigation into the matter, said that while there were attempts to penetrate the Republican committee's systems, they were not successful.
But the intelligence agencies' conclusions that the hacking efforts were successful, which have been presented to President Obama and other senior officials, add a complex wrinkle to the question of what the Kremlin's evolving objectives were in intervening in the American presidential election.
''We now have high confidence that they hacked the D.N.C. and the R.N.C., and conspicuously released no documents'' from the Republican organization, one senior administration official said, referring to the Russians.
It is unclear how many files were stolen from the Republican committee; in some cases, investigators never get a clear picture. It is also far from clear that Russia's original intent was to support Mr. Trump, and many intelligence officials '-- and former officials in Mrs. Clinton's campaign '-- believe that the primary motive of the Russians was to simply disrupt the campaign and undercut confidence in the integrity of the vote.
The Russians were as surprised as everyone else at Mr. Trump's victory, intelligence officials said. Had Mrs. Clinton won, they believe, emails stolen from the Democratic committee and from senior members of her campaign could have been used to undercut her legitimacy. The intelligence agencies' conclusion that Russia tried to help Mr. Trump was first reported by The Washington Post.
In briefings to the White House and Congress, intelligence officials, including those from the C.I.A. and the National Security Agency, have identified individual Russian officials they believe were responsible. But none have been publicly penalized.
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It is possible that in hacking into the Republican committee, Russian agents were simply hedging their bets. The attack took place in the spring, the senior officials said, about the same time that a group of hackers believed to be linked to the G.R.U., Russia's military intelligence agency, stole the emails of senior officials of the Democratic National Committee. Intelligence agencies believe that the Republican committee hack was carried out by the same Russians who penetrated the Democratic committee and other Democratic groups.
The finding about the Republican committee is expected to be included in a detailed report of ''lessons learned'' that Mr. Obama has ordered intelligence agencies to assemble before he leaves office on Jan. 20. That report is intended, in part, to create a comprehensive history of the Russian effort to influence the election, and to solidify the intelligence findings before Mr. Trump is sworn in.
Mr. Trump has repeatedly cast doubt about any intelligence suggesting a Russian effort to influence the election. ''I don't believe they interfered,'' he told Time magazine in an interview published this week. He suggested that hackers could come from China, or that ''it could be some guy in his home in New Jersey.''
Intelligence officials and private cybersecurity companies believe that the Democratic National Committee was hacked by two different Russian cyberunits. One, called ''Cozy Bear'' or ''A.P.T. 29'' by some Western security experts, is believed to have spent months inside the D.N.C. computer network, as well as other government and political institutions, but never made public any of the documents it took. (A.P.T. stands for ''Advanced Persistent Threat,'' which usually describes a sophisticated state-sponsored cyberintruder.)
The other, the G.R.U.-controlled unit known as ''Fancy Bear,'' or ''A.P.T. 28,'' is believed to have created two outlets on the internet, Guccifer 2.0 and DCLeaks, to make Democratic documents public. Many of the documents were also provided to WikiLeaks, which released them over many weeks before the Nov. 8 election.
Representative Michael McCaul, the Texas Republican who is the chairman of the House Homeland Security Committee, said on CNN in September that the R.N.C. had been hacked by Russia, but then quickly withdrew the claim.
Mr. McCaul, who was considered by Mr. Trump for secretary of Homeland Security, initially told CNN's Wolf Blitzer, ''It's important to note, Wolf, that they have not only hacked into the D.N.C. but also into the R.N.C.'' He added that ''the Russians have basically hacked into both parties at the national level, and that gives us all concern about what their motivations are.''
Minutes later, the R.N.C. issued a statement denying that it had been hacked. Mr. McCaul subsequently said that he had misspoken, but that it was true that ''Republican political operatives'' had been the target of Russian hacking. So were establishment Republicans with no ties to the campaign, including former Secretary of State Colin L. Powell.
Mr. McCaul may have had in mind a collection of more than 200 emails of Republican officials and activists that appeared this year on the website DCLeaks.com. That website got far more attention for the many Democratic Party documents it posted.
The messages stolen from Republicans have drawn little attention because most are routine business emails from local Republican Party officials in several states, congressional staff members and party activists.
Among those whose emails were posted was Peter W. Smith, who runs a venture capital firm in Chicago and has long been active in ''opposition research'' for the Republican Party. He said he was unaware that his emails had been hacked until he was called by a reporter on Thursday.
He said he believes that his material came from a hack of the Illinois Republican Party.
''I'm not upset at all,'' he said. ''I try in my communications, quite frankly, not to say anything that would be embarrassing if made public.''
Unpacking the New CIA Leak: Don't Ignore the Aluminum Tube Footnote - emptywheel
Sat, 10 Dec 2016 07:28
This post will unpack the leak from the CIA published in the WaPo tonight.
Before I start with the substance of the story, consider this background. First, if Trump comes into office on the current trajectory, the US will let Russia help Bashar al-Assad stay in power, thwarting a 4-year effort on the part of the Saudis to remove him from power. It will also restructure the hierarchy of horrible human rights abusing allies the US has, with the Saudis losing out to other human rights abusers, potentially up to and including that other petrostate, Russia. It will also install a ton of people with ties to the US oil industry in the cabinet, meaning the US will effectively subsidize oil production in this country, which will have the perhaps inadvertent result of ensuring the US remains oil-independent even though the market can't justify fracking right now.
The CIA is institutionally quite close with the Saudis right now, and has been in charge of their covert war against Assad.
This story came 24 days after the White House released an anonymous statement asserting, among other things, ''the Federal government did not observe any increased level of malicious cyber activity aimed at disrupting our electoral process on election day,'' suggesting that the Russians may have been deterred.
This story was leaked within hours of the time the White House announced it was calling for an all-intelligence community review of the Russia intelligence, offered without much detail. Indeed, this story was leaked and published as an update to that story.
Which is to say, the CIA and/or people in Congress (this story seems primarily to come from Democratic Senators) leaked this, apparently in response to President Obama's not terribly urgent call to have all intelligence agencies weigh in on the subject of Russian influence, after weeks of Democrats pressuring him to release more information. It was designed to both make the White House-ordered review more urgent and influence the outcome.
So here's what that story says.
In September, the spooks briefed ''congressional leaders'' (which for a variety of reasons I wildarseguess is either a Gang of Four briefing including Paul Ryan, Nancy Pelosi, Mitch McConnell, and Harry Reid or a briefing to SSCI plus McConnell, Reid, Jack Reed, and John McCain). Apparently, the substance of the briefing was that Russia's intent in hacking Democratic entities was not to increase distrust of institutions, but instead to elect Trump.
The CIA has concluded in a secret assessment that Russia intervened in the 2016 election to help Donald Trump win the presidency, rather than just to undermine confidence in the U.S. electoral system, according to officials briefed on the matter.
The difference between this story and other public assessments is that it seems to identify the people '-- who sound like people with ties to the Russian government but not necessarily part of it '-- who funneled documents from Russia's GRU to Wikileaks.
Intelligence agencies have identified individuals with connections to the Russian government who provided WikiLeaks with thousands of hacked emails from the Democratic National Committee and others, including Hillary Clinton's campaign chairman, according to U.S. officials. Those officials described the individuals as actors known to the intelligence community and part of a wider Russian operation to boost Trump and hurt Clinton's chances.
[snip]
[I]ntelligence agencies do not have specific intelligence showing officials in the Kremlin ''directing'' the identified individuals to pass the Democratic emails to WikiLeaks, a second senior U.S. official said. Those actors, according to the official, were ''one step'' removed from the Russian government, rather than government employees.
This is the part that has always been missing in the past: how the documents got from GRU, which hacked the DNC and John Podesta, to Wikileaks, which released them. It appears that CIA now thinks they know the answer: some people one step removed from the Russian government, funneling the documents from GRU hackers (presumably) to Wikileaks to be leaked, with the intent of electing Trump.
Not everyone buys this story. Mitch McConnell doesn't buy the intelligence.
In September, during a secret briefing for congressional leaders, Senate Republican Leader Mitch McConnell (Ky.) voiced doubts about the veracity of the intelligence, according to officials present.
That's one doubt raised about CIA's claim '-- though like you all, I assume Mitch McConnell shouldn't be trusted on this front.
But McConnell wasn't the only one. One source for this story '-- which sounds like someone like Harry Reid or Dianne Feinstein '-- claimed that this CIA judgment is the ''consensus'' view of all the intelligence agencies, a term of art.
''It is the assessment of the intelligence community that Russia's goal here was to favor one candidate over the other, to help Trump get elected,'' said a senior U.S. official briefed on an intelligence presentation made to U.S. senators. ''That's the consensus view.''
Except that in a briefing this week (which may have been what impressed John McCain and Lindsey Graham to do their own investigation), that's not what this represented.
The CIA shared its latest assessment with key senators in a closed-door briefing on Capitol Hill last week, in which agency officials cited a growing body of intelligence from multiple sources. Agency briefers told the senators it was now ''quite clear'' that electing Trump was Russia's goal, according to the officials, who spoke on the condition of anonymity to discuss intelligence matters.
The CIA presentation to senators about Russia's intentions fell short of a formal U.S. assessment produced by all 17 intelligence agencies. A senior U.S. official said there were minor disagreements among intelligence officials about the agency's assessment, in part because some questions remain unanswered. [my emphasis]
That's a conflict. Some senior US official (often code for senior member of Congress) says this is the consensus view. Another senior US official (or maybe the very same one) says there are ''minor disagreements.''
Remember: we went to war against Iraq, which turned out to have no WMD, in part because no one read the ''minor disagreements'' from a few agencies about some aluminum tubes. A number of Senators who didn't read that footnote closely (and at least one that did) are involved in this story. What we're being told is there are some aluminum tube type disagreements.
Let's hear about those disagreements this time, shall we?
Here's the big takeaway. The language ''a formal US assessment produced by all 17 intelligence agencies'' is, like ''a consensus view,'' a term of art. It's an opportunity for agencies which may have differing theories of what happened here to submit their footnotes.
That may be what Obama called for today: the formal assessment from all agencies (though admittedly, the White House purposely left the scope and intent of it vague).
Whatever that review is intended to be, what happened as soon as Obama announced it is that the CIA and/or Democratic Senators started leaking their conclusion. That's what this story is.
Update: One other really critical detail. When the White House announced the Obama review today, Wikileaks made what was a bizarre statement. Linking to a CNN story on the Obama ordered review that erred on the side of blaming Russia for everything, it said, ''CNN: Obama orders report into WikiLeaks timed for release just prior to Trump presidency.'' Even though none of the statements on the review focused on what this story does '-- that is, on the way that the DNC and Podesta emails got to Wikileaks '-- Wikileaks nevertheless interpreted it as an inquiry targeted at it.
Update: And now David Sanger (whose story on the Obama-ordered review was particularly bad) and Scott Shane reveal the RNC also got hacked, and it is the differential leaking that leads the spooks to believe the Russians wanted Trump to win.
They based that conclusion, in part, on another finding '-- which they say was also reached with high confidence '-- that the Russians hacked the Republican National Committee's computer systems in addition to their attacks on Democratic organizations, but did not release whatever information they gleaned from the Republican networks.
In the months before the election, it was largely documents from Democratic Party systems that were leaked to the public.
This may be a fair assessment. But you would have to account for two things before making it. First, you'd need to know the timing and hacker behind the RNC hack. That's because two entities are believed to have hacked the DNC: an FSB appearing hacking group, and a GRU one. The FSB is not believed to have leaked. GRU is believed to have. So if the FSB hacked the RNC but didn't leak it, it would be completely consistent with what FSB did with DNC.
NYT now says the RNC hack was by GRU in the spring, so it is a fair question why the DNC things got leaked but RNC did not.
Also, Sanger and Shane say ''largely documents'' from Dems were leaked. That's false. There were two streams of non-Wikileaks releases, Guccifer, which did leak all-Dem stuff, and DC Leaks, which leaked stuff that might be better qualified as Ukrainian related. The most publicized of documents from the latter were from Colin Powell, which didn't help Trump at all.
Marcy has been blogging full time since 2007. She's known for her live-blogging of the Scooter Libby trial, her discovery of the number of times Khalid Sheikh Mohammed was waterboarded, and generally for her weedy analysis of document dumps.Marcy Wheeler is an independent journalist writing about national security and civil liberties. She writes as emptywheel at her eponymous blog, publishes at outlets including the Guardian, Salon, and the Progressive, and appears frequently on television and radio. She is the author of Anatomy of Deceit, a primer on the CIA leak investigation, and liveblogged the Scooter Libby trial.
Marcy has a PhD from the University of Michigan, where she researched the ''feuilleton,'' a short conversational newspaper form that has proven important in times of heightened censorship. Before and after her time in academics, Marcy provided documentation consulting for corporations in the auto, tech, and energy industries. She lives with her spouse and dog in Grand Rapids, MI.
How Russian Hackers Can Blackmail Donald Trump'--and the GOP - The Daily Beast
Sun, 11 Dec 2016 13:41
If it is true that the Russians hacked the Republican National Committee as well as the DNC, then their power over POTUS potentially knows few bounds.
Former and current U.S. national security officials and experts say that if it is true that the Russian government possesses documents belonging to the Republican National Committee, Donald Trump's incoming administration may be the most compromised in U.S. history.
A senior U.S. administration official confirmed to The Daily Beast that the CIA believes the Russians hacked the RNC. He spoke anonymously because he was not authorized to discuss the matter publicly.
Last night, The New York Times reported that hackers connected to two separate Russian security services allegedly broke into the computer systems of the RNC, but chose not to disclose the digital contents of those systems, in marked contrast to the gradual release, via WikiLeaks, of emails belonging to the Democratic National Committee throughout the spring and summer.
As a result, the report said U.S. intelligence agencies concluded with ''high confidence'' that the Kremlin's motive in these cyberattacks was to get Trump elected, not just do harm to his rival Hillary Clinton or undermine American democracy, as the agencies had previously concluded with only ''confidence,'' when they announced concerns over Russian interference in October. One senior U.S. official told the Washington Post for its own story on the matter, ''It is the assessment of the intelligence community that Russia's goal here was to favor one candidate over the other, to help Trump get elected.''
''There's a real revolt going on,'' said a former intelligence officer of the CIA leaks, citing discussions with former colleagues. ''They don't like [National Security Adviser nominee Michael] Flynn and they hate Trump's guts. This is their whole life's work being thrown out the door. They feel like the whole intelligence committee is on probation.'' The ex-spy spoke anonymously because he was not authorized to discuss the agency's internal anguish publicly.
The DNC hacks, it is widely believed, were perpetrated by two independent organs of Russian intelligence. First, COZY BEAR, a hacker working for the FSB, the domestic intelligence arm, broke into the Committee's servers in mid-2015. Around the same time FANCY BEAR, a hacker affiliated with the GRU, Russia's military intelligence agency, also penetrated the servers. To drum up plausible deniability, the haul from these hacks was then sent to WikiLeaks and uploaded by two suspected cut-outs of Moscow, ''Guccifer 2.0'' and a newish website called DCLeaks.com.
The White House and Congress were informed by the Central Intelligence Agency and National Security Agency that the Russian officials responsible for both the RNC and DNC breaches were identified, according to the Times, although their names have not been publicized.
''[CIA director] John Brennan does believe the Russians are behind it,'' said ret. Col. Tony Shaffer, who briefed Trump National Security Advisor Michael Flynn this past week at Trump Tower. ''He did brief the senate on his belief that the Russians were involved, but he did not provide any specific evidence. My understanding is the data provided was only of opinion in nature, not details of specific attacks. The American people are owed an answer, but my understanding is they are never going to get an answer because there's no basic data to back up the allegation,'' said Shaffer, who is a member of the New York-based London Center for Policy Research where Flynn is a fellow.
House Homeland Security Committee Chairman Mike McCaul told Politico during the election he'd informed Trump that Russia was attempting to influence the elections.
''Now he hasn't had the briefing I had, but I made it clear that in my judgment it was a nation-state,'' McCaul said in October. His office declined to comment on the matter Saturday.
The CIA also declined to comment Saturday.
''The Russians hacked our democratic institutions and sought to interfere in our elections and sow discord,'' said House intelligence committee Ranking Member Adam Schiff (D-CA) Saturday, citing the Director of National Intelligence James Clapper's public statement. "Sadly, in this effort the Russians were spectacularly successful. One would also have to be willfully blind not to see that these Russian actions were uniformly damaging to Secretary Clinton and helpful to Donald Trump. I do not believe this was coincidental or unintended.''
Schiff would not confirm that the CIA specifically believes Russia was behind the hacking related to the election. The DNI is charged with marshaling the total view of the 16 intelligence agencies his department oversees.
An official close to Clapper pointed out that he has brought uncomfortable, unwelcome news to the Obama White House before, including the assessment that ISIS was rising'-- though not delivered as forcefully as then DIA-director Flynn thought it should have been. Clapper also told the White House more recently that the Syrian regime was using chemical weapons on the battlefield, despite a much-heralded deal negotiated by Russia where Syria supposedly gave up all of its chemical weapons stockpile in return for avoided bombing by the U.S. The official spoke anonymously because he was not allowed to discuss the sensitive communications between Clapper and the Obama White House publicly.
Meanwhile, Trump's transition team is having none of these revelations. Having serially denied or downplayed Russia's involvement in steering the U.S. election, the team issued an unsigned statement casting doubt on the competence of the very intelligence establishment the president-elect will inherit to help him run the country in a month and a half. ''These are the same people that said Saddam Hussein had weapons of mass destruction,'' the statement read. ''The election ended a long time ago in one of the biggest Electoral College victories in history. It's now time to move on and 'Make America Great Again.'''
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''We need a new election,'' said Bob Baer, a former CIA operative who himself used to interfere in the affairs of foreign governments. ''This is a constitutional crisis. It's unprecedented. If the CIA had hacked and steered a democratic election in a foreign country, say France or Germany, that country would demand a new election. No question,'' he said in an interview.
Baer said that he agrees with Trump in the sense that, once Trump is in charge, the Agency may bend to his wishes'--which makes the airing of the evidence the agency has imperative before December 19th when the Electoral College is set to certify Trump's presidency. ''We cant wait until after he becomes president and has a political appointee decide whether the evidence we have on the Russians is legit or not.''
In essence, Moscow's security organs could now be in possession of what the KGB used to call kompromat '-- compromising personal material '-- on Trump and his staff, which could then be used to blackmail them into doing Russia's bidding.
The mere possibility that Putin now knows the secrets of the RNC and the inner workings of the victorious party of the 2016 election is bound to color U.S.-Russian relations for the next four years, regardless or whether or not those secrets are in any way scandalous. Any perceived tilt by Washington toward Russia, or any accommodation struck with the Kremlin on the ongoing wars in Syria or Ukraine can now be interpreted as quid pro quo for Putin's keeping silent on what's he got on the sitting commander-in-chief or the latter's inner circle.
Tom Nichols, a professor of national security affairs at the U.S. Naval War College, told The Daily Beast, representing his personal views and not those of the War College:''The worst possibility is that the Russians are holding back what they've stolen from the RNC because it's valuable enough to keep in reserve until the president-elect is sworn in. This is a frankly terrifying possibility.''
Nichols has been an outspoken ''Never Trump'' Republican and written numerous articles explaining why he thinks the president-elect is unfit for office. The Trump transition team's response to the Times bombshell only solidified that view. ''Their answer is to 'move on,' which might be a sensible thing to say to political opponents who didn't like the outcome of the election, but it is a unimaginable answer in the face of an open Russian attack on the U.S. political system. The Russians have made it clear they have no intention of 'moving on,' and no amount of hand-waving will change that.''
Trump had campaigned beyond a platform of being in favor of improving relations with Russia, and has often taken to praising Putin personally, comparing his leadership style favorably to that of Barack Obama and casting doubt on the Russian government's well-documented human-rights abuses, including allegations of the Kremlin having ordered the murder of dissidents and muckraking journalists. Trump also denied that Russia had any role in the downing of the MH17 in July 2014 in the skies above east Ukraine, despite independent international investigations saying that a Russian-imported missile was used to shoot down the commercial airliner. He has also said that Crimeans wanted to be annexed by Russia while denying that Russia had invaded Ukraine.
And then there's the fact that Trump's rumored favorite for Secretary of State, Exxon Mobil CEO Rex Tillerson, once received Russia's Order of Friendship award from Putin himself.
A former CIA operative stationed in Moscow during the height of the Cold War said that it was too soon to tell how Langley came to the conclusion that Trump was Putin's favored candidate. ''They're ascribing motives to the Russians, but I'd like to see the evidence. In committee meetings and review sessions that go over this kind of thing, it's a circumstantial point to say 'they did it because of x or y.' In the absence of an intercept or of extremely reliable sources '-- more than one '-- you're making an inference that one could quibble with.''
As to what kompromat might do to Trump's decision-making, the former operative says it may not carry much weight at all.
''You're making an assumption that Trump will respond to kompromat and not to something else, such as his business interests in Russia. He clearly has a blind spot on the country. You can be manipulated by the Chekists in many ways,'' the source said, using the catch-all term for Russia spies, ''not just through blackmail. We also don't know what is in the RNC emails.''
Or, for that matter, who will ultimately be affected by them.
The DNC hacks led to the resignation of then-chairperson Debbie Wasserman-Schultz but it is entirely unclear if they really were the decisive factor that swayed the election in Trump's favor. Other analysts have pointed to Clinton's exceedingly poor outreach to white working-class voters in battleground states such as Ohio, Michigan and Pennsylvania, all of which Trump won by narrow margins. Others have also argued that FBI Director James Comey's eleventh-hour letter notifying Congress that the investigation into Hillary Clinton's email server was still active did more to damage the Democratic nominee's chances just before voters went to the polls, than did anything contained in the DNC emails, or in campaign chairman John Podesta's personal correspondence.
Andrei Soldatov, co-author of Red Web, a book about Russia's cybersecurity and use of the Internet to silence dissent, thinks that the likelier target of Moscow is not Trump but rather his now powerful party. ''I doubt there can be any kompromat on Trump which can hurt him,'' Soldatov said. ''But the Republican Party is a different story.''
For Soldatov, the threatened publication of documents confirming rumors or alleged ties between Trump's cabinet picks and the Russian government could be a useful tool to keep the administration in check. ''Remember the story about a former Defense Intelligence Agency chief giving interviews to [Russian state propaganda channel] RT and being paid for that?'' Soldatov said, referring to Flynn, who is now Trump's national security advisor. ''It would be bad enough simply to produce documentary evidence confirming things we already knew.''
A former Russian spymaster agrees with that assessment.
Oleg Kalugin was a KGB general in charge of operations in the United States; he also ran the First Chief Directorate's K Branch, or arm of counterintelligence, which got up to the very sort of dirty tricks, or ''active measures,'' that state hacking of a political party amounts to. ''In the old days, in my time, we relied on human efforts: penetration, handling, manipulating people from the inside,'' Kalugin told The Daily Beast, noting that he wasn't personally convinced the DNC and RNC hacks were done by the Russian government and not by ''individual actors.''
Nevertheless, Kalugin allowed that if the FSB and GRU were responsible and Putin was now sitting on crucial information about various GOP officials, it would be reckless and dangerous to try and blackmail the White House directly. High-level officials, such as cabinet secretaries, have rarely been cultivated as spies or informants of Moscow, owing to what Kalugin characterizes as ''potential repercussions.''
Middle and lower-cadre officials in the State Department or military-industrial complex are deemed easier and better marks for the spooks.
In this hypothetical, a heretofore semi-anonymous RNC staffer who may have written something professionally or personally damaging to himself is likelier to find himself approached by a Russian operative and offered a chance to switch sides than a member of the National Security Council.
''Just one man can destroy everything,'' Kalugin said. ''He doesn't have to be the president.''
Fake News
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Study: Half of people "remember" events that never happened - CBS News
Sat, 10 Dec 2016 15:45
''Memories'' of events can be influenced by other people's suggestions.
KC Slagle, Getty Images/iStockphoto
Ever find yourself caught up in a vivid memory of an event that, you later realize with confusion, didn't really happen the way you thought? According to new research by psychologists at the University of Warwick in the U.K., you are far from alone.
The study demonstrated that about half of individuals will come to believe a fictional event occurred if they are told about that event and then repeatedly imagine it happening.
More than 400 people participated in the study, led by professor Kimberley Wade.
The study experimented with implanting fake (but relatively harmless) memories, such as taking a childhood hot-air balloon ride, pulling a prank on a teacher, or causing trouble at a family wedding, into the minds of study participants. Researchers told them about the imaginary events as if they were real, and about 30 percent of participants appeared to ''remember'' it happening, even elaborating on how it occurred and describing details of what it was like. Another 23 percent showed signs of accepting the story to some degree, the researchers said.
Showing participants photos of the purported hot-air balloon ride actually diminished the chances that they would accept the account and develop false memory. The researchers theorize this could be because ''such photos may serve to constrain imagination during efforts to recall the event, thus leading to lower memory formation.''
In order to fit the definition of a false memory, they looked for instances where participants went beyond the ''facts'' initially told to them. ''As participants move from saying 'I do not remember that' to 'Now I remember'‰'...'‰,' they must report additional imagery or otherwise elaborate beyond the suggested material,'' the authors wrote in the study, published in the journal Memory. ''Thus, approximately one-third of participants showed evidence of a false memory, and more than half showed evidence of believing that the event occurred in the past.''
The study highlights the slippery nature of human memory, and is just the latest in a growing body of research looking into how memories form and how they can be manipulated.
''The finding that a large portion of people are prone to developing false beliefs is important. We know from other research that distorted beliefs can influence people's behaviors, intentions and attitudes,'' Wade said in a press statement.
The results also raise questions about the integrity of processes that rely heavily on human memory, from courtroom testimony to therapy treatments.
''It can be difficult to objectively determine when someone is recollecting the past, versus reporting other forms of knowledge or belief or describing mental representations that have originated in other sources of experience,'' the authors conclude. ''Even under highly controlled laboratory conditions, memory researchers struggle to define and observe memory. How, then, can we expect therapists, forensic investigators, medical personnel, human resource staff, or jurists to be any better at this task?''
(C) 2016 CBS Interactive Inc. All Rights Reserved.
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Washington Post Appends "Russian Propaganda Fake News" Story, Admits It May Be Fake | Zero Hedge
Fri, 09 Dec 2016 14:00
In the latest example why the "mainstream media" is facing a historic crisis of confidence among its readership, facing unprecedented blowback following Craig Timberg November 24 Washington Post story "Russian propaganda effort helped spread 'fake news' during election, experts say", on Wednesday a lengthy editor's note appeared on top of the original article in which the editor not only distances the WaPo from the "experts" quoted in the original article whose "work" served as the basis for the entire article (and which became the most read WaPo story the day it was published) but also admits the Post could not "vouch for the validity of PropOrNot's finding regarding any individual media outlet", in effect admitting the entire story may have been, drumroll "fake news" and conceding the Bezos-owned publication may have engaged in defamation by smearing numerous websites - Zero Hedge included - with patently false and unsubstantiated allegations.
It was the closest the Washington Post would come to formally retracting the story, which has now been thoroughly discredited not only by outside commentators, but by its own editor.
The apended note in question:
Editor's Note: The Washington Post on Nov. 24 published a story on the work of four sets of researchers who have examined what they say are Russian propaganda efforts to undermine American democracy and interests. One of them was PropOrNot, a group that insists on public anonymity, which issued a report identifying more than 200 websites that, in its view, wittingly or unwittingly published or echoed Russian propaganda. A number of those sites have objected to being included on PropOrNot's list, and some of the sites, as well as others not on the list, have publicly challenged the group's methodology and conclusions. The Post, which did not name any of the sites, does not itself vouch for the validity of PropOrNot's findings regarding any individual media outlet, nor did the article purport to do so. Since publication of The Post's story, PropOrNot has removed some sites from its list.
As The Washingtonian notes, the implicit concession follows intense and rising criticism of the article over the past two weeks. It was ''rife with obviously reckless and unproven allegations,'' Intercept reporters Glenn Greenwald and Ben Norton wrote, noting that PropOrNot, one of the groups whose research was cited in Timberg's piece, ''anonymous cowards.'' One of the sites PropOrNot cited as Russian-influenced was the Drudge Report.
The piece's description of some sharers of bogus news as ''useful idiots'' could ''theoretically include anyone on any social-media platform who shares news based on a click-bait headline,'' Mathew Ingram wrote for Fortune.
But the biggest issue was PropOrNot itself. As Adrian Chen wrote for the New Yorker, its methods were themselves suspect, hinting at counter-Russian propaganda - ostensibly with Ukrainian origins - and verification of its work was nearly impossible. Chen wrote ''the prospect of legitimate dissenting voices being labelled fake news or Russian propaganda by mysterious groups of ex-government employees, with the help of a national newspaper, is even scarier.''
Criticism culminated this week when the "Naked capitalism" blog threatened to sue the Washington Post, demanding a retraction.
Now, at least, the "national newspaper" has taken some responsibility, however the key question remains: by admitting it never vetted its primary source, whose biased and conflicted "work" smeared hundreds of websites, this one included, just how is the Washington Post any different from the "fake news" it has been deriding on a daily basis ever since its endorsed presidential candidate lost the elections?
FAKE NEWS-In Rolling Stone Defamation Case, Magazine and Reporter Ordered to Pay $3 Million - NYTimes.com
Thu, 08 Dec 2016 22:10
CHARLOTTESVILLE, Va. '-- A federal jury on Monday ordered Rolling Stone and one of its writers to pay $3 million in damages to a University of Virginia administrator over a discredited article two years ago about a supposed gang rape at the university.
The jury in Charlottesville, Va., had already decided on Friday, after a two-week trial, that Rolling Stone; Wenner Media, its parent company; and Sabrina Rubin Erdely, the author of the article, were all liable for defamation in a case that centered on faulty reporting and a failure to apply basic fail-safes in editing.
After deliberating for less than two hours on Monday, the jury of eight women and two men decided that Ms. Erdely was liable for $2 million of the total, and Rolling Stone and Wenner Media for $1 million. In her suit, filed in May 2015, the administrator, Nicole P. Eramo, had asked for $7.5 million in damages.
The jury found that assertions made in the story, as well as public statements made after publication by Ms. Erdely and Rolling Stone, were made with ''actual malice,'' the legal standard for libel against public figures. To meet that standard, a publisher must be found to have known that the information it published was false, or to have had reckless disregard for the truth.
Rolling Stone has not said whether it would appeal the verdict. Scott Sexton, a lawyer for Rolling Stone, said on Monday that according to its agreement with Ms. Erdely, the company was obligated to cover ''all liability arising out of the article.''
Ms. Erdely and her legal team declined to answer questions after the decision was read.
In its decision, the jury made no distinctions about what portion of the damages was tied to the article and what was tied to other comments made by Ms. Erdely and Rolling Stone after publication.
Outside the courtroom on Monday night, Deborah J. Parmelee, a teacher who was the jury forewoman, read a brief statement from the jury that said, in part: ''With careful consideration of the facts in evidence for determining damages, the jury made its determination. We were proud to execute our civic duty.''
Nicole P. Eramo, former associate dean of students at the University of Virginia, filed the lawsuit.
Steve Helber / Associated Press
Ms. Parmelee declined to answer any further questions about the case.
The article, ''A Rape on Campus,'' was published in November 2014 and intensified national attention on sexual assault of college students. But the article was soon called into question for its reliance on a single source, identified only as Jackie, in describing a brutal gang rape at a fraternity party near the grounds of the university, which was founded by Thomas Jefferson in 1819 and is steeped in tradition.
After a report by the Columbia Graduate School of Journalism reprimanded Rolling Stone for failing to take fundamental steps to verify Jackie's account, and after the Charlottesville police said they had found no evidence that an episode like the one described had occurred, the magazine retracted the article and removed it from its website.
Ms. Eramo, the former associate dean of students, sued for defamation, saying that she had been made out to be the ''chief villain'' in the article, which portrayed the university administration as being indifferent to the threat of sexual assault on campus. In one of the story's most scalding passages, Jackie said that Ms. Eramo had told her, ''Nobody wants to send their daughter to the rape school.''
Testifying on Monday in the damages hearing, Ms. Eramo wept repeatedly as she recounted personal and professional difficulties after the article was published. She spoke of a loss of self-confidence and a change of her job at the university.
Some members of the jury could be seen dabbing tears during Ms. Eramo's testimony.
Rolling Stone's lawyers pointed out that since the article was published, Ms. Eramo has gotten two raises, and her salary is now set at $113,000 a year. They also noted that a report from the United States Department of Education backed up the magazine's general findings by criticizing how the University of Virginia handled sexual assault cases.
David Paxton, a lawyer for Rolling Stone, also stressed how much the article had already damaged the magazine's reputation.
''This has been a badge of shame,'' he said, ''for Rolling Stone and Ms. Erdely.''
But Ms. Eramo found that response wanting.
''It took two years and all this to get an apology,'' Ms. Eramo said, gesturing around the courtroom. ''And I still don't believe it is a real apology. The regret I see is that they're in the position they're in today.''
Hawes Spencer reported from Charlottesville, Va., and Ben Sisario from New York.
Washington Post Refuses to Retract Article Defaming Naked Capitalism and Other Sites | naked capitalism
Fri, 09 Dec 2016 14:01
Our attorney, Jim Moody, sent a letter over the weekend to key figures at the Washington Post, demanding a retraction of its story, Russian propaganda effort helped spread 'fake news' during election by Craig Timberg, that defamed Naked Capitalism and other well-regarded websites.
Immediately after Timberg's dubious story ran, journalists immediately sounded alarms about the Post endorsing and promoting a McCarthyite blacklist, and even worse one that clearly had no sound evidentiary or methodological foundation. Timberg's piece was widely derided by other publications and prominent writers, including the New Yorker, the media watchdog FAIR, Ben Norton and Glenn Greenwald at The Intercept and Matt Taibbi at Rolling Stone. A representative assessment came from Patrick Maines, president of The Media Institute, at The Hill: '''....perhaps the shoddiest piece of feature writing since Rolling Stone published its blatantly false story about a campus rape at the University of Virginia.''
In addition to calling for a retraction, our lawyer also demanded a prominent public apology and an equally prominent opportunity to reply. He asked for a reply in three business days.
The Post did respond in three business days, posting a statement at the beginning of the Timberg article.
However, the Post's action was inadequate and served to confirm a lack of commitment to integrity and fact-based reporting. This text now appears at the beginning of the ''fake news'' story:
Editor's Note: The Washington Post on Nov. 24 published a story on the work of four sets of researchers who have examined what they say are Russian propaganda efforts to undermine American democracy and interests. One of them was PropOrNot, a group that insists on public anonymity, which issued a report identifying more than 200 websites that, in its view, wittingly or unwittingly published or echoed Russian propaganda. A number of those sites have objected to being included on PropOrNot's list, and some of the sites, as well as others not on the list, have publicly challenged the group's methodology and conclusions. The Post, which did not name any of the sites, does not itself vouch for the validity of PropOrNot's findings regarding any individual media outlet, nor did the article purport to do so. Since publication of The Post's story, PropOrNot has removed some sites from its list.
This part of the statement is remarkable: '''...does not itself vouch for the validity of PropOrNot's findings regarding any individual media outlet.'' This is tantamount to an admission that not only did the Washington Post do no fact-checking, but that it also does not consider fact-checking to be part of its job. And it has the temerity to accuse others of engaging in ''fake news''?
This minimalist walk-back does not remedy the considerable damage done to Naked Capitalism and other sites. The Post is being disingenuous in trying to take the position that its featuring of a newbie group with no track record whatsoever was not tantamount to an endorsement. It is also disingenuous to take the position that referring in the story to PropOrNot's ''200 websites as routine peddlers of Russian propaganda during the election season'' which had already published at PropOrNot's did not legitimate it and drive traffic to a previously unknown site. The fact that journalists almost immediately found the blacklisted sites and took the Post to task on Twitter and shortly thereafter in news stories shows that the Post did damage to Naked Capitalism and other publishers vastly beyond the original publication of the list by amplifying it, which led other major news sites like USA Today and Daily Beast to pile on.
As one of the publishers of another site on PropOrNot's hit list said via e-mail''
No mainstream news consumer will see this editorial comment, after having been blasted by WaPo and the other media which loudly trumpeted the faux study.
Here were some other reactions:
what a bunch of cowards. "This blacklist that served as the entire news basis of our piece is bullshit but we wont retract the story" https://t.co/V5ZSwSMgTg
'-- Adam H. Johnson (@adamjohnsonNYC) December 7, 2016
The @washingtonpost article on Fake News '' mindlessly spread and endorsed by countless journalists '' itself contained Fake News'... https://t.co/eloy3cw7ox
'-- Glenn Greenwald (@ggreenwald) December 7, 2016
@Truthdig@washingtonpost that note is not nearly enough. Their main source was invalid, therefore a retraction is in order.
'-- Joshua Frank (@joshua__frank) December 8, 2016
@abeaujon@lhfang OMG,Just retract it! @washingtonpost
'-- RogerFolken (@RogerFolken) December 8, 2016
From John Helmer's latest post:
Responding to consumer protests that WaPo's reading material on Russia is defective and false, and that its reporter on Russian propaganda, Craig Timberg, is a fabricator, the newspaper announced last night that it ''does not itself vouch for the validity'' of what it publishes about Russia, the recent US presidential election, or American democracy. For ''validity'', the Washington Post's editors mean truth. For ''does not vouch for'', they mean what Nash Holdings and Bezos are calculating as a put-call option on lying.
We also received many e-mails privately, none of which saw the Post's response as adequate. A representative note from a financial analyst and writer:
Not enough! They need to apologise. They should also fire Timberg.
From a journalist:
Mealy mouthed calculation. Now let's see whether management and their lawyers think this ''mitigation'' will stifle NC's legal demands. In the old days of defamation law, the entire story would be suspended or removed, and a notice put in place where the story was. This indicates WaPo thinks they can circulate lies so long as they signpost them. No duty or no responsibility for reporting the truth, and no liability for lying, faking, etc. If homicide were like lying, then the WaPo approach is that so long as murderers issue disclaimers, victims deserve what they get.
Readers were similarly unimpressed. For instance:
hunkerdownDecember 7, 2016 at 8:16 pmTranslation of WaPoo editor's note: This article was a means to an end, a sham designed to get the Cold War 2.0 into the NDAA, and now that the mission is accomplished, we're laughing at all of you.The Post has made clear that it does not consider fairness and accuracy to be important. How can journalists there, who, unlike Timberg, care about the integrity of their work, feel comfortable working for a management that is promoting a rush to the bottom in the interest of getting stories out faster and getting more eyeballs? And why should the public at large trust the Post? After the firestorm of criticism, the editors and publishers of the Post should recognize that they have a serious quality control problem. If Timberg and the editors responsible are not fired or demoted, this sends a clear message to all other writers that anything goes.
We want to thank readers for their support. Dealing with a libel of this magnitude has been emotionally draining not just for me but Lambert and other writers, enormously time consuming, and is already having an impact on my health. Other sites damaged by the Post have expressed interest in pursuing legal action. I doubt this handwave-masquerading-as-a-concession will dim their resolve.
But as much as Naked Capitalism has been caught in the crosshairs of an unwarranted attack, it is critical to recognize what is really at stake. Since the first net neutrality fights of the early 2000s, major media enterprises and pipeline providers schemed to restrict the freedom of the Internet and re-assert the position of traditional brands and the few newer players who have managed to attain the scale and brand recognition to make them Too Big To Squash. Because smaller web publishers have had enough natural allies in these fights, these legislative threats to an open Internet have been successfully beaten back.
But the multi-fronted censorship efforts, particularly using Facebook bans and software tools to silence or discourage readership of sites that successfully challenge mainstream narratives, is a new, private sector-led initiative which is far more challenging to contest by virtue of lacking a clear focus for joint action. We hope that other publishers as well as users of information recognize how serious this threat is and take forceful countermeasures. This is not the time to be complacent.
We hope you will help us rise to this challenge. And we will be taking more action, so stay tuned.
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Senate Passes Major Portman-Murphy Counter-Propaganda Bill as Part of NDAA - Press Releases - Newsroom - Rob Portman
Countering Disinformation and Propaganda Act
Sat, 10 Dec 2016 04:48
Portman/Murphy Bill Promotes Coordinated Strategy to Defend America, Allies Against Propaganda and Disinformation from Russia, China & Others
WASHINGTON, D.C. '' U.S. Senators Rob Portman (R-OH) and Chris Murphy (D-CT) today announced that their Countering Disinformation and Propaganda Act '' legislation designed to help American allies counter foreign government propaganda from Russia, China, and other nations '' has passed the Senate as part of the FY 2017 National Defense Authorization Act (NDAA) Conference Report. The bipartisan bill, which was introduced by Senators Portman and Murphy in March, will improve the ability of the United States to counter foreign propaganda and disinformation by establishing an interagency center housed at the State Department to coordinate and synchronize counter-propaganda efforts throughout the U.S. government. To support these efforts, the bill also creates a grant program for NGOs, think tanks, civil society and other experts outside government who are engaged in counter-propaganda related work. This will better leverage existing expertise and empower local communities to defend themselves from foreign manipulation.
''The passage of this bill in the Senate today takes us one critical step closer to effectively confronting the extensive, and destabilizing, foreign propaganda and disinformation operations being waged against us. While the propaganda and disinformation threat has grown, the U.S. government has been asleep at the wheel. Today we are finally signaling that enough is enough; the United States will no longer sit on the sidelines. We are going to confront this threat head-on,'' said Senator Portman. ''With the help of this bipartisan bill, the disinformation and propaganda used against our allies and our interests will fail.''
''Congress has taken a big step in fighting back against fake news and propaganda from countries like Russia. When the president signs this bill into law, the United States will finally have a dedicated set of tools and resources to confront our adversaries' widespread efforts to spread false narratives that undermine democratic institutions and compromise America's foreign policy goals,'' said Murphy. ''I'm proud of what Senator Portman and I accomplished here because it's long past time for the U.S. to get off the sidelines and confront these growing threats.''
NOTE: The bipartisan Countering Disinformation and Propaganda Act is organized around two main priorities to help achieve the goal of combatting the constantly evolving threat of foreign disinformation. They are as follows:
The first priority is developing a whole-of-government strategy for countering foreign propaganda and disinformation. The bill would increase the authority, resources, and mandate of the Global Engagement Center to include state actors like Russia and China in addition to violent extremists. The Center will be led by the State Department, but with the active senior level participation of the Department of Defense, USAID, the Broadcasting Board of Governors, the Intelligence Community, and other relevant agencies. The Center will develop, integrate, and synchronize whole-of-government initiatives to expose and counter foreign disinformation operations and proactively advance fact-based narratives that support U.S. allies and interests.Second, the legislation seeks to leverage expertise from outside government to create more adaptive and responsive U.S. strategy options. The legislation establishes a fund to help train local journalists and provide grants and contracts to NGOs, civil society organizations, think tanks, private sector companies, media organizations, and other experts outside the U.S. government with experience in identifying and analyzing the latest trends in foreign government disinformation techniques. This fund will complement and support the Center's role by integrating capabilities and expertise available outside the U.S. government into the strategy-making process. It will also empower a decentralized network of private sector experts and integrate their expertise into the strategy-making process.###
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Trump Transition
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Secretary of State Rex Tillerson was worth the President Trump wait
Sun, 11 Dec 2016 08:27
As another Lame Cherry exclusive in matter anti matter.
I have been informed that the MOG's and the asstards have been busy whining about Rex Tillerson in being nominated for Secretary of State for Russian ties, but the Lame Cherry is going to explain something so this will all make sense.
But first, Rush Limbaugh was man gushing over Rex Tillerson on his program, meaning Trump Trans leaked who it was to Limbaugh, and Limbaugh could not keep his mouth shut, but instead attacked Cathy Rodgers over the post.
Even before First is this Wikipedia statement on Rex Tillerson:
Tillerson is married and has four children.[5] He resides in Irving, Texas.[5] Tillerson is a Christian.[36] He and his wife donated $5,000-$10,000 to the National Association of Congregational Christian Churches in 2012.[37]
Secretary Tillerson, also apparently knows what a Bible is, and Who God is, as he is a daily worshiper of the Lord.This would mean that he is a Conservative Christian and the first one appointed by President Donald Trump to a premier position. We though must have the other positions with Christians appointed as one pick does not suffice.
No harping on this at the moment, as the Lame Cherry is about to provide you the reason why Rex Tillerson is the perfect choice, and why those complaining have no idea what President Trump foreign policy is.
Do you know what the Kentucky Derby is, the Preakness and the Belmont Stakes? Yes they are the triple crown, but each race is unique in one is a sprint for fast horses, one is a middle distance run, and one is a long distance marathon. That is why Secretariat was so fabulous, in he had all the capabilities to win all three races.
Secretary Tillerson is unique in he is perfect for President Trump foreign policy. If you remember that the Lame Cherry has stated that solving Russia, solves the Mideast and China......that is what Rex Tillerson does.The only American who has spent more time with President Vladimir Putin than Secretary Tillerson while at Exxon, is Henry Kissinger. President Putin adores Rex Tillerson, in presenting him with awards, and while the Rothschilds got their Soros oil asses booted out of Russia, Rex Tillerson heading Exxon increased their Russian holdings and oil interests.
So this is clear, the Vladimir Putin who distrusts W. Bush, the Vladimir Putin who detests image Obama, likes Secretary Rex Tillerson, in they know how to deal with each other.
Nominating this man to Secretary of State, sends an absolute signal to Russia, which Obama has aiming nuclear missiles at America and Europe, that Russia is the top priority and that America is making every effort to build a peaceful and cooperating relationship with Moscow forever, fulfilling the relationship which began during the Americans Civil War between the Czar and President Abraham Lincoln.
I have hope for Christians under President Putin's protection and the Christian's under President Trump's protection, that we will not be drawn into cartel wars, and if "we" can help elect in France and Germany, true Nationalist partners with President Putin and President Trump, "we" the Christian Western Peoples will not be led to Armageddon.
Nom des Deus, the opportunities now for healthy cooperation and competition, in Russians and Americans striving to their best, in our combined raw resources and hardworking Citizens. Christ Pax will be a reality in we will build bridges across oceans and into outer space for profits instead of World War IV.
That is why Rex Tillerson is perfect as Secretary of State. He is the horse for this race, just as Donald Trump was the only horse in the 2016 Presidential election. Secretary Tillerson is thee best choice of President Trump so far, and it is going to be almost impossible to top this choice.
So thank God for President Trump and thank God for Secretary of State Rex Tillerson. He is a Christian. He is a devout man. He is successful, diplomatic and strong. He has the best relationship of any American with President Vladimir Putin, and that is all America needs at this moment.
Those who are shortsighted do not see the big picture of what is the Trump Policy with our Russian Partner which there should not be any harm to explain what that is, in America with Russia, is going to crush terror oil, and become energy independent in cooperating across the globe for Peace, for the Christian Peoples.
For the Trump Putin Pax, there is no one on this planet more suited to the diplomacy than Rex Tillerson. America has the first Secretary of State in a generation who knows what he or she is doing.
Nuff Said
agtG
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ÐиÐ>>Ð>>еÑсон женат и имеет четвеÑых детей. [5]Он ÐÑоживает в Ð"оÑоде ÐÑвинÐ", Ñтат Ðехас. [5]ÐиÐ>>Ð>>еÑсон явÐ>>яется хÑистианином. [36]Он и еÐ"о жена ÐожеÑтвоваÐ>>и $ 5,000- $ 10000 в Ð'ационаÐ>>ьной ассоциации конÐ"ÑеÐ"ационаÐ>>истская хÑистианских цеÑквей в 2012 Ð"оду [37]
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Ð--остаточно
Trump's cabinet is a horror show
Fri, 09 Dec 2016 00:31
Joan Walsh's latest piece about Trump's staffing choices is inspiring .
He's betrayed his working-class supporters by naming a cabinet of millionaire and billionaire insiders.
The Dems aren't going to tell the story. They're too confused and disorganized. No leadership.
All the bullet points in her story need to be ads that run on CNN, Fox and MSNBC, starting now, before the confirmations start. Get the people involved.
There are many thousands of people who would chip in to fund those ads. Can't count on the press (they're trying to be friends with the new administration) or the Dems (who knows what they're thinking).
Ads, like the ones Hillary ran, but not based on what could happen, on what is happening.
Democrats Should Fight All of Trump's Nominees. Yes, All of Them. | The Nation
Thu, 08 Dec 2016 23:48
Clockwise from upper left: Scott Pruitt, Wilbur Ross, Tom Price, and Steven Mnuchin. (AP Photo / Sue Ogrocki; AP Photo / Mark Lennihan; Al Drago / CQ Roll Call; AP Photo / Evan Vucci)
As Donald Trump unveils his cabinet of deplorables, it's getting hard to imagine how Democrats are going to ''pick their battles'''--the warning that's become a clich(C) of Trump transition coverage (just Google it). The Wall Street Journal reported that even incoming Senate minority leader Chuck Schumer says, ''Democrats will pick their battles,'' as he singled out Trump's selection for attorney general, Senator Jeff Sessions, as someone who would be subject to tough Democratic scrutiny at confirmation hearings.
Ad PolicyAnd he should be; Sessions was rejected for a federal judgeship 30 years ago for his blinkered racial views and his persecution of black voting-rights advocates in Alabama while he was a federal prosecutor. But Democrats should be fighting virtually all of Trump's picks. The president-elect is presenting Democrats with a political opportunity even before he takes the oath of office. The so-called champion of the working class is assembling a gilded cabinet. Not only will it be the richest, ever; it features plutocrats who've presided over the hollowing out of the working class Trump pretended to care about. Party leaders should be shouting about this from every imaginable platform.
The Treasury secretary appointed after a campaign spent demonizing Wall Street and ''hedge-fund guys'' is a former Goldman Sachs banker and hedge-fund guy, Steve Mnuchin, whose bank foreclosed on 37,000 homeowners after the housing crash.Trump's reported choice for labor secretary is the minimum wage''opposing, job-killing fast-food mogul Andrew Pudzer, who talks fondly about the day robots will replace workers at his restaurants. Pudzer has been a leader of the corporate fight against the Fight for $15, and he was a passionate supporter of the immigration-reform bill that failed in 2013'--and he'll be in charge of enforcing labor laws.Then there's the billionaire nominee for Commerce Secretary, Wilbur Ross, who owned the deadly Sago Mine in West Virginia when 12 workers were killed in a 2006 explosion. Three years later, he closed the mine. Trump, you'll recall, has promised to ''bring back coal'' and ''bring back miners.'' How will coal country feel about Secretary Ross?Meanwhile, Trump's pick to head the Environmental Protection Agency, Scott Pruitt, is a climate-change denier who has sued the EPA as Oklahoma attorney general.His Health and Human Services nominee, Representative Tom Price, opposes the Affordable Care Act and wants to privatize Medicare. Price once claimed it was impossible that any woman would be unable to pay for her own birth control. ''Bring me one woman who has been left behind,'' he told the Conservative Political Action Conference. ''Bring me one. There's not one.''Then there's Housing and Urban Development nominee Ben Carson, who has zero experience in housing or urban development and appears to oppose Fair Housing laws.Betsy DeVos, the pick for education secretary, is yet another billionaire. She sent her children to private schools and has crusaded to privatize public education.I could go on, but I'll stop there. (There's also his troika of retired generals'--Mike Flynn as national security adviser, James Mattis as secretary of defense, and Jim Kelly as homeland security director'--who raise separate questions about military influence in the cabinet.)
Most PopularBut so far, presented with these political gifts, Democrats have been fairly silent. They've pledged to fight Sessions, and they should, but no one else has come in for much attack, although today Senator Ed Markey said he would oppose Pruitt's nomination to head the EPA, and Schumer had some tough words for Pudzer as labor secretary. That's good news, but it's not enough.
On one level, I understand the need for Democrats to ''pick their battles.'' They may be more likely to win GOP support to actually block a nominee or two by being selective. But no one has yet marshaled an argument to Trump voters that they've been hoodwinked: that the outsider candidate has picked a cabinet of insiders, who make an utter mockery of his promises to look out for the ''forgotten man.'' Democrats should be making the case, as Ben Adler argues in The Guardian, that Trump is ''a self-dealing political profiteer and a tool of the business and political elite.'' Jeff Hauser of the Revolving Door Project has suggested that Democrats refuse to consider any appointments until Trump discloses and then divests himself of his global and largely secret financial empire'--especially since we can't trust Trump's picks to monitor his self-dealing.
The stakes are higher now than ever. Get The Nation in your inbox.
Part of the problem is the Democrats have a leadership vacuum right now. President Obama has said he doesn't see anti-Trump agitation as his role. Hillary Clinton doesn't seem temperamentally inclined to do that, and at any rate, she'd be dismissed as a sore loser (though she won the popular vote by at least 2.7 million, let's always remember). House minority leader Nancy Pelosi is formidable on legislative strategy, but rarely stands as the public face of the party. Senate minority leader Harry Reid, a reliable fighter, is retiring. Schumer loves attention, but it seems as though he hasn't yet decided how hard he wants to fight. There's no permanent Democratic National Committee chair. Senator Bernie Sanders has been reliably vocal, and while he's still not a Democrat, he's been given a leadership role. Here's hoping he uses it to stiffen his colleagues' spines for these battles.
Maybe this will start to change after the holidays, when senators begin planning hearings for these nominees. There will be plenty of opportunity for rising stars to shine, by grilling nominees with strong research into their careers, their potential conflicts of interest, and their policy beliefs. But right now Democrats are missing an opportunity to brand the president-elect as a man who's betraying his base, right out of the gate. They should certainly pick their battles'--a lot of them.
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Events - Hamilton Electors
Sun, 11 Dec 2016 13:38
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Republican John Kennedy wins Louisiana Senate runoff, giving GOP 52-48 edge - Chicago Tribune
Sun, 11 Dec 2016 14:51
Louisiana voters chose Saturday to send Republican state Treasurer John Kennedy to the U.S. Senate, filling the nation's last Senate seat and giving the GOP a 52-48 edge in the chamber when the new term begins in January.
Kennedy had always been the runoff election's front-runner in a state that overwhelmingly supported Donald Trump. He defeated Democrat Foster Campbell, a state utility regulator whose chances were seen as such a long-shot that national Democratic organizations offered little assistance to Campbell's campaign.
As he celebrated the victory, Kennedy said he represented change in Washington.
"I believe that our future can be better than our present, but not if we keep going in the direction the Washington insiders have taken us the last eight years," he said. "That's about to change, folks."
Voters also filled two open U.S. House seats Saturday, choosing Republican Clay Higgins, a former sheriff's captain known as the "Cajun John Wayne," in the 3rd District representing southwest and south central Louisiana and Republican state Rep. Mike Johnson in the 4th District covering northwest Louisiana.
Louisiana has an open primary system in which all candidates run against each other. In the contests for the open congressional seats, the November primary ballots were packed with contenders, so the top two vote-getters advanced to Saturday's runoff.
The Senate runoff drew national attention, with President-elect Trump and Vice President-elect Mike Pence each traveling to Louisiana to rally for Kennedy. The national GOP provided resources and staff to assist Kennedy's campaign, while national Democratic organizations largely abandoned Campbell, assuming an easy Republican win.
Though Campbell's chance appeared slim, donations had poured in from around the country, and several Hollywood celebrities championed his candidacy aiming to bolster resistance to the Trump presidency. Campbell said the support he received across the country was "phenomenal."
"We worked as hard as possible. We left no stone unturned," Campbell said in his concession speech. "I make no excuses. We did everything humanly possible."
The co-chair of the Republican National Committee, Sharon Day, described Kennedy's win as capping "a year of historic Republican wins up and down the ballot.
"With 52 seats in the U.S. Senate, we are excited for Republicans to confirm a conservative Supreme Court justice and begin working with President-elect Trump to pass an agenda of change for the American people," Day said in a statement.
Louisiana Gov. John Bel Edwards, a Democrat and ardent Campbell supporter, congratulated Kennedy and pledged to work with him to "deliver great things for the people of Louisiana."
The Senate seat was open because Republican David Vitter decided against running for a third term after losing the governor's race last year. Both men vying for the seat are well-known figures, involved in Louisiana politics for decades.
Kennedy, an Oxford-educated lawyer from south Louisiana, is in his fifth term as treasurer, a role in which he repeatedly drew headlines for his financial clashes with Louisiana's governors.
He sprinkled speeches with examples of government-financed contracts he considered outrageous, like money "to study the effects of Swedish massage on bunny rabbits." In the runoff, he ran a safe, TV-focused effort highlighting his support for Trump and his opposition to the federal health overhaul.
Campbell, a cattle farmer and former state senator from north Louisiana, is a populist who railed against "Big Oil," wanted to increase the minimum wage and talked openly about man-made climate change. He pledged that in Washington he wouldn't "be in anybody's shirt pocket."
He also ran as a Louisiana Democrat '-- strongly opposed to abortion and supportive of gun rights.
Kennedy hit Campbell for supporting Clinton. Campbell called Kennedy a flip-flopper during prior Senate bids, because the treasurer ran in 2004 as a liberal Democrat and the most recent two times as a conservative Republican.
In the 3rd District race, Higgins traded blistering attacks with his fellow Republican opponent, Scott Angelle, a member of the Public Service Commission and well-known public official for nearly 30 years.
Angelle had been the presumed front-runner. But Higgins '-- a local celebrity known for attention-grabbing Crime Stoppers videos he filmed when he was a sheriff's captain '-- capitalized on disenchantment with career politicians to defeat Angelle with only a fraction of his money and a bare-bones organization.
In the 4th District, Johnson defeated Democrat Marshall Jones in a competition that was less attack-laden.
Johnson focused on his work on conservative issues as a constitutional attorney and on his two years as a state lawmaker. Jones, also a lawyer, downplayed his party affiliation, running as an anti-abortion, gun-rights Democrat who could work with Trump.
The House seats were open because Republicans Charles Boustany and John Fleming unsuccessfully sought the Senate seat instead of re-election.
Associated Press
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SJW
Either include women in the draft or drop it altogether. Requiring only men to register is the worst form of legalized misandry. Disgusting.
Fri, 09 Dec 2016 00:36
During consideration of the National Defense Authorization Act (NDAA) in the spring, the proposal that women be required to sign up with Selective Service just as are men started on a roller coaster ride in the United States Congress. That ride had a couple more turns this week. On Tuesday, a United States Senate and House of Representatives conference committee, which was creating a compromise version of the NDAA because the two bodies had passed differing bills, released a final bill that leaves out such a requirement. Then, on Thursday, the Obama administration announced support for requiring women to register with Selective Service.
If women are mandated to register with Selective Service, then the expectation would be that women are in the pool of people for drafting into the military if conscription is reintroduced in America. Thus, such a mandate in the NDAA or other legislation may be viewed as a women draft provision.
In the spring, a women draft provision was added to the House version of the NDAA in a peculiar way. Rep. Duncan Hunter (R-CA) proposed the requirement during House Armed Services Committee consideration of the bill. Hunter said he did so to start a debate regarding the ongoing expansion of women's involvement in US military combat, which he opposes. But, then, the committee voted on April 27 to approve the requirement, with Hunter voting against his own proposal.
On May 16, before the House Armed Services Committee-passed NDAA was moved to the House floor for debate and a vote of all House members, the House Rules Committee removed the provision from the bill. The altered bill was then considered by the full House, which approved an NDAA with no women draft provision included.
But, given that Congress is made up of two bodies, there was still a chance for a women draft provision to make it into the NDAA that Congress would send to President Barack Obama. Indeed, the Senate Armed Services Committee on May 12, as had its House counterpart before it, included in its version of the NDAA a requirement that women register with Selective Service. Ultimately, the full Senate passed an NDAA that includes a women draft provision.
The roller coaster ride seems to be reaching its end '' for now. It appears that the House and Senate will pass an NDAA that includes no requirement that women register with Selective Service and that Obama will sign that legislation into law. But, the significant support for such a provision indicated by votes in the House and Senate suggests a strong effort will continue in Washington, DC to mandate women register with Selective Service.
Reprinted from The Ron Paul Institute for Peace & Prosperity.
Shut Up Slave!
Geert Wilders guilty of 'insulting a group' after hate speech trial - CNN.com
Fri, 09 Dec 2016 15:43
But the court found him not guilty of incitement to hatred and handed down no punishment.
Wilders, the leader of the Party for Freedom (PVV), was charged after inciting supporters into a chant calling for fewer Moroccans in the Netherlands in 2014.
According to a court statement, Wilders asked his audience: "Do you want more or less Moroccans in this city and in the Netherlands?"
The court said that Wilders "singled out an entire group of citizens" and that the message "came through loud and clear." It convicted him of insulting a group and incitement to discrimination.
But the court found insufficient evidence to find him guilty of incitement to hatred.
The court, which could have fined Wilders, decided that verdicts were sufficient punishment and imposed no further penalty.
The 53-year-old far-right leader has campaigned against "Islamic immigration."
"Three PVV-hating judges just declared Moroccans a race and convicted me, as well as half of the Dutch population," Wilders tweeted shortly after the ruling.
Wilders said in a Twitter post ahead of the verdict Friday morning that he will "continue to speak the truth about the Moroccan problem."
"No judge, politician or terrorist will stop me," he added.
Wilders has previously called Islamic immigration "an invasion" that will "replace our people" and "erase our culture."Among his other policies, Wilders has called for a referendum on the Netherlands' membership in the European Union, and a full burqa ban.
Wilders, 53, came to international attention in 2008 with the provocative online film "Fitna," which juxtaposed the aftermath of terrorist attacks with verses from the Quran.Known as much for his anti-Muslim views as his bleached hair, Wilders has been called "Europe's Donald Trump" -- with his party gaining popularity in recent years.Previous charges
It's not the first time Wilders has appeared in court on hate speech charges.
In 2011 he was acquitted of inciting hatred against Muslims, after calling for the Quran to be banned in the Netherlands.Dutch election on the horizon
Friday's verdict comes three months ahead of the country's parliamentary election in March, when Wilders will be vying for the top job of prime minister.
The opposition party leader will face current prime minister Mark Rutte, whose conservative People's Party for Freedom and Democracy (VVD) rules in a coalition with the the Labour Party (PvdA).
Rutte said at a press conference Friday that neither he nor his party would be willing to govern with Wilders unless he retracted his comments about Moroccans.
Wilders has run on a party manifesto focused on a so-called "de-Islamification" of the Netherlands, in which he lays out an 11-point plan pledging, among other things, to shut down all the country's Islamic schools and close the borders to migrants from Islamic nations.Journalist Daan Marselis and CNN's Vasco Cotovio and Nic Robertson contributed to this report.
War on Men
Sexism May Be Harmful to Men's Mental Health
Thu, 08 Dec 2016 22:23
WASHINGTON '-- Men who see themselves as playboys or as having power over women are more likely to have psychological problems than men who conform less to traditionally masculine norms, according to research published by the American Psychological Association.
''In general, individuals who conformed strongly to masculine norms tended to have poorer mental health and less favorable attitudes toward seeking psychological help, although the results differed depending on specific types of masculine norms,'' said lead author Y. Joel Wong, PhD, of Indiana University Bloomington. The study was published in the Journal of Counseling Psychology®.
Wong and his colleagues conducted a meta-analysis of 78 research samples involving 19,453 participants that focused on the relationship between mental health and conformity to 11 norms generally considered by experts to reflect society's expectations of traditional masculinity:
Desire to win.Need for emotional control.Risk-taking.Violence.Dominance.Playboy (sexual promiscuity).Self-reliance.Primacy of work (importance placed on one's job).Power over women.Disdain for homosexuality.Pursuit of status.Specifically, they focused on three broad types of mental health outcomes: negative mental health (e.g., depression), positive mental health (e.g., life satisfaction) and psychological help seeking (e.g., seeking counseling services).
While most of the U.S.-based studies focused on predominantly white males, some focused predominantly on African-Americans and some on Asian-Americans.
While overall, conforming to masculine norms was associated with negative mental health outcomes in subjects, the researchers found the association to be most consistent for these three norms '-- self-reliance, pursuit of playboy behavior and power over women.
''The masculine norms of playboy and power over women are the norms most closely associated with sexist attitudes,'' said Wong. ''The robust association between conformity to these two norms and negative mental health-related outcomes underscores the idea that sexism is not merely a social injustice, but may also have a detrimental effect on the mental health of those who embrace such attitudes.''
Even more concerning, said Wong, was that men who strongly conformed to masculine norms were not only more likely to have poor mental health but also also less likely to seek mental health treatment.
There was one dimension for which the researchers were unable to find any significant effects.
''Primacy of work was not significantly associated with any of the mental health-related outcomes,'' said Wong. ''Perhaps this is a reflection of the complexity of work and its implications for well-being. An excessive focus on work can be harmful to one's health and interpersonal relationships, but work is also a source of meaning for many individuals.''
Also, conformity to the masculine norm of risk-taking was significantly associated with both negative and positive mental health outcomes, suggesting that risk-taking can have both positive and negative psychological consequences, said Wong.
Article: ''Meta-Analyses of the Relationship Between Conformity to Masculine Norms and Mental Health-Related Outcomes,'' by Y. Joel Wong, PhD, Shu-Yi Wang, MS, and S. Keino Miller, MA, Indiana University Bloomington, and Moon-Ho Ringo Ho, PhD, Nanyang Technological University. Journal of Counseling Psychology, published online Nov. 21, 2016.
Joel Wong can be contacted by email or by phone at (812) 856-8293.
The American Psychological Association, in Washington, D.C., is the largest scientific and professional organization representing psychology in the United States. APA's membership includes more than 117,500 researchers, educators, clinicians, consultants and students. Through its divisions in 54 subfields of psychology and affiliations with 60 state, territorial and Canadian provincial associations, APA works to advance the creation, communication and application of psychological knowledge to benefit society and improve people's lives.
pizzagate
HANDRAHAN: Executive branch porn problem - Washington Times
Sat, 10 Dec 2016 06:47
ANALYSIS/OPINION:
Allen W. Dulles, former director of the Central Intelligence Agency (CIA) wrote in ''The Craft of Intelligence,'' ''sex and hard-headed intelligence operations rarely mix well.'' Perhaps the boys at the Pentagon need a refresher course.
This past week, the Pentagon's Missile Defense Agency warned its staff not to view porn on U.S. government computers. The Pentagon also released a report on April's Secret Service Colombian scandal. The two are connected.
In April, I said the Colombian scandal exposed a national security problem, the epidemic of U.S. government employees viewing porn '-- child porn '-- on government networks. I suggested readers type ''Transportation Security Administration,'' ''U.S. State Department,'' ''Pentagon,'' ''Immigration and Customs Enforcement'' and ''child porn'' into Google's search field to understand the scope. I neglected to include ''Missile Defense Agency.''
Bloomberg quotes a cybersecurity expert saying the Missile Defense Agency's use of porn is concerning because ''many pornographic websites are infected and criminals and foreign intelligence services such as Russia's use them to gain access and harvest data.''
The only possible response is: Duh.
In 2006, the deputy press secretary for the Department of Homeland Security was arrested for trying to seduce online someone he thought was a teenage girl. Four years later, the Securities and Exchange Commission found that 17 of 31 employees caught accessing porn at work since 2008 '-- one for up to eight hours a day '-- were senior staff.
In 2010, the Boston Globe reported that senior Pentagon staff were downloading child porn. Instead of generating a media storm, the story died. Senior staff were watching the sexual torture of small children on Pentagon computers, and Americans were not outraged?
The latest revelation of missile-defense staff using porn should have America extremely alarmed. It is not yet confirmed if child porn was involved.
Of the Colombian Secret Service scandal, Rep. Darrell E. Issa, chairman of the House Committee on Government Oversight and Reform, asked if women younger than 18 (i.e., trafficked children) were involved. Mr. Issa must demand to know the same of the Missile Defense Agency.
In his book, Dulles said real intelligence work is unlike that portrayed by Hollywood's James Bond spies. An intelligence officer ''cannot permit himself to become entangled with luscious females who approach him in bars or step out of closets, lightly clad, in hotel rooms. Such lures might have been sent by the opposition to compromise or trap him.'' Dulles explained this was a favorite tactic of Soviet, now Russian, spies. He discussed the Soviet ''new look,'' which used female ''socialite spies'' and the 1963 British-Russian Profumo affair, ''using vice rings to aid blackmailing operations in later intelligence exploitation or merely to discredit [someone] in government positions in the Free World.''
America's most professional security officials, from the Secret Service to the Missile Defense Agency, seem eager to discredit themselves. Russians must be celebrating. During the Cold War, they had to train and deploy real female agents. Today, Americans come freely to honey pots directly from the Pentagon's missile-defense system.
How does this relate to President Obama's leadership problem?
The Colombia scandal was the president's wake-up call. The White House needed to order an in-depth and urgent investigation into porn, child porn and prostitution in all government agencies. Mr. Obama did no such thing. Now America's Missile Defense Agency may be exposing the core of our national security. So grave and unpatriotic is this violation, it might border on treason. Yet Mr. Obama remains unconcerned. Members of Congress are so alarmed by the president's behavior that they recently passed an amendment preventing the administration from sharing missile-defense technology with Russia. The Missile Defense Agency may have done so already.
Thomas Jefferson once said he feared for his country when he reflected that God was just. I, too, fear for my country. No one is home in the Obama White House, and the Russians know this. Allen Dulles must be rolling in his grave. Americans should be extremely concerned.
Lori Handrahan is a professor at American University's School of International Service.
A Man Armed with an AR15 Walked Into Comet Ping Pong... Is Pizzagate a Psyop to Shut Down the Alt Media? | The Daily Sheeple
Sun, 11 Dec 2016 08:23
UPDATE: The man who shot of an assault rifle at Comet Ping Pong has been identified. Turns out he's an actor.
Earlier today, just after watching a video about how Pizzagate might be a psyop to shut down free speech with a prediction that some type of false flag event might be coming to Comet Ping Pong, the pizza restaurant targeted at the center of the scandal '-- a yet unnamed man walked into Comet Ping Pong armed with an AR15 and, silently, walked to the back where the ping pong tables are and shot off one round into the floor.
The blame for the incident is not mostly falling on the guy with the gun. It's mostly falling on the ''alt right'' and alternative media conspiracy theorists for spreading fake conspiracies and ''fake news'' surrounding Pizzgate which ''influenced'' the guy with the gun.
This is how Pizzagate gets reported on in the mainstream media, as if it is a hate crime perpetrated by a horde of cyberbullies online. What happened today falls squarely, no, perfectly into the same narrative WUSA9 reported on November 24th, ''Fake news can have real victims'':
A popular Northwest, D.C. neighborhood pizza joint is trying to figure out how to fight back after what it suspects is a massive coordinated on-line attack suggesting the restaurant is involved in the worst kind of conspiracy.
The pizza shop owner suspects thousands of online bullies have set out to destroy him, maybe simply because he and a friend supported the Clinton campaign.
Now stop for a second and ask yourself, why would thousands of online bullies just randomly target anyone for being a Clinton supporter? That doesn't really make any sense'... There are lots of Clinton supporters who don't end up the target of worldwide online conspiracies about high level political pedophile rings.
What makes more sense after looking into this is that a very carefully constructed psyop has taken place with the goal of targeting and shutting down so-called ''fake news'' alternative media sites to coincide with a media campaign against ''fake news'' as a bastion of hate speech and cyberbullying that can have ''real life victims,'' while at the same time sending a large portion of the independent and alternative media down a conspiracy rabbit hole filled with speculation, allegations, and, while disturbing, what is offered comes with little real proof'... unlike some of the obviously much more damaging Wikileaks which are proof of hardcore corruption on the part of the Clinton campaign which have been dumped or overlooked because of Pizzagate.
So let's look into this a bit further, shall we?
First, take the restaurant owner James Alefantis. He's a pizza shop owner who also happens to have once been listed by GQ as one of the top 50 most influential people in DC, a town known for having lots and lots of influential people, and he's sending out stuff on his personal Instagram account that no one who is a small business owner of a business frequented by children and who cares about public perception would send out in a million years.
Things like this
and this (black square added over a man penetrating what appears to be a very small female's vagina):
and this, where he asks ''cumpanda?'':
and this where he says ''#pandacumhole'':
and this, which is self-explanatory:
Or this one:
That last one says ''#chickenlovers'' which is well-known to be slang for a grown male who is sexually attracted to young boys, but he added the hashtag to a picture with a baby in it. Not exactly the type of thing that would make most people want to take their kids to his restaurant, right? Or, again, something the owner of a ''family friendly'' restaurant where kids play ping pong or that hosts kid sleepovers would ever normally share publicly on the Internet if they wanted to stay in business.
Of course, if you point this out, then he rails against horrible people who would dare share his Instagram pictures of innocent children and say horrible, conspiratorial stuff like that in an evil, online bullying way'... Even though he's the guy who sent out a picture of a baby with the hashtag #chickenlovers on it in the first place.
But moreover, look at his avatar and let's discuss its significance. Someone traced that picture to where it was taken '' Prado Museum Madrid.
It's a bust of Antinous on display there circa 131-132 AD. Who was Antinous? The young (as in, underaged) Greek teen boy lover of the Roman emperor Hadrian. For centuries, pederasty (defined as ''sexual activity involving a man and a boy'') was socially acceptable, typically between older citizens in the leisured classes (aged 20-40) and young boys (aged 12-18). Author Royston Lambert wrote that sculptures of Antinous quote, ''remain without a doubt one of the most elevated and ideal monuments to pederastic love of the whole ancient world,'' according to the Wikipedia entry about Antinous.
Why would one of the most influential men in DC, a man who hangs out at the White House and rubs elbows with powerful people in Washington like the Podesta brothers, and a man who happens to own a ''family friendly'' pizza and ping pong restaurant, use such an overtly obvious symbol celebrating what would be considered pedophilia by today's standards as his Instagram avatar?
This isn't the only time this is referenced in Pizzagate, either. Remember this image John Podesta sent out in the Wikileaks emails (three times, mind you) of the number 14 and the fish drawn on his scarred hands?
Further down the Wikipedia page on Antinous, it is pointed out that Antinous was deified and an organized cult was created devoted to his worship in a place called Antinopolis which became the cultic center of Osiris-Antinous worship.
According to myth, Antinous drowned and was assimilated with Osiris to be reborn. Also according to myth, Osiris was cut into 14 pieces by his brother Set, and when Isis attempted to retrieve him, she was unable to retrieve the final piece (his penis) which was eaten by a fish.
So Podesta is directly referencing Osiris which is tied to Antinous, the gay underaged boy lover of a Roman emperor that Alefantis uses as his Instagram avatar.
(On an aside, the whole thing is extra creepy in reference to this Illuminati playing card which also references the number 14 and a creepy cult secret enough that the writing doesn't want to suggest exactly what it is about. Check it:
It says, ''We're sorry, but we're not even permitted to hint at what the Secret Knowledge is about goldfish. Your entire Power Structure is completely immune to attacks by Fanatic groups. No, we're really not going to explain why.'')
Alefantis, you may have heard, used to be in a lengthy romantic relationship with David Brock, the Democratic political operative who was chosen to run Media Matters by none other than John Podesta.
Brock got his start in Dem politics through disgraced former Congressman Barney Frank (see pic above of a much younger Brock in a leather collar standing next to Frank in the maroon shirt). Why disgraced?
Frank was caught up in a sex scandal back in the late 80s which involved allegations that a male prostitution ring was being run out of his DC apartment. This one ran all the way up the chain to the White House.
Brock used to lean conservative; the whole reason he switched to Democrat is because of Frank.
While these allegations in and of themselves prove nothing, the implications are everywhere.
Right now, they're working overtime on the narrative that a vast right-wing conspiracy of dangerous fake news cost their candidate Hillary Clinton the election.
Lots of alternative media websites including The Daily Sheeple have reported on the blown-up conspiracy of Pizzagate. Now, however, all sites who do report on it are being decried as ''fake news'' sites, and anyone who tries to legitimately report on this story is being labeled an ''online bully,'' one of thousands of online bullies that have led to the unfair targeting of Mr. Alefantis and his business (if you are to believe the mainstream media narrative on this).
News of the online bullying by so-called fake news outlets has spread far and wide, as the BBC is even reporting on ''The saga of 'Pizzagate': The fake story that shows how conspiracy theories spread''.
This story has been thrown all over the mainstream media as prime example of why so-called ''fake news'' must be shut down.
Alefantis, who called for anyone who reposts his Instagram posts to be prosecuted in an interview with the Washington City Paper, also said his ''attackers'' are:
''conspiracy theorist, white nationalists made up largely of racists, homophobic individuals who loosely tie together theories and do not attempt to find the truth'...''
He told NYT:
''From this insane, fabricated conspiracy theory, we've come under constant assault'... I've done nothing for days but try to clean this up and protect my staff and friends from being terrorized,'' he said.
He told NPR:
''We have talked to a few lawyers. It seems that there are not many outlets for people who have suffered this kind of attack and abuse. You're allowed to sue for defamation, but that suit takes many years and is very grueling. Additionally, these chat rooms where these people are based are protected by a law that claims that they're hosting sites, and therefore people can hide behind a screen name. So it's very difficult to identify who the bully or '' and harasser is.''
That statement, just by the way, is directly linked to Obama's plan for an ''Internet ID'' being assigned to each person online which would take away everyone's anonymity on the web'... a UN plan to track literally every single thing every person does online and tie it back to them in a permanent file.
You can already see how the narrative has been built up to use this story to shut down so-called ''fake news'' as a threat in real life.
And, as if right on cue, a man walks into Comet Ping Pong armed with the most vilified gun in American history and fires a single round into the floor.
Look. Let's sum this up.
Are some of the Wikileaks emails discussing pizza (and other foods) in an odd or disturbing way that does not really seem like they are talking about pizza?
Yes they seem to be.
Does Tony Podesta hang out with Alefantis and have birthday parties that involve flaccid penis cakes?
Yes apparently he does.
Is Tony Podesta's house (a house where a rich man with hundreds of thousands of dollars worth of art also keeps an assortment of stuffed animals next to his bed even though he has no children)
Is Tony Podesta's house filled with what many would consider creepy art by artists who sculpt headless women and artists who take pictures of naked teenagers or artists who paint children being abused?
Yes it is. And he also used to hang a twinkly mobile of female reproductive organs over his dining room table according to this 2008 Chicago Tribune article clip:
Do the Podestas and Alefantis hang out with and get invited to attend Spirit Cooking dinners with an artist who talks about drinking bodily fluids like breast milk and semen and discusses cutting one's self to drink the ''pain'' and is featured at occult ''art'' parties where they eat life-sized people cakes and drink substances off naked bodies that look like blood?
Yes, according to Wikileaks emails and Instagram posts, they do.
Does James Alefantis (whose name many people have pointed out is remarkably similar, in fact almost a direct anagram of, the French translation of the phrase ''I love kids'' or J'aime les enfants) send out sexually explicit and what some people would consider nasty hashtags on posts featuring children on his Instagram? Yes he has.
Would you do this if you were running a restaurant you described as a ''family friendly business'' that hosts child sleepovers but also hosts some of Washington's most powerful people for dinner? No, most people, probably would not.
Are powerful people in Washington involved in pedophile rings? There has been evidence to suggest it in the past, just think the Franklin Scandal.
Does all of this mean the allegations in the Pizzagate conspiracy are real or fake?
The answer is neither. All of this information ultimately proves nothing either way. Pizzagate is still an unconfirmed conspiracy theory.
BUT NOW, that isn't even the point anymore. The point is how this story will be used against the alternative media reporting on it. Lots of alt sites have already been attacked and many shut down for reporting on it, ours included. No doubt this will continue.
It bears repeating once more that this story involves a nest of political operatives working under the woman who literally coined the term ''vast right-wing conspiracy''. Now what if I told you that George Soros has indirectly funded Comet Ping Pong and Mr. Alefantis? Would you just consider for a moment the totality of what I'm suggesting here?
The point is that psyops can still have grains of truth. Lots of them. In fact, a psyop can be overflowing with truth'... and still completely misdirect people.
Are these people creepy individually and creepier together? A whole lot of people the globe over think they are, me included, and it has absolutely nothing whatsoever to do with their support of Hillary Clinton. Are there pedophile references here? Yes indeed.
Does that mean Pizzagate is proof of a pedophile ring? None of this information is hard proof of anything.
Will this whole situation be used to shut down the alternative media or at least kill anonymity online?
They are certainly going to try, and Pizzagate gives them a ton of ammunition with which to do so.
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Piper writes for The Daily Sheeple. There's a lot of B.S. out there. Someone has to write about it.
Poppie$tan
America's failed war on drugs in Afghanistan is threatening to doom its war on terror as well '-- Quartz
Fri, 09 Dec 2016 17:31
According to a recently released report by the Afghan Ministry of Counter Narcotics and the United Nations Office on Drugs and Crime (UNODC), opium production in Afghanistan has risen by 43% in the last year. The country's drug trade employs some 2.9 million people'--12% of the Afghan population'--and generates approximately $68 billion in revenue a year.
This increase comes despite the fact that drug eradication policies have been a cornerstone of US policy in Afghanistan since the invasion in 2001. In fact, winning the war on drugs in Afghanistan has been described as essential for winning the war on terror. The US government has spent some $12 billion in eradication efforts'--more than four times the size of the entire pre-invasion economy. Yet, Afghanistan now supplies around 90% of the world's opium.
This expansion of the opium economy in the face of such vast prevention efforts is actually a wholly predictable consequence of US drug policy.
Economics teaches us that banning a substance does not make it go away. Instead, it pushes the market into an underground or ''black'' market. Black markets lead to higher prices for banned goods. The higher prices for illegal opium have proved Afghan citizens a major incentive to produce opium on a scale never seen before.
As if the increase in the Afghan opium supply and $12 billion weren't enough to illustrate the utter failure of US operations in Afghanistan, consider the fact that anti-drug operations have actually worked to strengthen the Taliban and undermine the war on terror. Again, economics can tell us why.
In addition to creating black markets, another classic consequence of prohibition is the rise of cartels. Enticed by the potential for high profits, organized crime may find lucrative business opportunities manufacturing and selling illegal goods.
Cartels form in a variety of illegal drug markets'--from Chinese opium gangs in the early 1900s to Pablo Escobar's multi-billion dollar cocaine empire in Colombia to Mexico's cartels today. In each of these cases, existing criminal groups have taken advantage of their penchant for violence and working outside the law to earn serious cash.
In Afghanistan, the drug cartel is the Taliban. In fact, the terror group takes in an estimated $200-$400 million annually from the illicit opium economy. But US drug policy doesn't just offer the Taliban a profitable business opportunity; it also drives Afghan citizens toward the terror group.
Recall that some 12% of Afghans work in the illegal drug trade. Many of these people are poor farmers. Farmers say other crops simply do not provide enough money to support their families. Growing poppy, with its high black market price, provides the opportunity for a better life. Not only does US policy threaten their source of income, but it automatically criminalizes a large segment of the population.
This has caused many people in Afghanistan to turn to the Taliban for help. Recognizing a big revenue opportunity, the Taliban began offering protection to farmers in exchange for payment or part of their crops. Farmers, desperate to preserve their incomes, obliged. This not only gives ordinary citizens a stake in Taliban success, but makes them much less likely to support or cooperate with coalition forces or the new Afghan government.
This local support combined with the desire of the Taliban to protect its business interests is bad news for US troops. The UN has acknowledged that the Taliban insurgency and drug trade are intimately linked. But research has also found that provinces producing more opium see higher levels of terror attacks. Moreover, there appears to be a correlation between spikes in the number of terror attacks and the months in which opium is harvested. This not only makes the job of US forces more difficult, it also puts them in real danger.
The fact that US eradication efforts in Afghanistan have been met with more opium production than ever would be laughable if it weren't so lamentable. Simply put, US attempts to reduce the drug trade in the country have failed and are now effectively undermining the goals of the war on terror.
The best way to help Afghanistan is to get out of their way and allow for sovereign nations to rule without US interference. Not surprisingly, many scoff at such an idea. How could permitting the production and sale of drugs weaken a terrorist group that relies on such an industry for its income? Once again, the answer is basic economics.
Milton Friedman, the Nobel-winning economist, famously noted that, ''If even a small fraction of the money we now spend on trying to enforce drug prohibition were devoted to treatment and drug rehabilitation, in an atmosphere of compassion not punishment, the reduction in drug usage and in the harm done to users could be dramatic.'' The solution is as relevant today as it was when Friedman first offered it.
Indeed, when nations are allowed to control their domestic drug policies, dramatic reductions in drug use have often resulted. For example, Switzerland during the 1980s found itself battling a heroin epidemic that was increasing HIV/AIDS rates. Instead of cracking down on users and sellers, Switzerland adapted a harm reduction policy. This program opened free centers for addicts where they were given clean needles, high-grade heroin, showers, beds, and most important of all, treatment for their addiction.
The results speak for themselves'--the majority of addicts were able to secure regular employment because they could focus on other things besides financing their addiction. Today, over 70% of opiate or cocaine users in Switzerland utilize harm reduction treatment centers. Contraction of HIV has dropped dramatically and so have drug overdoses.
Prohibition doesn't work, and making something illegal doesn't stop the sale and consumption of the item prohibited. Those who lose out most of all are the people of Afghanistan. For 15 years their country has been in chaos, in no small part thanks to US efforts. And without a serious change in policy, this problem is unlikely to go away anytime soon.
Learn how to write for Quartz Ideas. We welcome your comments at ideas@qz.com.
Ministry of Truthiness
Is Van Jones another conflict of interest headache for CNN? | TheHill
Sun, 11 Dec 2016 03:41
CNN, which has just emerged from the backlash of former contributor Donna Brazile providing debate questions to the Hillary ClintonHillary Rodham ClintonTrump must not pull a bait-and-switch on American workersJewish groups divided over Hanukkah party at Trump hotelColo. AG: Electoral College lawsuit could cause 'chaos'MORE campaign, appears to have a new conflict of interest issue on its hands '-- this time, with the network's hottest commodity, Van Jones.
Jones is ''hot'' in that he was just given a prime-time, post-election special to host "The Messy Truth" that did relatively well from a ratings perspective.
The special easily finished as CNN's most-watched program of the evening in total viewers (1.226 million) and in the key demographic of 25- to 54-year-olds (449,000), the latter being good for second place at 9:00 p.m., behind a vacationing Megyn Kelly-less "The Kelly File."
No matter: In CNN's world, Jones's special was the only program to even break 1 million in total viewers, thereby making him the tallest kid in the class.
And he truly is CNN's "it" guy right now '-- he's landing interviews everywhere, from "The Daily Show" to Rolling Stone.
His commentaries '-- such as his blaming Donald TrumpDonald TrumpRepublican wins La. Senate runoff in final 2016 raceCorker calls Tillerson 'very impressive'The other face of immigration from Mexico is AfricanMORE's stunning victory on a "whitelash" of voters '-- go viral more than those of most network personalities lately.
But it was revealed on Thursday via a Washington Free Beacon report that Jones is also running a PR firm called Megaphone Strategies that is openly courting Electoral College electors in states across the country to not cast their vote for Trump on Dec. 19.
One of those electors is Chris Suprun, a Republican elector from Texas. Suprun recently made his plans known to not vote for Trump '-- who won his state's 38 electoral votes easily '-- in a New York Times opinion piece detailing the reasoning behind his defection.
Per the Free Beacon:
"Supron wrote in his Twitter bio to direct all media inquiries to an email address at Megaphone Strategies, a Washington, D.C.-based 'social justice' public relations firm.
''Van Jones, a left-wing CNN commentator and former adviser to President Obama who resigned after coming under fire for his affiliation to 9/11 conspiracy theorists and referring to Republicans as 'assholes,' founded Megaphone Strategies earlier this year."
"'We are working with a number of electors on this issue, not just Chris [Suprun],''' Megaphone's media director, Nina Smith, wrote said in a statement.
For his part, Jones recently spoke about a need to mobilize against the president-elect in large numbers.
"Tight around Trump is a little hate army '-- not every Trump voter '-- but tight around him is a little hate army of very cynical, nasty people who took over our government," Jones told Rolling Stone in its most recent issue. "We have to build a massive Love Army that can take the country and the government back in a better direction."
So is Jones now as compromised as Brazile was? And if so, what does CNN do about it?
An inquiry by The Hill has been sent to CNN. We will update this commentary accordingly upon hearing back.
Here's a few ideas that won't exactly shake the network to its core:
1) Place Jones on mandatory holiday until Dec. 19, when electors cast their votes. Everyone who worked tirelessly the last 540 days covering the Trump campaign and transition is exhausted. Jones '-- like almost everyone in this business '-- has earned some time off. And by taking Jones out of the equation until then, the conflict goes away.
2) If a vacation isn't in the cards, every segment that Jones appears in demands a disclaimer from the anchor or host stating he is representing at least two electoral defectors to Trump via the PR firm he founded this year.
Result: The business and agenda end of Jones outside of CNN is now known to the viewer, and they can decide from there if his commentary is compromised for whatever reason.
These are fair solutions and ones that sorely need to be implemented if many in the media, including CNN, were being serious when talking about a need for soul searching and being more transparent with its audiences in an effort to rebuild trust for an otherwise broken Fourth Estate.
To drive home this point, just before the election there was a segment done by Fox's Kelly, on Nov. 1, that explored the issue of having paid contributors at cable news networks also working outside their TV capacities in other areas that clearly present conflicts of interest.
The guest was Jon Klein, former president of CNN prior to the current one, Jeff Zucker. The impetus for the conversation was the Brazile debate question leak.
"I hope this can be the death knell for the surrogates that all the news networks employ because it's predictable," Klein argued. "As a viewer ... it's boring. We know what the Punch and Judy puppets are going to say every time."
Klein couldn't be any more correct: It is predictable. There is too much potential for conflicts of interest. And in the end, a contributor job where one is paid to opine on television may not be able to compete with what said contributor deems as a bigger, more important cause.
In Jones's case, that's a massive ''love army'' aided by his own boutique PR firm.
And that's fine. It's a free country.
But in an effort to avoid another Donna Brazile fiasco, CNN's audience either needs to be informed of this potential conflict of interest or Jones needs to be shown the bench when it comes to any Trump segment '-- at least until Dec. 19.
Starting today.
UPDATE: Friday afternoon, Nina Smith, the Director of Media Relations for Megaphone Strategies, issued this statement to The Hill:
"Megaphone Strategies is a public relations firm '-- our work centers around securing media attention for causes. Van Jones has no say in the clients we choose, plays no active management role in the firm, nor does he have any financial stake in Megaphone. His role on the board is in an advisory capacity as it pertains to our big picture mission and vision. Further, Megaphone is in no way engaged in persuading electors. We will and do represent any electors that wish to stop an unfit candidate from becoming President of the United States. We do this in coordination with our work to support the so-called Hamilton Electors."
Concha is a media reporter for The Hill
The views of Contributors are their own and are not the views of The Hill
Megaphone Strategies - Cutting Edge Communications Services
Sun, 11 Dec 2016 03:48
Jessica, also known as JAM, is an award-winning writer, activist, and poet. Her writings about race and ethnicity have been published and cited in the Huffington Post, the Business Insider, LA Progressive, and MSNBC. She's been featured on TV One's ''News One Now'' with Roland Martin, ''Roundtable with Stephanie Robinson,'' on the Tavis Smiley Network, and SiriusXM's ''Make It Plain'' with Mark Thompson.
Van Jones' PR Firm Working With GOP Electors Voting Against Trump
Sun, 11 Dec 2016 03:41
CNN contributor Van Jones / AP
BY:Joe SchoffstallDecember 7, 2016 4:16 pm
A progressive public relations firm founded by environmentalist and CNN political contributor Van Jones is representing ''a number'' of Republican electors who plan on voting against President-elect Donald Trump.
Chris Suprun, a Republican presidential elector from Texas, garnered media attention on Monday after having an opinion piece published in the New York Times explaining why he plans to defect from Trump with his Electoral College vote on Dec. 19.
''The election of the next president is not yet a done deal. Electors of conscience can still do the right thing for the good of the country,'' Suprun wrote. ''Presidential electors have the legal right and a constitutional duty to vote their conscience. I believe electors should unify behind a Republican alternative, an honorable and qualified man or woman such as Gov. John Kasich of Ohio. I pray my fellow electors will do their job and join with me in discovering who that person should be.''
Supron wrote in his Twitter bio to direct all media inquiries to an email address at Megaphone Strategies, a Washington, D.C.-based ''social justice'' public relations firm.
Van Jones, a left-wing CNN commentator and former adviser to President Obama who resigned after coming under fire for his affiliation to 9/11 conspiracy theorists and referring to Republicans as ''assholes,'' founded Megaphone Strategies earlier this year. Jones has attributed Trump's electoral success to a ''white-lash'' and said that a Trump ''hate wave'' could hit Canada.
''Megaphone Strategies is a new social justice media strategy firm run for purpose, not profit,'' the group says on its website. ''We offer cutting edge strategy, training, and media relations services to high-impact social justice organizations and individuals. Our mission is to use PR as a tool to diversify progressive movements''lifting up diverse progressive leadership in the media''and to provide services based on ability to change the world, not ability to pay.''
''We are run by and for the movement, profits are reinvested into the movement to provide services to up-and-coming groups who couldn't traditionally afford our work,'' the group says.
Megaphone Strategies lists a majority of its clients as environmental and ''social justice'' organizations such as 350.org, Green For All, Democracy Fund, and Demand Progress.
Nina Smith, the director of media relations at Megaphone Strategies, whose email is listed in the Twitter bio of Suprun, told the Washington Free Beacon that the group is working with ''a number'' of Republican and Democratic electors who do not plan on voting for Trump.
''We are working with a number of electors on this issue, not just Chris,'' Smith said in an email statement. ''Elector Suprun placed my email in his bio to help direct the deluge of media coming his way.''
Smith provided the Free Beacon with a press release for another presidential elector, Michael Baca, who does not plan on voting for Trump. Baca is the second presidential elector the firm is representing and said he will vote for Republican Ohio Gov. John Kasich.
Megaphone Strategies says that electors have reached out to their counterparts for advice on which Republican they would prefer. Kasich was the top pick.
''What's most clear is that Trump has many detractors, even among Electors who had previously pledged to support the eventual Republican nominee,'' the release says. ''Baca is the first Elector to formally announce his support of the Ohio Republican and the Hamilton Electors effort.''
The firm claims that Trump is facing a ''growing Electoral College revolt'' that hopes to deny him the presidency.
''In contrast, Trump is facing a growing Electoral College revolt, where Electors from both parties are working together to deny him the Presidency,'' the release says.'¯''Conversations with many other Electors, both Republican and Democratic, indicate that many more are coming forward to reject Trump in the days ahead.''
''If Trump loses an additional 36 votes in the Electoral College,'' the release continues, ''he will not win the Presidency, and the election would go to the U.S. House of Representatives, which has happened twice in our nation's history.''
Update 11:54 A.M.: Following publication, Smith clarified that Megaphone Strategies is working with a number of electors on both sides of the aisle.
WikiLeaks
Juliana Assange public statement
Fri, 09 Dec 2016 00:54
- no title specified14/15 NOVEMBER 2016 QUESTIONING AT THE ECUADORIAN EMBASSY
LEGALLY PRIVILEGED
You have subjected me to six years of unlawful, politicized detention without charge in prison, under house arrest and four and a half years at this embassy. You should have asked me this question six years ago. Your actions in refusing to take my statement for the last six years have been found to be unlawful by the UN Working Group on Arbitrary Detention and by the Swedish Court of Appeal. You have been found to have subjected me to cruel, inhuman and degrading treatment. You have denied me effective legal representation in this process. Despite this, I feel compelled to cooperate even though you are not safeguarding my rights.
I.THE SWEDISH PRELIMINARY INVESTIGATION
I, Julian Assange, an Australian citizen, have had my passport taken by British authorities and so cannot provide formal identification, am in a situation of arbitrary detention according to the decision of the United Nations Working Group of Arbitrary Detention (UNWGAD) of 4 December 2015; a political refugee since 19 June 2012 at the Embassy of Ecuador with asylum which was granted by Ecuador on 16 August 2012, and hereby appear before the authorities of Sweden and Ecuador in the framework of a rogatory commission that has been entered between these two states, requested by the Swedish prosecutor Marianne Ny, and declare that:
1.I ratify what has been expressed by my Ecuadorian lawyer, both in relation to this procedure today and the concerns about the procedure pursued against me in Sweden, including the failure to allow my Swedish lawyer to be present and the failure to provide me with exculpatory and other discovery material, which I have, to date, not been given proper access to, including in the preparation for this statement today.
2.Today, 14 November 2016, after having made myself available to the Swedish authorities since the start of this outrageous process six years ago, I am finally given the opportunity to give my statement to the Swedish preliminary investigation. I am grateful to Ecuador for attempting to facilitate this process in the circumstances where the Swedish prosecutor has declined, since 2010, to accept this, my first statement on the allegation against me.
3.I went to Sweden on 11 August 2010. During my stay, I met a woman (hereinafter called ''SW''). On the evening of 16 August, 2010 she invited me to her home. During the night and in the morning we had consensual sexual intercourse on several occasions.
4.I therefore could not believe my eyes when five days later I saw a headline in a Swedish tabloid that I was suspected of a crime and arrested in my absence. I immediately made myself available to the Swedish authorities to clarify any questions that might exist, although I had no obligation to do so.
5.That same day (21August 2010), the Chief Prosecutor of Stockholm, Eva Finn(C), dropped the arrest warrant against me and within days would close the preliminary investigation with the finding that no crime whatsoever had been committedagainst the woman ''SW'' (who is the subject of this procedure). I drew the conclusion that, other than the worldwide damage to my reputation caused by millions of web pages saying that I was ''wanted for rape'', my life, in this respect, would return to normal.
6.On 23 August 2010, the Chief Prosecutor of Stockholm, Eva Finn(C) stated she "made the assessment that the evidence did not disclose any offence of rape".
7.On 25 August, the Chief Prosecutor found that "The conduct alleged disclosed no crime at all and that file (K246314-10) would be closed".
8.A week later, I learned to my surprise that a different prosecutor by the name of ''Marianne Ny'' had reopened the preliminary investigation without any consultation or opportunity for me to be heard '' after I had already been cleared and the case had been closed.
9.That prosecutor eventually issued an extradition warrant against me, supposedly to take my statement, even though I left Sweden with her permission and in good faith, and had repeatedly tried to see if the prosecutor was ready to accept my statement. I hadnotand havestillnot been charged with a crime.
10.It has taken more than six years for the prosecutor to now obtain my statement. The delay is entirely caused by the prosecutor who re-opened the closed preliminary investigation. A prosecutor is, according to Swedish law (Chapter 23, Section 4 of the Procedural Code), obligated to conduct the preliminary investigationas expeditiously as possible and when there is no longer reason for pursuing the investigation, it shall be discontinued. At the preliminary investigation phase, the prosecutor is obligated to take into account all the circumstances: those against the suspect as well as those circumstances in favour of the suspect, and any evidence favourable to the suspect shall be preserved. The investigation shall be conducted so that no person is unnecessarily exposed to suspicion, or put to unnecessary cost or inconvenience.
11.Instead of following the law, prosecutor Marianne Ny has kept the preliminary investigation open without justification for over six years. She deliberately suspended her work to progress and bring to a conclusion the preliminary investigation. She has for more than six years refused to take my statement during which time she has done nothing to pursue the preliminary investigation. The preliminary investigation entered into a stasis more than six years ago. I have always demonstrated my willingness to cooperate in order to speed up the process ''although there is no obligation whatsoever for me to do so. All the obligation is on the prosecutor to progress the preliminary investigation. This attitude of the prosecutor has clearly breached mandatory rules in Swedish law.
12.I reiterate that over the past six years, I have continued to call for this prosecutor to accept my statement, including by:
'--Willingly attending a questioning on 30 August 2010 in Stockholm, where no questions were asked about the allegation, as I had already been cleared.
'--Staying in Sweden for more than five weeks longer than planned, repeatedly asking if or when I could give a statement, despite pressing commitments elsewhere.
'--Gaining the prosecutor's consent to leave Sweden before doing so on 27 September 2010 in good faith, understanding that I was not required to provide a further statement for the time being. On the day I left the country three of my encrypted laptops were seized from me at Stockholm's Arlanda airport. The laptops contained evidence of war crimes pending publication and protected legal correspondence.
'--Offering to return to Sweden to give a statement in October 2010.
'--Offering to give my statement from London via numerous methods including telephone or videolink or in writing from London between October 2010 and up to and through the prosecutor unnecessarily issuing a European Arrest Warrant. The European Arrest Warrant attempted to extradite me, without charge, from the UK to Sweden, to take my statement. I was actively offering the testimony she claimed she wanted when she sought my arrest.
'--Providing a DNA sample six years ago in December 2010 when I was first arrested at Sweden's request and which has been available to the prosecutor for the last six years. She has never bothered to even attempt to use it.
'--Offering to give a statement in London via Mutual Legal Assistance, among other suggestions, during my time of house arrest (7 December 2010 '' 19 June 2012).
'--Offering to give a statement in the Ecuadorian embassy in London as from 19 June 2012, for instance via email from my Swedish lawyers on 24 July 2012 and during a meeting between my lawyers and the prosecutors in Stockholm 7 May 2013 '' over four years ago and over three years ago respectively.
'--Offering to come to Sweden provided Sweden would give a guarantee that I am not extradited to another state over my publishing work. This offer was also requested by Ecuador through diplomatic channels and publicly in 2012, as I am a refugee in its jurisdiction.
13.As this demonstrates, although I have no obligation to do so, I have done everything within my power to offer my testimony to the prosecutor while protecting my right to asylum and protecting myself against the risk of extradition to the United States, where there is an open national security case against me. According to the UN Special Rapporteur on Torture, WikiLeaks' alleged source in that matter, Chelsea Manning, has been subjected to cruel, inhuman and degrading treatment in US detention, and has since been convicted and sentenced to 35 years in prison.
14.The state of Sweden has refused to provide me the necessary assurances against extradition or other transport to the United States since 2010 when such was asked by my lawyers and since 2012 when requested to do so by the state of Ecuador. Sweden has also refused to accept that the asylum Ecuador has granted me requires it to protect me from onwards extradition to the United States, despite this being the recognized norm in asylum cases, thus making it impossible for me to go to Sweden without giving up my fundamental right as a political refugee. This refusal to recognize my rights as a political refugee has been the sole impediment to my presence in Sweden. I explicitly offered to accept extradition to Sweden provided it simply guaranteethat it will nottransfer me toanother state.This was declined.
15.Nevertheless, I have continued to offer the prosecutor my statement through mechanisms which can be employed to achieve her stated purpose without putting at risk my fundamental rights, which she has, until recently, rejected.
16.Two years ago the Svea Court of Appeal on 20 November 2014 severely criticized the prosecutor for her negligence:
''The Court of Appeal notes, however, thatthe investigation into the suspected crimes has come to a haltand considers thatthe failure of the prosecutors to examine alternative avenues is not in line with their obligation'' in the interests of everyone concerned '' to move the preliminary investigation forward.''
17.It was not until March 2015 that Marianne Ny finally '' after she had been found in breach of her duties by Sweden's Court of Appeal and my case was before the Supreme Court and it became apparent that she might lose '' claimed that she would, under certain restrictive conditions, accept my statement after all.
18.Since that time, the United Nations Working Group on Arbitrary Detention (UNWGAD) released its ruling on 5 February 2016 that my situation in the embassy amounts to an unlawful and arbitrary detention, in breach of Sweden's binding legal obligations under international law. UNWGAD found that Sweden and the UK have disregarded the asylum that I have been granted by Ecuador, forcing me to choose between deprivation of liberty and the risk of losing Ecuador's protection and being extradited to the United States.
19.It then took Marianne Ny more than 18 months after her claimed change of position at the Supreme Court to arrange this meeting. I have not been responsible for a single day of delay in this process. All the delay has been caused by prosecutor Marianne Ny and the state authorities. Again note that all the obligation is on the prosecutor.
20.Furthermore, the UNWGAD concluded that the Swedish prosecutor has breached my due process rights in the conduct of this preliminary investigation and that seeking my extradition to Sweden as the only option in these circumstances was ''excessive and unnecessary'' [para 97]. In particular, it found:
''...after more than five years' time lapse, he is still left at the stage of preliminary investigation with no predictability as to whether and when a formal process of any judicial dealing would commence...''[para. 97]''...Mr Assange has been denied the opportunity to provide a statement, which is a fundamental aspect of the audi alteram partem principle, theaccess to exculpatory evidence, and thus the opportunity to defend himself against the allegations...''[para. 98]''...the duration of such detention is ipso facto incompatible with the presumption of innocence.''[para. 98]
21.As a result of the Swedish prosecutor's actions, UNWGAD found my circumstances to be of an increasingly serious deprivation of liberty which is of an indefinite nature and is already far longer than the maximum penalty I could ever theoretically face in Sweden. For these reasons UNWGAD found that the severe and indefinite nature of these deprivations amounts to cruel, inhuman and degrading treatment in breach of Sweden's obligation under the International Covenant on Civil and Political Rights (ICCPR) Article 7. The severity of this treatment is further confirmed by the expert opinion of Fernando Mari±o, the former President of the UN Committee Against Torture, which is entered into the official record of this proceeding.
22.Ten months after the UNWGAD determination the harshness of the situation continues to affect my physical and psychological health. My lawyers have informed the Swedish authorities of the ongoing deterioration of my health through the medical certificates and expert opinions of Dr. Michael Korzinski and Dr. Fluxman, from 11 November 2015; of Dr. Ladbrooke from 8 December 2015; of Dr. Michael Korzinski from 15 June 2016; and of Dr. Ladbrooke from 9 November 2016.
23.And so, finally, here we are today, under the jurisdiction of Ecuador, with my rights ever increasingly limited, as my Ecuadorian defence counsel has expressed. After more than six years, I am finally being given the ''opportunity'' to give my statement but with my Swedish counsel having been excluded and under a clear situation of legal defencelessness, resulting from years of negligence and intentional and unlawful delays by the Swedish authorities.
24.All the irregularities that have occurred through the acts or omissions of the prosecution authority and the six-year delay to date of this disproportionate, inhumane and unlawful preliminary investigation have permanently destroyed all possibilities for me toproperly defend myself'' which is no doubt their intention.
25.Following the above, I wish to express in the strongest terms, that, in addition to the breaches of my due process rights in the investigation to date, the procedure to be adopted today in taking my statement further breaches those rights:
'--In the opinion of my general practitioner, I am unfit to prepare and participate in these proceedings (afterhavingbeen denied hospital treatment and sunlight for 4.5 years).
'--My Ecuadorian defence counsel has had no access to the case file, let alone in Spanish, the language he understands, nor has he had adequate time to prepare my defence.
'--My lawyers and I have not been permitted access to the case file.
'--I have been denied my request to read the text messages that my Swedish defence lawyers have read, which are a key element to my defence because they clearly show that I am innocent.
26.Due to all the shortcomings stated above, prosecutor Marianne Ny should have drawn the obvious conclusion that she discontinue the preliminary investigation.
27.In this context I once again remind you that I have already been cleared and that the preliminary investigation was closed by Chief Prosecutor Eva Finn(C) in August 2010.
28.Given this history I have good reason to have concern about whether this ''preliminary investigation'' is being conducted in good faith and whether honest and impartial consideration will be given to my statement. I suspect that the real purpose of the Swedish prosecutor coming here today is not to obtain my statement but is simply a ruse to tick a box to ensure the technical possibility to indict me, irrespective of how I answer any questions.
29.I do not believe that prosecutor Marianne Ny is acting in good faith or with the objectivity and impartiality required of her office. For example, after circumventing the Chief Prosecutor of Stockholm's decision to close this case,prosecutor Nyhas made at least 40 press releases and press conferences about mewhere my name has been published, even though there is no charge against me and I have been previously cleared, subjecting me to endless needless suspicion,in clear violation of her duty to not do so under Chapter 23, Section 4 of the Swedish Procedural Code.
30.My overall conclusion is that the prosecutor's conduct of the preliminary investigation, for all the reasons above has continued to deprive me of the right to defend myself.
31.I have no obligation to cooperate with this abuse, but I find myself in a coercive situation. I am meant to be protected by the decision of the UNWGAD which makes it clear that this ''preliminary investigation'' has violated my human rights and that its attempts to arrest me should be discontinued immediately. That decision was issued almost a year ago, but my situation remains unchanged.Despite the many violations already described I feel compelled to give my statement today so that there can be no more excuses for the Swedish prosecutor Marianne Ny to continue my indefinite unlawful detention, which is a threat to my health and even to my life. I have been pushing and indeed litigating for this prosecutor to take my statement for more than six years. The prosecutor has made excuse after excuse to not take my statement. I will not grant this prosecutor any excuse to continue to avoid taking my statement as I fear she would use it as a means to indefinitely prolong my cruel, inhuman and degrading treatment.
II.REASONSWHYI TRAVELLEDTO STOCKHOLM IN AUGUST 2010
32.I am the editor-in-chief and publisher of WikiLeaks,a publishing organisationspecializing in the analysis of records under risk of censorship that are of political, diplomatic, historical or ethical importance. Among other countries, WikiLeaks publishes and analyses documents that concern the United States, Sweden and the United Kingdom, including millions of documents relating to actions of military, intelligence and foreign services. I have received numerous awards in relation to my publishing work, including the 2008 Index on Censorship Freedom of Expression Award, The Economist New Media Award (USA) 2008, the 2009 Amnesty International UK Media Award (New Media), the 2010 Sam Adams Associates for Integrity in Intelligence (USA)award, the 2011 Sydney Peace Foundation Gold Medal (Australia), the 2011 Martha Gellhorn Prize for Journalism (UK), the 2011 Walkley Award for Most Outstanding Contribution to Journalism (Australia), the 2011 Blanquerna Award for Best Communicator (Spain), the 2011 International Piero Passetti Journalism Prize of the National Union of Italian Journalists, the 2011 Jose Couso Press Freedom Award (Spain), the 2012 Privacy International Award, the 2013 Yoko Ono Lennon Courage Award, and the 2013 Global Exchange Human Rights Awards, as well as formal nominations for the United Nations'Mandela Prize (2014) and for the past six consecutive yearsforthe Nobel Peace Prize.
33.The US launched an investigation against me in early 2010 under the Obama administration, while Hillary Clinton was the US Secretary of State. This administration has expended very substantial resources on attempting to prosecute me and attempting to spy on my publishing work despite its constitutionally protected status. The US government's WikiLeaks investigation is described in official diplomatic correspondence as being''unprecedented in scale and nature''.
34.All the citations I mentionarein my affidavit from 2 September 2013, which I am entering into the official record of this proceeding.
35.The US government has periodically confirmed in public that the national security case against WikiLeaks remains open and ongoing, including in proceedings from this year. Numerous human rights and freedom of speech organizations such as Human Rights Watch have criticized the Obama administration for pursuing a criminal case against WikiLeaks and me.
36.The investigation against Wikileaks is led by the FBI and has involved a dozen other agencies, including the CIA, the NSA, and the Defence Intelligence Agency. The US government has described the investigation as a "whole of government" investigation. In Alexandria, Virginia, a Grand Jury has been meeting behind closed doors for the past six years under case number 10GJ3793 to explore ways to imprison me and seven others who they have identified as "founders, owners or managers of WikiLeaks". The prosecution in the Chelsea Manning case attempted to establish that Private Manning acted as an agent under my control rather than as a journalistic source of mine, even though in Private Manning's own statement to the court, she said this was not the case. The US military charged Private Manning with twenty-two counts in connection with the release of more than 700,000 classified or confidential documents to WikiLeaks. On 30 July 2013 private Manning was convicted of twenty of these counts and sentenced to thirty-five years in prison on 20 August 2013.
37.Private Manning was detained for more than 1,000 days before the trial commenced. During this time she remained for 258 days in solitary confinement. The UN Special Rapporteur on Torture found that the conditions and length of private Private Manning's confinement at Quantico, Virginia, amounted to ''inhuman and degrading treatment''. Private Manning's lawyer, David Coombs, said that the treatment of Private Manning was an attempt at breaking her so that Manning would implicate me. The US military court system eventually found that Private Manning was unlawfully punished as a result of this treatment while in US custody. Private Manning was convicted of espionage; the first whistleblower ever so convicted. Private Manning was acquitted of the "aiding the enemy" charge, but the US government could still seek to employ this charge against me. Private Manning is serving a 35 year prison sentence.
38.According to the respected UK newspaper The Independent, the US and Sweden entered informal talks regarding my extradition from Sweden to the United States in early December 2010. These talks of my extradition concerned the US Grand Jury and FBI investigation against WikiLeaks, which is also the reason that Ecuador granted me asylum.
39.The aggressive calls to stop WikiLeaks from publishing were thereason for my travel to Stockholm.US officials' rhetoricgrew increasinglyaggressiveinthe period immediatelypriorto my visit to Sweden on 11 August 2010. In June, aDaily Beast news report entitled 'The State Department's Worst Nightmare'revealed that the Pentagon was ''conducting an aggressive investigation'' into whether WikiLeaks had 260,000 US diplomatic cables and the material's whereabouts.
40.Two days later, an article titled 'Pentagon Manhunt'appeared,describingPentagon investigators desperately trying to track me down in relation to the impending publication of Cablegate:
''Anxious that Wikileaks may be on the verge of publishing a batch of secret State Department cables,investigators are desperately searching for founder Julian Assange''.
41.On 17 June 2010 US Department of Defense spokesman Geoff Morrellstatedthere was an
"ongoing criminal investigation [concerning WikiLeaks], involving the Army Criminal Investigation Division, as well as, I believe, some other law enforcement agencies.''
42.ThePentagonofficials ''would not discuss the methods being used to find Assange, nor would they say if they had information to suggest where he is now.'' On reading this, IrealisedWikiLeaks'continued ability to publish effectively and my own personal safetywere at serious risk.
43.During the month of July I worked with a team of journalists in the United Kingdom to publish the Afghan War Diaries: 75,000 secret Pentagon documents about the war in Afghanistan, which included the detailed records about the deaths of nearly 20,000 people. The day after WikiLeaks published the Afghan War Diaries, White House Press Secretary Robert Gibbs stated that WikiLeaks ''poses a very real and potential threat''.
44.I published the Afghan War Diaries approximately two weeks before Itravelledto Sweden. In the aftermath of the publication, US government officials made efforts to influence the way in which the media reported on our publications. The purpose wasto delegitimise WikiLeaks protections as a publisher under the US First Amendment. For example, it attempted to falsely cast WikiLeaks as an adversary, opposed to US national interests, a false claim that I would later see echoed in Swedish media.
45.The New York Times reported that the White House had emailed its reporters with suggested ''reporting tacks to take'' on WikiLeaks and WikiLeaks' disclosures, in an attempt to induce news outlets into referring to WikiLeaks in these terms.
46.The White House sent an e-mail with the subject heading ''Thoughts on Wikileaks'' containing a memo in which the White House
"advised journalists on possible reporting tacks to take on the [Afghan War Diaries] documents ['...] As you report on this issue, it's worth noting that wikileaks isnot an objective news outlet but rather an organization that opposes US policy in Afghanistan."
47.I also learned from news reports that security authorities from my home country Australia were assisting the US intelligence investigation into WikiLeaks and me:
"Australian security authorities are assisting a United States intelligence probe into the whistleblower website Wikileaks and its Australian founder and editor, Julian Assange. TheUS request for support in what Australian national security sources described as 'a counter-espionage investigation' preceded Wikileaks' dramatic publication yesterdayof a leaked US military operations log, described as an ''extraordinary compendium'' of 91,000 reports by United States and allied soldiers fighting in Afghanistan.''
48.On July 28th, just three days after publishing the Afghan War Diaries and two weeks before I travelled to Sweden, US Department of Defense Secretary Gates ''called FBI Director Robert Mueller and asked for the FBI's assistance in [the WikiLeaks] investigation as a partner.'' The US Defence Department declared:
"Calling on the FBI to aid the investigation ensures that the department will have all the resources needed to investigate... noting that use of the bureau ensuresthe investigation can go wherever it needs to go.''
49.The New York Times reported that US Defense Secretary Robert Gates
"declined to comment about the investigation beyond noting that he had enlisted theFederal Bureau of Investigation to assist Army investigators, a move that is seen as a precursor to potentially charging people who are not uniformed service members[...] A person familiar with the investigation has said that Justice Department lawyers are exploring whetherMr. Assange and WikiLeaks could be charged with inducing, or conspiring in, violations of the Espionage Act, a 1917 lawthat prohibits the unauthorized disclosure of national security information."
50.On 1 August 2010, the press reported that the FBI and British police were carrying out searches and interrogations in the UK, where I found myself at the time, in connection with WikiLeaks' publications.
51.Over the next days, US rhetoric and actions against WikiLeaks intensified. Prominent commentators and former White House officials championed extraterritorial measures and the violation of international law ''if necessary''.
52.One of these commentators was former presidential speech writer Marc Thiessen, who published a Washington Post article entitled 'WikiLeaks Must be Stopped':
"'...the government has a wide range of options for dealing with him. It can employ not only law enforcement but also intelligence and military assets to bring Assange to justice."
53.Thiessen argued that the US should put pressure on any state in which I was located and that the US should, if necessary, arrest me even without the consent of that state. He cited legal advice from the Department of Justice regarding FBI operations abroad:
''The United States should make clear that it will not tolerate any country -- and particularly NATO allies such as Belgium and Iceland -- providing safe haven for criminals who put the lives of NATO forces at risk.With appropriate diplomatic pressure, these governments may cooperate in bringing Assange to justice. But if they refuse, the United States can arrest Assange on their territory without their knowledge or approval."
54.Thiessen further asserted that the FBI could violate international law in order to stop me and apprehend other people associated with WikiLeaks' publishing activities. Thiessen cited a Department of Justice memo:
"the FBI may use its statutory authority to investigate and arrest individuals for violating United States law, even if the FBI's actions contravene customary international law" and that an "arrest that is inconsistent with international or foreign law does not violate the Fourth Amendment." In other words, we do not need permission to apprehend Assange or his co-conspirators anywhere in the world.
Arresting Assange would be a major blow to his organization. But taking him off the streets is not enough; we must also recover the documents he unlawfully possesses and disable the system he has built to illegally disseminate classified information.
This should be done, ideally, through international law enforcement cooperation. But if such cooperation is not forthcoming, the United States can and should act alone."
55.Seven days before I travelled to Sweden I was acutely aware that my personal safety was at risk.Scott Horton, legal affairs and national security contributor at Harper's, wrote the article 'WikiLeaks: The National-Security State Strikes Back':
"[Assange] will certainly be targeted for petty harassment and subject to steady surveillance, andefforts to kidnap him are almost certainly being spun at this very moment."
56.Pentagon Press Secretary Geoff Morrell announced an anti-WikiLeaks task force comprised of 80 people was operating 24 hours a day. One month later, it had grown to 120 people. The ''distinct responsibility'' of the Information Review Task Force '' dubbed by some occupants as the ''WikiLeaks War Room'' '' was
57.The article '''The General Gunning for WikiLeaks'' described the task force:
"In a nondescript suite of government offices not far from the Pentagon,nearly 120 intelligence analysts, FBI agents, and others are at work'--24 hours a day, seven days a week'--on the frontlines of the government's secret war against WikiLeaks.
Dubbed the WikiLeaks War Room by some of its occupants,the round-the-clock operation is on high alert this month '..."
58.The same article states that Brig. General Robert A. Carr, who runs ''the Pentagon's equivalent to the CIA'', the Defense Counterintelligence and Human Intelligence Center of the Defense Intelligence Agency (DIA), was ''handpicked'' by Defense Secretary Robert Gates to head the team because he ''is highly respected '...and a fitting adversary to Assange''.
59.General Carr's ''central assignment'' was reportedly ''to try to determine exactly what classified information might have been leaked to WikiLeaks''. General Carr testified at the Chelsea Manning sentencing hearing on 31 July 2013.
60.I followed closely how pressure mounted on US allies to track my movements and to stop our publications. Official sources within the administration revealed to the press that the US was not only considering how to prosecute me in relation to WikiLeaks' publications in the US, but was also requesting their allies to prosecute me under their own national security laws:
"American officials confirmed last month that the Justice Department was weighing a range of criminal charges against Assange and others [...]
Now, the officials say, they want other foreign governments to consider the same sorts of criminal charges."
An article published the day before I went to Sweden stated that "The Obama administration is pressing Britain, Germany, Australia, and other allied Western governments toconsider opening criminal investigations of WikiLeaks founder Julian Assange and to severely limit his nomadic travels across international borders, American officials say."
61.In addition to the stated intention to restrict my freedom of movement, the US government attempted to convince its allies not to allow me entry into their territory as a warning to me, to those working with me and WikiLeaks, and to our supporters:
"Through diplomatic and military channels, the Obama administration is hoping to convinceBritain, Germany, and Australia,among other allied governments, that Assange should not be welcome on their shores either,given the danger that his group poses totheir troops stationed in Afghanistan, American officials say. They saysevere limitations on Assange's travels might serve as a useful warning to his followers that their own freedom is now at risk."
62.The Australian government publicly entertained the possibility of canceling my passport, reportedly as a result of pressure placed on Australia by the United States. Australian Attorney General Robert McClelland assured the United States that the Australian government would ''provide every assistance to United States law-enforcement authorities'', including by exploring the possibility of canceling my passport.
63.US pressure even resulted in public attempts to influence decisions based on human rights considerations where I and WikiLeaks were concerned. Through US ambassador to SwitzerlandDonald Beyer, the Obama administration pressured Switzerland not to grant me political asylum while I participated at the UN Human Rights Council's Universal Periodic Review of the United States. US ambassadorBeyer gave an interview to Swiss newspaper Sonntag:
"The United States ambassador to Switzerland, Donald Beyer, has also entered the Wikileaks debate. He has warned the Swiss government against granting Assange asylum, which the Australian founder of Wikileaks has said he was considering requesting. ''Switzerland should very carefully consider whether to provide shelter to someone who is on the run from the law''.
64.The Daily Beast reported that Washington was prepared to review its diplomatic relations with Iceland because parts of WikiLeaks operations had been conducted in that country:
''An American military official tells The Daily Beast thatWashington may also want to closely review its relations with Iceland in the wake of the release of the Afghan war logs.''
65.In the context of my heightened concerns about US activities in the United Kingdom in relation to the WikiLeaks investigation, I decided to leave the country. When I travelled to Sweden on 11 August 2010, the aggressive rhetoricagainst me had reached new heights.Former CIA general counsel Jeffrey Smith told National Public Radio:
''I think it is entirely appropriate for us to be very aggressive[...]If I were the US government, I would be trying to make it as difficult as possible for the WikiLeaks founder to continue to do business...To the extent we can persuade our allies to consider prosecution, I think that's all to the good.''
66.On the same day I arrived in Sweden, 11 August 2010, I received information from an Australian intelligence source that extra-legal actions might be taken against me by the US or its allies. This was later reported in the Australian newspaper The Age:
''An Australian intelligence official privately warned Wikileaks on August 11 last year that Assange was the subject of inquiries by the Australian Security Intelligence Organisation, and thatinformation relating to him and others associated with Wikileaks had been provided to the US in response to requests through intelligence liaison channels.The Australian intelligence official is also claimed to havespecifically warned that Assange could be at risk of 'dirty tricks' from the US intelligence community.''
67.Friends and associates of mine and volunteers for WikiLeaks were regularly targeted at borders from this moment on. Border searches and interrogations have affected security researcher Jacob Appelbaum, who had given the keynote speech in my place at the HOPE conference on 16 July 2010. In an interview for Democracy Now, Appelbaum described the targeting he experiences at airports:
In the period of time since [the HOPE conference on 16 July 2010] they've started detaining me, around a dozen-plus times... I was put into a special room, where they frisked me, put me up against the wall... they took my laptop... then they interrogated me, denied me access to a lawyer. And when they did the interrogation, they have a member of the U.S. Army, on American soil. And they refused to let me go.They ... implied that if I didn't make a deal with them, that I'd be sexually assaulted in prison.
68.Within days of arriving in Sweden I became concerned about my safety and security there, in particular because of the pressure being brought to bear on US allies, including Sweden.
69.I was aware of the publicly stated attempts to track my movements. I used a number of risk minimisation procedures, including relying on the goodwill of friends and their circles for my safety and to protect the confidentiality of my whereabouts and communications.
70.My contacts in Sweden had arranged for me to stay in two safe houses during the few days I had intended to stay in Sweden. One of the safe houses belonged to a journalist who I knew and another to a Social Democrat party figure unknown to me who had lent her apartment while she was away, or so I had been told. However, because these two original safe houses arranged prior to my arrival became known very soon, I stayed in three additional safe houses between 11 and 20 August 2010.
71.I travelled to Sweden to put in place a legal strategy to try to protect our publishing servers, some of which were in Sweden. I believed these assets were at risk as a result of the intense political pressure from the US described above. I met with the Swedish Pirate Party, which was represented at the European Parliament at the time, who agreed to host copies of WikiLeaks servers under their party name in order to further protect our publishing work. I also felt it was best to leave the United Kingdom at that time because the FBI was known to be carrying out operations in connection with the investigation into our publications. I intended to stay in Sweden for less than a week.
72.My dependency on other people while in Sweden was aggravated when, shortly after my arrival in Stockholm, my personal bank cards were blocked. On 13 August 2010, the WikiLeaks organization's Moneybookers account could no longer be accessed. That same day, I contacted the company, who replied: ''following recent publicity and the subsequently (sic) addition of the Wikileaks entity to blacklists in Australia and watch lists in the USA, we have terminated the business relationship''. I requested further information from MoneyBookers on 13 August and 16 August regarding the closure, including which blacklists and watchlists my accounts and/or WikiLeaks' account had been added to, but I was refused this information.
73.The freezing of WikiLeaks' Moneybookers account was an early example of what in December 2010 would become a concerted extra-judicial global economic blockade against WikiLeaks by US financial service companies, including VISA, MasterCard, PayPal, Bank of America, Western Union and American Express. The blockade was the subject of several court actions, a European Commission investigation, a resolution by the European Parliament, and condemnation by the United Nations Special Rapporteur on the Promotion and Protection of the Right to Freedom of Opinion and Expression and the Inter-American Commission on Human Rights Special Rapporteur for Freedom of Expression. On 24 April 2013 the Supreme Court of Iceland found the blockadeagainst WikiLeaksto be unlawful.
74.As a result of being suddenly cut off from personal and organizational funds upon arriving in Sweden, I had to rely on others not only for shelter, but also for food, safety and telephone credit. Unfortunately, I knew very few people in Sweden and those I did were only sporadically in the country.
75.On 13 August 2010 one of the main Swedish newspapers, Svenska Dagbladet, published an article entitled 'Defence ministry prepared for the next leak', which reported that the Swedish Ministry of Defence had a dedicated group'preparing for WikiLeaks next publication' and had analysed 76,000 previous publications from WikiLeaks in relation to Swedish troops in Afghanistan.
76.Five days later, Swedish state television (SVT) published a segment entitled 'We risk United States relationship deteriorating', which argued that the presence of WikiLeaks in Sweden would negatively affect the strategic relationship between Sweden and the United States.
III.THE PERIOD 14-20 AUGUST 2010
77.I met ''SW'' during my visit to Stockholm. The first time I met her was on the morning of 14 August 2010 when she came to a speech I gave on what my work revealed about the war in Afghanistan,in which Sweden has troops under US command. She sat in the front row and photographed me. She came to the small private lunch after my talk where one of the organizers stated that she was a volunteer for their organization although they would later claim that this was not true. Due to the security threats against me as a result of my work, I was in a precarious situation. I relied on the kindness of strangers and the safety and discretion they were willing to offer me. I was in a foreign northern country, where I did not speak the language. I had no access to cash because the bank cards I was travelling with had been frozen due to the extra-judicial political measures taken by financial service companies against my organization and me (which are well-documented and the subject of extensive litigation).
78.Prominent ''pro-war'' personalities were calling for my assassination and capture, and the US administration had stated publicly that my movements were being tracked. "SW" appeared to be sympathetic to my plight and also appeared to be romantically interested in me. She was not close to people I was close to, so it seemed that those who meant me harm would be unlikely to try to find me by monitoring her movements. She said she worked at the National Museum so I asked her to show me, to try to establish her bonafides. At the Museum an IMAX film was playing, where she kissed me and placed my hands on her breasts. She asked whether I was staying with woman ''AA'', a Swedish politician, and seemed concerned by it in a manner which I found strange.
79.At her initiative we met again on the evening of 16 August 2010 and she suggested we go to a hotel in Stockholm. For security reasons, I said I would prefer to go to her house even though it was outside of Stockholm. She then invited me to her home. We went by train and she paid for my ticket since my bank cards had been frozen.
80."SW" made it very clear that she wanted to have sexual intercourse with me. I felt concerned about the intensity of ''SW'''s interest and I also deeply loved another woman, which played on my mind and left me emotionally distracted. "SW" knew an unusual amount of detail about me, and appeared annoyed with me when I was on my phone searching for news related to the US official government statements against me. I perceived she was irritated when I wasn't giving her my full attention.
81.I felt there was a risk my location would be revealed and that she might act unpredictably if she believed I was rejecting her. During that night and again in the morning we had consensual sexual intercourse on four or five occasions. Her words, her expressions and her physical reactions made it clear to me that she encouraged and enjoyed our interactions.
82.I would later discover that she had collected dozens of photos of me in the weeks before we even met. Her recent FLIKR photo account was filled with pages and pages of photos of me and no other person.
83.In the morning she went out to pick up breakfast for us. After enjoying breakfast together, I left her home on good terms. At no stage when I was with her did she express that I had disrespected her in any way or acted contrary to her wishes other than to not be interested in her enough to pay her attention above my security situation or attempts to sleep. She accompanied me to the train station on her bicycle and we kissed each other goodbye. She asked that I call her so we could see each other again and I said I would. She called the next day or the day after. We made friendly small talk but we were quickly disconnected due to a failing mobile connection. I did not call her back due to problems obtaining telephone credit (as a result of my bank cards being blocked) and the pressing security situation.
84.I spoke to her next on Friday 20 August, after a Swedish friend said that he had heard that ''SW'' was at the hospital and that she wanted to talk to me. As I had not called her back, and she had previously gone through considerable effort to attract my attention, I was initially concerned that she may have attempted self-harm in order to force me to pay attention to her. So I called her. She said she was at a hospital and asked me to come down to meet her to test myself for sexually transmitted diseases so she would not have to worry while she was waiting for her own test results (HIV, for instance, needs months to show up).
85.But I was busy that dayattempting to deal with the escalating political and legal threats against me from the Pentagon. I said I couldn't do anything until the next day (a Saturday). She said that it was normal in Sweden to go to the police to get advice about STDs and that if I didn't come down to the hospital she would go to the police to ask whether I could be forced to get tested. I told her I found her mention of police strange and threatening. She stated that she was only concerned about the tests and that it had no concealed meaning. I agreed to take the test out of goodwill and to reassure her, although I told her I could not do it until the following day, Saturday.
86.We were in agreement and arranged to meet the following day in the nearby park around lunchtime when I would have time to get tested. She said she was fine and seemed at ease.
87.You can imagine my disbelief when I woke the next morning to the news that I had been arrested in my absence for ''rape'' and that police were ''hunting'' all over Stockholm for me.
88.Her behaviour towards me on the night in question and in the morning made it clear that she actively and enthusiastically wanted me to have sex with her. This is also shown by text messages "SW" sent to her friends during the course of the evening I was at her home and during that week, which the Swedish police collected from her phone. Although the prosecutor has fought for years to prevent me, the public and the courts from seeing them, my lawyers were permitted to see them at the police station and were able to note down a number of them, including:
'--On 17 August "SW" wrote that we had long foreplay, but nothing happened (01:14); then it got better (05:15);
'--On 17 August, after all sex had occurred, ''SW'' wrote to a friend that it ''turned out all right'' other than STD/pregnancy risk (10:29);
'--On 20 August "SW", while at the police station, wrote that she ''did not want to put any charges on Julian Assange'' but that ''the police were keen on getting their hands on him'' (14:26); and that she was ''chocked (sic shocked) when they arrested him'' because she ''only wanted him to take a test'' (17:06);
'--On 21 August "SW" wrote that she ''did not want to accuse'' Julian Assange ''for anything'', (07:27); and that it was the ''police who made up the charges (sic)'' (22:25);
'--On 23 August "AA" (the other woman whose case was dropped in August 2015) wrote to "SW" that it was important that she went public with her story so that they could form public opinion for their case (06:43);
'--On 23 August "SW" wrote that it was the police, not herself, who started the whole thing (16:02);
'--On 26 August "AA" wrote to "SW" that they ought to sell their stories for money to a newspaper (13:38);
'--On 28 August "AA" wrote that they had a contact on the biggest Swedish tabloid (12:53); and "SW" wrote that their lawyer negotiated with the tabloid (15:59);
89.These text messages clearly show what really happened between "SW" and me. It is clearly consensual sex between adults. The communication between "AA" and "SW" later sadly speaks for itself.
90.The prosecutor's allegation in the extradition proceeding was reported to be that one of these sexual interactions started the next morning while "SW" was asleep (in the same bed after a night of consensual intercourse) and that when she woke up she consented to the intercourse in question, but for the first few moments was not theoretically capable of consent due to sleep.
91.This is false. I was certain "SW" was not asleep. I was also certain she expressly consented to unprotected sex before such intercourse started. This is also evidenced by ''SW'''s own text messages. For example, my lawyers refer me to the following text message to her friend:
92.Then a day later she explicitly texts her friend that she had not, in fact, been asleep.
IV. SUBSEQUENTDEVELOPMENTS
93.Although the police initially opened an investigation into 'rape' in relation to woman AA, there was no allegation in her testimony that she had been raped. She expressed in her statement to the police that she consented to sex and subsequently tweeted on 22 April in 2013 ''I have not beenraped''.
94.The press was immediately and unlawfully informed that there was a warrant for my arrest forwhat was reported asthe ''rape of two'' women.The prosecutor unlawfully, and without any subsequent explanation or remedy, immediately confirmed to the press that there was a live warrant for my arrest. The prosecutor's breach triggered an avalanche of news reports. Within days there were millions of references online which associated my name with the word 'rape'.
95.Immediately the police accusations were used to attack WikiLeaks' work and my reputation as its publisher.USDefense Secretary Robert Gates celebrated the news of my'rape'arrest warrant with a smile, telling reporters that the arrest ''sounds like good news to me''. Various twitter accounts officially associated with the Pentagon spread descriptions of me as a ''rapist'' and a ''fugitive''.This slander was then used as a means to attack my organization's reputation.
96.I canceled my other appointments and remained in Sweden. I gave an interview to the police on 30 August 2010 in relation to the only remaining allegation. The Agreed Statement of Facts and Issues submitted to the Supreme Court of the UK states:
''On30th August 2010, the Appellant, who had voluntarily remained in Sweden to cooperate with the investigation, attended for police interview in respect of the ongoing Preliminary Investigation in respect of AA's report.He answered all questions asked of him.''
97.I was highly concerned for my personal safety and the safety of WikiLeaks'operationswhile I remained in Sweden, but I stayed for another five weeks after the 'preliminary investigation' was initiated in order to clear my name and to cooperate with the police investigation. Only after I had obtained an assurance from the prosecutor Marianne Ny that I could leave the jurisdiction did I prepare to leave the country
98.Less than 24 hours after the warrantfor my arrestwas issued, the chief prosecutor of Stockholm was appointed to take over the investigation and canceled the arrest warrant, stating ''I don't believe there is any reason to suspect that he has committed rape''.
99.Shortly after prosecutor Marianne Ny had resurrected the ''SW'' allegation, the head of the Swedish military intelligence service (''MUST'')publishedan article 'WikiLeaksisa threat to our soldiers'. I became increasingly concerned about Sweden's close relationship to the USgovernmentin military and intelligence matters.
100.Through the diplomatic cables I also learned of secret, informal arrangements between Sweden and the United States. The cables revealed that Swedish intelligence services have a pattern of lawless conduct where US government interests are concerned. The US diplomatic cables revealed that the Swedish Justice Department had deliberately hidden particular intelligence information exchanges with the United States from the Parliament of Sweden because they believed the exchanges were likely unlawful.
101.The US diplomatic cables, reports by major human rights organizations, and the UN's own findings made me aware that Sweden had been complicit in torture as a result of its participation in secret CIA renditions from 2001 through to at least 2006 (which I would subsequently reveal). The rendition of the Swedish political refugees Agiza and Alzery resulted in strong condemnation by the UN Committee Against Torture, Amnesty International, Human Rights Watch, and others. There is still complete impunity for the officers of the Swedish state involved and their US counterparts. No charges have been laid although the complicity of the Swedish state has been well established in successful civil litigation. I subsequently learned that Sweden was partly implicated in CIA renditions of its own citizens from Djibouti in 2013. My Swedish lawyer Thomas Olsson represents one of the rendered.
102.Through an intelligence source, I became aware that on 19 August 2010, the Swedish Security Service (SPO) had requested information about me from an Australian intelligence organization. The Australian intelligence organization (ASIO) responded to the request with information about me on 21 August 2010.
103.On 29 November2010WikiLeaks commenced publishingCablegate, 251,287 USState Departmentdiplomatic cables. The classified diplomatic dispatches related to every countryin the world. In terms of content, it was the largest set of classified documents ever to be published.
104.The next dayState Department spokesman P.J. Crowley stated that ''we are investigating aggressively'' into WikiLeaks and that a State Department ''War Room'', which is different from the Pentagon ''War Room'', had been set up.
105.On 30 November 2010, two days after WikiLeaks started publishingCablegate,Interpol,at the request of Swedish prosecutor Marianne Ny,issued a Red Notice to 188 countries for my arrest in relation to the Swedish ''preliminary investigation'' (for which no charges or indictment existed).At the request of the Swedish prosecutor Interpol also made the notice public.
106.The Swedish prosecutor issued a European Arrest Warrant on 2 December 2010 to the UK which was processed by the UK Serious Organised Crimes Agency (SOCA).
107.I lost my freedom on7 December 2010, the day after UK authorities certified the Swedishextradition warrant.I appeared at the police station, having made a prior appointment. I was arrested and placed in solitary confinement inthe highest security unit ofWandsworthprison,the CSU.
108.The dayafter I was imprisoned, the UK newspaperThe Independentreported thatUS and Swedish officialshad entered informal talks regarding my extradition from Sweden to the United Statesin connection with the US Grand Jury and FBI investigation against WikiLeaks.
109.After ten days,the UK courts found that I should be released on bail. In response the Swedish prosecutor Marianne Ny instructed her representatives in the UK, the Crown Prosecution Service(CPS), to appealto keep me in prison,but the UK courts found her request to be excessive.
110.I was moved to house arrest after providing UK authoritieswith £340,000(nearly half a million dollars) and havingan electronic monitoring devicefitted to my ankle.
111.On 13 January 2011 the UK's Crown Prosecution Service (CPS) wrote to Marianne Ny, assuring her ''Please do not think that the case is being dealt with as just another extradition request".
112.I was forced to meet withpolice for 551 daysin a row.Icontinued publishingregardless.
113.I applied for asylumat the Ecuadorian embassy on19June 2012.The embassy was then surrounded by police at anadmitted cost to the UK taxpayer of £12.6 million by October 2015.
114.On 28 October 2014, the UK Minister of State of Hugo Swire, told Parliament that ''if she [Marianne Ny] wishes to travel here to question Mr. Assange in the embassy in London, we would do absolutely everything to facilitate that, indeed, we would actively welcome it.''
115.On 14 November 2014 I submitted my case to the United Nations Working Group on Arbitrary Detention (UNWGAD).
116.On 20 November 2014 Sweden's Court of Appeal (Svea) found that the Swedish prosecutor had breached her duty by failing toaccept my statement.
117.On 12 October 2015 the UK announced that it was removing the overt police around the embassy as it was ''no longer proportionate''.
118.On 14 October 2015 London police chief Bernard Hogan-Howe told theStandardthat the visible police were being removed from the embassy encirclement as ''it seems a disproportionate response'' and ''we think the public are not necessarily supportive of it.''
119.Subsequently (6 Feb 2016) the LondonTimeswould report that the removal of overt police was also due to ''fears that officers of the diplomatic protection group standing guard were thought to resemble jailers'' during the UNWGAD determination. However the 12 October statement reveals that the ''overt'' police had in fact been replaced with a ''strengthened'' ''covert plan''.
120.On 5February2016UNWGADfound that I have been unlawfully deprived of my liberty since 7 December 2010as a result of the actions of the Swedish prosecutor.
Answer to subsequent questions:
You have subjected me to six years of unlawful, politicized detention without charge in prison, under house arrest and four and a half years at this embassy. You should have asked me this question six years ago. Your actions in refusing to take my statement for the last six years have been found to be unlawful by the UN Working Group on Arbitrary Detention and by the Swedish Court of Appeal. You have been found to have subjected me to cruel, inhuman and degrading treatment. You have denied me effective legal representation in this process. Despite this, I feel compelled to cooperate even though you are not safeguarding my rights. I refer you to my statement where all these questions were answered.
- no title specified14/15 NOVEMBER 2016 QUESTIONING AT THE ECUADORIAN EMBASSY
LEGALLY PRIVILEGED
You have subjected me to six years of unlawful, politicized detention without charge in prison, under house arrest and four and a half years at this embassy. You should have asked me this question six years ago. Your actions in refusing to take my statement for the last six years have been found to be unlawful by the UN Working Group on Arbitrary Detention and by the Swedish Court of Appeal. You have been found to have subjected me to cruel, inhuman and degrading treatment. You have denied me effective legal representation in this process. Despite this, I feel compelled to cooperate even though you are not safeguarding my rights.
I.THE SWEDISH PRELIMINARY INVESTIGATION
I, Julian Assange, an Australian citizen, have had my passport taken by British authorities and so cannot provide formal identification, am in a situation of arbitrary detention according to the decision of the United Nations Working Group of Arbitrary Detention (UNWGAD) of 4 December 2015; a political refugee since 19 June 2012 at the Embassy of Ecuador with asylum which was granted by Ecuador on 16 August 2012, and hereby appear before the authorities of Sweden and Ecuador in the framework of a rogatory commission that has been entered between these two states, requested by the Swedish prosecutor Marianne Ny, and declare that:
1.I ratify what has been expressed by my Ecuadorian lawyer, both in relation to this procedure today and the concerns about the procedure pursued against me in Sweden, including the failure to allow my Swedish lawyer to be present and the failure to provide me with exculpatory and other discovery material, which I have, to date, not been given proper access to, including in the preparation for this statement today.
2.Today, 14 November 2016, after having made myself available to the Swedish authorities since the start of this outrageous process six years ago, I am finally given the opportunity to give my statement to the Swedish preliminary investigation. I am grateful to Ecuador for attempting to facilitate this process in the circumstances where the Swedish prosecutor has declined, since 2010, to accept this, my first statement on the allegation against me.
3.I went to Sweden on 11 August 2010. During my stay, I met a woman (hereinafter called ''SW''). On the evening of 16 August, 2010 she invited me to her home. During the night and in the morning we had consensual sexual intercourse on several occasions.
4.I therefore could not believe my eyes when five days later I saw a headline in a Swedish tabloid that I was suspected of a crime and arrested in my absence. I immediately made myself available to the Swedish authorities to clarify any questions that might exist, although I had no obligation to do so.
5.That same day (21August 2010), the Chief Prosecutor of Stockholm, Eva Finn(C), dropped the arrest warrant against me and within days would close the preliminary investigation with the finding that no crime whatsoever had been committedagainst the woman ''SW'' (who is the subject of this procedure). I drew the conclusion that, other than the worldwide damage to my reputation caused by millions of web pages saying that I was ''wanted for rape'', my life, in this respect, would return to normal.
6.On 23 August 2010, the Chief Prosecutor of Stockholm, Eva Finn(C) stated she "made the assessment that the evidence did not disclose any offence of rape".
7.On 25 August, the Chief Prosecutor found that "The conduct alleged disclosed no crime at all and that file (K246314-10) would be closed".
8.A week later, I learned to my surprise that a different prosecutor by the name of ''Marianne Ny'' had reopened the preliminary investigation without any consultation or opportunity for me to be heard '' after I had already been cleared and the case had been closed.
9.That prosecutor eventually issued an extradition warrant against me, supposedly to take my statement, even though I left Sweden with her permission and in good faith, and had repeatedly tried to see if the prosecutor was ready to accept my statement. I hadnotand havestillnot been charged with a crime.
10.It has taken more than six years for the prosecutor to now obtain my statement. The delay is entirely caused by the prosecutor who re-opened the closed preliminary investigation. A prosecutor is, according to Swedish law (Chapter 23, Section 4 of the Procedural Code), obligated to conduct the preliminary investigationas expeditiously as possible and when there is no longer reason for pursuing the investigation, it shall be discontinued. At the preliminary investigation phase, the prosecutor is obligated to take into account all the circumstances: those against the suspect as well as those circumstances in favour of the suspect, and any evidence favourable to the suspect shall be preserved. The investigation shall be conducted so that no person is unnecessarily exposed to suspicion, or put to unnecessary cost or inconvenience.
11.Instead of following the law, prosecutor Marianne Ny has kept the preliminary investigation open without justification for over six years. She deliberately suspended her work to progress and bring to a conclusion the preliminary investigation. She has for more than six years refused to take my statement during which time she has done nothing to pursue the preliminary investigation. The preliminary investigation entered into a stasis more than six years ago. I have always demonstrated my willingness to cooperate in order to speed up the process ''although there is no obligation whatsoever for me to do so. All the obligation is on the prosecutor to progress the preliminary investigation. This attitude of the prosecutor has clearly breached mandatory rules in Swedish law.
12.I reiterate that over the past six years, I have continued to call for this prosecutor to accept my statement, including by:
'--Willingly attending a questioning on 30 August 2010 in Stockholm, where no questions were asked about the allegation, as I had already been cleared.
'--Staying in Sweden for more than five weeks longer than planned, repeatedly asking if or when I could give a statement, despite pressing commitments elsewhere.
'--Gaining the prosecutor's consent to leave Sweden before doing so on 27 September 2010 in good faith, understanding that I was not required to provide a further statement for the time being. On the day I left the country three of my encrypted laptops were seized from me at Stockholm's Arlanda airport. The laptops contained evidence of war crimes pending publication and protected legal correspondence.
'--Offering to return to Sweden to give a statement in October 2010.
'--Offering to give my statement from London via numerous methods including telephone or videolink or in writing from London between October 2010 and up to and through the prosecutor unnecessarily issuing a European Arrest Warrant. The European Arrest Warrant attempted to extradite me, without charge, from the UK to Sweden, to take my statement. I was actively offering the testimony she claimed she wanted when she sought my arrest.
'--Providing a DNA sample six years ago in December 2010 when I was first arrested at Sweden's request and which has been available to the prosecutor for the last six years. She has never bothered to even attempt to use it.
'--Offering to give a statement in London via Mutual Legal Assistance, among other suggestions, during my time of house arrest (7 December 2010 '' 19 June 2012).
'--Offering to give a statement in the Ecuadorian embassy in London as from 19 June 2012, for instance via email from my Swedish lawyers on 24 July 2012 and during a meeting between my lawyers and the prosecutors in Stockholm 7 May 2013 '' over four years ago and over three years ago respectively.
'--Offering to come to Sweden provided Sweden would give a guarantee that I am not extradited to another state over my publishing work. This offer was also requested by Ecuador through diplomatic channels and publicly in 2012, as I am a refugee in its jurisdiction.
13.As this demonstrates, although I have no obligation to do so, I have done everything within my power to offer my testimony to the prosecutor while protecting my right to asylum and protecting myself against the risk of extradition to the United States, where there is an open national security case against me. According to the UN Special Rapporteur on Torture, WikiLeaks' alleged source in that matter, Chelsea Manning, has been subjected to cruel, inhuman and degrading treatment in US detention, and has since been convicted and sentenced to 35 years in prison.
14.The state of Sweden has refused to provide me the necessary assurances against extradition or other transport to the United States since 2010 when such was asked by my lawyers and since 2012 when requested to do so by the state of Ecuador. Sweden has also refused to accept that the asylum Ecuador has granted me requires it to protect me from onwards extradition to the United States, despite this being the recognized norm in asylum cases, thus making it impossible for me to go to Sweden without giving up my fundamental right as a political refugee. This refusal to recognize my rights as a political refugee has been the sole impediment to my presence in Sweden. I explicitly offered to accept extradition to Sweden provided it simply guaranteethat it will nottransfer me toanother state.This was declined.
15.Nevertheless, I have continued to offer the prosecutor my statement through mechanisms which can be employed to achieve her stated purpose without putting at risk my fundamental rights, which she has, until recently, rejected.
16.Two years ago the Svea Court of Appeal on 20 November 2014 severely criticized the prosecutor for her negligence:
''The Court of Appeal notes, however, thatthe investigation into the suspected crimes has come to a haltand considers thatthe failure of the prosecutors to examine alternative avenues is not in line with their obligation'' in the interests of everyone concerned '' to move the preliminary investigation forward.''
17.It was not until March 2015 that Marianne Ny finally '' after she had been found in breach of her duties by Sweden's Court of Appeal and my case was before the Supreme Court and it became apparent that she might lose '' claimed that she would, under certain restrictive conditions, accept my statement after all.
18.Since that time, the United Nations Working Group on Arbitrary Detention (UNWGAD) released its ruling on 5 February 2016 that my situation in the embassy amounts to an unlawful and arbitrary detention, in breach of Sweden's binding legal obligations under international law. UNWGAD found that Sweden and the UK have disregarded the asylum that I have been granted by Ecuador, forcing me to choose between deprivation of liberty and the risk of losing Ecuador's protection and being extradited to the United States.
19.It then took Marianne Ny more than 18 months after her claimed change of position at the Supreme Court to arrange this meeting. I have not been responsible for a single day of delay in this process. All the delay has been caused by prosecutor Marianne Ny and the state authorities. Again note that all the obligation is on the prosecutor.
20.Furthermore, the UNWGAD concluded that the Swedish prosecutor has breached my due process rights in the conduct of this preliminary investigation and that seeking my extradition to Sweden as the only option in these circumstances was ''excessive and unnecessary'' [para 97]. In particular, it found:
''...after more than five years' time lapse, he is still left at the stage of preliminary investigation with no predictability as to whether and when a formal process of any judicial dealing would commence...''[para. 97]''...Mr Assange has been denied the opportunity to provide a statement, which is a fundamental aspect of the audi alteram partem principle, theaccess to exculpatory evidence, and thus the opportunity to defend himself against the allegations...''[para. 98]''...the duration of such detention is ipso facto incompatible with the presumption of innocence.''[para. 98]
21.As a result of the Swedish prosecutor's actions, UNWGAD found my circumstances to be of an increasingly serious deprivation of liberty which is of an indefinite nature and is already far longer than the maximum penalty I could ever theoretically face in Sweden. For these reasons UNWGAD found that the severe and indefinite nature of these deprivations amounts to cruel, inhuman and degrading treatment in breach of Sweden's obligation under the International Covenant on Civil and Political Rights (ICCPR) Article 7. The severity of this treatment is further confirmed by the expert opinion of Fernando Mari±o, the former President of the UN Committee Against Torture, which is entered into the official record of this proceeding.
22.Ten months after the UNWGAD determination the harshness of the situation continues to affect my physical and psychological health. My lawyers have informed the Swedish authorities of the ongoing deterioration of my health through the medical certificates and expert opinions of Dr. Michael Korzinski and Dr. Fluxman, from 11 November 2015; of Dr. Ladbrooke from 8 December 2015; of Dr. Michael Korzinski from 15 June 2016; and of Dr. Ladbrooke from 9 November 2016.
23.And so, finally, here we are today, under the jurisdiction of Ecuador, with my rights ever increasingly limited, as my Ecuadorian defence counsel has expressed. After more than six years, I am finally being given the ''opportunity'' to give my statement but with my Swedish counsel having been excluded and under a clear situation of legal defencelessness, resulting from years of negligence and intentional and unlawful delays by the Swedish authorities.
24.All the irregularities that have occurred through the acts or omissions of the prosecution authority and the six-year delay to date of this disproportionate, inhumane and unlawful preliminary investigation have permanently destroyed all possibilities for me toproperly defend myself'' which is no doubt their intention.
25.Following the above, I wish to express in the strongest terms, that, in addition to the breaches of my due process rights in the investigation to date, the procedure to be adopted today in taking my statement further breaches those rights:
'--In the opinion of my general practitioner, I am unfit to prepare and participate in these proceedings (afterhavingbeen denied hospital treatment and sunlight for 4.5 years).
'--My Ecuadorian defence counsel has had no access to the case file, let alone in Spanish, the language he understands, nor has he had adequate time to prepare my defence.
'--My lawyers and I have not been permitted access to the case file.
'--I have been denied my request to read the text messages that my Swedish defence lawyers have read, which are a key element to my defence because they clearly show that I am innocent.
26.Due to all the shortcomings stated above, prosecutor Marianne Ny should have drawn the obvious conclusion that she discontinue the preliminary investigation.
27.In this context I once again remind you that I have already been cleared and that the preliminary investigation was closed by Chief Prosecutor Eva Finn(C) in August 2010.
28.Given this history I have good reason to have concern about whether this ''preliminary investigation'' is being conducted in good faith and whether honest and impartial consideration will be given to my statement. I suspect that the real purpose of the Swedish prosecutor coming here today is not to obtain my statement but is simply a ruse to tick a box to ensure the technical possibility to indict me, irrespective of how I answer any questions.
29.I do not believe that prosecutor Marianne Ny is acting in good faith or with the objectivity and impartiality required of her office. For example, after circumventing the Chief Prosecutor of Stockholm's decision to close this case,prosecutor Nyhas made at least 40 press releases and press conferences about mewhere my name has been published, even though there is no charge against me and I have been previously cleared, subjecting me to endless needless suspicion,in clear violation of her duty to not do so under Chapter 23, Section 4 of the Swedish Procedural Code.
30.My overall conclusion is that the prosecutor's conduct of the preliminary investigation, for all the reasons above has continued to deprive me of the right to defend myself.
31.I have no obligation to cooperate with this abuse, but I find myself in a coercive situation. I am meant to be protected by the decision of the UNWGAD which makes it clear that this ''preliminary investigation'' has violated my human rights and that its attempts to arrest me should be discontinued immediately. That decision was issued almost a year ago, but my situation remains unchanged.Despite the many violations already described I feel compelled to give my statement today so that there can be no more excuses for the Swedish prosecutor Marianne Ny to continue my indefinite unlawful detention, which is a threat to my health and even to my life. I have been pushing and indeed litigating for this prosecutor to take my statement for more than six years. The prosecutor has made excuse after excuse to not take my statement. I will not grant this prosecutor any excuse to continue to avoid taking my statement as I fear she would use it as a means to indefinitely prolong my cruel, inhuman and degrading treatment.
II.REASONSWHYI TRAVELLEDTO STOCKHOLM IN AUGUST 2010
32.I am the editor-in-chief and publisher of WikiLeaks,a publishing organisationspecializing in the analysis of records under risk of censorship that are of political, diplomatic, historical or ethical importance. Among other countries, WikiLeaks publishes and analyses documents that concern the United States, Sweden and the United Kingdom, including millions of documents relating to actions of military, intelligence and foreign services. I have received numerous awards in relation to my publishing work, including the 2008 Index on Censorship Freedom of Expression Award, The Economist New Media Award (USA) 2008, the 2009 Amnesty International UK Media Award (New Media), the 2010 Sam Adams Associates for Integrity in Intelligence (USA)award, the 2011 Sydney Peace Foundation Gold Medal (Australia), the 2011 Martha Gellhorn Prize for Journalism (UK), the 2011 Walkley Award for Most Outstanding Contribution to Journalism (Australia), the 2011 Blanquerna Award for Best Communicator (Spain), the 2011 International Piero Passetti Journalism Prize of the National Union of Italian Journalists, the 2011 Jose Couso Press Freedom Award (Spain), the 2012 Privacy International Award, the 2013 Yoko Ono Lennon Courage Award, and the 2013 Global Exchange Human Rights Awards, as well as formal nominations for the United Nations'Mandela Prize (2014) and for the past six consecutive yearsforthe Nobel Peace Prize.
33.The US launched an investigation against me in early 2010 under the Obama administration, while Hillary Clinton was the US Secretary of State. This administration has expended very substantial resources on attempting to prosecute me and attempting to spy on my publishing work despite its constitutionally protected status. The US government's WikiLeaks investigation is described in official diplomatic correspondence as being''unprecedented in scale and nature''.
34.All the citations I mentionarein my affidavit from 2 September 2013, which I am entering into the official record of this proceeding.
35.The US government has periodically confirmed in public that the national security case against WikiLeaks remains open and ongoing, including in proceedings from this year. Numerous human rights and freedom of speech organizations such as Human Rights Watch have criticized the Obama administration for pursuing a criminal case against WikiLeaks and me.
36.The investigation against Wikileaks is led by the FBI and has involved a dozen other agencies, including the CIA, the NSA, and the Defence Intelligence Agency. The US government has described the investigation as a "whole of government" investigation. In Alexandria, Virginia, a Grand Jury has been meeting behind closed doors for the past six years under case number 10GJ3793 to explore ways to imprison me and seven others who they have identified as "founders, owners or managers of WikiLeaks". The prosecution in the Chelsea Manning case attempted to establish that Private Manning acted as an agent under my control rather than as a journalistic source of mine, even though in Private Manning's own statement to the court, she said this was not the case. The US military charged Private Manning with twenty-two counts in connection with the release of more than 700,000 classified or confidential documents to WikiLeaks. On 30 July 2013 private Manning was convicted of twenty of these counts and sentenced to thirty-five years in prison on 20 August 2013.
37.Private Manning was detained for more than 1,000 days before the trial commenced. During this time she remained for 258 days in solitary confinement. The UN Special Rapporteur on Torture found that the conditions and length of private Private Manning's confinement at Quantico, Virginia, amounted to ''inhuman and degrading treatment''. Private Manning's lawyer, David Coombs, said that the treatment of Private Manning was an attempt at breaking her so that Manning would implicate me. The US military court system eventually found that Private Manning was unlawfully punished as a result of this treatment while in US custody. Private Manning was convicted of espionage; the first whistleblower ever so convicted. Private Manning was acquitted of the "aiding the enemy" charge, but the US government could still seek to employ this charge against me. Private Manning is serving a 35 year prison sentence.
38.According to the respected UK newspaper The Independent, the US and Sweden entered informal talks regarding my extradition from Sweden to the United States in early December 2010. These talks of my extradition concerned the US Grand Jury and FBI investigation against WikiLeaks, which is also the reason that Ecuador granted me asylum.
39.The aggressive calls to stop WikiLeaks from publishing were thereason for my travel to Stockholm.US officials' rhetoricgrew increasinglyaggressiveinthe period immediatelypriorto my visit to Sweden on 11 August 2010. In June, aDaily Beast news report entitled 'The State Department's Worst Nightmare'revealed that the Pentagon was ''conducting an aggressive investigation'' into whether WikiLeaks had 260,000 US diplomatic cables and the material's whereabouts.
40.Two days later, an article titled 'Pentagon Manhunt'appeared,describingPentagon investigators desperately trying to track me down in relation to the impending publication of Cablegate:
''Anxious that Wikileaks may be on the verge of publishing a batch of secret State Department cables,investigators are desperately searching for founder Julian Assange''.
41.On 17 June 2010 US Department of Defense spokesman Geoff Morrellstatedthere was an
"ongoing criminal investigation [concerning WikiLeaks], involving the Army Criminal Investigation Division, as well as, I believe, some other law enforcement agencies.''
42.ThePentagonofficials ''would not discuss the methods being used to find Assange, nor would they say if they had information to suggest where he is now.'' On reading this, IrealisedWikiLeaks'continued ability to publish effectively and my own personal safetywere at serious risk.
43.During the month of July I worked with a team of journalists in the United Kingdom to publish the Afghan War Diaries: 75,000 secret Pentagon documents about the war in Afghanistan, which included the detailed records about the deaths of nearly 20,000 people. The day after WikiLeaks published the Afghan War Diaries, White House Press Secretary Robert Gibbs stated that WikiLeaks ''poses a very real and potential threat''.
44.I published the Afghan War Diaries approximately two weeks before Itravelledto Sweden. In the aftermath of the publication, US government officials made efforts to influence the way in which the media reported on our publications. The purpose wasto delegitimise WikiLeaks protections as a publisher under the US First Amendment. For example, it attempted to falsely cast WikiLeaks as an adversary, opposed to US national interests, a false claim that I would later see echoed in Swedish media.
45.The New York Times reported that the White House had emailed its reporters with suggested ''reporting tacks to take'' on WikiLeaks and WikiLeaks' disclosures, in an attempt to induce news outlets into referring to WikiLeaks in these terms.
46.The White House sent an e-mail with the subject heading ''Thoughts on Wikileaks'' containing a memo in which the White House
"advised journalists on possible reporting tacks to take on the [Afghan War Diaries] documents ['...] As you report on this issue, it's worth noting that wikileaks isnot an objective news outlet but rather an organization that opposes US policy in Afghanistan."
47.I also learned from news reports that security authorities from my home country Australia were assisting the US intelligence investigation into WikiLeaks and me:
"Australian security authorities are assisting a United States intelligence probe into the whistleblower website Wikileaks and its Australian founder and editor, Julian Assange. TheUS request for support in what Australian national security sources described as 'a counter-espionage investigation' preceded Wikileaks' dramatic publication yesterdayof a leaked US military operations log, described as an ''extraordinary compendium'' of 91,000 reports by United States and allied soldiers fighting in Afghanistan.''
48.On July 28th, just three days after publishing the Afghan War Diaries and two weeks before I travelled to Sweden, US Department of Defense Secretary Gates ''called FBI Director Robert Mueller and asked for the FBI's assistance in [the WikiLeaks] investigation as a partner.'' The US Defence Department declared:
"Calling on the FBI to aid the investigation ensures that the department will have all the resources needed to investigate... noting that use of the bureau ensuresthe investigation can go wherever it needs to go.''
49.The New York Times reported that US Defense Secretary Robert Gates
"declined to comment about the investigation beyond noting that he had enlisted theFederal Bureau of Investigation to assist Army investigators, a move that is seen as a precursor to potentially charging people who are not uniformed service members[...] A person familiar with the investigation has said that Justice Department lawyers are exploring whetherMr. Assange and WikiLeaks could be charged with inducing, or conspiring in, violations of the Espionage Act, a 1917 lawthat prohibits the unauthorized disclosure of national security information."
50.On 1 August 2010, the press reported that the FBI and British police were carrying out searches and interrogations in the UK, where I found myself at the time, in connection with WikiLeaks' publications.
51.Over the next days, US rhetoric and actions against WikiLeaks intensified. Prominent commentators and former White House officials championed extraterritorial measures and the violation of international law ''if necessary''.
52.One of these commentators was former presidential speech writer Marc Thiessen, who published a Washington Post article entitled 'WikiLeaks Must be Stopped':
"'...the government has a wide range of options for dealing with him. It can employ not only law enforcement but also intelligence and military assets to bring Assange to justice."
53.Thiessen argued that the US should put pressure on any state in which I was located and that the US should, if necessary, arrest me even without the consent of that state. He cited legal advice from the Department of Justice regarding FBI operations abroad:
''The United States should make clear that it will not tolerate any country -- and particularly NATO allies such as Belgium and Iceland -- providing safe haven for criminals who put the lives of NATO forces at risk.With appropriate diplomatic pressure, these governments may cooperate in bringing Assange to justice. But if they refuse, the United States can arrest Assange on their territory without their knowledge or approval."
54.Thiessen further asserted that the FBI could violate international law in order to stop me and apprehend other people associated with WikiLeaks' publishing activities. Thiessen cited a Department of Justice memo:
"the FBI may use its statutory authority to investigate and arrest individuals for violating United States law, even if the FBI's actions contravene customary international law" and that an "arrest that is inconsistent with international or foreign law does not violate the Fourth Amendment." In other words, we do not need permission to apprehend Assange or his co-conspirators anywhere in the world.
Arresting Assange would be a major blow to his organization. But taking him off the streets is not enough; we must also recover the documents he unlawfully possesses and disable the system he has built to illegally disseminate classified information.
This should be done, ideally, through international law enforcement cooperation. But if such cooperation is not forthcoming, the United States can and should act alone."
55.Seven days before I travelled to Sweden I was acutely aware that my personal safety was at risk.Scott Horton, legal affairs and national security contributor at Harper's, wrote the article 'WikiLeaks: The National-Security State Strikes Back':
"[Assange] will certainly be targeted for petty harassment and subject to steady surveillance, andefforts to kidnap him are almost certainly being spun at this very moment."
56.Pentagon Press Secretary Geoff Morrell announced an anti-WikiLeaks task force comprised of 80 people was operating 24 hours a day. One month later, it had grown to 120 people. The ''distinct responsibility'' of the Information Review Task Force '' dubbed by some occupants as the ''WikiLeaks War Room'' '' was
57.The article '''The General Gunning for WikiLeaks'' described the task force:
"In a nondescript suite of government offices not far from the Pentagon,nearly 120 intelligence analysts, FBI agents, and others are at work'--24 hours a day, seven days a week'--on the frontlines of the government's secret war against WikiLeaks.
Dubbed the WikiLeaks War Room by some of its occupants,the round-the-clock operation is on high alert this month '..."
58.The same article states that Brig. General Robert A. Carr, who runs ''the Pentagon's equivalent to the CIA'', the Defense Counterintelligence and Human Intelligence Center of the Defense Intelligence Agency (DIA), was ''handpicked'' by Defense Secretary Robert Gates to head the team because he ''is highly respected '...and a fitting adversary to Assange''.
59.General Carr's ''central assignment'' was reportedly ''to try to determine exactly what classified information might have been leaked to WikiLeaks''. General Carr testified at the Chelsea Manning sentencing hearing on 31 July 2013.
60.I followed closely how pressure mounted on US allies to track my movements and to stop our publications. Official sources within the administration revealed to the press that the US was not only considering how to prosecute me in relation to WikiLeaks' publications in the US, but was also requesting their allies to prosecute me under their own national security laws:
"American officials confirmed last month that the Justice Department was weighing a range of criminal charges against Assange and others [...]
Now, the officials say, they want other foreign governments to consider the same sorts of criminal charges."
An article published the day before I went to Sweden stated that "The Obama administration is pressing Britain, Germany, Australia, and other allied Western governments toconsider opening criminal investigations of WikiLeaks founder Julian Assange and to severely limit his nomadic travels across international borders, American officials say."
61.In addition to the stated intention to restrict my freedom of movement, the US government attempted to convince its allies not to allow me entry into their territory as a warning to me, to those working with me and WikiLeaks, and to our supporters:
"Through diplomatic and military channels, the Obama administration is hoping to convinceBritain, Germany, and Australia,among other allied governments, that Assange should not be welcome on their shores either,given the danger that his group poses totheir troops stationed in Afghanistan, American officials say. They saysevere limitations on Assange's travels might serve as a useful warning to his followers that their own freedom is now at risk."
62.The Australian government publicly entertained the possibility of canceling my passport, reportedly as a result of pressure placed on Australia by the United States. Australian Attorney General Robert McClelland assured the United States that the Australian government would ''provide every assistance to United States law-enforcement authorities'', including by exploring the possibility of canceling my passport.
63.US pressure even resulted in public attempts to influence decisions based on human rights considerations where I and WikiLeaks were concerned. Through US ambassador to SwitzerlandDonald Beyer, the Obama administration pressured Switzerland not to grant me political asylum while I participated at the UN Human Rights Council's Universal Periodic Review of the United States. US ambassadorBeyer gave an interview to Swiss newspaper Sonntag:
"The United States ambassador to Switzerland, Donald Beyer, has also entered the Wikileaks debate. He has warned the Swiss government against granting Assange asylum, which the Australian founder of Wikileaks has said he was considering requesting. ''Switzerland should very carefully consider whether to provide shelter to someone who is on the run from the law''.
64.The Daily Beast reported that Washington was prepared to review its diplomatic relations with Iceland because parts of WikiLeaks operations had been conducted in that country:
''An American military official tells The Daily Beast thatWashington may also want to closely review its relations with Iceland in the wake of the release of the Afghan war logs.''
65.In the context of my heightened concerns about US activities in the United Kingdom in relation to the WikiLeaks investigation, I decided to leave the country. When I travelled to Sweden on 11 August 2010, the aggressive rhetoricagainst me had reached new heights.Former CIA general counsel Jeffrey Smith told National Public Radio:
''I think it is entirely appropriate for us to be very aggressive[...]If I were the US government, I would be trying to make it as difficult as possible for the WikiLeaks founder to continue to do business...To the extent we can persuade our allies to consider prosecution, I think that's all to the good.''
66.On the same day I arrived in Sweden, 11 August 2010, I received information from an Australian intelligence source that extra-legal actions might be taken against me by the US or its allies. This was later reported in the Australian newspaper The Age:
''An Australian intelligence official privately warned Wikileaks on August 11 last year that Assange was the subject of inquiries by the Australian Security Intelligence Organisation, and thatinformation relating to him and others associated with Wikileaks had been provided to the US in response to requests through intelligence liaison channels.The Australian intelligence official is also claimed to havespecifically warned that Assange could be at risk of 'dirty tricks' from the US intelligence community.''
67.Friends and associates of mine and volunteers for WikiLeaks were regularly targeted at borders from this moment on. Border searches and interrogations have affected security researcher Jacob Appelbaum, who had given the keynote speech in my place at the HOPE conference on 16 July 2010. In an interview for Democracy Now, Appelbaum described the targeting he experiences at airports:
In the period of time since [the HOPE conference on 16 July 2010] they've started detaining me, around a dozen-plus times... I was put into a special room, where they frisked me, put me up against the wall... they took my laptop... then they interrogated me, denied me access to a lawyer. And when they did the interrogation, they have a member of the U.S. Army, on American soil. And they refused to let me go.They ... implied that if I didn't make a deal with them, that I'd be sexually assaulted in prison.
68.Within days of arriving in Sweden I became concerned about my safety and security there, in particular because of the pressure being brought to bear on US allies, including Sweden.
69.I was aware of the publicly stated attempts to track my movements. I used a number of risk minimisation procedures, including relying on the goodwill of friends and their circles for my safety and to protect the confidentiality of my whereabouts and communications.
70.My contacts in Sweden had arranged for me to stay in two safe houses during the few days I had intended to stay in Sweden. One of the safe houses belonged to a journalist who I knew and another to a Social Democrat party figure unknown to me who had lent her apartment while she was away, or so I had been told. However, because these two original safe houses arranged prior to my arrival became known very soon, I stayed in three additional safe houses between 11 and 20 August 2010.
71.I travelled to Sweden to put in place a legal strategy to try to protect our publishing servers, some of which were in Sweden. I believed these assets were at risk as a result of the intense political pressure from the US described above. I met with the Swedish Pirate Party, which was represented at the European Parliament at the time, who agreed to host copies of WikiLeaks servers under their party name in order to further protect our publishing work. I also felt it was best to leave the United Kingdom at that time because the FBI was known to be carrying out operations in connection with the investigation into our publications. I intended to stay in Sweden for less than a week.
72.My dependency on other people while in Sweden was aggravated when, shortly after my arrival in Stockholm, my personal bank cards were blocked. On 13 August 2010, the WikiLeaks organization's Moneybookers account could no longer be accessed. That same day, I contacted the company, who replied: ''following recent publicity and the subsequently (sic) addition of the Wikileaks entity to blacklists in Australia and watch lists in the USA, we have terminated the business relationship''. I requested further information from MoneyBookers on 13 August and 16 August regarding the closure, including which blacklists and watchlists my accounts and/or WikiLeaks' account had been added to, but I was refused this information.
73.The freezing of WikiLeaks' Moneybookers account was an early example of what in December 2010 would become a concerted extra-judicial global economic blockade against WikiLeaks by US financial service companies, including VISA, MasterCard, PayPal, Bank of America, Western Union and American Express. The blockade was the subject of several court actions, a European Commission investigation, a resolution by the European Parliament, and condemnation by the United Nations Special Rapporteur on the Promotion and Protection of the Right to Freedom of Opinion and Expression and the Inter-American Commission on Human Rights Special Rapporteur for Freedom of Expression. On 24 April 2013 the Supreme Court of Iceland found the blockadeagainst WikiLeaksto be unlawful.
74.As a result of being suddenly cut off from personal and organizational funds upon arriving in Sweden, I had to rely on others not only for shelter, but also for food, safety and telephone credit. Unfortunately, I knew very few people in Sweden and those I did were only sporadically in the country.
75.On 13 August 2010 one of the main Swedish newspapers, Svenska Dagbladet, published an article entitled 'Defence ministry prepared for the next leak', which reported that the Swedish Ministry of Defence had a dedicated group'preparing for WikiLeaks next publication' and had analysed 76,000 previous publications from WikiLeaks in relation to Swedish troops in Afghanistan.
76.Five days later, Swedish state television (SVT) published a segment entitled 'We risk United States relationship deteriorating', which argued that the presence of WikiLeaks in Sweden would negatively affect the strategic relationship between Sweden and the United States.
III.THE PERIOD 14-20 AUGUST 2010
77.I met ''SW'' during my visit to Stockholm. The first time I met her was on the morning of 14 August 2010 when she came to a speech I gave on what my work revealed about the war in Afghanistan,in which Sweden has troops under US command. She sat in the front row and photographed me. She came to the small private lunch after my talk where one of the organizers stated that she was a volunteer for their organization although they would later claim that this was not true. Due to the security threats against me as a result of my work, I was in a precarious situation. I relied on the kindness of strangers and the safety and discretion they were willing to offer me. I was in a foreign northern country, where I did not speak the language. I had no access to cash because the bank cards I was travelling with had been frozen due to the extra-judicial political measures taken by financial service companies against my organization and me (which are well-documented and the subject of extensive litigation).
78.Prominent ''pro-war'' personalities were calling for my assassination and capture, and the US administration had stated publicly that my movements were being tracked. "SW" appeared to be sympathetic to my plight and also appeared to be romantically interested in me. She was not close to people I was close to, so it seemed that those who meant me harm would be unlikely to try to find me by monitoring her movements. She said she worked at the National Museum so I asked her to show me, to try to establish her bonafides. At the Museum an IMAX film was playing, where she kissed me and placed my hands on her breasts. She asked whether I was staying with woman ''AA'', a Swedish politician, and seemed concerned by it in a manner which I found strange.
79.At her initiative we met again on the evening of 16 August 2010 and she suggested we go to a hotel in Stockholm. For security reasons, I said I would prefer to go to her house even though it was outside of Stockholm. She then invited me to her home. We went by train and she paid for my ticket since my bank cards had been frozen.
80."SW" made it very clear that she wanted to have sexual intercourse with me. I felt concerned about the intensity of ''SW'''s interest and I also deeply loved another woman, which played on my mind and left me emotionally distracted. "SW" knew an unusual amount of detail about me, and appeared annoyed with me when I was on my phone searching for news related to the US official government statements against me. I perceived she was irritated when I wasn't giving her my full attention.
81.I felt there was a risk my location would be revealed and that she might act unpredictably if she believed I was rejecting her. During that night and again in the morning we had consensual sexual intercourse on four or five occasions. Her words, her expressions and her physical reactions made it clear to me that she encouraged and enjoyed our interactions.
82.I would later discover that she had collected dozens of photos of me in the weeks before we even met. Her recent FLIKR photo account was filled with pages and pages of photos of me and no other person.
83.In the morning she went out to pick up breakfast for us. After enjoying breakfast together, I left her home on good terms. At no stage when I was with her did she express that I had disrespected her in any way or acted contrary to her wishes other than to not be interested in her enough to pay her attention above my security situation or attempts to sleep. She accompanied me to the train station on her bicycle and we kissed each other goodbye. She asked that I call her so we could see each other again and I said I would. She called the next day or the day after. We made friendly small talk but we were quickly disconnected due to a failing mobile connection. I did not call her back due to problems obtaining telephone credit (as a result of my bank cards being blocked) and the pressing security situation.
84.I spoke to her next on Friday 20 August, after a Swedish friend said that he had heard that ''SW'' was at the hospital and that she wanted to talk to me. As I had not called her back, and she had previously gone through considerable effort to attract my attention, I was initially concerned that she may have attempted self-harm in order to force me to pay attention to her. So I called her. She said she was at a hospital and asked me to come down to meet her to test myself for sexually transmitted diseases so she would not have to worry while she was waiting for her own test results (HIV, for instance, needs months to show up).
85.But I was busy that dayattempting to deal with the escalating political and legal threats against me from the Pentagon. I said I couldn't do anything until the next day (a Saturday). She said that it was normal in Sweden to go to the police to get advice about STDs and that if I didn't come down to the hospital she would go to the police to ask whether I could be forced to get tested. I told her I found her mention of police strange and threatening. She stated that she was only concerned about the tests and that it had no concealed meaning. I agreed to take the test out of goodwill and to reassure her, although I told her I could not do it until the following day, Saturday.
86.We were in agreement and arranged to meet the following day in the nearby park around lunchtime when I would have time to get tested. She said she was fine and seemed at ease.
87.You can imagine my disbelief when I woke the next morning to the news that I had been arrested in my absence for ''rape'' and that police were ''hunting'' all over Stockholm for me.
88.Her behaviour towards me on the night in question and in the morning made it clear that she actively and enthusiastically wanted me to have sex with her. This is also shown by text messages "SW" sent to her friends during the course of the evening I was at her home and during that week, which the Swedish police collected from her phone. Although the prosecutor has fought for years to prevent me, the public and the courts from seeing them, my lawyers were permitted to see them at the police station and were able to note down a number of them, including:
'--On 17 August "SW" wrote that we had long foreplay, but nothing happened (01:14); then it got better (05:15);
'--On 17 August, after all sex had occurred, ''SW'' wrote to a friend that it ''turned out all right'' other than STD/pregnancy risk (10:29);
'--On 20 August "SW", while at the police station, wrote that she ''did not want to put any charges on Julian Assange'' but that ''the police were keen on getting their hands on him'' (14:26); and that she was ''chocked (sic shocked) when they arrested him'' because she ''only wanted him to take a test'' (17:06);
'--On 21 August "SW" wrote that she ''did not want to accuse'' Julian Assange ''for anything'', (07:27); and that it was the ''police who made up the charges (sic)'' (22:25);
'--On 23 August "AA" (the other woman whose case was dropped in August 2015) wrote to "SW" that it was important that she went public with her story so that they could form public opinion for their case (06:43);
'--On 23 August "SW" wrote that it was the police, not herself, who started the whole thing (16:02);
'--On 26 August "AA" wrote to "SW" that they ought to sell their stories for money to a newspaper (13:38);
'--On 28 August "AA" wrote that they had a contact on the biggest Swedish tabloid (12:53); and "SW" wrote that their lawyer negotiated with the tabloid (15:59);
89.These text messages clearly show what really happened between "SW" and me. It is clearly consensual sex between adults. The communication between "AA" and "SW" later sadly speaks for itself.
90.The prosecutor's allegation in the extradition proceeding was reported to be that one of these sexual interactions started the next morning while "SW" was asleep (in the same bed after a night of consensual intercourse) and that when she woke up she consented to the intercourse in question, but for the first few moments was not theoretically capable of consent due to sleep.
91.This is false. I was certain "SW" was not asleep. I was also certain she expressly consented to unprotected sex before such intercourse started. This is also evidenced by ''SW'''s own text messages. For example, my lawyers refer me to the following text message to her friend:
92.Then a day later she explicitly texts her friend that she had not, in fact, been asleep.
IV. SUBSEQUENTDEVELOPMENTS
93.Although the police initially opened an investigation into 'rape' in relation to woman AA, there was no allegation in her testimony that she had been raped. She expressed in her statement to the police that she consented to sex and subsequently tweeted on 22 April in 2013 ''I have not beenraped''.
94.The press was immediately and unlawfully informed that there was a warrant for my arrest forwhat was reported asthe ''rape of two'' women.The prosecutor unlawfully, and without any subsequent explanation or remedy, immediately confirmed to the press that there was a live warrant for my arrest. The prosecutor's breach triggered an avalanche of news reports. Within days there were millions of references online which associated my name with the word 'rape'.
95.Immediately the police accusations were used to attack WikiLeaks' work and my reputation as its publisher.USDefense Secretary Robert Gates celebrated the news of my'rape'arrest warrant with a smile, telling reporters that the arrest ''sounds like good news to me''. Various twitter accounts officially associated with the Pentagon spread descriptions of me as a ''rapist'' and a ''fugitive''.This slander was then used as a means to attack my organization's reputation.
96.I canceled my other appointments and remained in Sweden. I gave an interview to the police on 30 August 2010 in relation to the only remaining allegation. The Agreed Statement of Facts and Issues submitted to the Supreme Court of the UK states:
''On30th August 2010, the Appellant, who had voluntarily remained in Sweden to cooperate with the investigation, attended for police interview in respect of the ongoing Preliminary Investigation in respect of AA's report.He answered all questions asked of him.''
97.I was highly concerned for my personal safety and the safety of WikiLeaks'operationswhile I remained in Sweden, but I stayed for another five weeks after the 'preliminary investigation' was initiated in order to clear my name and to cooperate with the police investigation. Only after I had obtained an assurance from the prosecutor Marianne Ny that I could leave the jurisdiction did I prepare to leave the country
98.Less than 24 hours after the warrantfor my arrestwas issued, the chief prosecutor of Stockholm was appointed to take over the investigation and canceled the arrest warrant, stating ''I don't believe there is any reason to suspect that he has committed rape''.
99.Shortly after prosecutor Marianne Ny had resurrected the ''SW'' allegation, the head of the Swedish military intelligence service (''MUST'')publishedan article 'WikiLeaksisa threat to our soldiers'. I became increasingly concerned about Sweden's close relationship to the USgovernmentin military and intelligence matters.
100.Through the diplomatic cables I also learned of secret, informal arrangements between Sweden and the United States. The cables revealed that Swedish intelligence services have a pattern of lawless conduct where US government interests are concerned. The US diplomatic cables revealed that the Swedish Justice Department had deliberately hidden particular intelligence information exchanges with the United States from the Parliament of Sweden because they believed the exchanges were likely unlawful.
101.The US diplomatic cables, reports by major human rights organizations, and the UN's own findings made me aware that Sweden had been complicit in torture as a result of its participation in secret CIA renditions from 2001 through to at least 2006 (which I would subsequently reveal). The rendition of the Swedish political refugees Agiza and Alzery resulted in strong condemnation by the UN Committee Against Torture, Amnesty International, Human Rights Watch, and others. There is still complete impunity for the officers of the Swedish state involved and their US counterparts. No charges have been laid although the complicity of the Swedish state has been well established in successful civil litigation. I subsequently learned that Sweden was partly implicated in CIA renditions of its own citizens from Djibouti in 2013. My Swedish lawyer Thomas Olsson represents one of the rendered.
102.Through an intelligence source, I became aware that on 19 August 2010, the Swedish Security Service (SPO) had requested information about me from an Australian intelligence organization. The Australian intelligence organization (ASIO) responded to the request with information about me on 21 August 2010.
103.On 29 November2010WikiLeaks commenced publishingCablegate, 251,287 USState Departmentdiplomatic cables. The classified diplomatic dispatches related to every countryin the world. In terms of content, it was the largest set of classified documents ever to be published.
104.The next dayState Department spokesman P.J. Crowley stated that ''we are investigating aggressively'' into WikiLeaks and that a State Department ''War Room'', which is different from the Pentagon ''War Room'', had been set up.
105.On 30 November 2010, two days after WikiLeaks started publishingCablegate,Interpol,at the request of Swedish prosecutor Marianne Ny,issued a Red Notice to 188 countries for my arrest in relation to the Swedish ''preliminary investigation'' (for which no charges or indictment existed).At the request of the Swedish prosecutor Interpol also made the notice public.
106.The Swedish prosecutor issued a European Arrest Warrant on 2 December 2010 to the UK which was processed by the UK Serious Organised Crimes Agency (SOCA).
107.I lost my freedom on7 December 2010, the day after UK authorities certified the Swedishextradition warrant.I appeared at the police station, having made a prior appointment. I was arrested and placed in solitary confinement inthe highest security unit ofWandsworthprison,the CSU.
108.The dayafter I was imprisoned, the UK newspaperThe Independentreported thatUS and Swedish officialshad entered informal talks regarding my extradition from Sweden to the United Statesin connection with the US Grand Jury and FBI investigation against WikiLeaks.
109.After ten days,the UK courts found that I should be released on bail. In response the Swedish prosecutor Marianne Ny instructed her representatives in the UK, the Crown Prosecution Service(CPS), to appealto keep me in prison,but the UK courts found her request to be excessive.
110.I was moved to house arrest after providing UK authoritieswith £340,000(nearly half a million dollars) and havingan electronic monitoring devicefitted to my ankle.
111.On 13 January 2011 the UK's Crown Prosecution Service (CPS) wrote to Marianne Ny, assuring her ''Please do not think that the case is being dealt with as just another extradition request".
112.I was forced to meet withpolice for 551 daysin a row.Icontinued publishingregardless.
113.I applied for asylumat the Ecuadorian embassy on19June 2012.The embassy was then surrounded by police at anadmitted cost to the UK taxpayer of £12.6 million by October 2015.
114.On 28 October 2014, the UK Minister of State of Hugo Swire, told Parliament that ''if she [Marianne Ny] wishes to travel here to question Mr. Assange in the embassy in London, we would do absolutely everything to facilitate that, indeed, we would actively welcome it.''
115.On 14 November 2014 I submitted my case to the United Nations Working Group on Arbitrary Detention (UNWGAD).
116.On 20 November 2014 Sweden's Court of Appeal (Svea) found that the Swedish prosecutor had breached her duty by failing toaccept my statement.
117.On 12 October 2015 the UK announced that it was removing the overt police around the embassy as it was ''no longer proportionate''.
118.On 14 October 2015 London police chief Bernard Hogan-Howe told theStandardthat the visible police were being removed from the embassy encirclement as ''it seems a disproportionate response'' and ''we think the public are not necessarily supportive of it.''
119.Subsequently (6 Feb 2016) the LondonTimeswould report that the removal of overt police was also due to ''fears that officers of the diplomatic protection group standing guard were thought to resemble jailers'' during the UNWGAD determination. However the 12 October statement reveals that the ''overt'' police had in fact been replaced with a ''strengthened'' ''covert plan''.
120.On 5February2016UNWGADfound that I have been unlawfully deprived of my liberty since 7 December 2010as a result of the actions of the Swedish prosecutor.
Answer to subsequent questions:
You have subjected me to six years of unlawful, politicized detention without charge in prison, under house arrest and four and a half years at this embassy. You should have asked me this question six years ago. Your actions in refusing to take my statement for the last six years have been found to be unlawful by the UN Working Group on Arbitrary Detention and by the Swedish Court of Appeal. You have been found to have subjected me to cruel, inhuman and degrading treatment. You have denied me effective legal representation in this process. Despite this, I feel compelled to cooperate even though you are not safeguarding my rights. I refer you to my statement where all these questions were answered.
Assange Testimony - Justice for Assange
Fri, 09 Dec 2016 00:49
Cover letter by Julian Assange:
"Six years ago today, on 7 December 2010, I was handcuffed and locked into Wandsworth prison by order of a Swedish prosecutor, Marianne Ny. I had not and still have not been charged with an offence. The claimed grounds for my arrest and extradition without charge were so that Ny could question me. But it was not until six years later - three weeks ago - that I was questioned for the first time. I have decided to release my responses. But first, some background:
I am Australian. I am not Swedish. I do not speak Swedish. I have never resided in Sweden.
I am entirely innocent. I was already cleared of exactly this allegation in 2010 by the Chief Prosecutor of Stockholm, Eva Finne, who closed the case.
During the height of the Pentagon's conflict with me the following month, the allegation was resurrected by the current prosecutor, Marianne Ny. It was immediately seized on to extinguish my freedom of movement and harm my reputation.
Without even bothering to take my statement, the Swedish Prosecution Authority broke its own rules and released my name to a tabloid newspaper. Prosecutor Ny went on to produce more than 40 press releases and press conferences about me. As a result, to this day more than half a million webpages falsely conflate my name with the word "rape".
For six years I called for my statement to be taken so that the 'preliminary investigation' might again be swiftly closed.
In February this year the United Nations found that Prosecutor Ny has caused Sweden and the UK to breach their international human rights obligations. The UN found that her actions are subjecting me to "cruel, inhuman and degrading treatment" and an unlawful deprivation of liberty which must immediately cease.
Finally, as a result, last month Marianne Ny sent a deputy and a policewoman to London to question me over two days, but '' true to form '' my Swedish lawyer was excluded from the room in yet another breach of my basic rights.
On 30 November the United Nations re-affirmed its decision in relation to my case. I am now releasing my statement to the public. The reason is simple. I want people to know the truth about how abusive this process has been. Furthermore, in the past the prosecution has fed partial information to tabloids that politically oppose me. It is better that my statement, which I am happy with, and which makes it obvious to all that I am innocent, sees the light in full.
Julian Assange
London, 7 December 2016"
Link to full text of Assange testimony (HTML):
https://justice4assange.com/IMG/htm...
Case Fact-checker
FBI sent planeload of agents to frame Assange in Iceland, got snubbed by minister '-- RT News
Sun, 11 Dec 2016 13:58
The US sent a ''planeload of FBI agents'' to Iceland in 2011 to frame WikiLeaks and its co-founder Julian Assange, according to a former Icelandic minister of interior, who refused them any cooperation and asked them to cease their activities.
In June 2011, Obama administration implied to Iceland's authorities they had knowledge of hackers wanting to destroy software systems in the country, and offered help, then-Interior Minister Ogmundur Jonasson, said in an interview with the Katoikos publication.
However, Jonasson said he instantly became ''suspicious'' of the US good intentions, ''well aware that a helping hand might easily become a manipulating hand.''
Read more
Later in the summer 2011, the US ''sent a planeload of FBI agents to Iceland seeking our cooperation in what I understood as an operation set up to frame Julian Assange and WikiLeaks,'' Jonasson said.
Icelanders seemed like a tough nut to crack, though.
''Since they had not been authorized by the Icelandic authorities to carry out police work in Iceland and since a crack-down on WikiLeaks was not on my agenda, to say the least, I ordered that all cooperation with them be promptly terminated and I also made it clear that they should cease all activities in Iceland immediately,'' the politician said.
So the US were told to leave, and moreover, the politician made things quite clear for them.
''If I had to take sides with either WikiLeaks or the FBI or CIA, I would have no difficulty in choosing: I would be on the side of WikiLeaks,'' he said.
J"nasson went on to discuss other whistleblowers like Edward Snowden: the Althing, the Icelandic parliament, debated whether Snowden should have been granted citizenship, but ''there hasn't been political consensus'' on the matter.
''Iceland is part of NATO and such a decision would be strongly objected to by the US,'' Jonasson said.
Both whistleblowers have spent several years under protection: Assange has been staying in the Ecuadorian Embassy in London for about four years, while Snowden was granted asylum in Russia in 2013, and he is still staying at an undisclosed location there.
War on Vape
Health warning: Now e-cigarettes can give you malware | Technology | The Guardian
Fri, 09 Dec 2016 21:30
E-cigarette can either be charged from the wall or by plugging the cigarette itself into a USB port. Photograph: Ian West/PA
E-cigarettes may be better for your health than normal ones, but spare a thought for your poor computer '' electronic cigarettes have become the latest vector for malicious software, according to online reports.
Many e-cigarettes can be charged over USB, either with a special cable, or by plugging the cigarette itself directly into a USB port. That might be a USB port plugged into a wall socket or the port on a computer '' but, if so, that means that a cheap e-cigarette from an untrustworthy supplier gains physical access to a device.
A report on social news site Reddit suggests that at least one ''vaper'' has suffered the downside of trusting their cigarette manufacturer. ''One particular executive had a malware infection on his computer from which the source could not be determined,'' the user writes. ''After all traditional means of infection were covered, IT started looking into other possibilities.
''The made in China e-cigarette had malware hardcoded into the charger, and when plugged into a computer's USB port the malware phoned home and infected the system.''
Rik Ferguson, a security consultant for Trend Micro, says the story is entirely plausible. ''Production line malware has been around for a few years, infecting photo frames, MP3 players and more,'' he says. In 2008, for instance, a photo frame produced by Samsung shipped with malware on the product's install disc.
Even more concerning is a recent proof-of-concept attack called ''BadUSB'', which involves reprogramming USB devices at the hardware level. ''Very widely spread USB controller chips, including those in thumb drives, have no protection from such reprogramming,'' says Berlin-based firm SRLabs, which released the code.
Combine the two, says Ferguson, ''and a very strong case can be made for enterprises disabling USB ports, or at least using device management to allow only authorised devices.
''For consumers it's a case of running up-to-date anti-malware for the production line stuff and only using trusted devices to counter the threat.''
Dave Goss, of London's Vape Emporium, says that vapers can remain safe by buying from respected manufacturers such as Aspire, KangerTech and Innokin, and by checking for ''scratch checkers'' on the box, which mark out authentic goods from counterfeits.
''Any electrical device that uses a USB charger could be targeted in this way, and just about every one of these electrical devices will come from China,'' he adds.
In early November, figures obtained by the Press Association revealed that e-cigarettes and related equipment, such as chargers, were involved in more than 100 fires in less than two years.
Big Pharma
Text - H.R.6 - 114th Congress (2015-2016): 21st Century Cures Act | Congress.gov | Library of Congress
Fri, 09 Dec 2016 13:58
H. R. 6
To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,SECTION 1.Short title; table of contents.(a) Short title.'--This Act may be cited as the ''21st Century Cures Act''.
(b) Table of contents.'--The table of contents for this Act is as follows:
Sec.'‚1.'‚Short title; table of contents.Sec.'‚2.'‚NIH and Cures Innovation Fund.Sec.'‚1001.'‚National Institutes of Health reauthorization.Sec.'‚1002.'‚Prize competitions.Sec.'‚1021.'‚NIH research strategic plan.Sec.'‚1022.'‚Increasing accountability at the National Institutes of Health.Sec.'‚1023.'‚Reducing administrative burdens of researchers.Sec.'‚1024.'‚Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements.Sec.'‚1025.'‚NIH travel.Sec.'‚1026.'‚Other transactions authority.Sec.'‚1027.'‚NCATS phase IIB restriction.Sec.'‚1028.'‚High-risk, high-reward research.Sec.'‚1029.'‚Sense of Congress on increased inclusion of underrepresented communities in clinical trials.Sec.'‚1041.'‚Improvement of loan repayment programs of the National Institutes of Health.Sec.'‚1042.'‚Report.Sec.'‚1061.'‚Capstone award.Sec.'‚1081.'‚National pediatric research network.Sec.'‚1082.'‚Global pediatric clinical study network sense of Congress.Sec.'‚1083.'‚Appropriate age groupings in clinical research.Sec.'‚1101.'‚Standardization of data in Clinical Trial Registry Data Bank on eligibility for clinical trials.Sec.'‚1121.'‚Clinical trial data system.Sec.'‚1122.'‚National neurological diseases surveillance system.Sec.'‚1123.'‚Data on natural history of diseases.Sec.'‚1124.'‚Accessing, sharing, and using health data for research purposes.Sec.'‚1141.'‚Council for 21st Century Cures.Sec.'‚2001.'‚Development and use of patient experience data to enhance structured risk-benefit assessment framework.Sec.'‚2021.'‚Qualification of drug development tools.Sec.'‚2022.'‚Accelerated approval development plan.Sec.'‚2041.'‚Precision medicine guidance and other programs of Food and Drug Administration.Sec.'‚2061.'‚Broader application of Bayesian statistics and adaptive trial designs.Sec.'‚2062.'‚Utilizing evidence from clinical experience.Sec.'‚2063.'‚Streamlined data review program.Sec.'‚2081.'‚Sense of Congress.Sec.'‚2082.'‚Expanded access policy.Sec.'‚2083.'‚Finalizing draft guidance on expanded access.Sec.'‚2101.'‚Facilitating dissemination of health care economic information.Sec.'‚2102.'‚Facilitating responsible communication of scientific and medical developments.Sec.'‚2121.'‚Approval of certain drugs for use in a limited population of patients.Sec.'‚2122.'‚Susceptibility test interpretive criteria for microorganisms.Sec.'‚2123.'‚Encouraging the development and use of DISARM drugs.Sec.'‚2141.'‚Timely review of vaccines by the Advisory Committee on Immunization Practices.Sec.'‚2142.'‚Review of processes and consistency of ACIP recommendations.Sec.'‚2143.'‚Meetings between CDC and vaccine developers.Sec.'‚2151.'‚Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition.Sec.'‚2152.'‚Reauthorization of rare pediatric disease priority review voucher incentive program.Sec.'‚2161.'‚Grants for studying the process of continuous drug manufacturing.Sec.'‚2162.'‚Re-exportation among members of the European Economic Area.Sec.'‚2181.'‚Enhancing combination products review.Sec.'‚2201.'‚Priority review for breakthrough devices.Sec.'‚2221.'‚Third-party quality system assessment.Sec.'‚2222.'‚Valid scientific evidence.Sec.'‚2223.'‚Training and oversight in least burdensome appropriate means concept.Sec.'‚2224.'‚Recognition of standards.Sec.'‚2225.'‚Easing regulatory burden with respect to certain class I and class II devices.Sec.'‚2226.'‚Advisory committee process.Sec.'‚2227.'‚Humanitarian device exemption application.Sec.'‚2228.'‚CLIA waiver study design guidance for in vitro diagnostics.Sec.'‚2241.'‚Health software.Sec.'‚2242.'‚Applicability and inapplicability of regulation.Sec.'‚2243.'‚Exclusion from definition of device.Sec.'‚2261.'‚Protection of human subjects in research; applicability of rules.Sec.'‚2262.'‚Use of non-local institutional review boards for review of investigational device exemptions and human device exemptions.Sec.'‚2263.'‚Alteration or waiver of informed consent for clinical investigations.Sec.'‚2281.'‚Silvio O. Conte Senior Biomedical Research Service.Sec.'‚2282.'‚Enabling FDA scientific engagement.Sec.'‚2283.'‚Reagan-Udall Foundation for the Food and Drug Administration.Sec.'‚2284.'‚Collection of certain voluntary information exempted from Paperwork Reduction Act.Sec.'‚2285.'‚Hiring authority for scientific, technical, and professional personnel.Sec.'‚2301.'‚Exempting from sequestration certain user fees of Food and Drug Administration.Sec.'‚2321.'‚Sense of Congress.Sec.'‚3001.'‚Ensuring interoperability of health information technology.Sec.'‚3021.'‚Telehealth services under the Medicare Program.Sec.'‚3041.'‚Exempting from manufacturer transparency reporting certain transfers used for educational purposes.Sec.'‚3061.'‚Treatment of certain items and devices.Sec.'‚3081.'‚Improvements in the Medicare local coverage determination (LCD) process.Sec.'‚3101.'‚Medicare pharmaceutical and technology ombudsman.Sec.'‚3121.'‚Medicare site-of-Service price transparency.Sec.'‚3141.'‚Programs to prevent prescription drug abuse under Medicare parts C and D.Sec.'‚4001.'‚Limiting Federal Medicaid reimbursement to States for durable medical equipment (DME) to Medicare payment rates.Sec.'‚4002.'‚Excluding authorized generics from calculation of average manufacturer price.Sec.'‚4003.'‚Medicare payment incentive for the transition from traditional x-ray imaging to digital radiography and other Medicare imaging payment provision.Sec.'‚4004.'‚Treatment of infusion drugs furnished through durable medical equipment.Sec.'‚4005.'‚Extension and expansion of prior authorization for power mobility devices (PMDs) and accessories and prior authorization audit limitations.Sec.'‚4006.'‚Civil monetary penalties for violations related to grants, contracts, and other agreements.Sec.'‚4041.'‚SPR drawdown.Sec.'‚4061.'‚Lyme disease and other tick-borne diseases.Sec.'‚4062.'‚Outreach to historically black colleges and universities.SEC. 2.NIH and Cures Innovation Fund.(a) Establishment.'--There is hereby established in the Treasury of the United States a fund to be known as the NIH and Cures Innovation Fund.
(b) Amounts made available to Fund.'--
(1) IN GENERAL.'--There is authorized to be appropriated, and appropriated, to the NIH and Cures Innovation Fund, out of any funds in the Treasury not otherwise appropriated, $1,860,000,000 for each of fiscal years 2016 through 2020. The amounts appropriated to the NIH and Cures Innovation Fund by the preceding sentence shall be in addition to any amounts otherwise made available to the Department of Health and Human Services.
(2) ALLOCATION OF AMOUNTS.'--Of the amounts made available from the NIH and Cures Innovation Fund for a fiscal year'--
(A) $1,750,000,000 shall be for biomedical research of the National Institutes of Health under subsection (c)(1), of which'--
(i) not less than $500,000,000 shall be for the Accelerating Advancement Program under subsection (d)(2);
(ii) not less than 35 percent of such amounts remaining after subtracting the allocation for the Accelerating Advancement Program shall be for early stage investigators as defined in subsection (g);
(iii) not less than 20 percent of such amounts remaining after subtracting the allocation for the Accelerating Advancement Program shall be for high-risk, high-reward research under section 409L of the Public Health Service Act, as added by section 1028; and
(iv) not more than 10 percent of such amounts (without subtracting the allocation for the Accelerating Advancement Program) shall be for intramural research; and
(B) $110,000,000 shall be for carrying out the provisions listed in subsection (c)(2).
(3) INAPPLICABILITY OF CERTAIN PROVISIONS.'--Amounts in the NIH and Cures Innovation Fund (including amounts made available to the National Institutes of Health) shall not be subject to'--
(A) any transfer authority of the Secretary of Health and Human Services or the Director of the National Institutes of Health under sections 241, 402A(c), or 402A(d) of the Public Health Service Act (42 U.S.C. 238j, 282a(c) and (d)) or any other provision of law (other than this section); or
(B) the Nonrecurring expenses fund under section 223 of division G of the Consolidated Appropriations Act, 2008 (42 U.S.C. 3514a).
(c) Authorized uses.'--
(1) NIH BIOMEDICAL RESEARCH.'--Amounts in the NIH and Cures Innovation Fund that are allocated pursuant to subsection (b)(2)(A) may only be used for the purpose of conducting or supporting biomedical research (including basic, translational, and clinical research) through the following:
(A) Research in which'--
(i) a principal investigator has a specific project or specific objectives; and
(ii) funding is tied to pursuit of such project or objectives.
(B) Research in which'--
(i) a principal investigator has shown promise in biomedical research; and
(ii) funding is not tied to a specific project or specific objectives.
(C) Research to be carried out by an early stage investigator (as defined in subsection (g)).
(D) Research to be carried out by a small business concern (as defined in section 3 of the Small Business Act).
(E) The Accelerating Advancement Program under subsection (d)(2).
(F) Development and implementation of the strategic plan under subsection (d)(3).
(2) CURES DEVELOPMENT.'--Amounts in the NIH and Cures Innovation Fund that are allocated pursuant to subsection (b)(2)(B) may only be used for the purpose of carrying out the following provisions:
(A) Section 229A of the Public Health Service Act, as added by section 1123 (relating to data on natural history of diseases).
(B) Section 2001 and the amendments made by such section (relating to development and use of patient experience data to enhance structured risk-benefit assessment framework).
(C) Section 2021 and the amendments made by such section (relating to qualification of drug development tools).
(D) Section 2062 and the amendments made by such section (relating to utilizing evidence from clinical experience).
(E) Section 2161 (relating to grants for studying the process of continuous drug manufacturing).
(F) Section 2201 and the amendments made by such section (relating to priority review for breakthrough devices).
(G) Section 2221 and the amendments made by such section (relating to third-party quality system assessments).
(H) Sections 2241, 2242, and 2243 and the amendments made by such sections (relating to health software).
(I) Section 513(j) of the Federal Food, Drug, and Cosmetic Act, as added by section 2223 (relating to training and oversight in least burdensome appropriate means concept).
(d) NIH Innovation Fund.'--
(1) COORDINATION.'--In conducting or supporting biomedical research pursuant to funds allocated pursuant to subsection (b)(2)(A), the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall'--
(A) ensure coordination among the national research institutes, the national centers, and other departments, agencies, and offices of the Federal Government; and
(B) minimize unnecessary duplication.
(2) ACCELERATING ADVANCEMENT PROGRAM.'--The Director of the National Institutes of Health shall establish a program, to be known as the Accelerating Advancement Program, under which'--
(A) the Director partners with national research institutes and national centers to accomplish important biomedical research objectives; and
(B) for every $1 made available by the Director to a national research institute or national center for a research project, the institute or center makes $1 available for such project from funds that are not derived from the NIH and Cures Innovation Fund.
(3) STRATEGIC PLAN.'--
(A) IN GENERAL.'--The Director of the National Institutes of Health shall ensure that scientifically based strategic planning is implemented in support of research priorities, including through development, use, and updating of a research strategic plan that'--
(i) is designed to increase the efficient and effective focus of biomedical research in a manner that leverages the best scientific opportunities through a deliberative planning process;
(ii) identifies areas, to be known as strategic focus areas, in which the resources of the NIH and Cures Innovation Fund can contribute to the goals of expanding knowledge to address, and find more effective treatments for, unmet medical needs in the United States, including the areas of'--
(I) biomarkers;
(II) precision medicine;
(III) infectious diseases, including pathogens listed as a qualifying pathogen under section 505E(f) of the Federal Food, Drug, and Cosmetic Act or listed or designated as a tropical disease under section 524 of such Act; and
(IV) antibiotics;
(iii) includes objectives for each such strategic focus area; and
(iv) ensures that basic research remains a priority.
(B) UPDATES AND REVIEWS.'--The Director of the National Institutes of Health shall review and, as appropriate, update the research strategic plan under subparagraph (A) not less than every 18 months.
(e) Transfer authority.'--The Committee on Appropriations of the Senate and the Committee on Appropriations of the House of Representatives may provide for the transfer of funds in the NIH and Cures Innovation Fund for the purposes specified in subsection (c).
(f) Supplement, not supplant; limitations.'--Funds appropriated by subsection (b)'--
(1) shall be used to supplement, not supplant, amounts otherwise made available to the Department of Health and Human Services;
(2) are subject to the requirements and limitations of the most recently enacted regular or full-year continuing appropriation Act or resolution (as of the date of obligation) for programs of the National Institutes of Health or the Food and Drug Administration, as applicable; and
(3) notwithstanding any transfer authority in any appropriation Act, shall not be used for any purpose other than the purposes specified in subsection (c).
(g) Definition.'--In this subsection:
(1) The term ''early stage investigator'' means an investigator who'--
(A) will be the principal investigator or the program director of the proposed research;
(B) has never been awarded, or has been awarded only once, a substantial, competing grant by the National Institutes of Health for independent research; and
(C) is within 10 years of having completed'--
(i) the investigator's terminal degree; or
(ii) a medical residency (or the equivalent).
(2) The terms ''national center'' and ''national research institute'' have the meanings given to those terms in section 401(g) of the Public Health Service Act (42 U.S.C. 281(g)).
SEC. 1001.National Institutes of Health reauthorization.Section 402A(a)(1) of the Public Health Service Act (42 U.S.C. 282a(a)(1)) is amended'--
(1) in subparagraph (B), by striking at the end ''and'';
(2) in subparagraph (C), by striking at the end the period and inserting a semicolon; and
(3) by adding at the end the following new subparagraphs:
''(D) $31,811,000,000 for fiscal year 2016;
''(E) $33,331,000,000 for fiscal year 2017; and
''(F) $34,851,000,000 for fiscal year 2018.''.
SEC. 1002.Prize competitions.Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.) is amended by adding at the end the following:
''SEC. 409K.Prize competitions for improving health outcomes and reducing Federal expenditures.
''(a) Establishment; goals.'--The Director of NIH shall establish and implement an Innovation Prizes Program for one or both of the following goals:
''(1) Identifying and funding areas of biomedical science that could realize significant advancements through the creation of a prize competition.
''(2) Improving health outcomes, particularly with respect to human diseases and conditions for which public and private investment in research is disproportionately small relative to Federal Government expenditures on prevention and treatment activities, thereby reducing Federal expenditures on health programs.
''(b) Design of prize competitions.'--Not later than 6 months after the date of enactment of this section, the Director of NIH shall'--
''(1) design prize competitions'--
''(A) to cooperate with competitors to realize innovations to identify and address areas of biomedical science that could realize significant advancements through the creation of a prize competition; and
''(B) to award one or more prizes'--
''(i) if appropriate, at the beginning of or during the competitions, to the competitors whose innovations are most promising or demonstrate progress; and
''(ii) at the end of the competitions, to the competitors whose innovations prove to be the best solutions;
''(2) ensure that the design of such competitions'--
''(A) is realistic, given the amount of funds to be awarded as prizes;
''(B) does not reflect any bias concerning the type of innovations which will prove to be the best solutions; and
''(C) allows any person to participate as a competitor without regard to the person's place of incorporation, primary place of business, citizenship, and residency, as applicable; and
''(3) submit to the Congress a report on the design of such competitions.
''(c) Innovation Prizes Advisory Board.'--
''(1) ESTABLISHMENT.'--The Director of NIH shall establish and maintain a board, to be known as the I-Prize Board, to advise and assist the Director of NIH in carrying out this section.
''(2) COMPOSITION; TERMS.'--
''(A) COMPOSITION.'--The I-Prize Board shall be composed of nine voting members as follows:
''(i) The Director of NIH (or the Director's designee).
''(ii) Four members appointed by the Director of NIH.
''(iii) One member appointed by the Speaker of the House of Representatives.
''(iv) One member appointed by the majority leader of the Senate.
''(v) One member appointed by the minority leader of the House of Representatives.
''(vi) One member appointed by the minority leader in the Senate.
''(B) INCLUSION OF CERTAIN EXPERTS.'--The members of the I-Prize Board appointed under clauses (ii) through (vi) of subparagraph (A) shall, collectively, include medical, economic, budgetary, innovation, or venture capital experts from for-profit and not-for-profit private sector entities with experience in awarding prizes similar to the prizes under this section.
''(C) TERMS.'--The appointed members of the I-Prize Board shall each be appointed for a term of 5 years.
''(D) APPOINTMENT OF INITIAL MEMBERS.'--The initial appointed members of the I-Prize Board shall be appointed not later than 120 days after the date of enactment of this section.
''(3) RESPONSIBILITIES.'--The I-Prize Board shall be responsible for advising the Director of NIH by'--
''(A) identifying areas of biomedical science that could realize significant advancements through the creation of a prize competition;
''(B) making recommendations on establishing the criteria for prize competitions under this section;
''(C) making recommendations on which business organizations or other entities have successfully met the criteria established for the prize competition; and
''(D) gaining insight from researchers, health economists, academia, and industry on how to conduct prize competitions.
''(d) Restrictions.'--
''(1) NO FINANCIAL CONFLICTS OF INTEREST.'--Any member of the I-Prize Board, and any officer or employee of the National Institutes of Health responsible for carrying out this section, may not personally or substantially participate in the consideration or determination by the I-Prize Board of any matter that would directly or predictably effect any financial interest of'--
''(A) the individual or a relative (as such term is defined in section 109(16) of the Ethics in Government Act of 1978) of the individual; or
''(B) of any business organization or other entity'--
''(i) of which the individual is an officer or employee;
''(ii) with respect to which the individual is negotiating for employment; or
''(iii) in which the individual has any other financial interest.
''(2) NO AWARDS TO COMPETITORS LIKELY TO REAP FINANCIAL BENEFIT FROM INNOVATION.'--The Director of NIH may not, with respect to an innovation, award a prize under this section to any individual or entity that has a vested financial interest in any product or procedure that is likely to be developed or marketed because of such innovation.
''(e) Process of award.'--The full monetary amount of any prize awarded under this section shall be made available to the prize winner not later than 90 days after the date of such award.
''(f) Simulation.'--The Director of NIH may'--
''(1) award one or more contracts'--
''(A) to perform a simulation of the prize competitions to be conducted under this section, based on the designs developed under subsection (b); and
''(B) to use the simulation to assess the effectiveness of the design; and
''(2) not later than 4 months after awarding such one or more contracts, submit to the Congress a report on the results of the simulation and assessment.
''(g) Implementation of prize competitions.'--
''(1) IN GENERAL.'--The Director of NIH may enter into an agreement with one or more entities described in section 501(c), and exempt from tax under section 501(a), of the Internal Revenue Code of 1986 to implement prize competitions based on the designs developed under subsection (b).
''(2) MINIMUM PERCENTAGE FOR PRIZES.'--If the Director of NIH enters into an agreement under paragraph (1) to provide funds or other assistance (including in-kind contributions and testing or other technical support) to an entity to implement a prize competition under this section'--
''(A) not more than 15 percent of such assistance shall be for administration of the prize competition; and
''(B) not less than 85 percent of such assistance shall be for activities in direct support of competitors such as demonstration, testing, education, and prize awards.
''(h) Tracking; reporting.'--The Director of NIH shall'--
''(1) collect information on'--
''(A) the medical efficacy of innovations funded through the prize competitions under this section; and
''(B) the actual and potential effect of the innovations on Federal expenditures; and
''(2) not later than 1 year after the conclusion of the prize competitions under this section, and not later than the end of each of the 4 succeeding years, submit to the Congress a report on the information collected under paragraph (1).
''(i) Intellectual property.'--
''(1) PROHIBITION ON THE GOVERNMENT ACQUIRING INTELLECTUAL PROPERTY RIGHTS.'--The Federal Government may not gain an interest in intellectual property developed by a participant in a prize competition under this section without the written consent of the participant.
''(2) LICENSES.'--The Federal Government may negotiate a license for the use of intellectual property developed by a participant in a prize competition under this section.''.
SEC. 1021.NIH research strategic plan.Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended'--
(1) in subsection (b), by amending paragraph (5) to read as follows:
''(5) shall ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the agencies of the National Institutes of Health, including through development, use, and updating of the research strategic plan under subsection (m);''; and
(2) by adding at the end the following:
''(m) Research strategic plan.'--
''(1) FIVE-YEAR PLANS FOR BIOMEDICAL RESEARCH STRATEGY.'--
''(A) IN GENERAL.'--For each successive 5-year period beginning with the period of fiscal years 2016 through 2020, the Director of NIH, in consultation with the entities described in subparagraph (B), shall develop and maintain a biomedical research strategic plan that'--
''(i) is designed to increase the efficient and effective focus of biomedical research in a manner that leverages the best scientific opportunities through a deliberative planning process;
''(ii) identifies areas, to be known as strategic focus areas, in which the resources of the National Institutes of Health can best contribute to the goal of expanding knowledge on human health in the United States through biomedical research; and
''(iii) includes objectives for each such strategic focus area.
''(B) ENTITIES DESCRIBED.'--The entities described in this subparagraph are the directors of the national research institutes and national centers, researchers, patient advocacy groups, and industry leaders.
''(2) USE OF PLAN.'--The Director of NIH and the directors of the national research institutes and national centers shall use the strategic plan'--
''(A) to identify research opportunities; and
''(B) to develop individual strategic plans for the research activities of each of the national research institutes and national centers that'--
''(i) have a common template; and
''(ii) identify strategic focus areas in which the resources of the national research institutes and national centers can best contribute to the goal of expanding knowledge on human health in the United States through biomedical research.
''(3) CONTENTS OF PLANS.'--
''(A) STRATEGIC FOCUS AREAS.'--The strategic focus areas identified pursuant to paragraph (1)(A)(ii) shall'--
''(i) be identified in a manner that'--
''(I) considers the return on investment to the United States public through the investments of the National Institutes of Health in biomedical research; and
''(II) contributes to expanding knowledge to improve the United States public's health through biomedical research; and
''(ii) include overarching and trans-National Institutes of Health strategic focus areas, to be known as Mission Priority Focus Areas, which best serve the goals of preventing or eliminating the burden of a disease or condition and scientifically merit enhanced and focused research over the next 5 years.
''(B) RARE AND PEDIATRIC DISEASES AND CONDITIONS.'--In developing and maintaining a strategic plan under this subsection, the Director of NIH shall ensure that rare and pediatric diseases and conditions remain a priority.
''(C) WORKFORCE.'--In developing and maintaining a strategic plan under this subsection, the Director of NIH shall ensure that maintaining the biomedical workforce of the future, including the participation by scientists from groups traditionally underrepresented in the scientific workforce, remains a priority.
''(4) INITIAL PLAN.'--Not later than 270 days after the date of enactment of this subsection, the Director of NIH and the directors of the national research institutes and national centers shall'--
''(A) complete the initial strategic plan required by paragraphs (1) and (2); and
''(B) make such initial strategic plan publicly available on the website of the National Institutes of Health.
''(5) REVIEW; UPDATES.'--
''(A) PROGRESS REVIEWS.'--Not less than annually, the Director of NIH, in consultation with the directors of the national research institutes and national centers, shall conduct progress reviews for each strategic focus area identified under paragraph (1)(A)(ii).
''(B) UPDATES.'--Not later than the end of the 5-year period covered by the initial strategic plan under this subsection, and every 5 years thereafter, the Director of NIH, in consultation with the directors of the national research institutes and national centers, stakeholders in the scientific field, advocates, and the public at large, shall'--
''(i) conduct a review of the plan, including each strategic focus area identified under paragraph (2)(B); and
''(ii) update such plan in accordance with this section.''.
SEC. 1022.Increasing accountability at the National Institutes of Health.(a) Appointment and terms of directors of national research institutes and national centers.'--Subsection (a) of section 405 of the Public Health Service Act (42 U.S.C. 284) is amended to read as follows:'' (a) Appointment; terms.'--
''(1) APPOINTMENT.'--The Director of the National Cancer Institute shall be appointed by the President and the directors of the other national research institutes, as well as the directors of the national centers, shall be appointed by the Director of NIH. The directors of the national research institutes, as well as national centers, shall report directly to the Director of NIH.
''(2) TERMS.'--
''(A) IN GENERAL.'--The term of office of a director of a national research institute or national center shall be 5 years.
''(B) REMOVAL.'--The director of a national research institute or national center may be removed from office by the Director of NIH prior to the expiration of such director's 5-year term.
''(C) REAPPOINTMENT.'--At the end of the term of a director of a national research institute or national center, the director may be reappointed. There is no limit on the number of terms a director may serve.
''(D) VACANCIES.'--If the office of a director of a national research institute or national center becomes vacant before the end of such director's term, the director appointed to fill the vacancy shall be appointed for a 5-year term starting on the date of such appointment.
''(E) TRANSITIONAL PROVISION.'--Each director of a national research institute or national center serving on the date of enactment of the 21st Century Cures Act is deemed to be appointed for a 5-year term under this subsection starting on such date of enactment.''.
(b) Compensation to consultants or individual scientists.'--Section 202 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 (Public Law 102''394; 42 U.S.C. 238f note) is amended by striking ''portable structures;'' and all that follows and inserting ''portable structures.''.
(c) Review of certain awards by directors.'--Section 405(b) of the Public Health Service Act (42 U.S.C. 284(b)) is amended by adding at the end the following:
''(3) Before an award is made by a national research institute or by a national center for a grant for a research program or project (commonly referred to as an 'R-series grant'), other than an award constituting a noncompeting renewal of such grant, or a noncompeting administrative supplement to such grant, the director of such national research institute or national center'--
''(A) shall review and approve the award; and
''(B) shall take into consideration'--
''(i) the mission of the national research institute or national center and the scientific priorities identified in the strategic plan under section 402(m); and
''(ii) whether other agencies are funding programs or projects to accomplish the same goal.''.
(d) IOM study on duplication in Federal biomedical research.'--The Secretary of Health and Human Services shall enter into an arrangement with the Institute of Medicine of the National Academies (or, if the Institute declines, another appropriate entity) under which the Institute (or other appropriate entity) not later than 2 years after the date of enactment of this Act will'--
(1) complete a study on the extent to which biomedical research conducted or supported by Federal agencies is duplicative; and
(2) submit a report to the Congress on the results of such study, including recommendations on how to prevent such duplication.
SEC. 1023.Reducing administrative burdens of researchers.(a) Plan Preparation and implementation of measures To reduce administrative burdens.'--The Director of the National Institutes of Health shall prepare a plan, including time frames, and implement measures to reduce the administrative burdens of researchers funded by the National Institutes of Health, taking into account the recommendations, evaluations, and plans researched by the following entities:
(1) The Scientific Management Review Board.
(2) The National Academy of Sciences.
(3) The 2007 and 2012 Faculty Burden Survey conducted by The Federal Demonstration Partnership.
(4) Relevant recommendations from the Research Business Models Working Group.
(b) Report.'--Not later than 2 years after the date of enactment of this Act, the Director of the National Institutes of Health shall submit to Congress a report on the extent to which the Director has implemented measures pursuant to subsection (a).
SEC. 1024.Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements.Section 3518(c)(1) of title 44, United States Code, is amended'--
(1) in subparagraph (C), by striking ''; or'' and inserting a semicolon;
(2) in subparagraph (D), by striking the period at the end and inserting ''; or''; and
(3) by inserting at the end the following new subparagraph:
''(E) during the conduct of research by the National Institutes of Health.''.
It is the sense of Congress that participation in or sponsorship of scientific conferences and meetings is essential to the mission of the National Institutes of Health.
SEC. 1026.Other transactions authority.Section 480 of the Public Health Service Act (42 U.S.C. 287a) is amended'--
(1) in subsection (b), by striking ''the appropriation of funds as described in subsection (g)'' and inserting ''the availability of funds as described in subsection (f)'';
(2) in subsection (e)(3), by amending subparagraph (C) to read as follows:
''(C) OTHER TRANSACTIONS AUTHORITY.'--The Director of the Center shall have other transactions authority in entering into transactions to fund projects in accordance with the terms and conditions of this section.'';
(3) by striking subsection (f); and
(4) by redesignating subsection (g) as subsection (f).
SEC. 1027.NCATS phase IIB restriction.Section 479 of the Public Health Service Act (42 U.S.C. 287) is amended'--
(1) prior to making the amendments under paragraph (2), by striking ''IIB'' each place it appears and inserting ''III''; and
(2) by striking ''IIA'' each place it appears and inserting ''IIB''.
SEC. 1028.High-risk, high-reward research.Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.), as amended by section 1002 of this Act, is amended by adding at the end the following:
''SEC. 409L.High-risk, high-reward research program.
''The director of each national research institute shall, as appropriate'--
''(1) establish programs to conduct or support research projects that pursue innovative approaches to major contemporary challenges in biomedical research that involve inherent high risk, but have the potential to lead to breakthroughs; and
''(2) set aside a specific percentage of funding, to be determined by the Director of NIH for each national research institute, for such projects.''.
SEC. 1029.Sense of Congress on increased inclusion of underrepresented communities in clinical trials.It is the sense of Congress that the National Institute on Minority Health and Health Disparities (NIMHD) should include within its strategic plan ways to increase representation of underrepresented communities in clinical trials.
SEC. 1041.Improvement of loan repayment programs of the National Institutes of Health.(a) In general.'--Part G of title IV of the Public Health Service Act (42 U.S.C. 288 et seq.) is amended'--
(1) by redesignating the second section 487F (42 U.S.C. 288''6; relating to pediatric research loan repayment program) as section 487G; and
(2) by inserting after section 487G, as so redesignated, the following:
''SEC. 487H.Loan repayment program.
''(a) In general.'--The Secretary shall establish a program, based on workforce and scientific needs, of entering into contracts with qualified health professionals under which such health professionals agree to engage in research in consideration of the Federal Government agreeing to pay, for each year of engaging in such research, not more than $50,000 of the principal and interest of the educational loans of such health professionals.
''(b) Adjustment for inflation.'--Beginning with respect to fiscal year 2017, the Secretary may increase the maximum amount specified in subsection (a) by an amount that is determined by the Secretary, on an annual basis, to reflect inflation.
''(c) Limitation.'--The Secretary may not enter into a contract with a health professional pursuant to subsection (a) unless such professional has a substantial amount of educational loans relative to income.
''(d) Applicability of certain provisions regarding obligated service.'--Except to the extent inconsistent with this section, the provisions of sections 338B, 338C, and 338E shall apply to the program established under this section to the same extent and in the same manner as such provisions apply to the National Health Service Corps Loan Repayment Program established under section 338B.
''(e) Availability of appropriations.'--Amounts appropriated for a fiscal year for contracts under subsection (a) are authorized to remain available until the expiration of the second fiscal year beginning after the fiscal year for which the amounts were appropriated.''.
(b) Update of other loan repayment programs.'--
(1) Section 464z''5(a) of the Public Health Service Act (42 U.S.C.285t''2(a)) is amended'--
(A) by striking ''$35,000'' and inserting ''$50,000''; and
(B) by adding at the end the following new sentence: ''Subsection (b) of section 487H shall apply with respect to the maximum amount specified in this subsection in the same manner as it applies to the maximum amount specified in subsection (a) of such section.''.
(2) Section 487A(a) of such Act (42 U.S.C. 288''1(a)) is amended'--
(A) by striking ''$35,000'' and inserting ''$50,000''; and
(B) by adding at the end the following new sentence: ''Subsection (b) of section 487H shall apply with respect to the maximum amount specified in this subsection in the same manner as it applies to the maximum amount specified in subsection (a) of such section.''.
(3) Section 487B(a) of such Act (42 U.S.C. 288''2(a)) is amended'--
(A) by striking ''$35,000'' and inserting ''$50,000''; and
(B) by adding at the end the following new sentence: ''Subsection (b) of section 487H shall apply with respect to the maximum amount specified in this subsection in the same manner as it applies to the maximum amount specified in such subsection (a) of such section.''.
(4) Section 487C(a)(1) of such Act (42 U.S.C. 288''3(a)(1)) is amended'--
(A) by striking ''$35,000'' and inserting ''$50,000''; and
(B) by adding at the end the following new sentence: ''Subsection (b) of section 487H shall apply with respect to the maximum amount specified in this paragraph in the same manner as it applies to the maximum amount specified in such subsection (a) of such section.''.
(5) Section 487E(a)(1) of such Act (42 U.S.C. 288''5(a)(1)) is amended'--
(A) by striking ''$35,000'' and inserting ''$50,000''; and
(B) by adding at the end the following new sentence: ''Subsection (b) of section 487H shall apply with respect to the maximum amount specified in this paragraph in the same manner as it applies to the maximum amount specified in such subsection (a) of such section.''.
(6) Section 487F(a) of such Act (42 U.S.C. 288''5a(a)), as added by section 205 of Public Law 106''505, is amended'--
(A) by striking ''$35,000'' and inserting ''$50,000''; and
(B) by adding at the end the following new sentence: ''Subsection (b) of section 487H shall apply with respect to the maximum amount specified in this subsection in the same manner as it applies to the maximum amount specified in such subsection (a) of such section.''.
(7) Section 487G of such Act (42 U.S.C. 288''6, as redesignated by subsection (a)(1)), is further amended'--
(A) in subsection (a)(1), by striking ''$35,000'' and inserting ''$50,000''; and
(B) in subsection (b), by adding at the end the following new sentence: ''Subsection (b) of section 487H shall apply with respect to the maximum amount specified in subsection (a)(1) in the same manner as it applies to the maximum amount specified in such subsection (a) of such section.''.
Not later than 18 months after the date of the enactment of this Act, the Director of the National Institutes of Health shall submit to Congress a report on efforts of the National Institutes of Health to attract, retain, and develop emerging scientists, including underrepresented individuals in the sciences, such as women and other minorities.
SEC. 1061.Capstone award.Part G of title IV of the Public Health Service Act (42 U.S.C. 288 et seq.) is amended by adding at the end the following:
''SEC. 490.Capstone award.
''(a) In general.'--The Secretary may make awards (each of which, hereafter in this section, referred to as a 'Capstone Award') to support outstanding scientists who have been funded by the National Institutes of Health.
''(b) Purpose.'--Capstone Awards shall be made to facilitate the successful transition or conclusion of research programs, or for other purposes, as determined by the Director of NIH, in consultation with the directors of the national research institutes and national centers.
''(c) Duration and amount.'--The duration and amount of each Capstone Award shall be determined by the Director of NIH in consultation with the directors of the national research institutes and national centers.
''(d) Limitation.'--Individuals who have received a Capstone Award shall not be eligible to have principle investigator status on subsequent awards from the National Institutes of Health.''.
SEC. 1081.National pediatric research network.Section 409D(d) of the Public Health Service Act (42 U.S.C. 284h(d)) is amended'--
(1) in paragraph (1)'--
(A) by striking ''in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and in collaboration with other appropriate national research institutes and national centers that carry out activities involving pediatric research'' and inserting ''in collaboration with the national research institutes and national centers that carry out activities involving pediatric research'';
(B) by striking subparagraph (B);
(C) by striking ''may be comprised of, as appropriate'' and all that follows through ''the pediatric research consortia'' and inserting ''may be comprised of, as appropriate, the pediatric research consortia''; and
(D) by striking ''; or'' at the end and inserting a period; and
(2) in paragraph (1), paragraph (2)(A), the first sentence of paragraph (2)(E), and paragraph (4), by striking ''may'' each place it appears and inserting ''shall''.
SEC. 1082.Global pediatric clinical study network sense of Congress.It is the sense of Congress that'--
(1) the National Institutes of Health should encourage a global pediatric clinical study network through the allocation of grants, contracts, or cooperative agreements to supplement the salaries of new and early investigators who participate in the global pediatric clinical study network;
(2) National Institutes of Health grants, contracts, or cooperative agreements should be awarded, solely for the purpose of supplementing the salaries of new and early investigators, to entities that participate in the global pediatric clinical study network;
(3) the Food and Drug Administration should engage the European Medicines Agency and other foreign regulatory entities during the formation of the global pediatric clinical study network to encourage their participation; and
(4) once a global pediatric clinical study network is established and becomes operational, the Food and Drug Administration should continue to engage the European Medicines Agency and other foreign regulatory entities to encourage and facilitate their participation in the network with the goal of enhancing the global reach of the network.
SEC. 1083.Appropriate age groupings in clinical research.(a) Input from experts.'--Not later than 180 days after the date of enactment of this Act, the Director of the National Institutes of Health shall convene a workshop of experts on pediatrics and experts on geriatrics to provide input on'--
(1) appropriate age groupings to be included in research studies involving human subjects; and
(2) acceptable scientific justifications for excluding participants from a range of age groups from human subjects research studies.
(b) Guidelines.'--Not later than 180 days after the conclusion of the workshop under subsection (a), the Director of the National Institutes of Health shall publish guidelines'--
(1) addressing the consideration of age as an inclusion variable in research involving human subjects; and
(2) identifying criteria for justifications for any age-related exclusions in such research.
(c) Public availability of findings and conclusions.'--The Director of the National Institutes of Health shall'--
(1) make the findings and conclusions resulting from the workshop under subsection (a) available to the public on the website of the National Institutes of Health; and
(2) not less than biennially, disclose to the public on such website the number of children included in research that is conducted or supported by the National Institutes of Health, disaggregated by developmentally appropriate age group, race, and gender.
SEC. 1101.Standardization of data in Clinical Trial Registry Data Bank on eligibility for clinical trials.(a) Standardization.'--
(1) IN GENERAL.'--Section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) is amended'--
(A) by redesignating paragraph (7) as paragraph (8); and
(B) by inserting after paragraph (6) the following:
''(7) STANDARDIZATION.'--The Director of NIH shall'--
''(A) ensure that the registry and results data bank is easily used by the public;
''(B) ensure that entries in the registry and results data bank are easily compared;
''(C) ensure that information required to be submitted to the registry and results data bank, including recruitment information under paragraph (2)(A)(ii)(II), is submitted by persons and posted by the Director of NIH in a standardized format and includes at least'--
''(i) the disease or indication being studied;
''(ii) inclusion criteria such as age, gender, diagnosis or diagnoses, laboratory values, or imaging results; and
''(iii) exclusion criteria such as specific diagnosis or diagnoses, laboratory values, or prohibited medications; and
''(D) to the extent possible, in carrying out this paragraph, make use of standard health care terminologies, such as the International Classification of Diseases or the Current Procedural Terminology, that facilitate electronic matching to data in electronic health records or other relevant health information technologies.''.
(2) CONFORMING AMENDMENT.'--Clause (iv) of section 402(j)(2)(B) of the Public Health Service Act (42 U.S.C. 282(j)(2)(B)) is hereby stricken.
(b) Consultation.'--Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services shall consult with stakeholders (including patients, researchers, physicians, industry representatives, health information technology providers, the Food and Drug Administration, and standard setting organizations such as CDISC that have experience working with Federal agencies to standardize health data submissions) to receive advice on enhancements to the clinical trial registry data bank under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) (including enhancements to usability, functionality, and search capability) that are necessary to implement paragraph (7) of section 402(j) of such Act, as added by subsection (a).
(c) Applicability.'--Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall begin implementation of paragraph (7) of section 402(j) of the Public Health Service Act, as added by subsection (a).
SEC. 1121.Clinical trial data system.(a) Establishment.'--The Secretary, acting through the Commissioner of Food and Drugs and the Director of the National Institutes of Health, shall enter into a cooperative agreement, contract, or grant for a period of 7 years, to be known as the Clinical Trial Data System Agreement, with one or more eligible entities to implement a pilot program with respect to all clinical trial data obtained from qualified clinical trials for purposes of registered users conducting further research on such data.
(b) Application.'--Eligible entities seeking to enter into a cooperative agreement, contract, or grant with the Secretary under this section shall submit to the Secretary an application in such time and manner, and containing such information, as the Secretary may require in accordance with this section. The Secretary shall not enter into a cooperative agreement, contract, or grant under this section with an eligible entity unless such entity submits an application including the following:
(1) A certification that the eligible entity is not currently and does not plan to be involved in sponsoring, operating, or participating in a clinical trial nor collaborating with another entity for the purposes of sponsoring, operating, or participating in a clinical trial.
(2) Information demonstrating that the eligible entity can compile clinical trial data in standardized formats using terminologies and standards that have been developed by recognized standards developing organizations with input from diverse stakeholder groups, and information demonstrating that the eligible entity can de-identify clinical trial data consistent with the requirements of section 164.514 of title 45, Code of Federal Regulations (or successor regulations).
(3) A description of the system the eligible entity will use to store and maintain such data, and information demonstrating that this system will comply with applicable standards and requirements for ensuring the security of the clinical trial data.
(4) A certification that the eligible entity will allow only registered users to access and use de-identified clinical trial data, gathered from qualified clinical trials, and that the eligible entity will allow each registered user to access and use such data only after such registered user agrees in writing to the terms described in (e)(4)(B), and such other carefully controlled contractual terms as may be defined by the Secretary.
(5) Evidence demonstrating the ability of the eligible entity to ensure that registered users disseminate the results of the research conducted in accordance with this section to interested parties to serve as a guide to future medical product development or scientific research.
(6) The plan of the eligible entity for securing funding for the activities it would conduct under the clinical trial data system agreement from governmental sources and private foundations, entities, and individuals.
(7) Evidence demonstrating a proven track record of'--
(A) being a neutral third party in working with medical product manufacturers, academic institutions, and the Food and Drug Administration; and
(B) having the ability to protect confidential data.
(8) An agreement that the eligible entity will work with the Comptroller General of the United States for purposes of the study and report under subsection (d).
(c) Extension, expansion, termination.'--The Secretary, acting through the Commissioner of Food and Drugs and the Director of the National Institutes of Health, upon the expiration of the 7-year period referred to in subsection (a), may extend (including permanently), expand, or terminate the pilot program established under such subsection, in whole or in part.
(d) Study and report.'--
(1) IN GENERAL.'--The Comptroller General of the United States shall conduct a study and issue a report to the Congress and the Secretary with respect to the pilot program established under subsection (a), not later than 6 years after the date on which the pilot program is established under subsection (a).
(2) STUDY.'--The study under paragraph (1) shall'--
(A) review the effectiveness of the pilot program established under subsection (a); and
(B) be designed to formulate recommendations on improvements to the program.
(3) REPORT.'--The report under paragraph (1) shall contain at least the following information:
(A) The new discoveries, research inquiries, or clinical trials that have resulted from accessing clinical trial data under the pilot program established under subsection (a).
(B) The number of times scientists have accessed such data, disaggregated by research area and clinical trial phase.
(C) An analysis of whether the program has helped to reduce adverse events in clinical trials.
(D) An analysis of whether scientists have raised any concerns about the burden of having to share data with the system established under the program and, if so, a description of such concerns.
(E) An analysis of privacy and data integrity practices used in the program.
(e) Definitions.'--In this section:
(1) The term ''eligible entity'' means an entity that has experienced personnel with clinical and other technical expertise in the biomedical sciences and biomedical ethics and that is'--
(A) an institution of higher education (as such term is defined in section 1001 of the Higher Education Act of 1965 (20 U.S.C. 1001)) or a consortium of such institutions; or
(B) an organization described in section 501(c)(3) of title 26 of the Internal Revenue Code of 1986 and exempt from tax under section 501(a) of such title.
(2) The term ''medical product'' means a drug (as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(g))), a device (as defined in section 201(h) of such Act (21 U.S.C. 331(h)), a biological product (as defined in section 351 of the Public Health Service Act (42 U.S.C. 262)), or any combination thereof.
(3) The term ''qualified clinical trial'' means a clinical trial sponsored solely by an agency of the Department of Health and Human Services with respect to a medical product'--
(A) that'--
(i) was approved or cleared under section 505, 510(k), or 515, or has an exemption for investigational use in effect under section 505 or 520(m), of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 301 et seq.); or
(ii) was licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) or has an exemption for investigational use in effect under such section 351; or
(B) that is an investigational product for which the original development was discontinued and with respect to which'--
(i) no additional work to support approval, licensure, or clearance of such medical product is being or is planned to be undertaken by the sponsor of the original development program, its successors, assigns, or collaborators; and
(ii) the sponsor of the original investigational development program has provided its consent to the Secretary for inclusion of data regarding such product in the system established under this section.
(4) The term ''registered user'' means a scientific or medical researcher who has'--
(A) a legitimate biomedical research purpose for accessing information from the clinical trials data system and has appropriate qualifications to conduct such research; and
(B) agreed in writing not to transfer to any other person that is not a registered user de-identified clinical trial data from qualified clinical trials accessed through an eligible entity, use such data for reasons not specified in the research proposal, or seek to re-identify qualified clinical trial participants.
(5) The term ''Secretary'' means the Secretary of Health and Human Services.
SEC. 1122.National neurological diseases surveillance system.Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end the following:
''SEC. 399V''6Surveillance of neurological diseases.
''(a) In general.'--The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other agencies as determined appropriate by the Secretary, shall'--
''(1) enhance and expand infrastructure and activities to track the epidemiology of neurological diseases, including multiple sclerosis and Parkinson's disease; and
''(2) incorporate information obtained through such activities into a statistically sound, scientifically credible, integrated surveillance system, to be known as the National Neurological Diseases Surveillance System.
''(b) Research.'--The Secretary shall ensure that the National Neurological Diseases Surveillance System is designed in a manner that facilitates further research on neurological diseases.
''(c) Content.'--In carrying out subsection (a), the Secretary'--
''(1) shall provide for the collection and storage of information on the incidence and prevalence of neurological diseases in the United States;
''(2) to the extent practicable, shall provide for the collection and storage of other available information on neurological diseases, such as information concerning'--
''(A) demographics and other information associated or possibly associated with neurological diseases, such as age, race, ethnicity, sex, geographic location, and family history;
''(B) risk factors associated or possibly associated with neurological diseases, including genetic and environmental risk factors; and
''(C) diagnosis and progression markers;
''(3) may provide for the collection and storage of information relevant to analysis on neurological diseases, such as information concerning'--
''(A) the epidemiology of the diseases;
''(B) the natural history of the diseases;
''(C) the prevention of the diseases;
''(D) the detection, management, and treatment approaches for the diseases; and
''(E) the development of outcomes measures; and
''(4) may address issues identified during the consultation process under subsection (d).
''(d) Consultation.'--In carrying out this section, the Secretary shall consult with individuals with appropriate expertise, including'--
''(1) epidemiologists with experience in disease surveillance or registries;
''(2) representatives of national voluntary health associations that'--
''(A) focus on neurological diseases, including multiple sclerosis and Parkinson's disease; and
''(B) have demonstrated experience in research, care, or patient services;
''(3) health information technology experts or other information management specialists;
''(4) clinicians with expertise in neurological diseases; and
''(5) research scientists with experience conducting translational research or utilizing surveillance systems for scientific research purposes.
''(e) Grants.'--The Secretary may award grants to, or enter into contracts or cooperative agreements with, public or private nonprofit entities to carry out activities under this section.
''(f) Coordination with other Federal, State, and local agencies.'--Subject to subsection (h), the Secretary shall make information and analysis in the National Neurological Diseases Surveillance System available, as appropriate'--
''(1) to Federal departments and agencies, such as the National Institutes of Health, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Agency for Healthcare Research and Quality, the Department of Veterans Affairs, and the Department of Defense; and
''(2) to State and local agencies.
''(g) Public access.'--Subject to subsection (h), the Secretary shall make information and analysis in the National Neurological Diseases Surveillance System available, as appropriate, to the public, including researchers.
''(h) Privacy.'--The Secretary shall ensure that privacy and security protections applicable to the National Neurological Diseases Surveillance System are at least as stringent as the privacy and security protections under HIPAA privacy and security law (as defined in section 3009(a)(2)).
''(i) Report.'--Not later than 4 years after the date of the enactment of this section, the Secretary shall submit a report to the Congress concerning the implementation of this section. Such report shall include information on'--
''(1) the development and maintenance of the National Neurological Diseases Surveillance System;
''(2) the type of information collected and stored in the System;
''(3) the use and availability of such information, including guidelines for such use; and
''(4) the use and coordination of databases that collect or maintain information on neurological diseases.
''(j) Definition.'--In this section, the term 'national voluntary health association' means a national nonprofit organization with chapters, other affiliated organizations, or networks in States throughout the United States.
''(k) Authorization of appropriations.'--To carry out this section, there is authorized to be appropriated $5,000,000 for each of fiscal years 2016 through 2020.''.
SEC. 1123.Data on natural history of diseases.(a) Sense of Congress.'--It is the sense of the Congress that studies on the natural history of diseases can help to facilitate and expedite the development of medical products for such diseases.
(b) Authority.'--Part A of title II of the Public Health Service Act (42 U.S.C. 202 et seq.) is amended by adding at the end the following:
''SEC. 229A.Data on natural history of diseases.
''(a) In general.'--The Secretary, acting through the Commissioner of Food and Drugs, may, for the purposes described in subsection (b)'--
''(1) participate in public-private partnerships engaged in one or more activities specified in subsection (c); and
''(2) award grants to patient advocacy groups or other organizations determined appropriate by the Secretary.
''(b) Purposes described.'--The purposes described in this subsection are to establish or facilitate the collection, maintenance, analysis, and interpretation of data regarding the natural history of diseases, with a particular focus on rare diseases.
''(c) Activities of public-Private partnerships.'--The activities of public-private partnerships in which the Secretary may participate for purposes of this section include'--
''(1) cooperating with other entities that sponsor or maintain disease registries, including disease registries and disease registry platforms for rare diseases;
''(2) developing or enhancing a secure information technology system that'--
''(A) has the capacity to support data needs across a wide range of disease studies;
''(B) is easily modified as knowledge is gained during such studies; and
''(C) is capable of handling increasing amounts of data as more studies are carried out; and
''(3) providing advice to clinical researchers, patient advocacy groups, and other entities with respect to'--
''(A) the design and conduct of disease studies;
''(B) the modification of any such ongoing studies; and
''(C) addressing associated patient privacy issues.
''(d) Availability of data on natural history of diseases.'--Data relating to the natural history of diseases obtained, aggregated, or otherwise maintained by a public-private partnership in which the Secretary participates under subsection (a) shall be made available, consistent with otherwise applicable Federal and State privacy laws, to the public (including patient advocacy groups, researchers, and drug developers) to help to facilitate and expedite medical product development programs.
''(e) Confidentiality.'--Notwithstanding subsection (d), nothing in this section authorizes the disclosure of any information that is a trade secret or commercial or financial information that is privileged or confidential and subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
''(f) Authorization of appropriations.'--There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2016 through 2020.''.
SEC. 1124.Accessing, sharing, and using health data for research purposes.(a) In general.'-- (1) The HITECH Act (title XIII of division A of Public Law 111''5) is amended by adding at the end of subtitle D of such Act (42 U.S.C. 17921 et seq.) the following:
''SEC. 13441.References.''In this part:
''(1) THE RULE.'--References to 'the Rule' refer to part 160 or part 164, as appropriate, of title 45, Code of Federal Regulations (or any successor regulation).
''(2) PART 164.'--References to a specified section of 'part 164', refer to such specified section of part 164 of title 45, Code of Federal Regulations (or any successor section).
''SEC. 13442.Defining health data research as part of health care operations.''(a) In general.'--Subject to subsection (b), the Secretary shall revise or clarify the Rule to allow the use and disclosure of protected health information by a covered entity for research purposes, including studies whose purpose is to obtain generalizable knowledge, to be treated as the use and disclosure of such information for health care operations described in subparagraph (1) of the definition of health care operations in section 164.501 of part 164.
''(b) Modifications to rules for disclosures for health care operations.'--In applying section 164.506 of part 164 to the disclosure of protected health information described in subsection (a)'--
''(1) the Secretary shall revise or clarify the Rule so that the disclosure may be made by the covered entity to only'--
''(A) another covered entity for health care operations (as defined in section 164.501 of part 164);
''(B) a business associate that has entered into a contract under section 164.504(e) of part 164 with a disclosing covered entity to perform health care operations; or
''(C) a business associate that has entered into a contract under section 164.504(e) of part 164 for the purpose of data aggregation (as defined in section 164.501 of part 164); and
''(2) the Secretary shall further revise or clarify the Rule so that the limitation specified by section 164.506(c)(4) of part 164 does not apply to disclosures that are described by subsection (a).
''(c) Rule of construction.'--This section shall not be construed as prohibiting or restricting a use or disclosure of protected health information for research purposes that is otherwise permitted under part 164.
''SEC. 13443.Treating disclosures of protected health information for research similarly to disclosures of such information for public health purposes.''(a) Remuneration.'--The Secretary shall revise or clarify the Rule so that disclosures of protected health information for research purposes are not subject to the limitation on remuneration described in section 164.502(a)(5)(ii)(B)(2)(ii) of part 164.
''(b) Permitted uses and disclosures.'--The Secretary shall revise or clarify the Rule so that research activities, including comparative research activities, related to the quality, safety, or effectiveness of a product or activity that is regulated by the Food and Drug Administration are included as public health activities for purposes of which a covered entity may disclose protected health information to a person described in section 164.512(b)(1)(iii) of part 164.
''SEC. 13444.Permitting remote access to protected health information by researchers.''The Secretary shall revise or clarify the Rule so that subparagraph (B) of section 164.512(i)(1)(ii) of part 164 (prohibiting the removal of protected health information by a researcher) does not prohibit remote access to health information by a researcher so long as'--
''(1) appropriate security and privacy safeguards are maintained by the covered entity and the researcher; and
''(2) the protected health information is not copied or otherwise retained by the researcher.
''SEC. 13445.Allowing one-time authorization of use and disclosure of protected health information for research purposes.''(a) In general.'--The Secretary shall revise or clarify the Rule to specify that an authorization for the use or disclosure of protected health information, with respect to an individual, for future research purposes shall be deemed to contain a sufficient description of the purpose of the use or disclosure if the authorization'--
''(1) sufficiently describes the purposes such that it would be reasonable for the individual to expect that the protected health information could be used or disclosed for such future research;
''(2) either'--
''(A) states that the authorization will expire on a particular date or on the occurrence of a particular event; or
''(B) states that the authorization will remain valid unless and until it is revoked by the individual; and
''(3) provides instruction to the individual on how to revoke such authorization at any time.
''(b) Revocation of authorization.'--The Secretary shall revise or clarify the Rule to specify that, if an individual revokes an authorization for future research purposes such as is described by subsection (a), the covered entity may not make any further uses or disclosures based on that authorization, except, as provided in paragraph (b)(5) of section 164.508 of part 164, to the extent that the covered entity has taken action in reliance on the authorization.''.
(2) The table of sections in section 13001(b) of such Act is amended by adding at the end of the items relating to subtitle D the following new items:
''PART 4'--ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH PURPOSES
''Sec.'‚13441.'‚References.''Sec.'‚13442.'‚Defining health data research as part of health care operations.''Sec.'‚13443.'‚Treating disclosures of protected health information for research similarly to disclosures of such information for public health purposes.''Sec.'‚13444.'‚Permitting remote access to protected health information by researchers.''Sec.'‚13445.'‚Allowing one-time authorization of use and disclosure of protected health information for research purposes.''.(b) Revision of regulations.'--Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall revise and clarify the provisions of title 45, Code of Federal Regulations, for consistency with part 4 of subtitle D of the HITECH Act, as added by subsection (a).
SEC. 1141.Council for 21st Century Cures.Title II of the Public Health Service Act (42 U.S.C. 202 et seq.) is amended by adding at the end the following:
''PART E'--Council for 21st Century Cures
''SEC. 281.Establishment.
''A nonprofit corporation to be known as the Council for 21st Century Cures (referred to in this part as the 'Council') shall be established in accordance with this section. The Council shall be a public-private partnership headed by an Executive Director (referred to in this part as the 'Executive Director'), appointed by the members of the Board of Directors. The Council shall not be an agency or instrumentality of the United States Government.
''SEC. 281A.Purpose.
''The purpose of the Council is to accelerate the discovery, development, and delivery in the United States of innovative cures, treatments, and preventive measures for patients.
''SEC. 281B.Duties.
''For the purpose described in section 281A, the Council shall'--
''(1) foster collaboration and coordination among the entities that comprise the Council, including academia, government agencies, industry, health care payors and providers, patient advocates, and others engaged in the cycle of discovery, development, and delivery of life-saving and health-enhancing innovative interventions;
''(2) undertake communication and dissemination activities;
''(3) publish information on the activities funded under section 281D;
''(4) establish a strategic agenda for accelerating the discovery, development, and delivery in the United States of innovative cures, treatments, and preventive measures for patients;
''(5) identify gaps and opportunities within and across the discovery, development, and delivery cycle;
''(6) develop and propose recommendations based on the gaps and opportunities so identified;
''(7) facilitate the interoperability of the components of the discovery, development, and delivery cycle;
''(8) propose recommendations that will facilitate precompetitive collaboration;
''(9) identify opportunities to work with, but not duplicate the efforts of, nonprofit organizations and other public-private partnerships; and
''(10) identify opportunities for collaboration with organizations operating outside of the United States, such as the Innovative Medicines Initiative of the European Union.
''SEC. 281C.Organization; administration.
''(a) Board of directors.'--
''(1) ESTABLISHMENT.'--
''(A) IN GENERAL.'--The Council shall have a Board of Directors (in this part referred to as the 'Board of Directors'), which shall be composed of the ex officio members under subparagraph (B) and the appointed members under subparagraph (C). All members of the Board shall be voting members.
''(B) EX OFFICIO MEMBERS.'--The ex officio members of the Board shall be the following individuals or their designees:
''(i) The Director of the National Institutes of Health.
''(ii) The Commissioner of Food and Drugs.
''(iii) The Administrator of the Centers for Medicare & Medicaid Services.
''(iv) The heads of five other Federal agencies deemed by the Secretary to be engaged in biomedical research and development.
''(C) APPOINTED MEMBERS.'--The appointed members of the Board shall consist of 17 individuals, of whom'--
''(i) eight shall be appointed by the Comptroller General of the United States from a list of nominations submitted by leading trade associations'--
''(I) four of whom shall be representatives of the biopharmaceutical industry;
''(II) two of whom shall be representatives of the medical device industry; and
''(III) two of whom shall be representatives of the information and digital technology industry; and
''(ii) nine shall be appointed by the Comptroller General of the United States, after soliciting nominations'--
''(I) two of whom shall be representatives of academic researchers;
''(II) three of whom shall be representatives of patients;
''(III) two of whom shall be representatives of health care providers; and
''(IV) two of whom shall be representatives of health care plans and insurers.
''(D) CHAIR.'--The Chair of the Board shall be selected by the members of the Board by majority vote from among the members of the Board.
''(2) TERMS AND VACANCIES.'--
''(A) IN GENERAL.'--The term of office of each member of the Board appointed under paragraph (1)(C) shall be 5 years.
''(B) VACANCY.'--Any vacancy in the membership of the Board'--
''(i) shall not affect the power of the remaining members to execute the duties of the Board; and
''(ii) shall be filled by appointment by the appointed members described in paragraph (1)(C) by majority vote.
''(C) PARTIAL TERM.'--If a member of the Board does not serve the full term applicable under subparagraph (A), the individual appointed under subparagraph (B) to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
''(3) RESPONSIBILITIES.'--Not later than 90 days after the date on which the Council is incorporated and its Board of Directors is fully constituted, the Board of Directors shall establish bylaws and policies for the Council that'--
''(A) are published in the Federal Register and available for public comment;
''(B) establish policies for the selection and, as applicable, appointment of'--
''(i) the officers, employees, agents, and contractors of the Council; and
''(ii) the members of any committees of the Council;
''(C) establish policies, including ethical standards, for the conduct of programs and other activities under section 281D; and
''(D) establish specific duties of the Executive Director.
''(4) MEETINGS.'--
''(A) IN GENERAL.'--The Board of Directors shall'--
''(i) meet on a quarterly basis; and
''(ii) submit to Congress, and make publicly available, the minutes of such meetings.
''(B) AGENDA.'--The Board of Directors shall, not later than 3 months after the incorporation of the Council'--
''(i) issue an agenda (in this part referred to as the 'agenda') outlining how the Council will achieve the purpose described in section 281A; and
''(ii) annually thereafter, in consultation with the Executive Director, review and update such agenda.
''(b) Appointment and incorporation.'--Not later than 6 months after the date of enactment of the 21st Century Cures Act'--
''(1) the Comptroller General of the United States shall appoint the appointed members of the Board of Directors under subsection (a)(1)(C); and
''(2) the ex officio members of the Board of Directors under subsection (a)(1)(B) shall serve as incorporators and shall take whatever actions are necessary to incorporate the Council.
''(c) Nonprofit Status.'--In carrying out this part, the Board of Directors shall establish such policies and bylaws, and the Executive Director shall carry out such activities, as may be necessary to ensure that the Council maintains status as an organization that'--
''(1) is described in subsection (c)(3) of section 501 of the Internal Revenue Code of 1986; and
''(2) is, under subsection (a) of such section, exempt from taxation.
''(d) Executive Director.'--The Executive Director shall'--
''(1) be the chief executive officer of the Council; and
''(2) subject to the oversight of the Board of Directors, be responsible for the day-to-day management of the Council.
''SEC. 281D.Operational activities and assistance.
''(a) In general.'--The Council shall establish a sufficient operational infrastructure to fulfill the duties specified in section 281B.
''(b) Private sector matching funds.'--The Council may accept financial or in-kind support from participating entities or private foundations or organizations when such support is deemed appropriate.
''SEC. 281E.Termination; report.
''(a) In general.'--The Council shall terminate on September 30, 2023.
''(b) Report.'--Not later than 1 year after the date on which the Council is established and each year thereafter, the Executive Director shall submit to the appropriate congressional committees a report on the performance of the Council. In preparing such report, the Council shall consult with a nongovernmental consultant with appropriate expertise.
''SEC. 281F.Funding.
''For the each of fiscal years 2016 through 2023, there is authorized to be appropriated $10,000,000 to the Council for purposes of carrying out the duties of the Council under this part.''.
SEC. 2001.Development and use of patient experience data to enhance structured risk-benefit assessment framework.(a) In general.'--Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended'--
(1) in subsection (d), by striking ''The Secretary shall implement'' and all that follows through ''premarket approval of a drug.''; and
(2) by adding at the end the following new subsections:
''(x) Structured risk-Benefit assessment framework.'--
''(1) IN GENERAL.'--The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process'--
''(A) to facilitate the balanced consideration of benefits and risks; and
''(B) to develop and implement a consistent and systematic approach to the discussion of, regulatory decisionmaking with respect to, and the communication of, the benefits and risks of new drugs.
''(2) RULE OF CONSTRUCTION.'--Nothing in paragraph (1) shall alter the criteria for evaluating an application for premarket approval of a drug.
''(y) Development and use of patient experience data To enhance structured risk-Benefit assessment framework.'--
''(1) IN GENERAL.'--Not later than 2 years after the date of the enactment of this subsection, the Secretary shall establish and implement processes under which'--
''(A) an entity seeking to develop patient experience data may submit to the Secretary'--
''(i) initial research concepts for feedback from the Secretary; and
''(ii) with respect to patient experience data collected by the entity, draft guidance documents, completed data, and summaries and analyses of such data;
''(B) the Secretary may request such an entity to submit such documents, data, and summaries and analyses; and
''(C) patient experience data may be developed and used to enhance the structured risk-benefit assessment framework under subsection (x).
''(2) PATIENT EXPERIENCE DATA.'--In this subsection, the term 'patient experience data' means data collected by patients, parents, caregivers, patient advocacy organizations, disease research foundations, medical researchers, research sponsors, or other parties determined appropriate by the Secretary that is intended to facilitate or enhance the Secretary's risk-benefit assessments, including information about the impact of a disease or a therapy on patients' lives.''.
(b) Guidance.'--
(1) IN GENERAL.'--The Secretary of Health and Human Services shall publish guidance on the implementation of subsection (y) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as added by subsection (a). Such guidance shall include'--
(A) with respect to draft guidance documents, data, or summaries and analyses submitted to the Secretary under paragraph (1)(A) of such subsection, guidance'--
(i) specifying the timelines for the review of such documents, data, or summaries and analyses by the Secretary; and
(ii) on how the Secretary will use such documents, data, or summaries and analyses to update any guidance documents published under this subsection or publish new guidance;
(B) with respect to the collection and analysis of patient experience data (as defined in paragraph (2) of such subsection (y)), guidance on'--
(i) methodological considerations for the collection of patient experience data, which may include structured approaches to gathering information on'--
(I) the experience of a patient living with a particular disease;
(II) the burden of living with or managing the disease;
(III) the impact of the disease on daily life and long-term functioning; and
(IV) the effect of current therapeutic options on different aspects of the disease; and
(ii) the establishment and maintenance of registries designed to increase understanding of the natural history of a disease;
(C) methodological approaches that may be used to assess patients' beliefs with respect to the benefits and risks in the management of the patient's disease; and
(D) methodologies, standards, and potential experimental designs for patient-reported outcomes.
(2) TIMING.'--Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance on the implementation of subsection (y) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as added by subsection (a). The Secretary shall issue final guidance on the implementation of such subsection not later than 1 year after the date on which the comment period for the draft guidance closes.
(3) WORKSHOPS.'--
(A) IN GENERAL.'--Not later than 6 months after the date of the enactment of this Act and once every 6 months during the following 12-month period, the Secretary of Health and Human Services shall convene a workshop to obtain input regarding methodologies for developing the guidance under paragraph (1), including the collection of patient experience data.
(B) ATTENDEES.'--A workshop convened under this paragraph shall include'--
(i) patients;
(ii) representatives from patient advocacy organizations, biopharmaceutical companies, and disease research foundations;
(iii) representatives of the reviewing divisions of the Food and Drug Administration; and
(iv) methodological experts with significant expertise in patient experience data.
(4) PUBLIC MEETING.'--Not later than 90 days after the date on which the draft guidance is published under this subsection, the Secretary of Health and Human Services shall convene a public meeting to solicit input on the guidance.
SEC. 2021.Qualification of drug development tools.(a) Findings.'--Congress finds the following:
(1) Development of new drugs has become increasingly challenging and resource intensive.
(2) Development of drug development tools can benefit the availability of new medical therapies by helping to translate scientific discoveries into clinical applications.
(3) Biomedical research consortia (as defined in section 507(f) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (c)) can play a valuable role in helping to develop and qualify drug development tools.
(b) Sense of Congress.'--It is the sense of Congress that'--
(1) Congress should promote and facilitate a collaborative effort among the biomedical research consortia described in subsection (a)(3)'--
(A) to develop, through a transparent public process, data standards and scientific approaches to data collection accepted by the medical and clinical research community for purposes of qualifying drug development tools;
(B) to coordinate efforts toward developing and qualifying drug development tools in key therapeutic areas; and
(C) to encourage the development of accessible databases for collecting relevant drug development tool data for such purposes; and
(2) an entity seeking to qualify a drug development tool should be encouraged, in addition to consultation with the Secretary, to consult with biomedical research consortia and other individuals and entities with expert knowledge and insights that may assist the requestor and benefit the process for such qualification.
(c) Qualification of drug development tools.'--Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506F the following new section:
''SEC. 507.Qualification of drug development tools.
''(a) Process for qualification.'--
''(1) IN GENERAL.'--The Secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which'--
''(A) (i) a requestor initiates such process by submitting a letter of intent to the Secretary; and
''(ii) the Secretary accepts or declines to accept such letter of intent;
''(B) (i) if the Secretary accepts the letter of intent, a requestor submits a qualification plan to the Secretary; and
''(ii) the Secretary accepts or declines to accept the qualification plan; and
''(C) (i) if the Secretary accepts the qualification plan, the requestor submits to the Secretary a full qualification package;
''(ii) the Secretary determines whether to accept such qualification package for review; and
''(iii) if the Secretary accepts such qualification package for review, the Secretary conducts such review in accordance with this section.
''(2) ACCEPTANCE AND REVIEW OF SUBMISSIONS.'--
''(A) IN GENERAL.'--The succeeding provisions of this paragraph shall apply with respect to the treatment of a letter of intent, a qualification plan, or a full qualification package submitted under paragraph (1) (referred to in this paragraph as 'qualification submissions').
''(B) ACCEPTANCE FACTORS; NONACCEPTANCE.'--The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the submission and the available resources of the Food and Drug Administration to review the qualification submission. A determination not to accept a submission under paragraph (1) shall not be construed as a final determination by the Secretary under this section regarding the qualification of a drug development tool for its proposed context of use.
''(C) PRIORITIZATION OF QUALIFICATION REVIEW.'--The Secretary may prioritize the review of a full qualification package submitted under paragraph (1) with respect to a drug development tool, based on factors determined appropriate by the Secretary, including'--
''(i) as applicable, the severity, rarity, or prevalence of the disease or condition targeted by the drug development tool and the availability or lack of alternative treatments for such disease or condition; and
''(ii) the identification, by the Secretary or by biomedical research consortia and other expert stakeholders, of such a drug development tool and its proposed context of use as a public health priority.
''(D) ENGAGEMENT OF EXTERNAL EXPERTS.'--The Secretary may, for purposes of the review of qualification submissions, through the use of cooperative agreements, grants, or other appropriate mechanisms, consult with biomedical research consortia and may consider the recommendations of such consortia with respect to the review of any qualification plan submitted under paragraph (1) or the review of any full qualification package under paragraph (3).
''(3) REVIEW OF FULL QUALIFICATION PACKAGE.'--The Secretary shall'--
''(A) conduct a comprehensive review of a full qualification package accepted under paragraph (1)(C); and
''(B) determine whether the drug development tool at issue is qualified for its proposed context of use.
''(4) QUALIFICATION.'--The Secretary shall determine whether a drug development tool is qualified for a proposed context of use based on the scientific merit of a full qualification package reviewed under paragraph (3).
''(b) Effect of qualification.'--
''(1) IN GENERAL.'--A drug development tool determined to be qualified under subsection (a)(4) for a proposed context of use specified by the requestor may be used by any person in such context of use for the purposes described in paragraph (2).
''(2) USE OF A DRUG DEVELOPMENT TOOL.'--Subject to paragraph (3), a drug development tool qualified under this section may be used for'--
''(A) supporting or obtaining approval or licensure (as applicable) of a drug or biological product (including in accordance with section 506(c)) under section 505 of this Act or section 351 of the Public Health Service Act; or
''(B) supporting the investigational use of a drug or biological product under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act.
''(3) RESCISSION OR MODIFICATION.'--
''(A) IN GENERAL.'--The Secretary may rescind or modify a determination under this section to qualify a drug development tool if the Secretary determines that the drug development tool is not appropriate for the proposed context of use specified by the requestor. Such a determination may be based on new information that calls into question the basis for such qualification.
''(B) MEETING FOR REVIEW.'--If the Secretary rescinds or modifies under subparagraph (A) a determination to qualify a drug development tool, the requestor involved shall, on request, be granted a meeting with the Secretary to discuss the basis of the Secretary's decision to rescind or modify the determination before the effective date of the rescission or modification.
''(c) Transparency.'--
''(1) IN GENERAL.'--Subject to paragraph (3), the Secretary shall make publicly available, and update on at least a biannual basis, on the Internet website of the Food and Drug Administration the following:
''(A) Information with respect to each qualification submission under the qualification process under subsection (a), including'--
''(i) the stage of the review process applicable to the submission;
''(ii) the date of the most recent change in stage status;
''(iii) whether the external scientific experts were utilized in the development of a qualification plan or the review of a full qualification package; and
''(iv) submissions from requestors under the qualification process under subsection (a), including any data and evidence contained in such submissions, and any updates to such submissions.
''(B) The Secretary's formal written determinations in response to such qualification submissions.
''(C) Any rescissions or modifications under subsection (b)(3) of a determination to qualify a drug development tool.
''(D) Summary reviews that document conclusions and recommendations for determinations to qualify drug development tools under subsection (a).
''(E) A comprehensive list of'--
''(i) all drug development tools qualified under subsection (a); and
''(ii) all surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or biological product (including in accordance with section 506(c)) under section 505 of this Act or section 351 of the Public Health Service Act.
''(2) RELATION TO TRADE SECRETS ACT.'--Information made publicly available by the Secretary under paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18, United States Code.
''(3) APPLICABILITY.'--Nothing in this section shall be construed as authorizing the Secretary to disclose any information contained in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act that is confidential commercial or trade secret information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
''(d) Rule of construction.'--Nothing in this section shall be construed'--
''(1) to alter the standards of evidence under subsection (c) or (d) of section 505, including the substantial evidence standard in such subsection (d), or under section 351 of the Public Health Service Act (as applicable); or
''(2) to limit the authority of the Secretary to approve or license products under this Act or the Public Health Service Act, as applicable (as in effect before the date of the enactment of the 21st Century Cures Act).
''(e) Definitions.'--In this section:
''(1) BIOMARKER.'-- (A) The term 'biomarker' means a characteristic (such as a physiologic, pathologic, or anatomic characteristic or measurement) that is objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to a therapeutic intervention; and
''(B) such term includes a surrogate endpoint.
''(2) BIOMEDICAL RESEARCH CONSORTIA.'--The term 'biomedical research consortia' means collaborative groups that may take the form of public-private partnerships and may include government agencies, institutions of higher education (as defined in section 101(a) of the Higher Education Act of 1965), patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant entities and individuals.
''(3) CLINICAL OUTCOME ASSESSMENT.'-- (A) The term 'clinical outcome assessment' means a measurement of a patient's symptoms, overall mental state, or the effects of a disease or condition on how the patient functions; and
''(B) such term includes a patient-reported outcome.
''(4) CONTEXT OF USE.'--The term 'context of use' means, with respect to a drug development tool, the circumstances under which the drug development tool is to be used in drug development and regulatory review.
''(5) DRUG DEVELOPMENT TOOL.'--The term 'drug development tool' includes'--
''(A) a biomarker;
''(B) a clinical outcome assessment; and
''(C) any other method, material, or measure that the Secretary determines aids drug development and regulatory review for purposes of this section.
''(6) PATIENT-REPORTED OUTCOME.'--The term 'patient-reported outcome' means a measurement based on a report from a patient regarding the status of the patient's health condition without amendment or interpretation of the patient's report by a clinician or any other person.
''(7) QUALIFICATION.'--The terms 'qualification' and 'qualified' mean a determination by the Secretary that a drug development tool and its proposed context of use can be relied upon to have a specific interpretation and application in drug development and regulatory review under this Act.
''(8) REQUESTOR.'--The term 'requestor' means an entity or entities, including a drug sponsor or a biomedical research consortia, seeking to qualify a drug development tool for a proposed context of use under this section.
''(9) SURROGATE ENDPOINT.'--The term 'surrogate endpoint' means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit, and'--
''(A) is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product; or
''(B) is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section 506(c).
''(f) Authorization of appropriations.'--There are authorized to be appropriated to carry out this section, $10,000,000 for each of fiscal years 2016 through 2020.''.
(d) Guidance.'--
(1) IN GENERAL.'--The Secretary of Health and Human Services shall, in consultation with biomedical research consortia (as defined in subsection (f) of section 507 the Federal Food, Drug, and Cosmetic Act (as added by subsection (c))) and other interested parties through a collaborative public process, issue guidance to implement such section 507 that'--
(A) provides a conceptual framework describing appropriate standards and scientific approaches to support the development of biomarkers delineated under the taxonomy established under paragraph (3);
(B) makes recommendations for demonstrating that a surrogate endpoint is reasonably likely to predict clinical benefit for the purpose of supporting the accelerated approval of a drug under section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c));
(C) with respect to the qualification process under such section 507'--
(i) describes the requirements that entities seeking to qualify a drug development tool under such section shall observe when engaging in such process;
(ii) outlines reasonable timeframes for the Secretary's review of letters, qualification plans, or full qualification packages submitted under such process; and
(iii) establishes a process by which such entities or the Secretary may consult with biomedical research consortia and other individuals and entities with expert knowledge and insights that may assist the Secretary in the review of qualification plans and full qualification submissions under such section; and
(D) includes such other information as the Secretary determines appropriate.
(2) TIMING.'--Not later than 24 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance under paragraph (1) on the implementation of section 507 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (c)). The Secretary shall issue final guidance on the implementation of such section not later than 6 months after the date on which the comment period for the draft guidance closes.
(3) TAXONOMY.'--
(A) IN GENERAL.'--For purposes of informing guidance under this subsection, the Secretary of Health and Human Services shall, in consultation with biomedical research consortia and other interested parties through a collaborative public process, establish a taxonomy for the classification of biomarkers (and related scientific concepts) for use in drug development.
(B) PUBLIC AVAILABILITY.'--Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall make such taxonomy publicly available in draft form for public comment. The Secretary shall finalize the taxonomy not later than 12 months after the close of the public comment period.
(e) Meeting and report.'--
(1) MEETING.'--Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall convene a public meeting to describe and solicit public input regarding the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (c).
(2) REPORT.'--Not later than 5 years after the date of the enactment of this Act, the Secretary shall make publicly available on the Internet website of the Food and Drug Administration a report. Such report shall include, with respect to the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (c), information on'--
(A) the number of requests submitted, as a letter of intent, for qualification of a drug development tool (as defined in subsection (f) of such section);
(B) the number of such requests accepted and determined to be eligible for submission of a qualification plan or full qualification package (as such terms are defined in such subsection), respectively;
(C) the number of such requests for which external scientific experts were utilized in the development of a qualification plan or review of a full qualification package;
(D) the number of qualification plans and full qualification packages, respectively, submitted to the Secretary; and
(E) the drug development tools qualified through such qualification process, specified by type of tool, such as a biomarker or clinical outcome assessment (as such terms are defined in subsection (f) of such section 507).
SEC. 2022.Accelerated approval development plan.(a) In general.'--Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) is amended by adding the following subsection:
''(g) Accelerated approval development plan.'--
''(1) IN GENERAL.'--In the case of a drug that the Secretary determines may be eligible for accelerated approval in accordance with subsection (c), the sponsor of such drug may request, at any time after the submission of an application for the investigation of the drug under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, that the Secretary agree to an accelerated approval development plan described in paragraph (2).
''(2) PLAN DESCRIBED.'--A plan described in this paragraph, with respect to a drug described in paragraph (1), is an accelerated approval development plan, which shall include agreement on'--
''(A) the surrogate endpoint to be assessed under such plan;
''(B) the design of the study that will utilize the surrogate endpoint; and
''(C) the magnitude of the effect of the drug on the surrogate endpoint that is the subject of the agreement that would be sufficient to form the primary basis of a claim that the drug is effective.
''(3) MODIFICATION; TERMINATION.'--The Secretary may require the sponsor of a drug that is the subject of an accelerated approval development plan to modify or terminate the plan if additional data or information indicates that'--
''(A) the plan as originally agreed upon is no longer sufficient to demonstrate the safety and effectiveness of the drug involved; or
''(B) the drug is no longer eligible for accelerated approval under subsection (c).
''(4) SPONSOR CONSULTATION.'--If the Secretary requires the modification or termination of an accelerated approval development plan under paragraph (3), the sponsor shall be granted a request for a meeting to discuss the basis of the Secretary's decision before the effective date of the modification or termination.
''(5) DEFINITION.'--In this section, the term 'accelerated approval development plan' means a development plan agreed upon by the Secretary and the sponsor submitting the plan that contains study parameters for the use of a surrogate endpoint that'--
''(A) is reasonably likely to predict clinical benefit; and
''(B) is intended to be the basis of the accelerated approval of a drug in accordance with subsection (c).''.
(b) Technical amendments.'--Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) is amended'--
(1) by striking ''(f) Awareness efforts'' and inserting ''(e) Awareness efforts''; and
(2) by striking ''(e) Construction'' and inserting ''(f) Construction''.
SEC. 2041.Precision medicine guidance and other programs of Food and Drug Administration.Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end the following:
''subchapter J'--Precision Medicine
''SEC. 591.General agency guidance on precision medicine.
''(a) In general.'--The Secretary shall issue and periodically update guidance to assist sponsors in the development of a precision drug or biological product. Such guidance shall'--
''(1) define the term 'precision drug or biological product'; and
''(2) address the topics described in subsection (b).
''(b) Certain issues.'--The topics to be addressed by guidance under subsection (a) are'--
''(1) the evidence needed to support the use of biomarkers (as defined in section 507(e)) that identify subsets of patients as likely responders to therapies in order to streamline the conduct of clinical trials;
''(2) recommendations for the design of studies to demonstrate the validity of a biomarker as a predictor of drug or biological product response;
''(3) the manner and extent to which a benefit-risk assessment may be affected when clinical trials are limited to patient population subsets that are identified using biomarkers;
''(4) the development of companion diagnostics in the context of a drug development program; and
''(5) considerations for developing biomarkers that inform prescribing decisions for a drug or biological product, and when information regarding a biomarker may be included in the approved prescription labeling for a precision drug or biological product.
''(c) Date certain for initial guidance.'--The Secretary shall issue guidance under subsection (a) not later than 18 months after the date of the enactment of the 21st Century Cures Act.
''SEC. 592.Precision medicine regarding orphan-drug and expedited-approval programs.
''(a) In general.'--In the case of a precision drug or biological product that is the subject of an application submitted under section 505(b)(1), or section 351(a) of the Public Health Service Act, for the treatment of a serious or life-threatening disease or condition and has been designated under section 526 as a drug for a rare disease or condition, the Secretary may'--
''(1) consistent with applicable standards for approval, rely upon data or information previously submitted by the sponsor of the precision drug or biological product, or another sponsor, provided that the sponsor of the precision drug or biological product has obtained a contractual right of reference to such other sponsor's data and information, in an application approved under section 505(c) or licensed under section 351(a) of the Public Health Service Act, as applicable'--
''(A) for a different drug or biological product; or
''(B) for a different indication for such precision drug or biological product,
in order to expedite clinical development for a precision drug or biological product that is using the same or similar approach as that used to support approval of the prior approved application or license, as appropriate; and
''(2) as appropriate, consider the application for approval of such precision drug or biological product to be eligible for expedited review and approval programs described in section 506, including accelerated approval in accordance with subsection (c) of such section.
''(b) Rule of construction.'--Nothing in this section shall be construed to'--
''(1) limit the authority of the Secretary to approve products pursuant to this Act and the Public Health Service Act as authorized prior to the date of enactment of this section; or
''(2) confer any new rights, beyond those authorized under this Act prior to enactment of this section, with respect to a sponsor's ability to reference information contained in another application submitted under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act.''.
SEC. 2061.Broader application of Bayesian statistics and adaptive trial designs.(a) Proposals for use of innovative statistical methods in clinical protocols for drugs and biological products.'--For purposes of assisting sponsors in incorporating adaptive trial design and Bayesian methods into proposed clinical protocols and applications for new drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological products under section 351 of the Public Health Service Act (42 U.S.C. 262), the Secretary shall conduct a public meeting and issue guidance in accordance with subsection (b).
(b) Guidance addressing use of adaptive trial designs and Bayesian methods.'--
(1) IN GENERAL.'--The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs (in this subsection referred to as the ''Secretary''), shall'--
(A) update and finalize the draft guidance addressing the use of adaptive trial design for drugs and biological products; and
(B) issue draft guidance on the use of Bayesian methods in the development and regulatory review and approval or licensure of drugs and biological products.
(2) CONTENTS.'--The guidances under paragraph (1) shall address'--
(A) the use of adaptive trial designs and Bayesian methods in clinical trials, including clinical trials proposed or submitted to help to satisfy the substantial evidence standard under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));
(B) how sponsors may obtain feedback from the Secretary on technical issues related to modeling and simulations prior to'--
(i) completion of such modeling or simulations; or
(ii) the submission of resulting information to the Secretary;
(C) the types of quantitative and qualitative information that should be submitted for review; and
(D) recommended analysis methodologies.
(3) PUBLIC MEETING.'--Prior to updating or developing the guidances required by paragraph (1), the Secretary shall consult with stakeholders, including representatives of regulated industry, academia, patient advocacy organizations, and disease research foundations, through a public meeting to be held not later than 1 year after the date of enactment of this Act.
(4) SCHEDULE.'--The Secretary shall publish'--
(A) the final guidance required by paragraph (1)(A) not later than 18 months after the date of the public meeting required by paragraph (3); and
(B) the guidance required by paragraph (1)(B) not later than 48 months after the date of the public meeting required by paragraph (3).
SEC. 2062.Utilizing evidence from clinical experience.Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505E of such Act (21 U.S.C. 355f) the following:
''SEC. 505F.Utilizing evidence from clinical experience.
''(a) In general.'--The Secretary shall establish a program to evaluate the potential use of evidence from clinical experience'--
''(1) to help to support the approval of a new indication for a drug approved under section 505(b); and
''(2) to help to support or satisfy postapproval study requirements.
''(b) Evidence from clinical experience defined.'--In this section, the term 'evidence from clinical experience' means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials, including from observational studies, registries, and therapeutic use.
''(c) Program framework.'--
''(1) IN GENERAL.'--Not later than 18 months after the date of enactment of this section, the Secretary shall establish a draft framework for implementation of the program under this section.
''(2) CONTENTS OF FRAMEWORK.'--The framework shall include information describing'--
''(A) the current sources of data developed through clinical experience, including ongoing safety surveillance, registry, claims, and patient-centered outcomes research activities;
''(B) the gaps in current data collection activities;
''(C) the current standards and methodologies for collection and analysis of data generated through clinical experience; and
''(D) the priority areas, remaining challenges, and potential pilot opportunities that the program established under this section will address.
''(3) CONSULTATION.'--
''(A) IN GENERAL.'--In developing the program framework under this subsection, the Secretary shall consult with regulated industry, academia, medical professional organizations, representatives of patient advocacy organizations, disease research foundations, and other interested parties.
''(B) PROCESS.'--The consultation under subparagraph (A) may be carried out through approaches such as'--
''(i) a public-private partnership with the entities described in such subparagraph in which the Secretary may participate; or
''(ii) a contract, grant, or other arrangement, as determined appropriate by the Secretary with such a partnership or an independent research organization.
''(d) Program implementation.'--The Secretary shall, not later than 24 months after the date of enactment of this section and in accordance with the framework established under subsection (c), implement the program to evaluate the potential use of evidence from clinical experience.
''(e) Guidance for industry.'--The Secretary shall'--
''(1) utilize the program established under subsection (a), its activities, and any subsequent pilots or written reports, to inform a guidance for industry on'--
''(A) the circumstances under which sponsors of drugs and the Secretary may rely on evidence from clinical experience for the purposes described in subsection (a)(1) or (a)(2); and
''(B) the appropriate standards and methodologies for collection and analysis of evidence from clinical experience submitted for such purposes;
''(2) not later than 36 months after the date of enactment of this section, issue draft guidance for industry as described in paragraph (1); and
''(3) not later than 48 months after the date of enactment of this section, after providing an opportunity for public comment on the draft guidance, issue final guidance.
''(f) Rule of construction.'--
''(1) Subject to paragraph (2), nothing in this section prohibits the Secretary from using evidence from clinical experience for purposes not specified in this section, provided the Secretary determines that sufficient basis exists for any such nonspecified use.
''(2) This section shall not be construed to alter'--
''(A) the standards of evidence under'--
''(i) subsection (c) or (d) of section 505, including the substantial evidence standard in such subsection (d); or
''(ii) section 351(a) of the Public Health Service Act; or
''(B) the Secretary's authority to require postapproval studies or clinical trials, or the standards of evidence under which studies or trials are evaluated.
''SEC. 505G.Collecting evidence from clinical experience through targeted extensions of the Sentinel System.
''(a) In general.'--The Secretary shall, in parallel to implementing the program established under section 505F and in order to build capacity for utilizing the evidence from clinical experience described in that section, identify and execute pilot demonstrations to extend existing use of the Sentinel System surveillance infrastructure authorized under section 505(k).
''(b) Pilot demonstrations.'--
''(1) IN GENERAL.'--The Secretary'--
''(A) shall design and implement pilot demonstrations to utilize data captured through the Sentinel System surveillance infrastructure authorized under section 505(k) for purposes of, as appropriate'--
''(i) generating evidence from clinical experience to improve characterization or assessment of risks or benefits of a drug approved under section 505(c);
''(ii) protecting the public health; or
''(iii) advancing patient-centered care; and
''(B) may make strategic linkages with sources of complementary public health data and infrastructure the Secretary determines appropriate and necessary.
''(2) CONSULTATION.'--In developing the pilot demonstrations under this subsection, the Secretary shall'--
''(A) consult with regulated industry, academia, medical professional organizations, representatives of patient advocacy organizations, disease research foundations, and other interested parties through a public process; and
''(B) develop a framework to promote appropriate transparency and dialogue about research conducted under these pilot demonstrations, including by'--
''(i) providing adequate notice to a sponsor of a drug approved under section 505 or section 351 of the Public Health Service Act of the Secretary's intent to conduct analyses of such sponsor's drug or drugs under these pilot demonstrations;
''(ii) providing adequate notice of the findings related to analyses described in clause (i) and an opportunity for the sponsor of such drug or drugs to comment on such findings; and
''(iii) ensuring the protection from public disclosure of any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
''(3) HIPAA PRIVACY RULE; HUMAN SUBJECT RESEARCH REGULATION.'--The Secretary may deem such pilot demonstrations'--
''(A) public health activities, for purposes of which a use or disclosure of protected health information would be permitted as described in section 164.512(b)(1) of title 45, Code of Federal Regulations (or any successor regulation); and
''(B) outside the scope of 'research' as defined in section 46.102(d) of title 45, Code of Federal Regulations (or any successor regulation).
''(c) Authorization of appropriations.'--There are authorized to be appropriated to carry out this section $3,000,000 for each of fiscal years 2016 through 2020.''.
SEC. 2063.Streamlined data review program.(a) In general.'--Chapter V of the Federal Food, Drug, and Cosmetic Act, as amended by section 2062, is further amended by inserting after section 505G of such Act the following:
''SEC. 505H.Streamlined data review program.
''(a) In general.'--The Secretary shall establish a streamlined data review program under which a holder of an approved application submitted under section 505(b)(1) or under section 351(a) of the Public Health Service Act may, to support the approval or licensure (as applicable) of the use of the drug that is the subject of such approved application for a new qualified indication, submit qualified data summaries.
''(b) Eligibility.'--In carrying out the streamlined data review program under subsection (a), the Secretary may authorize the holder of the approved application to include one or more qualified data summaries described in subsection (a) in a supplemental application if'--
''(1) the drug has been approved under section 505(c) of this Act or licensed under section 351(a) of the Public Health Service Act for one or more indications, and such approval or licensure remains in effect;
''(2) the supplemental application is for approval or licensure (as applicable) under such section 505(c) or 351(a) of the use of the drug for a new qualified indication under such section 505(c) or 351(a);
''(3) there is an existing database acceptable to the Secretary regarding the safety of the drug developed for one or more indications of the drug approved under such section 505(c) or licensed under such section 351(a);
''(4) the supplemental application incorporates or supplements the data submitted in the application for approval or licensure referred to in paragraph (1); and
''(5) the full data sets used to develop the qualified data summaries are submitted, unless the Secretary determines that the full data sets are not required.
''(c) Public availability of information on program.'--The Secretary shall post on the public website of the Food and Drug Administration and update annually'--
''(1) the number of applications reviewed under the streamlined data review program;
''(2) the average time for completion of review under the streamlined data review program versus other review of applications for new indications; and
''(3) the number of applications reviewed under the streamlined data review program for which the Food and Drug Administration made use of full data sets in addition to the qualified data summary.
''(d) Definitions.'--In this section:
''(1) The term 'qualified indication' means'--
''(A) an indication for the treatment of cancer, as determined appropriate by the Secretary; or
''(B) such other types of indications as the Secretary determines to be subject to the streamlined data review program under this section.
''(2) The term 'qualified data summary' means a summary of clinical data intended to demonstrate safety and effectiveness with respect to a qualified indication for use of a drug.''.
(b) Sense of Congress.'--It is the sense of Congress that the streamlined data review program under section 505H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), should enable the Food and Drug Administration to make approval decisions for certain supplemental applications based on qualified data summaries (as defined in such section 505H).
(c) Guidance; regulations.'--The Commissioner of Food and Drugs'--
(1) shall'--
(A) issue final guidance for implementation of the streamlined data review program established under section 505H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), not later than 24 months after the date of enactment of this Act; and
(B) include in such guidance the process for expanding the types of indications to be subject to the streamlined data review program, as authorized by section 505H(c)(1)(B) of such Act; and
(2) in addition to issuing guidance under paragraph (1), may issue such regulations as may be necessary for implementation of the program.
SEC. 2081.Sense of Congress.It is the sense of Congress that the Food and Drug Administration should continue to expedite the approval of drugs designated as breakthrough therapies pursuant to section 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)) by approving drugs so designated as early as possible in the clinical development process, regardless of the phase of development, provided that the Secretary of Health and Human Services determines that an application for such a drug meets the standards of evidence of safety and effectiveness under section 505 of such Act (21 U.S.C. 355), including the substantial evidence standard under subsection (d) of such section or under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)).
SEC. 2082.Expanded access policy.Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 561 (21 U.S.C. 360bbb) the following:
''SEC. 561A.Expanded access policy required for investigational drugs.
''(a) In general.'--The manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make publicly available the policy of the manufacturer or distributor on evaluating and responding to requests submitted under section 561(b) for provision of such a drug. A manufacturer or distributor may satisfy the requirement of the preceding sentence by posting such policy as generally applicable to all of such manufacturer's or distributor's investigational drugs.
''(b) Content of policy.'--A policy described in subsection (a) shall include making publicly available'--
''(1) contact information for the manufacturer or distributor to facilitate communication about requests described in subsection (a);
''(2) procedures for making such requests;
''(3) the general criteria the manufacturer or distributor will consider or use to approve such requests; and
''(4) the length of time the manufacturer or distributor anticipates will be necessary to acknowledge receipt of such requests.
''(c) No guarantee of access.'--The posting of policies by manufacturers and distributors under subsection (a) shall not serve as a guarantee of access to any specific investigational drug by any individual patient.
''(d) Revised policy.'--A manufacturer or distributor that has made a policy publicly available as required by this section may revise the policy at any time.
''(e) Application.'--This section shall apply to a manufacturer or distributor with respect to an investigational drug beginning on the later of'--
''(1) the date that is 60 days after the date of enactment of the 21st Century Cures Act; or
''(2) the first initiation of a phase 2 or phase 3 study (as such terms are defined in section 312.21(b) and (c) of title 21, Code of Federal Regulations (or any successor regulations)) with respect to such investigational new drug.''.
SEC. 2083.Finalizing draft guidance on expanded access.(a) In general.'--Not later than 12 months after the date of enactment of this Act, the Secretary of Health and Human Services shall finalize the draft guidance entitled ''Expanded Access to Investigational Drugs for Treatment Use'--Qs & As'' and dated May 2013.
(b) Contents.'--The final guidance referred to in subsection (a) shall clearly define how the Secretary of Health and Human Services interprets and uses adverse drug event data reported by investigators in the case of data reported from use under a request submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)).
SEC. 2101.Facilitating dissemination of health care economic information.Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(a)) is amended'--
(1) by striking ''(a) If its'' and inserting ''(a)(1) If its'';
(2) by striking ''a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations'' and inserting ''a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement'';
(3) by striking ''directly relates'' and inserting ''relates'';
(4) by striking ''and is based on competent and reliable scientific evidence. The requirements set forth in section 505(a) or in section 351(a) of the Public Health Service Act shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph'' and inserting '', is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug under section 505 or under section 351 of the Public Health Service Act. The requirements set forth in section 505(a) or in subsections (a) and (k) of section 351 of the Public Health Service Act shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph''; and
(5) by striking ''In this paragraph, the term'' and all that follows and inserting the following:
''(2) (A) For purposes of this paragraph, the term 'health care economic information' means any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug. Such analysis may be comparative to the use of another drug, to another health care intervention, or to no intervention.
''(B) Such term does not include any analysis that relates only to an indication that is not approved under section 505 or under section 351 of the Public Health Service Act for such drug.''.
SEC. 2102.Facilitating responsible communication of scientific and medical developments.(a) Guidance.'--Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance on facilitating the responsible dissemination of truthful and nonmisleading scientific and medical information not included in the approved labeling of drugs and devices.
(b) Definition.'--In this section, the terms ''drug'' and ''device'' have the meaning given to such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
SEC. 2121.Approval of certain drugs for use in a limited population of patients.(a) Purpose.'--The purpose of this section is to help to expedite the development and availability of treatments for serious or life-threatening bacterial or fungal infections in patients with unmet needs, while maintaining safety and effectiveness standards for such treatments, taking into account the severity of the infection and the availability or lack of alternative treatments.
(b) Approval of certain antibacterial and antifungal drugs.'--Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 2001, is further amended by adding at the end the following new subsection:
''(z) Approval of certain antibacterial and antifungal drugs for use in a limited population of patients.'--
''(1) PROCESS.'--At the request of the sponsor of an antibacterial or antifungal drug that is intended to treat a serious or life-threatening infection, the Secretary'--
''(A) may execute a written agreement with the sponsor on the process for developing data to support an application for approval of such drug, for use in a limited population of patients in accordance with this subsection;
''(B) shall proceed in accordance with this subsection only if a written agreement is reached under subparagraph (A);
''(C) shall provide the sponsor with an opportunity to request meetings under paragraph (2);
''(D) if a written agreement is reached under subparagraph (A), may approve the drug under this subsection for such use'--
''(i) in a limited population of patients for which there is an unmet medical need;
''(ii) based on a streamlined development program; and
''(iii) only if the standards for approval under subsections (c) and (d) of this section or licensure under section 351 of the Public Health Service Act, as applicable, are met; and
''(E) in approving a drug in accordance with this subsection, subject to subparagraph (D)(iii), may rely upon'--
''(i) traditional endpoints, alternate endpoints, or a combination of traditional and alternate endpoints, and, as appropriate, data sets of a limited size; and
''(ii) (I) additional data, including preclinical, pharmacologic, or pathophysiologic evidence;
''(II) nonclinical susceptibility and pharmacokinetic data;
''(III) data from phase 2 clinical trials; and
''(IV) such other confirmatory evidence as the Secretary determines appropriate to approve the drug.
''(2) FORMAL MEETINGS.'--
''(A) IN GENERAL.'--To help to expedite and facilitate the development and review of a drug for which a sponsor intends to request approval in accordance with this subsection, the Secretary may, at the request of the sponsor, conduct meetings that provide early consultation, timely advice, and sufficient opportunities to develop an agreement described in paragraph (1)(A) and help the sponsor design and conduct a drug development program as efficiently as possible, including the following types of meetings:
''(i) An early consultation meeting.
''(ii) An assessment meeting.
''(iii) A postapproval meeting.
''(B) NO ALTERING OF GOALS.'--Nothing in this paragraph shall be construed to alter agreed-upon goals and procedures identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012.
''(C) BREAKTHROUGH THERAPIES.'--In the case of a drug designated as a breakthrough therapy under section 506(a), the sponsor of such drug may elect to utilize meetings provided under such section with respect to such drug in lieu of meetings described in subparagraph (A).
''(3) LABELING REQUIREMENT.'--The labeling of an antibacterial or antifungal drug approved in accordance with this subsection shall contain the statement 'Limited Population' in a prominent manner and adjacent to, and not more prominent than, the brand name of the product. The prescribing information for such antibacterial or antifungal drug required by section 201.57 of title 21, Code of Federal Regulations (or any successor regulation) shall also include the following statement: 'This drug is indicated for use in a limited and specific population of patients.'.
''(4) PROMOTIONAL MATERIALS.'--The provisions of section 506(c)(2)(B) shall apply with respect to approval in accordance with this subsection to the same extent and in the same manner as such provisions apply with respect to accelerated approval in accordance with section 506(c)(1).
''(5) TERMINATION OF REQUIREMENTS OR CONDITIONS.'--If a drug is approved in accordance with this subsection for an indication in a limited population of patients and is subsequently approved or licensed under this section or section 351 of the Public Health Service Act, other than in accordance with this subsection, for'--
''(A) the same indication and the same conditions of use, the Secretary shall remove any labeling requirements or postmarketing conditions that were made applicable to the drug under this subsection; or
''(B) a different indication or condition of use, the Secretary shall not apply the labeling requirements and postmarketing conditions that were made applicable to the drug under this subsection to the subsequent approval of the drug for such different indication or condition of use.
''(6) RELATION TO OTHER PROVISIONS.'--Nothing in this subsection shall be construed to prohibit the approval of a drug for use in a limited population of patients in accordance with this subsection, in combination with'--
''(A) an agreement on the design and size of a clinical trial pursuant to subparagraphs (B) and (C) of subsection (b)(5);
''(B) designation and treatment of the drug as a breakthrough therapy under section 506(a);
''(C) designation and treatment of the drug as a fast track product under section 506(b); or
''(D) accelerated approval of the drug in accordance with section 506(c).
''(7) RULE OF CONSTRUCTION.'--Nothing in this subsection shall be construed'--
''(A) to alter the standards of evidence under subsection (c) or (d) (including the substantial evidence standard in subsection (d));
''(B) to waive or otherwise preclude the application of requirements under subsection (o);
''(C) to otherwise, in any way, limit the authority of the Secretary to approve products pursuant to this Act and the Public Health Service Act as authorized prior to the date of enactment of this subsection; or
''(D) to restrict in any manner, the prescribing of antibiotics or other products by health care providers, or to otherwise limit or restrict the practice of health care.
''(8) EFFECTIVE IMMEDIATELY.'--The Secretary shall have the authorities vested in the Secretary by this subsection beginning on the date of enactment of this subsection, irrespective of when and whether the Secretary promulgates final regulations or guidance.
''(9) DEFINITIONS.'--In this subsection:
''(A) EARLY CONSULTATION MEETING.'--The term 'early consultation meeting' means a pre-investigational new drug meeting or an end-of-phase-1 meeting that'--
''(i) is conducted to review and reach a written agreement'--
''(I) on the scope of the streamlined development plan for a drug for which a sponsor intends to request approval in accordance with this subsection; and
''(II) which, as appropriate, may include agreement on the design and size of necessary preclinical and clinical studies early in the development process, including clinical trials whose data are intended to form the primary basis for an effectiveness claim; and
''(ii) provides an opportunity to discuss expectations of the Secretary regarding studies or other information that the Secretary deems appropriate for purposes of applying paragraph (5), relating to the termination of labeling requirements or postmarketing conditions.
''(B) ASSESSMENT MEETING.'--The term 'assessment meeting' means an end-of-phase-2 meeting, pre-new drug application meeting, or pre-biologics license application meeting conducted to resolve questions and issues raised during the course of clinical investigations, and details addressed in the written agreement regarding postapproval commitments or expansion of approved uses.
''(C) POSTAPPROVAL MEETING.'--The term 'postapproval meeting' means a meeting following initial approval or licensure of the drug for use in a limited population, to discuss any issues identified by the Secretary or the sponsor regarding postapproval commitments or expansion of approved uses.''.
(c) Guidance.'--Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance describing criteria, process, and other general considerations for demonstrating the safety and effectiveness of antibacterial and antifungal drugs to be approved for use in a limited population in accordance with section 505(z) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b).
(d) Conforming amendments.'--
(1) LICENSURE OF CERTAIN BIOLOGICAL PRODUCTS.'--Section 351(j) of the Public Health Service Act (42 U.S.C. 262(j)) is amended'--
(A) by striking ''(j)'' and inserting ''(j)(1)'';
(B) by inserting ''505(z),'' after ''505(p),''; and
(C) by adding at the end the following new paragraph:
''(2) In applying section 505(z) of the Federal Food, Drug, and Cosmetic Act to the licensure of biological products under this section'--
''(A) references to an antibacterial or antifungal drug that is intended to treat a serious or life-threatening infection shall be construed to refer to a biological product intended to treat a serious or life-threatening bacterial or fungal infection; and
''(B) references to approval of a drug under section 505(c) of such Act shall be construed to refer to a licensure of a biological product under subsection (a) of this section.''.
(2) MISBRANDING.'--Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following new subsection:
''(dd) If it is a drug approved in accordance with section 505(z) and its labeling does not meet the requirements under paragraph (3) of such subsection, subject to paragraph (5) of such subsection.''.
(e) Evaluation.'--
(1) ASSESSMENT.'--Not later than 48 months after the date of enactment of this Act, the Secretary of Health and Human Services shall publish for public comment an assessment of the program established under section 505(z) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b). Such assessment shall determine if the limited-use pathway established under such section 505(z) has improved or is likely to improve patient access to novel antibacterial or antifungal treatments and assess how the pathway could be expanded to cover products for serious or life-threatening diseases or conditions beyond bacterial and fungal infections.
(2) MEETING.'--Not later than 90 days after the date of the publication of such assessment, the Secretary, acting through the Commissioner of Food and Drugs, shall hold a public meeting to discuss the findings of the assessment, during which public stakeholders may present their views on the success of the program established under section 505(z) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b), and the appropriateness of expanding such program.
(f) Expansion of program.'--If the Secretary of Health and Human Services determines, based on the assessment under subsection (e)(1), evaluation of the assessment, and any other relevant information, that the public health would benefit from expansion of the limited-use pathway established under section 505(z) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (b)) beyond the drugs approved in accordance with such section, the Secretary may expand such limited-use pathway in accordance with such a determination. The approval of any drugs under any such expansion shall be subject to the considerations and requirements described in such section 505(z) for purposes of expansion to other serious or life-threatening diseases or conditions.
(g) Monitoring.'--The Public Health Service Act is amended by inserting after section 317T (42 U.S.C. 247b''22) the following:
''SEC. 317U.Monitoring antibacterial and antifungal drug use and resistance.
''(a) Monitoring.'--The Secretary shall use an appropriate monitoring system to monitor'--
''(1) the use of antibacterial and antifungal drugs, including those receiving approval or licensure for a limited population pursuant to section 505(z) of the Federal Food, Drug, and Cosmetic Act; and
''(2) changes in bacterial and fungal resistance to drugs.
''(b) Public availability of data.'--The Secretary shall make summaries of the data derived from monitoring under this section publicly available for the purposes of'--
''(1) improving the monitoring of important trends in antibacterial and antifungal resistance; and
''(2) ensuring appropriate stewardship of antibacterial and antifungal drugs, including those receiving approval or licensure for a limited population pursuant to section 505(z) of the Federal Food, Drug, and Cosmetic Act.''.
SEC. 2122.Susceptibility test interpretive criteria for microorganisms.(a) In general.'--Section 511 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360a) is amended to read as follows:
''SEC. 511.Identifying and updating susceptibility test interpretive criteria for microorganisms.
''(a) Purpose; Identification of criteria.'--
''(1) PURPOSE.'--The purpose of this section is to provide the Secretary with an expedited, flexible method for'--
''(A) clearance or premarket approval of antimicrobial susceptibility testing devices utilizing updated, recognized susceptibility test interpretive criteria to characterize the in vitro susceptibility of particular bacteria, fungi, or other microorganisms to antimicrobial drugs; and
''(B) providing public notice of the availability of recognized interpretive criteria to meet premarket submission requirements or other requirements under this Act for antimicrobial susceptibility testing devices.
''(2) IN GENERAL.'--The Secretary shall identify appropriate susceptibility test interpretive criteria with respect to antimicrobial drugs'--
''(A) if such criteria are available on the date of approval of the drug under section 505 of this Act or licensure of the drug under section 351 of the Public Health Service Act (as applicable), upon such approval or licensure; or
''(B) if such criteria are unavailable on such date, on the date on which such criteria are available for such drug.
''(3) BASES FOR INITIAL IDENTIFICATION.'--The Secretary shall identify appropriate susceptibility test interpretive criteria under paragraph (2), based on the Secretary's review of, to the extent available and relevant'--
''(A) preclinical and clinical data, including pharmacokinetic, pharmacodynamic, and epidemiological data;
''(B) Bayesian and pharmacometric statistical methodologies; and
''(C) such other evidence and information as the Secretary considers appropriate.
''(b) Susceptibility test Interpretive Criteria Website.'--
''(1) IN GENERAL.'--Not later than 1 year after the date of the enactment of the 21st Century Cures Act, the Secretary shall establish, and maintain thereafter, on the website of the Food and Drug Administration, a dedicated website that contains a list of any appropriate new or updated susceptibility test interpretive criteria standards in accordance with paragraph (2) (referred to in this section as the 'Interpretive Criteria Website').
''(2) LISTING OF SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA STANDARDS.'--
''(A) IN GENERAL.'--The list described in paragraph (1) shall consist of any new or updated susceptibility test interpretive criteria standards that are'--
''(i) established by a nationally or internationally recognized standard development organization that'--
''(I) establishes and maintains procedures to address potential conflicts of interest and ensure transparent decisionmaking;
''(II) holds open meetings to ensure that there is an opportunity for public input by interested parties, and establishes and maintains processes to ensure that such input is considered in decisionmaking; and
''(III) permits its standards to be made publicly available, through the National Library of Medicine or another similar source acceptable to the Secretary; and
''(ii) recognized in whole, or in part, by the Secretary under subsection (c).
''(B) OTHER LIST.'--The Interpretive Criteria Website shall, in addition to the list described in subparagraph (A), include a list of interpretive criteria, if any, that the Secretary has determined to be appropriate with respect to legally marketed antimicrobial drugs, where'--
''(i) the Secretary does not recognize, in whole or in part, an interpretive criteria standard described under subparagraph (A) otherwise applicable to such a drug;
''(ii) the Secretary withdraws under subsection (c)(1)(B) recognition of a standard, in whole or in part, otherwise applicable to such a drug;
''(iii) the Secretary approves an application under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, with respect to marketing of such a drug for which there are no relevant interpretive criteria included in a standard recognized by the Secretary under subsection (c); or
''(iv) because the characteristics of such a drug differ from other drugs with the same active ingredient, the interpretive criteria with respect to such drug'--
''(I) differ from otherwise applicable interpretive criteria included in a standard listed under subparagraph (A) or interpretive criteria otherwise listed under this subparagraph; and
''(II) are determined by the Secretary to be appropriate for the drug.
''(C) REQUIRED STATEMENTS OF LIMITATIONS OF INFORMATION.'--The Interpretive Criteria Website shall include the following:
''(i) A statement that'--
''(I) the website provides information about the susceptibility of bacteria, fungi, or other microorganisms to a certain drug (or drugs); and
''(II) the safety and efficacy of the drug in treating clinical infections due to such bacteria, fungi, or other microorganisms may not have been established in adequate and well-controlled clinical trials and the clinical significance of such susceptibility information in such trials is unknown.
''(ii) A statement that directs health care practitioners to consult the approved product labeling for specific drugs to determine the uses for which the Food and Drug Administration has approved the product.
''(iii) Any other statement that the Secretary determines appropriate to adequately convey the limitations of the data supporting susceptibility test interpretive criteria standard listed on the website.
''(3) NOTICE.'--Not later than the date on which the Interpretive Criteria Website is established, the Secretary shall publish a notice of that establishment in the Federal Register.
''(4) INAPPLICABILITY OF MISBRANDING PROVISION.'--The inclusion in the approved labeling of an antimicrobial drug of a reference or hyperlink to the Interpretive Criteria Website, in and of itself, shall not cause the drug to be misbranded in violation of section 502, or the regulations promulgated thereunder.
''(5) TRADE SECRETS AND CONFIDENTIAL INFORMATION.'--Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code.
''(c) Recognition of susceptibility test interpretive criteria from standard development organizations.'--
''(1) IN GENERAL.'--Beginning on the date of the establishment of the Interpretive Criteria Website, and at least every 6 months thereafter, the Secretary shall'--
''(A) evaluate any appropriate new or updated susceptibility test interpretive criteria standards established by a nationally or internationally recognized standard development organization described in subsection (b)(2)(A)(i); and
''(B) publish on the public website of the Food and Drug Administration a notice'--
''(i) withdrawing recognition of any different susceptibility test interpretive criteria standard, in whole or in part;
''(ii) recognizing the new or updated standards;
''(iii) recognizing one or more parts of the new or updated interpretive criteria specified in such a standard and declining to recognize the remainder of such standard; and
''(iv) making any necessary updates to the lists under subsection (b)(2).
''(2) BASES FOR UPDATING INTERPRETIVE CRITERIA STANDARDS.'--In evaluating new or updated susceptibility test interpretive criteria standards under paragraph (1)(A), the Secretary may consider'--
''(A) the Secretary's determination that such a standard is not applicable to a particular drug because the characteristics of the drug differ from other drugs with the same active ingredient;
''(B) information provided by interested third parties, including public comment on the annual compilation of notices published under paragraph (3);
''(C) any bases used to identify susceptibility test interpretive criteria under subsection (a)(2); and
''(D) such other information or factors as the Secretary determines appropriate.
''(3) ANNUAL COMPILATION OF NOTICES.'--Each year, the Secretary shall compile the notices published under paragraph (1)(B) and publish such compilation in the Federal Register and provide for public comment. If the Secretary receives comments, the Secretary shall review such comments and, if the Secretary determines appropriate, update pursuant to this subsection susceptibility test interpretive criteria standards'--
''(A) recognized by the Secretary under this subsection; or
''(B) otherwise listed on the Interpretive Criteria Website under subsection (b)(2).
''(4) RELATION TO SECTION 514(c).'--Any susceptibility test interpretive standard recognized under this subsection or any criteria otherwise listed under subsection (b)(2)(B) shall be deemed to be recognized as a standard by the Secretary under section 514(c)(1).
''(5) VOLUNTARY USE OF INTERPRETIVE CRITERIA.'--Nothing in this section prohibits a person from seeking approval or clearance of a drug or device, or changes to the drug or the device, on the basis of susceptibility test interpretive criteria standards which differ from those recognized pursuant to paragraph (1).
''(d) Antimicrobial drug labeling.'--
''(1) DRUGS MARKETED PRIOR TO ESTABLISHMENT OF INTERPRETIVE CRITERIA WEBSITE.'--With respect to an antimicrobial drug lawfully introduced or delivered for introduction into interstate commerce for commercial distribution before the establishment of the Interpretive Criteria Website, a holder of an approved application under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, for each such drug'--
''(A) not later than 1 year after establishment of the Interpretive Criteria Website, shall submit to the Secretary a supplemental application for purposes of changing the drug's labeling to substitute a reference or hyperlink to such Website for any susceptibility test interpretive criteria and related information; and
''(B) may begin distribution of the drug involved upon receipt by the Secretary of the supplemental application for such change.
''(2) DRUGS MARKETED SUBSEQUENT TO ESTABLISHMENT OF INTERPRETIVE CRITERIA WEBSITE.'--With respect to antimicrobial drugs lawfully introduced or delivered for introduction into interstate commerce for commercial distribution on or after the date of the establishment of the Interpretive Criteria Website, the labeling for such a drug shall include, in lieu of susceptibility test interpretive criteria and related information, a reference to such Website.
''(e) Special condition for marketing of antimicrobial susceptibility testing devices.'--
''(1) IN GENERAL.'--Notwithstanding sections 501, 502, 510, 513, and 515, if the conditions specified in paragraph (2) are met (in addition to other applicable provisions under this chapter) with respect to an antimicrobial susceptibility testing device described in subsection (f)(1), the Secretary may authorize the marketing of such device for a use described in such subsection.
''(2) CONDITIONS APPLICABLE TO ANTIMICROBIAL SUSCEPTIBILITY TESTING DEVICES.'--The conditions specified in this paragraph are the following:
''(A) The device is used to make a determination of susceptibility using susceptibility test interpretive criteria that are'--
''(i) included in a standard recognized by the Secretary under subsection (c); or
''(ii) otherwise listed on the Interpretive Criteria Website under subsection (b)(2).
''(B) The labeling of such device prominently and conspicuously'--
''(i) includes a statement that'--
''(I) the device provides information about the susceptibility of bacteria and fungi to certain drugs; and
''(II) the safety and efficacy of such drugs in treating clinical infections due to such bacteria or fungi may not have been established in adequate and well-controlled clinical trials and the clinical significance of such susceptibility information in those instances is unknown;
''(ii) includes a statement directing health care practitioners to consult the approved labeling for drugs tested using such a device, to determine the uses for which the Food and Drug Administration has approved such drugs; and
''(iii) includes any other statement the Secretary determines appropriate to adequately convey the limitations of the data supporting the interpretive criteria described in subparagraph (A).
''(f) Definitions.'--In this section:
''(1) The term 'antimicrobial susceptibility testing device' means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs).
''(2) The term 'qualified infectious disease product' means a qualified infectious disease product designated under section 505E(d).
''(3) The term 'susceptibility test interpretive criteria' means'--
''(A) one or more specific numerical values which characterize the susceptibility of bacteria or other microorganisms to the drug tested; and
''(B) related categorizations of such susceptibility, including categorization of the drug as susceptible, intermediate, resistant, or such other term as the Secretary determines appropriate.
''(4) (A) The term 'antimicrobial drug' means, subject to subparagraph (B), a systemic antibacterial or antifungal drug that'--
''(i) is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus;
''(ii) may include a qualified infectious disease product designated under section 505E(d); and
''(iii) is subject to section 503(b)(1).
''(B) If provided by the Secretary through regulations, such term may include'--
''(i) drugs other than systemic antibacterial and antifungal drugs; and
''(ii) biological products (as such term is defined in section 351 of the Public Health Service Act) to the extent such products exhibit antimicrobial activity.
''(g) Rule of construction.'--Nothing in this section shall be construed'--
''(1) to alter the standards of evidence'--
''(A) under subsection (c) or (d) of section 505, including the substantial evidence standard in section 505(d), or under section 351 of the Public Health Service Act (as applicable); or
''(B) with respect to marketing authorization for devices, under section 510, 513, or 515;
''(2) to apply with respect to any drug, device, or biological product, in any context other than'--
''(A) an antimicrobial drug; or
''(B) an antimicrobial susceptibility testing device that uses susceptibility test interpretive criteria to characterize and report the in vitro susceptibility of certain bacteria, fungi, or other microorganisms to antimicrobial drugs in accordance with this section; or
''(3) unless specifically stated, to have any effect on authorities provided under other sections of this Act, including any regulations issued under such sections.''.
(b) Conforming amendments.'--
(1) REPEAL OF RELATED AUTHORITY.'--Section 1111 of the Food and Drug Administration Amendments Act of 2007 (42 U.S.C. 247d''5a; relating to identification of clinically susceptible concentrations of antimicrobials) is repealed.
(2) CLERICAL AMENDMENT.'--The table of contents in section 2 of the Food and Drug Administration Amendments Act of 2007 is amended by striking the item relating to section 1111.
(3) MISBRANDING.'--Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352), as amended by section 2121, is further amended by adding at the end the following:
''(ee) If it is an antimicrobial drug and its labeling fails to conform with the requirements under section 511(d).''.
(4) RECOGNITION OF INTERPRETIVE CRITERIA AS DEVICE STANDARD.'--Section 514(c)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by inserting after ''the Secretary shall, by publication in the Federal Register'' the following: ''(or, with respect to susceptibility test interpretive criteria or standards recognized or otherwise listed under section 511, by posting on the Interpretive Criteria Website in accordance with such section)''.
(c) Report to Congress.'--Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the progress made in implementing section 511 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360a), as amended by this section.
(d) Requests for updates to Interpretive Criteria Website.'--Chapter 35 of title 44, United States Code, shall not apply to the collection of information from interested parties regarding the updating of lists under paragraph (2) of subsection (b) section 511 of the Federal Food, Drug, and Cosmetic Act (as amended by subsection (a)) and posted on the Interpretive Criteria Website established under paragraph (1) of such subsection (b).
(e) No effect on health care practice.'--Nothing in this subtitle (including the amendments made by this subtitle) shall be construed to restrict, in any manner, the prescribing or administering of antibiotics or other products by health care practitioners, or to limit the practice of health care.
SEC. 2123.Encouraging the development and use of DISARM drugs.(a) Additional payment for DISARM drugs under Medicare.'--
(1) IN GENERAL.'--Section 1886(d)(5) of the Social Security Act (42 U.S.C. 1395ww(d)(5)) is amended by adding at the end the following new subparagraph:
''(M) (i) As part of the annual rulemaking conducted with respect to payment for subsection (d) hospitals for each fiscal year beginning with fiscal year 2018, the Secretary shall'--
''(I) include a list of the DISARM drugs for such fiscal year; and
''(II) with respect to discharges by eligible hospitals that involve a drug so listed, provide for an additional payment to be made under this subsection in accordance with the provisions of this subparagraph.
''(ii) Additional payments may not be made for a drug under this subparagraph'--
''(I) other than during the 5-fiscal-year period beginning with the fiscal year for which the drug is first included in the list described in clause (i)(I); and
''(II) with respect to which payment has ever been made pursuant to subparagraph (K).
''(iii) For purposes of this subparagraph, the term 'DISARM drug' means a product that is approved for use, or a product for which an indication is first approved for use, by the Food and Drug Administration on or after December 1, 2014, and that the Food and Drug Administration determines is an antimicrobial product (as defined in clause (iv)) and is intended to treat an infection'--
''(I) for which there is an unmet medical need; and
''(II) which is associated with high rates of mortality or significant patient morbidity, as determined in consultation with the Director of the Centers for Disease Control and Prevention and the infectious disease professional community.
''(iv) For purposes of clause (iii), the term 'antimicrobial product' means a product that either'--
''(I) is intended to treat an infection caused by, or likely to be caused by, a qualifying pathogen (as defined under section 505E(f) of the Federal Food, Drug, and Cosmetic Act); or
''(II) meets the definition of a qualified infectious disease product under section 505E(g) of the Federal Food, Drug, and Cosmetic Act.
Such determination may be revoked only upon a finding that the request for such determination contained an untrue statement of material fact.
''(v) For purposes of this subparagraph, the term 'eligible hospital' means a subsection (d) hospital that participates in the National Healthcare Safety Network of the Centers for Disease Control and Prevention (or, to the extent a similar surveillance system that includes reporting about antimicrobial drugs is determined by the Secretary to be available to such hospitals, such similar surveillance system as the Secretary may specify).
''(vi) Subject to the succeeding provisions of this subparagraph, the additional payment under this subparagraph, with respect to a drug, shall be in the amount provided for such drug under section 1847A.
''(vii) As part of the rulemaking referred to in clause (i) for each fiscal year, the Secretary shall estimate'--
''(I) total add-on payments (as defined in subclause (I) of clause (ix)); and
''(II) total hospital payments (as defined in subclause (II) of such clause).
''(viii) If the total add-on payments estimated pursuant to clause (vii)(I) for a fiscal year exceed 0.02 percent of the total hospital payments estimated pursuant to clause (vii)(II) for such fiscal year, the Secretary shall reduce in a pro rata manner the amount of each additional payment under this subsection pursuant to this subparagraph for such fiscal year in order to ensure that the total add-on payments estimated for such fiscal year do not exceed 0.02 percent of the total hospital payments estimated for such fiscal year.
''(ix) In this subparagraph:
''(I) The term 'total add-on payments' means, with respect to a fiscal year, the total amount of the additional payments under this subsection pursuant to this subparagraph for discharges in such fiscal year without regard to the application of clause (viii).
''(II) The term 'total hospital payments' means, with respect to a fiscal year, the total amount of payments made under this subsection for all discharges in such fiscal year.''.
(2) CONFORMING AMENDMENTS.'--
(A) NO DUPLICATIVE NTAP PAYMENTS.'--Section 1886(d)(5)(K)(vi) of the Social Security Act (42 U.S.C. 1395ww(d)(5)(K)(vi)) is amended by inserting ''and if additional payment has never been made under this subsection pursuant to subparagraph (M) with respect to the service or technology'' before the period at the end.
(B) ACCESS TO PRICE INFORMATION.'--Section 1927(b)(3)(A) of the Social Security Act (42 U.S.C. 1396r''8(b)(3)(A)) is amended'--
(i) in clause (ii)'--
(I) by striking ''for each'' and inserting '', for each''; and
(II) by striking ''and'' at the end;
(ii) in clause (iii)'--
(I) in subclause (II), by inserting ''or under section 1886(d) pursuant to paragraph (5)(M) of such section,'' after ''1847A,'';
(II) in the matter following subclause (III), by striking ''or 1881(b)(13)(A)(ii)'' and inserting '', section 1881(b)(13)(A)(ii), or section 1886(d)(5)(M)''; and
(III) by striking the period at the end and inserting ''; and''; and
(iii) in clause (iv), by striking the semicolon at the end and inserting a period.
(b) Study and report on removing barriers to development of DISARM drugs.'--
(1) STUDY.'--The Comptroller General of the United States shall, in consultation with the Director of the National Institutes of Health, the Commissioner of Food and Drugs, and the Director of the Centers for Disease Control and Prevention, conduct a study to'--
(A) identify and examine the barriers that prevent the development of DISARM drugs, as defined in section 1886(d)(5)(M)(iii) of the Social Security Act (42 U.S.C. 1395ww(d)(5)(M)(iii)), as added by subsection (a)(1); and
(B) develop recommendations for actions to be taken in order to overcome any barriers identified under subparagraph (A).
(2) REPORT.'--Not later than 1 year after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report on the study conducted under paragraph (1).
(c) Study and report on the impact of additional Medicare payment for DISARM drugs on usage practices and development of resistance.'--
(1) STUDY.'--The Director of the Centers for Disease Control and Prevention shall conduct a study to examine the effects of the additional payment for DISARM drugs under the Medicare Program provided under subparagraph (M) of section 1886(d)(5) of the Social Security Act (42 U.S.C. 1395ww(d)(5)), as added by subsection (a), on'--
(A) the usage of DISARM drugs (as defined by clause (iii) of such subparagraph) by subsection (d) hospitals (as defined in section 1886(d)(1)(B) of such Act); and
(B) the development of resistance by individuals to such DISARM drugs.
(2) REPORT.'--Not later than 3 years after the date of the enactment of this Act, such Director shall submit to Congress a report on the study conducted under paragraph (1).
SEC. 2141.Timely review of vaccines by the Advisory Committee on Immunization Practices.Section 2102(a) of the Public Health Service Act (42 U.S.C. 300aa''2(a)) is amended by adding at the end the following:
''(10) ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES.'--
''(A) STANDARD PERIODS OF TIME FOR MAKING RECOMMENDATIONS.'--Upon the licensure of any vaccine or any new indication for a vaccine, the Director of the Program shall direct the Advisory Committee on Immunization Practices, at its next regularly scheduled meeting, to consider the use of the vaccine.
''(B) EXPEDITED REVIEW PURSUANT TO REQUEST BY SPONSOR OR MANUFACTURER.'--If the Advisory Committee does not make recommendations with respect to the use of a vaccine at the Advisory Committee's first regularly scheduled meeting after the licensure of the vaccine or any new indication for the vaccine, the Advisory Committee, at the request of the sponsor of the vaccine, shall make such recommendations on an expedited basis.
''(C) EXPEDITED REVIEW FOR BREAKTHROUGH THERAPIES AND FOR USE DURING PUBLIC HEALTH EMERGENCIES.'--If a vaccine is designated as a breakthrough therapy under section 506 of the Federal Food, Drug, and Cosmetic Act, and is licensed under section 351 of this Act, the Advisory Committee shall make recommendations with respect to the use of the vaccine on an expedited basis.
''(D) DEFINITION.'--In this paragraph, the terms 'Advisory Committee on Immunization Practices' and 'Advisory Committee' mean the advisory committee on immunization practices established by the Secretary pursuant to section 222, acting through the Director of the Centers for Disease Control and Prevention.''.
SEC. 2142.Review of processes and consistency of ACIP recommendations.(a) Review.'--The Director of the Centers for Disease Control and Prevention shall conduct a review of the process used by the Advisory Committee on Immunization Practices to evaluate consistency in formulating and issuing recommendations pertaining to vaccines.
(b) Considerations.'--The review under subsection (a) shall include assessment of'--
(1) the criteria used to evaluate new and existing vaccines;
(2) the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to the review and analysis of scientific and economic data, including the scientific basis for such approach; and
(3) the extent to which the processes used by the working groups of the Advisory Committee on Immunization Practices are consistent among groups.
(c) Stakeholders.'--In carrying out the review under subsection (a), the Director of the Centers for Disease Control and Prevention shall solicit input from vaccine stakeholders.
(d) Report.'--Not later than 18 months after the date of enactment of this Act, the Director of the Centers for Disease Control and Prevention shall submit to the appropriate committees of the Congress and make publicly available a report on the results of the review under subsection (a), including recommendations on improving the consistency of the process described in such subsection.
(e) Definition.'--In this section, the term ''Advisory Committee on Immunization Practices'' means the advisory committee on immunization practices established by the Secretary of Health and Human Services pursuant to section 222 of the Public Health Service Act (42 U.S.C. 217a), acting through the Director of the Centers for Disease Control and Prevention.
SEC. 2143.Meetings between CDC and vaccine developers.Section 310 of the Public Health Service Act (42 U.S.C. 242o) is amended by adding at the end the following:
''(c) (1) In this subsection, the term 'vaccine developer' means a nongovernmental entity engaged in'--
''(A) (i) the development of a vaccine with the intent to pursue licensing of the vaccine by the Food and Drug Administration; or
''(ii) the production of a vaccine licensed by the Food and Drug Administration; and
''(B) vaccine research.
''(2) (A) Upon the submission of a written request for a meeting by a vaccine developer, that includes a valid justification for the meeting, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall convene a meeting of representatives of the vaccine developer and experts from the Centers for Disease Control and Prevention in immunization programs, epidemiology, and other relevant areas at which the Director (or the Director's designee), for the purpose of informing the vaccine developer's understanding of public health needs and priorities, shall provide the perspectives of the Centers for Disease Control and Prevention and other relevant Federal agencies regarding'--
''(i) public health needs, epidemiology, and implementation considerations with regard to a vaccine developer's potential vaccine profile; and
''(ii) potential implications of such perspectives for the vaccine developer's vaccine research and development planning.
''(B) In addition to the representatives specified in subparagraph (A), the Secretary may, with the agreement of the vaccine developer requesting a meeting under such subparagraph, include in such meeting representatives of'--
''(i) the Food and Drug Administration; and
''(ii) the National Vaccine Program.
''(C) The Secretary shall convene a meeting requested with a valid justification under subparagraph (A) not later than 120 days after receipt of the request for the meeting.
''(3) (A) Upon the submission of a written request by a vaccine developer, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall provide to the vaccine developer any age-based or other demographically assessed disease epidemiological analyses or data that'--
''(i) are specified in the request;
''(ii) have been published;
''(iii) have been performed by or are in the possession of the Centers;
''(iv) are not a trade secret or commercial or financial information that is privileged or confidential and subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code; and
''(v) do not contain individually identifiable information.
''(B) The Secretary shall provide analyses requested by a vaccine manufacturer under subparagraph (A) not later than 120 calendar days after receipt of the request for the analyses.
''(4) The Secretary shall promptly notify a vaccine developer if'--
''(A) the Secretary becomes aware of any significant change to information that was'--
''(i) shared by the Secretary with the vaccine developer during a meeting under paragraph (2); or
''(ii) provided by the Secretary to the vaccine developer in one or more analyses under paragraph (3); and
''(B) the change to such information may have implications for the vaccine developer's vaccine research and development.''.
SEC. 2151.Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition.(a) In general.'--Chapter V of the Federal Food, Drug, and Cosmetic Act, as amended by sections 2062 and 2063, is further amended by inserting after section 505H of such Act the following:
''SEC. 505I.Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition.
''(a) Designation.'--
''(1) IN GENERAL.'--The Secretary shall designate a drug as a drug approved for a new indication to prevent, diagnose, or treat a rare disease or condition for purposes of granting the extensions under subsection (b) if'--
''(A) prior to approval of an application or supplemental application for the new indication, the drug was approved or licensed for marketing under section 505(c) of this Act or section 351(a) of the Public Health Service Act but was not so approved or licensed for the new indication;
''(B) (i) the sponsor of the approved or licensed drug files an application or a supplemental application for approval of the new indication for use of the drug to prevent, diagnose, or treat the rare disease or condition; and
''(ii) the Secretary approves the application or supplemental application; and
''(C) the application or supplemental application for the new indication contains the consent of the applicant to notice being given by the Secretary under paragraph (4) respecting the designation of the drug.
''(2) REVOCATION OF DESIGNATION.'--
''(A) IN GENERAL.'--Except as provided in subparagraph (B), a designation under paragraph (1) shall not be revoked for any reason.
''(B) EXCEPTION.'--The Secretary may revoke a designation of a drug under paragraph (1) if the Secretary finds that the application or supplemental application resulting in such designation contained an untrue statement of material fact.
''(3) NOTIFICATION PRIOR TO DISCONTINUANCE OF PRODUCTION FOR SOLELY COMMERCIAL REASONS.'--A designation of a drug under paragraph (1) shall be subject to the condition that the sponsor of the drug will notify the Secretary of any discontinuance of the production of the drug for solely commercial reasons at least 1 year before such discontinuance.
''(4) NOTICE TO PUBLIC.'--Notice respecting the designation of a drug under paragraph (1) shall be made available to the public.
''(b) Extension.'--If the Secretary designates a drug as a drug approved for a new indication for a rare disease or condition, as described in subsection (a)(1)'--
''(1) (A) the 4-, 5-, and 7½-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of section 505, and the 7-year period described in section 527, as applicable, shall be extended by 6 months; or
''(B) the 4- and 12-year periods described in subparagraphs (A) and (B) of section 351(k)(7) of the Public Health Service Act and the 7-year period described in section 527, as applicable, shall be extended by 6 months; and
''(2) (A) if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 or a listed patent for which a certification has been submitted under subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of 6 months after the date the patent expires (including any patent extensions); or
''(B) if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of 6 months after the date the patent expires (including any patent extensions).
''(c) Relation to pediatric and qualified infectious disease product exclusivity.'--Any extension under subsection (b) of a period shall be in addition to any extension of the periods under sections 505A and 505E of this Act and section 351(m) of the Public Health Service Act, as applicable, with respect to the drug.
''(d) Limitations.'--The extension described in subsection (b) shall not apply if the drug designated under subsection (a)(1) has previously received an extension by operation of subsection (b).
''(e) Definition.'--In this section, the term 'rare disease or condition' has the meaning given to such term in section 526(a)(2).''.
(b) Application.'--Section 505G of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies only with respect to a drug for which an application or supplemental application described in subsection (a)(1)(B)(i) of such section 505G is first approved under section 505(c) of such Act (21 U.S.C. 355(c)) or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) on or after the date of the enactment of this Act.
(c) Conforming amendments.'--
(1) RELATION TO PEDIATRIC EXCLUSIVITY FOR DRUGS.'--Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended'--
(A) in subsection (b), by adding at the end the following:
''(3) RELATION TO EXCLUSIVITY FOR A DRUG APPROVED FOR A NEW INDICATION FOR A RARE DISEASE OR CONDITION.'--Notwithstanding the references in paragraph (1) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in paragraph (1) shall be in addition to any extensions under section 505G.''; and
(B) in subsection (c), by adding at the end the following:
''(3) RELATION TO EXCLUSIVITY FOR A DRUG APPROVED FOR A NEW INDICATION FOR A RARE DISEASE OR CONDITION.'--Notwithstanding the references in paragraph (1) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in paragraph (1) shall be in addition to any extensions under section 505G.''.
(2) RELATION TO EXCLUSIVITY FOR NEW QUALIFIED INFECTIOUS DISEASE PRODUCTS THAT ARE DRUGS.'--Subsection (b) of section 505E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355f) is amended'--
(A) by amending the subsection heading to read as follows: ''Relation to pediatric exclusivity and exclusivity for a drug approved for a new indication for a rare disease or condition.'--''; and
(B) by striking ''any extension of the period under section 505A'' and inserting ''any extension of the periods under sections 505A and 505G, as applicable,''.
(3) RELATION TO PEDIATRIC EXCLUSIVITY FOR BIOLOGICAL PRODUCTS.'--Section 351(m) of the Public Health Service Act (42 U.S.C. 262(m)) is amended by adding at the end the following:
''(5) RELATION TO EXCLUSIVITY FOR A BIOLOGICAL PRODUCT APPROVED FOR A NEW INDICATION FOR A RARE DISEASE OR CONDITION.'--Notwithstanding the references in paragraphs (2)(A), (2)(B), (3)(A), and (3)(B) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in such paragraphs shall be in addition to any extensions under section 505G.''.
SEC. 2152.Reauthorization of rare pediatric disease priority review voucher incentive program.(a) In general.'--Section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff) is amended'--
(1) in subsection (a)'--
(A) in paragraph (3), by amending subparagraph (A) to read as follows:
''(A) The disease is a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents.''; and
(B) in paragraph (4)'--
(i) in subparagraph (E), by striking ''and'' at the end;
(ii) in subparagraph (F), by striking the period at the end and inserting ''; and''; and
(iii) by adding at the end the following:
''(G) is for a drug or biological product for which a priority review voucher has not been issued under section 524 (relating to tropical disease products).''; and
(2) in subsection (b), by striking paragraph (5) and inserting the following:
''(5) TERMINATION OF AUTHORITY.'--
''(A) IN GENERAL.'--The Secretary may not award any priority review vouchers under paragraph (1) after December 31, 2018.
''(B) EXCEPTION.'--Notwithstanding subparagraph (A), the sponsor of a drug that is designated under subsection (d) as a drug for a rare pediatric disease and that is the subject of a rare pediatric disease product application that is submitted during the period beginning on the date of enactment of the 21st Century Cures Act and ending the date specified in subparagraph (A) shall remain eligible to receive a priority review voucher under paragraph (1) irrespective of whether the rare pediatric disease product application with respect to such drug is approved after the end of such period.''.
(b) GAO study and report.'--
(1) STUDY.'--The Comptroller General of the United States shall conduct a study on the effectiveness of awarding priority review vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff) in providing incentives for the development of drugs that treat or prevent rare pediatric diseases (as defined in subsection (a)(3) of such section) that would not otherwise have been developed. In conducting such study, the Comptroller General shall examine the following:
(A) The indications for which each drug for which a priority review voucher was awarded under such section 529 was approved under section 505 of such Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262).
(B) Whether the priority review voucher impacted a sponsor's decision to invest in developing a drug to treat or prevent a rare pediatric disease.
(C) An analysis of the drugs that utilized such priority review vouchers, which shall include'--
(i) the indications for which such drugs were approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262);
(ii) whether unmet medical needs were addressed through the approval of such drugs, including, for each such drug'--
(I) if an alternative therapy was previously available to treat the indication; and
(II) the benefit or advantage the drug provided over another available therapy;
(iii) the number of patients potentially treated by such drugs;
(iv) the value of the priority review voucher if transferred; and
(v) the length of time between the date on which a priority review voucher was awarded and the date on which it was used.
(D) With respect to the priority review voucher program under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff)'--
(i) the resources used by, and burden placed on, the Food and Drug Administration in implementing such program, including the effect of such program on the Food and Drug Administration's review of drugs for which a priority review voucher was not awarded or used;
(ii) the impact of the program on the public health as a result of the expedited review of applications for drugs that treat or prevent non-serious indications that are generally used by the broader public; and
(iii) alternative approaches to improving such program so that the program is appropriately targeted toward providing incentives for the development of clinically important drugs that'--
(I) prevent or treat rare pediatric diseases; and
(II) would likely not otherwise have been developed to prevent or treat such diseases.
(2) REPORT.'--Not later than December 31, 2017, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing the results of the study of conducted under paragraph (1).
SEC. 2161.Grants for studying the process of continuous drug manufacturing.(a) In general.'--The Commissioner of Food and Drugs may award grants to institutions of higher education and nonprofit organizations for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.
(b) Definitions.'--In this section:
(1) The term ''drug'' has the meaning given to such term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
(2) The term ''biological product'' has the meaning given to such term in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)).
(3) The term ''institution of higher education'' has the meaning given to such term in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001).
(c) Authorization of appropriations.'--There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2016 through 2020.
SEC. 2162.Re-exportation among members of the European Economic Area.Section 1003 of the Controlled Substances Import and Export Act (21 U.S.C. 953) is amended'--
(1) in subsection (f)'--
(A) in paragraph (5)'--
(i) by striking ''(5)'' and inserting ''(5)(A)'';
(ii) by inserting '', except that the controlled substance may be exported from the second country to another country that is a member of the European Economic Area'' before the period at the end; and
(iii) by adding at the end the following:
''(B) Subsequent to any re-exportation described in subparagraph (A), a controlled substance may continue to be exported from any country that is a member of the European Economic Area to any other such country, provided that'--
''(i) the conditions applicable with respect to the first country under paragraphs (1), (2), (3), (4), (6), and (7) are met by each subsequent country from which the controlled substance is exported pursuant to this paragraph; and
''(ii) the conditions applicable with respect to the second country under such paragraphs are met by each subsequent country to which the controlled substance is exported pursuant to this paragraph.''; and
(B) in paragraph (6)'--
(i) by striking ''(6)'' and inserting ''(6)(A)''; and
(ii) by adding at the end the following:
''(B) In the case of re-exportation among members of the European Economic Area, within 30 days after each re-exportation, the person who exported the controlled substance from the United States delivers to the Attorney General'--
''(i) documentation certifying that such re-exportation has occurred; and
''(ii) information concerning the consignee, country, and product.''; and
(2) by adding at the end the following:
''(g) Limitation.'--Subject to paragraphs (5) and (6) of subsection (f) in the case of any controlled substance in schedule I or II or any narcotic drug in schedule III or IV, the Attorney General shall not promulgate nor enforce any regulation, subregulatory guidance, or enforcement policy which impedes re-exportation of any controlled substance among European Economic Area countries, including by promulgating or enforcing any requirement that'--
''(1) re-exportation from the first country to the second country or re-exportation from the second country to another country occur within a specified period of time; or
''(2) information concerning the consignee, country, and product be provided prior to exportation of the controlled substance from the United States or prior to each re-exportation among members of the European Economic Area.''.
SEC. 2181.Enhancing combination products review.Section 503(g)(4)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)(4)(C)) is amended by adding at the end the following new clause:
''(iii) Not later than 18 months after the date of the enactment of the 21st Century Cures Act, the Secretary shall issue final guidance that describes the responsibilities of each agency center regarding its review of combination products. The Secretary shall, after soliciting public comment, review and update the guidance periodically.''.
SEC. 2201.Priority review for breakthrough devices.(a) In general.'--Chapter V of the Federal Food, Drug, and Cosmetic Act is amended'--
(1) in section 515(d)'--
(A) by striking paragraph (5); and
(B) by redesignating paragraph (6) as paragraph (5); and
(2) by inserting after section 515A (21 U.S.C. 360e''1) the following:
''SEC. 515B.Priority review for breakthrough devices.
''(a) In general.'--In order to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions, the Secretary shall establish a program to provide priority review for devices'--
''(1) representing breakthrough technologies;
''(2) for which no approved alternatives exist;
''(3) offering significant advantages over existing approved or cleared alternatives, including the potential to, compared to existing approved or cleared alternatives, reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients' ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or
''(4) the availability of which is in the best interest of patients.
''(b) Request for designation.'--A sponsor of a device may request that the Secretary designate the device for priority review under this section. Any such request for designation may be made at any time prior to the submission of an application under section 515(c), a petition for classification under section 513(f)(2), or a notification under section 510(k).
''(c) Designation process.'--
''(1) IN GENERAL.'--Not later than 60 calendar days after the receipt of a request under subsection (b), the Secretary shall determine whether the device that is the subject of the request meets the criteria described in subsection (a). If the Secretary determines that the device meets the criteria, the Secretary shall designate the device for priority review.
''(2) REVIEW.'--Review of a request under subsection (b) shall be undertaken by a team that is composed of experienced staff and managers of the Food and Drug Administration and is chaired by a senior manager.
''(3) DESIGNATION DETERMINATION.'--A determination approving or denying a request under subsection (b) shall be considered a significant decision under section 517A and the Secretary shall provide a written, substantive summary of the basis for the determination in accordance with section 517A(a).
''(4) RECONSIDERATION.'--
''(A) REQUEST FOR RECONSIDERATION.'--Any person whose request under subsection (b) is denied may, within 30 days of the denial, request reconsideration of the denial in accordance with section 517A(b)'--
''(i) based upon the submission of documents by such person; or
''(ii) based upon such documents and a meeting or teleconference.
''(B) RESPONSE.'--Reconsideration of a designation determination under this paragraph shall be conducted in accordance with section 517A(b).
''(5) WITHDRAWAL.'--If the Secretary approves a priority review designation for a device under this section, the Secretary may not withdraw the designation based on the fact that the criteria specified in subsection (a) are no longer met because of the subsequent clearance or approval of another device that was designated under'--
''(A) this section; or
''(B) section 515(d)(5) (as in effect immediately prior to the enactment of the 21st Century Cures Act).
''(d) Priority review.'--
''(1) ACTIONS.'--For purposes of expediting the development and review of devices designated under subsection (c), the Secretary shall'--
''(A) assign a team of staff, including a team leader with appropriate subject matter expertise and experience, for each device for which a request is submitted under subsection (b);
''(B) provide for oversight of the team by senior agency personnel to facilitate the efficient development of the device and the efficient review of any submission described in subsection (b) for the device;
''(C) adopt an efficient process for timely dispute resolution;
''(D) provide for interactive communication with the sponsor of the device during the review process;
''(E) expedite the Secretary's review of manufacturing and quality systems compliance, as applicable;
''(F) disclose to the sponsor in advance the topics of any consultation concerning the sponsor's device that the Secretary intends to undertake with external experts or an advisory committee and provide the sponsor an opportunity to recommend such external experts;
''(G) for applications submitted under section 515(c), provide for advisory committee input, as the Secretary determines appropriate (including in response to the request of the sponsor); and
''(H) assign staff to be available within a reasonable time to address questions posed by institutional review committees concerning the conditions and clinical testing requirements applicable to the investigational use of the device pursuant to an exemption under section 520(g).
''(2) ADDITIONAL ACTIONS.'--In addition to the actions described in paragraph (1), for purposes of expediting the development and review of devices designated under subsection (c), the Secretary, in collaboration with the device sponsor, may, as appropriate'--
''(A) coordinate with the sponsor regarding early agreement on a data development plan;
''(B) take steps to ensure that the design of clinical trials is as efficient as practicable, such as through adoption of shorter or smaller clinical trials, application of surrogate endpoints, and use of adaptive trial designs and Bayesian statistics, to the extent scientifically appropriate;
''(C) facilitate, to the extent scientifically appropriate, expedited and efficient development and review of the device through utilization of timely postmarket data collection, with regard to applications for approval under section 515(c); and
''(D) agree to clinical protocols that the Secretary will consider binding on the Secretary and the sponsor, subject to'--
''(i) changes agreed to by the sponsor and the Secretary;
''(ii) changes that the Secretary determines are required to prevent an unreasonable risk to the public health; or
''(iii) the identification of a substantial scientific issue determined by the Secretary to be essential to the safety or effectiveness of the device involved.
''(e) Priority review guidance.'--
''(1) CONTENT.'--The Secretary shall issue guidance on the implementation of this section. Such guidance shall include the following:
''(A) The process for a person to seek a priority review designation.
''(B) A template for requests under subsection (b).
''(C) The criteria the Secretary will use in evaluating a request for priority review.
''(D) The standards the Secretary will use in assigning a team of staff, including team leaders, to review devices designated for priority review, including any training required for such personnel on effective and efficient review.
''(2) PROCESS.'--Prior to finalizing the guidance under paragraph (1), the Secretary shall propose such guidance for public comment.
''(f) Construction.'--
''(1) PURPOSE.'--This section is intended to encourage the Secretary and provide the Secretary sufficient authorities to apply efficient and flexible approaches to expedite the development of, and prioritize the agency's review of, devices that represent breakthrough technologies.
''(2) CONSTRUCTION.'--Nothing in this section shall be construed to alter the criteria and standards for evaluating an application pursuant to section 515(c), a report and request for classification under section 513(f)(2), or a report under section 510(k), including the recognition of valid scientific evidence as described in section 513(a)(3)(B), and consideration of the least burdensome means of evaluating device effectiveness or demonstrating substantial equivalence between devices with differing technological characteristics, as applicable. Nothing in this section alters the authority of the Secretary to act on an application pursuant to section 515(d) before completion of an establishment inspection, as the Secretary deems appropriate.''.
(b) Conforming amendment related to designation determinations.'--Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g''1(a)(1)) is amended by inserting ''a request for designation under section 515B,'' after ''an application under section 515,''.
SEC. 2221.Third-party quality system assessment.(a) Establishment of third-Party quality system assessment program.'--Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 524A (21 U.S.C. 360n''1) the following new section:
''SEC. 524B.Third-party quality system assessment.
''(a) Accreditation and assessment.'--
''(1) IN GENERAL; CERTIFICATION OF DEVICE QUALITY SYSTEM.'--The Secretary shall, in accordance with this section, establish a third-party quality system assessment program'--
''(A) to accredit persons to assess whether a requestor's quality system, including its design controls, can reasonably assure the safety and effectiveness of in-scope devices subject to device-related changes;
''(B) under which accredited persons shall (as applicable) certify that a requestor's quality system meets the criteria included in the guidance issued under paragraph (5) with respect to the in-scope devices at issue; and
''(C) under which the Secretary shall rely on such certifications for purposes of determining the safety and effectiveness (or as applicable, substantial equivalence) of in-scope devices subject to the device-related changes involved, in lieu of compliance with the following submission requirements:
''(i) A premarket notification.
''(ii) A 30-day notice.
''(iii) A Special PMA supplement.
''(2) DEFINITIONS.'--For purposes of this section'--
''(A) the term 'device-related changes' means changes made by a requestor with respect to in-scope devices, which are'--
''(i) changes to a device found to be substantially equivalent under sections 513(i) and 510(k) to a predicate device, that'--
''(I) would otherwise be subject to a premarket notification; and
''(II) do not alter'--
''(aa) the intended use of the changed device; or
''(bb) the fundamental scientific technology of such device;
''(ii) manufacturing changes subject to a 30-day notice;
''(iii) changes that qualify for a Special PMA Supplement; and
''(iv) such other changes relating to the devices or the device manufacturing process as the Secretary determines appropriate;
''(B) the term 'in-scope device' means a device within the scope of devices agreed to by the requestor and the accredited person for purposes of a request for certification under this section;
''(C) the term 'premarket notification' means a premarket notification under section 510(k);
''(D) the term 'quality system' means the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of devices, as described in section 520(f);
''(E) the term 'requestor' means a device manufacturer that is seeking certification under this section of a quality system used by such manufacturer;
''(F) the term 'Special PMA' means a Special PMA supplement under section 814.39(d) of title 21, Code of Federal Regulations (or any successor regulations); and
''(G) the term '30-day notice' means a notice described in section 515(d)(6).
''(3) ACCREDITATION PROCESS; ACCREDITATION RENEWAL.'--Except as inconsistent with this section, the process and qualifications for accreditation of persons and renewal of such accreditation under section 704(g) shall apply with respect to accreditation of persons and renewal of such accreditation under this section.
''(4) USE OF ACCREDITED PARTIES TO CONDUCT ASSESSMENTS.'--
''(A) INITIATION OF ASSESSMENT SERVICES.'--
''(i) DATE ASSESSMENTS AUTHORIZED.'--Beginning after the date on which the final guidance is issued under paragraph (5), an accredited person may conduct an assessment under this section.
''(ii) INITIATION OF ASSESSMENTS.'--Use of one or more accredited persons to assess a requestor's quality system under this section with respect to in-scope devices shall be at the initiation of the person who registers and lists the devices at issue under section 510.
''(B) COMPENSATION.'--Compensation for such accredited persons shall'--
''(i) be determined by agreement between the accredited person and the person who engages the services of the accredited person; and
''(ii) be paid by the person who engages such services.
''(C) ACCREDITED PERSON SELECTION.'--Each person who chooses to use an accredited person to assess a requestor's quality system, as described in this section, shall select the accredited person from a list of such persons published by the Secretary in accordance with section 704(g)(4).
''(5) GUIDANCE; CRITERIA FOR CERTIFICATION.'--
''(A) IN GENERAL.'--The criteria for certification of a quality system under this section shall be as specified by the Secretary in guidance issued under this paragraph.
''(B) CONTENTS; CRITERIA.'--The guidance under this paragraph shall include specification of'--
''(i) evaluative criteria to be used by an accredited person to assess and, as applicable, certify a requestor's quality system under this section with respect to in-scope devices; and
''(ii) criteria for accredited persons to apply for a waiver of, and exemptions from, the criteria under clause (i).
''(C) TIMEFRAME FOR ISSUING GUIDANCE.'--The Secretary shall issue under this paragraph'--
''(i) draft guidance not later than 12 months after the enactment of the 21st Century Cures Act; and
''(ii) final guidance not later than 12 months after issuance of the draft guidance under clause (i).
''(b) Use of third-Party assessment.'--
''(1) ASSESSMENT SUMMARY; CERTIFICATION.'--
''(A) SUBMISSION OF ASSESSMENT TO SECRETARY.'--An accredited person who assesses a requestor's quality system under subsection (a) shall submit to the Secretary a summary of the assessment'--
''(i) within 30 days of the assessment; and
''(ii) which shall include (as applicable)'--
''(I) the accredited person's certification that the requestor has satisfied the criteria specified in the guidance issued under subsection (a)(5) for quality system certification with respect to the in-scope devices at issue; and
''(II) any waivers or exemptions from such criteria applied by the accredited person.
''(B) TREATMENT OF ASSESSMENTS.'--Subject to action by the Secretary under subparagraph (C), with respect to assessments which include a certification under this section'--
''(i) the Secretary's review of the assessment summary shall be deemed complete on the day that is 30 days after the date on which the Secretary receives the summary under subparagraph (A); and
''(ii) the assessment summary and certification of the quality system of a requestor shall be deemed accepted by the Secretary on such 30th day.
''(C) ACTIONS BY SECRETARY.'--
''(i) IN GENERAL.'--Within 30 days of receiving an assessment summary and certification under subparagraph (A), the Secretary may, by written notice to the accredited person submitting such assessment certification, deem any such certification to be provisional beyond such 30-day period, suspended pending further review by the Secretary, or otherwise qualified or cancelled, based on the Secretary's determination that (as applicable)'--
''(I) additional information is needed to support such certification;
''(II) such assessment or certification is unwarranted; or
''(III) such action with regard to the certification is otherwise justified according to such factors and criteria as the Secretary finds appropriate.
''(ii) ACCEPTANCE OF CERTIFICATION.'--If following action by the Secretary under clause (i) with respect to a certification, the Secretary determines that such certification is acceptable, the Secretary shall issue written notice to the applicable accredited person indicating such acceptance.
''(2) NOTIFICATIONS TO SECRETARY BY CERTIFIED REQUESTORS OR ACCREDITED PERSONS FOR PROGRAM EVALUATION PURPOSES.'--
''(A) ANNUAL SUMMARY REPORT FOR DEVICE-RELATED CHANGES OTHERWISE SUBJECT TO PREMARKET NOTIFICATION.'--A requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices, without prior submission of a premarket notification, shall ensure that an annual summary report is submitted to the Secretary by the accredited person which'--
''(i) describes the changes made to the in-scope device; and
''(ii) indicates the effective dates of such changes.
''(B) PERIODIC NOTIFICATION FOR MANUFACTURING CHANGES OTHERWISE SUBJECT TO 30-DAY NOTICE.'--A requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices, without prior submission of a 30-day notice, shall provide notification to the Secretary of such changes in the requestor's next periodic report under section 814.84(b) of title 21, Code of Federal Regulations (or any successor regulation). Such notification shall'--
''(i) describe the changes made; and
''(ii) indicate the effective dates of such changes.
''(C) PERIODIC NOTIFICATION FOR DEVICE-RELATED CHANGES OTHERWISE SUBJECT TO SPECIAL PMA SUPPLEMENT.'--A requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices, without prior submission of a Special PMA Supplement, shall provide notification to the Secretary of such changes in the requestor's next periodic report under section 814.84(b) of title 21, Code of Federal Regulations (or any successor regulation). Such notification shall'--
''(i) describe the changes made, including a full explanation of the basis for the changes; and
''(ii) indicate the effective dates of such changes.
''(D) USE OF NOTIFICATIONS FOR PROGRAM EVALUATION PURPOSES.'--Information submitted to the Secretary under subparagraphs (A) through (C) shall be used by the Secretary for purposes of the program evaluation under subsection (d).
''(c) Duration and effect of certification.'--A certification under this section'--
''(1) shall remain in effect for a period of 2 years from the date such certification is accepted by the Secretary, subject to paragraph (6);
''(2) may be renewed through the process described in subsection (a)(3);
''(3) shall continue to apply with respect to device-related changes made during such 2-year period, provided the certification remains in effect, irrespective of whether such certification is renewed after such 2-year period;
''(4) shall have no effect on the need to comply with applicable submission requirements specified in subsection (a)(1)(C) with respect to any change pertaining to in-scope devices which is not a device-related change under subsection (a)(2);
''(5) shall have no effect on the authority of the Secretary to conduct an inspection or otherwise determine whether the requestor has complied with the applicable requirements of this Act; and
''(6) may be revoked by the Secretary upon a determination that the requestor's quality system no longer meets the criteria specified in the guidance issued under subsection (a)(5) with respect to the in-scope devices at issue.
''(d) Notice of revocation.'--The Secretary shall provide written notification to the requestor of a revocation pursuant to subsection (c)(6) not later than 10 business days after the determination described in such subsection. Upon receipt of the written notification, the requestor shall satisfy the applicable submission requirements specified in subsection (a)(1)(C) for any device-related changes effectuated after the date of such determination. After such revocation, such requestor is eligible to seek re-certification under this section of its quality system.
''(e) Program evaluation; sunset.'--
''(1) PROGRAM EVALUATION AND REPORT.'--
''(A) EVALUATION.'--The Secretary shall complete an evaluation of the third-party quality system assessment program under this section no later than January 31, 2021, based on'--
''(i) analysis of information from a representative group of device manufacturers obtained from notifications provided by certified requestors or accredited persons under subsection (b)(2); and
''(ii) such other available information and data as the Secretary determines appropriate.
''(B) REPORT.'--No later than 1 year after completing the evaluation under subparagraph (A), the Secretary shall issue a report of the evaluation's findings on the website of the Food and Drug Administration, which shall include the Secretary's recommendations with respect to continuation and as applicable expansion of the program under this section to encompass'--
''(i) device submissions beyond those identified in subsection (a)(1)(C); and
''(ii) device changes beyond those described in subsection (a)(2)(A).
''(2) SUNSET.'--This section shall cease to be effective October 1, 2022.
''(f) Rule of construction.'--Nothing in this section shall be construed to limit the authority of the Secretary to request and review the complete assessment of a certified requestor under this section on a for-cause basis.''.
(b) Conforming amendments.'--
(1) REQUIREMENTS FOR PREMARKET APPROVAL SUPPLEMENTS.'--Section 515(d)(5)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)(5)(A)(i)), as redesignated by section 2201, is further amended by inserting '', subject to section 524B'' after ''that affects safety or effectiveness''.
(2) REQUIREMENTS FOR 30-DAY NOTICE.'--Section 515(d)(5)(A)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)(5)(A)(ii)), as redesignated by section 2201, is further amended by inserting '', subject to section 524B'' after ''the date on which the Secretary receives the notice''.
(3) REQUIREMENTS FOR PREMARKET NOTIFICATION; TECHNICAL CORRECTION TO REFERENCE TO SECTION 510(K).'--Section 510(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is amended by striking ''of this subsection under subsection (m)'' and inserting ''of subsection (k) under subsection (m) or section 524B''.
(4) MISBRANDED DEVICES.'--Section 502(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(t)) is amended by inserting ''or 524B'' after ''section 519''.
SEC. 2222.Valid scientific evidence.Section 513(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(a)(3)(B)) is amended'--
(1) by redesignating clauses (i) and (ii) as subclauses (I) and (II), respectively;
(2) by striking ''(B) If the Secretary'' and inserting ''(B)(i) If the Secretary''; and
(3) by adding at the end the following:
''(ii) For purposes of clause (i), valid scientific evidence may include'--
''(I) evidence described in well-documented case histories, including registry data, that are collected and monitored under a protocol determined to be acceptable by the Secretary;
''(II) studies published in peer-reviewed journals; and
''(III) data collected in countries other than the United States so long as such data otherwise meet the criteria specified in this subparagraph.
''(iii) In the case of a study published in a peer-reviewed journal that is offered as valid scientific evidence for purposes of clause (i), the Secretary may request data underlying the study if'--
''(I) the Secretary, in making such request, complies with the requirement of subparagraph (D)(ii) to consider the least burdensome appropriate means of evaluating device effectiveness or subsection (i)(1)(D) to consider the least burdensome means of determining substantial equivalence, as applicable;
''(II) the Secretary furnishes a written rationale for so requesting the underlying data together with such request; and
''(III) if the requested underlying data for such a study are unavailable, the Secretary shall consider such study to be part of the totality of the evidence with respect to the device, as the Secretary determines appropriate.''.
SEC. 2223.Training and oversight in least burdensome appropriate means concept.(a) In general.'--Section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end the following:
''(j) Training and oversight in least burdensome appropriate means concept.'--
''(1) TRAINING.'--Each employee of the Food and Drug Administration who is involved in the review of premarket submissions under section 515 or section 510(k), including supervisors, shall receive training regarding the meaning and implementation of the least burdensome appropriate means concept in the context of the use of that term in subsections (a)(3)(D) and (i)(1)(D) of this section and in section 515(c)(5).
''(2) GUIDANCE DOCUMENTS.'--
''(A) DRAFT UPDATED GUIDANCE.'--Not later than 12 months after the date of enactment of the 21st Century Cures Act, the Secretary shall issue a draft guidance document updating the October 4, 2002, guidance document entitled 'The Least Burdensome Provision of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry'.
''(B) MEETING OF STAKEHOLDERS.'--In developing such draft guidance document, the Secretary shall convene a meeting of stakeholders to ensure a full record to support the publication of such document.
''(3) OMBUDSMAN AUDIT.'--Not later than 18 months after the date of issuance of final version of the draft guidance under paragraph (2), the ombudsman for the organizational unit of the Food and Drug Administration responsible for the premarket review of devices shall'--
''(A) conduct, or have conducted, an audit of the training described in paragraph (1); and
''(B) include in such audit interviews with a representative sample of persons from industry regarding their experience in the device premarket review process.''.
(b) Additional information regarding premarket applications.'--Subsection (c) of section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) is amended by adding at the end the following:
''(5) (A) Whenever the Secretary requests additional information from an applicant regarding an application under paragraph (1), the Secretary shall consider the least burdensome appropriate means necessary to demonstrate device safety and effectiveness, and request information accordingly.
''(B) For purposes of subparagraph (A), the term 'necessary' means the minimum required information that would support a determination by the Secretary that an application provides a reasonable assurance of the safety and effectiveness of the device.
''(C) Nothing in this paragraph alters the standards for premarket approval of a device.''.
SEC. 2224.Recognition of standards.Section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)) is amended'--
(1) in paragraph (1), by inserting after subparagraph (B) the following new subparagraphs:
''(C) (i) Any person may submit a request for recognition under subparagraph (A) of all or part of an appropriate standard established by a nationally or internationally recognized standard organization.
''(ii) Not later than 60 days after the Secretary receives such a request, the Secretary shall'--
''(I) make a determination to recognize all, part, or none of the standard that is the subject of the request; and
''(II) issue to the person who submitted such request a response in writing that states the Secretary's rationale for that determination, including the scientific, technical, regulatory, or other basis for such determination.
''(iii) The Secretary shall make a response issued under clause (ii)(II) publicly available, in such manner as the Secretary determines appropriate.
''(iv) The Secretary shall take such actions as may be necessary to implement all or part of a standard recognized under clause (i)(I), in accordance with subparagraph (A).
''(D) The Secretary shall make publicly available, in such manner as the Secretary determines appropriate, the rationale for recognition under subparagraph (A) of part of a standard, including the scientific, technical, regulatory, or other basis for such recognition.
(2) by adding at the end the following new paragraphs:
''(4) TRAINING ON USE OF STANDARDS.'--The Secretary shall provide to all employees of the Food and Drug Administration who review premarket submissions for devices periodic training on the concept and use of recognized standards for purposes of meeting a premarket submission requirement or other applicable requirement under this Act, including standards relevant to an employee's area of device review.
''(5) GUIDANCE.'--
''(A) DRAFT GUIDANCE.'--The Secretary shall publish guidance identifying the principles for recognizing standards under this section. In publishing such guidance, the Secretary shall consider'--
''(i) the experience with, and reliance on, a standard by other Federal regulatory authorities and the device industry; and
''(ii) whether recognition of a standard will promote harmonization among regulatory authorities in the regulation of devices.
''(B) TIMING.'--The Secretary shall publish'--
''(i) draft guidance under subparagraph (A) not later than 12 months after the date of the enactment of the 21st Century Cures Act; and
''(ii) final guidance not later than 12 months after the close of the public comment period for the draft guidance under clause (i).''.
SEC. 2225.Easing regulatory burden with respect to certain class I and class II devices.(a) Class I devices.'--Section 510(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is amended'--
(1) by striking ''A report under subsection (k)'' and inserting ''(1) A report under subsection (k)''; and
(2) by adding at the end the following new paragraph:
''(2) Not later than 120 days after the date of the enactment of the 21st Century Cures Act, the Secretary shall identify, through publication in the Federal Register, any type of class I device that the Secretary determines no longer requires a report under subsection (k) to provide reasonable assurance of safety and effectiveness. Upon such publication'--
''(A) each type of class I device so identified shall be exempt from the requirement for a report under subsection (k); and
''(B) the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.''.
(b) Class II devices.'--Section 510(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) is amended'--
(1) by striking paragraph (1) and inserting the following new paragraph: '' (1) The Secretary shall'--
''(A) not later than 60 days after the date of the enactment of the 21st Century Cures Act'--
''(i) publish in the Federal Register a notice that contains a list of each type of class II device that the Secretary determines no longer requires a report under subsection (k) to provide reasonable assurance of safety and effectiveness; and
''(ii) provide for a period of not less than 60 days for public comment beginning on the date of the publication of such notice; and
''(B) not later than 180 days after the date of the enactment of 21st Century Cures Act, publish in the Federal Register a list representing the Secretary's final determination with respect to the devices included in the list published under subparagraph (A).'';
(2) in paragraph (2)'--
(A) by striking ''1 day after the date of the publication of a list under this subsection,'' and inserting ''1 day after the date of publication of the final list under paragraph (1)(B),''; and
(B) by striking ''30-day period'' and inserting ''60-day period''; and
(3) by adding at the end the following new paragraph:
''(3) Upon the publication of the final list under paragraph (1)(B)'--
''(A) each type of class II device so listed shall be exempt from the requirement for a report under subsection (k); and
''(B) the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.''.
SEC. 2226.Advisory committee process.(a) Classification panels.'--Paragraph (5) of section 513(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended'--
(1) by striking ''(5)'' and inserting ''(5)(A)''; and
(2) by adding at the end the following:
''(B) When a device is specifically the subject of review by a classification panel, the Secretary shall'--
''(i) ensure that adequate expertise is represented on the classification panel to assess'--
''(I) the disease or condition which the device is intended to cure, treat, mitigate, prevent, or diagnose; and
''(II) the technology of the device; and
''(ii) as part of the process to ensure adequate expertise under clause (i), give due consideration to the recommendations of the person whose premarket submission is subject to panel review on the expertise needed among the voting members of the panel.
''(C) For purposes of subparagraph (B)(ii), the term 'adequate expertise' means, with respect to the membership of the classification panel reviewing a premarket submission, that such membership includes'--
''(i) two or more voting members, with a specialty or other expertise clinically relevant to the device under review; and
''(ii) at least one voting member who is knowledgeable about the technology of the device.''.
(b) Panel review process.'--Section 513(b)(6) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended'--
(1) in subparagraph (A)(iii), by inserting before the period at the end '', including by designating a representative who will be provided a time during the panel meeting to address the panel individually (or accompanied by experts selected by such representative) for the purpose of correcting misstatements of fact or providing clarifying information, subject to the discretion of the panel chairperson''; and
(2) by striking subparagraph (B) and inserting the following new subparagraph:
''(B) (i) Any meeting of a classification panel for a device that is specifically the subject of review shall'--
''(I) provide adequate time for initial presentations by the person whose device is specifically the subject of a classification panel review and by the Secretary; and
''(II) encourage free and open participation by all interested persons.
''(ii) Following the initial presentations described in clause (i), the panel may'--
''(I) pose questions to a designated representative described in subparagraph (A)(iii); and
''(II) consider the responses to such questions in the panel's review of the device that is specifically the subject of review by the panel.''.
SEC. 2227.Humanitarian device exemption application.(a) In general.'--Section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amended'--
(1) in paragraph (1) by striking ''fewer than 4,000'' and inserting ''not more than 8,000'';
(2) in paragraph (2)(A) by striking ''fewer than 4,000'' and inserting ''not more than 8,000''; and
(3) in paragraph (6)(A)(ii), by striking ''4,000'' and inserting ''8,000''.
(b) Guidance document on probable benefit.'--Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance document that defines the criteria for establishing ''probable benefit'' as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)(C)).
SEC. 2228.CLIA waiver study design guidance for in vitro diagnostics.(a) Draft revised guidance.'--Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall publish a draft guidance that'--
(1) revises ''Section V. Demonstrating Insignificant Risk of an Erroneous Result'-- 'Accuracy''' of the guidance entitled ''Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices'' and dated January 30, 2008; and
(2) includes guidance on the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.
(b) Final revised guidance.'--The Secretary of Health and Human Services shall finalize the draft guidance published under subsection (a) not later than 12 months after the comment period for such draft guidance closes.
SEC. 2241.Health software.Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:
''(ss) (1) The term 'health software' means software that does not, through use of an in vitro diagnostic device or signal acquisition system, acquire, process, or analyze an image or physiological signal, is not an accessory, is not an integral part of a device necessary to support the use of the device, is not used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease in humans, and'--
''(A) is intended for use for administrative or operational support or the processing and maintenance of financial records;
''(B) is intended for use in clinical, laboratory, or administrative workflow and related recordkeeping;
''(C) (i) is intended for use solely in the transfer, aggregation, conversion (in accordance with a present specification), storage, management, retrieval, or transmission of data or information;
''(ii) utilizes a connectivity software platform, electronic or electrical hardware, or a physical communications infrastructure; and
''(iii) is not intended for use'--
''(I) in active patient monitoring; or
''(II) in controlling or altering the functions or parameters of a device that is connected to such software;
''(D) is intended for use to organize and present information for health or wellness education or for use in maintaining a healthy lifestyle, including medication adherence and health management tools;
''(E) is intended for use to analyze information to provide general health information that does not include patient-specific recommended options to consider in the prevention, diagnosis, treatment, cure, or mitigation of a particular disease or condition; or
''(F) is intended for use to analyze information to provide patient-specific recommended options to consider in the prevention, diagnosis, treatment, cure, or mitigation of a particular disease or condition.
''(2) The term 'accessory' means a product that'--
''(A) is intended for use with one or more parent devices;
''(B) is intended to support, supplement, or augment the performance of one or more parent devices; and
''(C) shall be classified by the Secretary'--
''(i) according to its intended use; and
''(ii) independently of any classification of any parent device with which it is used.''.
SEC. 2242.Applicability and inapplicability of regulation.Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by section 2221(a), is further amended by adding at the end the following:
''SEC. 524C.Health software.
''(a) Inapplicability of regulation to health software.'--Except as provided in subsection (b), health software shall not be subject to regulation under this Act.
''(b) Exception.'--
''(1) IN GENERAL.'--Subsection (a) shall not apply with respect to a software product'--
''(A) of a type described in subparagraph (F) of section 201(ss)(1); and
''(B) that the Secretary determines poses a significant risk to patient safety.
''(2) CONSIDERATIONS.'--In making a determination under subparagraph (B) of paragraph (1) with respect to a product to which such paragraph applies, the Secretary shall consider the following:
''(A) The likelihood and severity of patient harm if the product were to not perform as intended.
''(B) The extent to which the product is intended to support the clinical judgment of a medical professional.
''(C) Whether there is a reasonable opportunity for a medical professional to review the basis of the information or treatment recommendation provided by the product.
''(D) The intended user and user environment, such as whether a medical professional will use a software product of a type described in subparagraph (F) of section 201(ss)(1).
''(c) Delegation.'--The Secretary shall delegate primary jurisdiction for regulating a software product determined under subsection (b) to be subject to regulation under this Act to the center at the Food and Drug Administration charged with regulating devices.
''(d) Regulation of software.'--
''(1) IN GENERAL.'--The Secretary shall review existing regulations and guidance regarding the regulation of software under this Act. The Secretary may implement a new framework for the regulation of software and shall, as appropriate, modify such regulations and guidance or issue new regulations or guidance.
''(2) ISSUANCE BY ORDER.'--Notwithstanding subchapter II of chapter 5 of title 5, United States Code, the Secretary may modify or issue regulations for the regulation of software under this Act by administrative order published in the Federal Register following the publication of a proposed order.
''(3) AREAS UNDER REVIEW.'--The review of existing regulations and guidance under paragraph (1) may include review of the following areas:
''(A) Classification of software.
''(B) Standards for development of software.
''(C) Standards for validation and verification of software.
''(D) Review of software.
''(E) Modifications to software.
''(F) Manufacturing of software.
''(G) Quality systems for software.
''(H) Labeling requirements for software.
''(I) Postmarketing requirements for reporting of adverse events.
''(4) PROCESS FOR ISSUING PROPOSED REGULATIONS, ADMINISTRATIVE ORDER, AND GUIDANCE.'--Not later than 18 months after the date of enactment of this section, the Secretary shall consult with external stakeholders (including patients, industry, health care providers, academia, and government) to gather input before issuing regulations, an administrative order, and guidance under this subsection.
''(e) Rule of construction.'--Nothing in this section shall be construed as providing the Secretary with the authority to regulate under this Act any health software product of the type described in subparagraph (F) of section 201(ss)(1) unless and until the Secretary has made a determination described in subsection (b)(1)(B) with respect to such product.''.
SEC. 2243.Exclusion from definition of device.Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended'--
(1) in subparagraph (2), by striking ''or'' after ''or other animals,'';
(2) in subparagraph (3), by striking ''and'' and inserting ''or''; and
(3) by inserting after subparagraph (3) the following:
''(4) not health software (other than software determined to be a risk to patient safety under section 524B(b)), and''.
SEC. 2261.Protection of human subjects in research; applicability of rules.(a) In general.'--In order to simplify and facilitate compliance by researchers with applicable regulations for the protection of human subjects in research, the Secretary of Health and Human Services shall, to the extent possible and consistent with other statutory provisions, harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations in accordance with subsection (b).
(b) Avoiding regulatory duplication and unnecessary delays.'--
(1) IN GENERAL.'--The Secretary shall'--
(A) make such modifications to the provisions of the HHS Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable-populations rules as may be necessary'--
(i) to reduce regulatory duplication and unnecessary delays;
(ii) to modernize such provisions in the context of multisite and cooperative research projects; and
(iii) to incorporate local considerations, community values, and mechanisms to protect vulnerable populations; and
(B) ensure that human subject research that is subject to the HHS Human Subject Regulations or to the FDA Human Subject Regulations may'--
(i) use joint or shared review;
(ii) rely upon the review of'--
(I) an independent institutional review board; or
(II) an institutional review board of an entity other than the sponsor of the research; or
(iii) use similar arrangements to avoid duplication of effort.
(2) REGULATIONS AND GUIDANCE.'--Not later than 36 months after the date of enactment of this Act, the Secretary, acting through the relevant agencies and offices of the Department of Health and Human Services, including the Office for Human Research Protections and relevant agencies and offices of the Food and Drug Administration, shall issue such regulations and guidance and take such other actions as may be necessary to implement this section and help to facilitate the broader use of single, central, or lead institutional review boards. Such regulations and guidance shall clarify the requirements and policies relating to the following:
(A) Arrangements to avoid duplication described in paragraph (1)(A)(i), including'--
(i) delineating the roles of institutional review boards in multisite or cooperative, multisite studies where one or more local institutional review boards are relied upon, or similar arrangements are used;
(ii) the risks and benefits to human subjects;
(iii) standardizing the informed consent and other processes and legal documents; and
(iv) incorporating community values through the use of local institutional review boards while continuing to use central or lead institutional review boards.
(B) Concerns about regulatory and legal liability contributing to decisions by the sponsors of research to rely on local institutional review boards for multisite research.
(3) CONSULTATION.'--In issuing regulations or guidance under paragraph (2), the Secretary shall consult with stakeholders (including researchers, academic organizations, hospitals, institutional research boards, pharmaceutical, biotechnology and medical device developers, clinical research organizations, patient groups, and others).
(c) Timing.'--The Secretary shall complete the harmonization described in subsection (a) not later than 36 months after the date of enactment of this Act.
(d) Progress report.'--Not later than 24 months after the date of enactment of this Act, the Secretary shall submit to Congress a report on the progress made toward completing such harmonization.
(e) Draft NIH policy.'--Not later than 12 months after the date of enactment of this Act, the Secretary, acting through the Director of the National Institutes of Health, shall finalize the draft policy entitled ''Draft NIH Policy on Use of a Single Institutional Review Board for Multi-Site Research''.
(f) Definitions.'--
(1) HUMAN SUBJECT REGULATIONS.'--In this section:
(A) FDA HUMAN SUBJECT REGULATIONS.'--The term ''FDA Human Subject Regulations'' means the provisions of parts 50, 56, 312, and 812 of title 21, Code of Federal Regulations (or any successor regulations).
(B) HHS HUMAN SUBJECT REGULATIONS.'--The term ''HHS Human Subject Regulations'' means the provisions of subpart A of part 46 of title 45, Code of Federal Regulations (or any successor regulations).
(C) VULNERABLE-POPULATIONS RULES.'--The term ''vulnerable-populations rules'''--
(i) subject to clause (ii), means the provisions of subparts B through D of such part 46 (or any successor regulations); or
(ii) as applicable to research that is subject to the FDA Human Subject Regulations, means the provisions applicable to vulnerable populations under part 56 of such title 21 (or any successor regulations) and subpart D of part 50 of such title 21 (or any successor regulations).
(2) OTHER DEFINITIONS.'--In this section:
(A) INSTITUTIONAL REVIEW BOARD.'--The term ''institutional review board'' has the meaning that applies to the term ''institutional review board'' under the HHS Human Subject Regulations.
(B) LEAD INSTITUTIONAL REVIEW BOARD.'--The term ''lead institutional review board'' means an institutional review board that otherwise meets the requirements of the HHS Human Subject Regulations and enters into a written agreement with an institution, another institutional review board, a sponsor, or a principal investigator to approve and oversee human subject research that is conducted at multiple locations. References to an institutional review board include an institutional review board that serves a single institution as well as a lead institutional review board.
SEC. 2262.Use of non-local institutional review boards for review of investigational device exemptions and human device exemptions.(a) In general.'--Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(j)) is amended'--
(1) in subsection (g)(3)'--
(A) by striking ''local'' each place it appears; and
(B) in subparagraph (A)(i), by striking ''which has been''; and
(2) in subsection (m)(4)'--
(A) by striking ''local'' each place it appears; and
(B) by striking subparagraph (A) and inserting the following new subparagraph:
''(A) in facilities in which clinical testing of devices is supervised by an institutional review committee established in accordance with the regulations of the Secretary, and''.
(b) Regulations.'--Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall revise or issue such regulations or guidance as may be necessary to carry out the amendments made by subsection (a).
SEC. 2263.Alteration or waiver of informed consent for clinical investigations.(a) Devices.'--Section 520(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended'--
(1) in subparagraph (D), by striking ''except where subject to such conditions as the Secretary may prescribe, the investigator'' and inserting the following: ''except where, subject to such conditions as the Secretary may prescribe'--
''(i) the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject; or
''(ii) the investigator''; and
(2) in the matter following subparagraph (D), by striking ''subparagraph (D)'' and inserting ''subparagraph (D)(ii)''.
(b) Drugs.'--Section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking ''except where it is not feasible or it is contrary to the best interests of such human beings'' and inserting ''except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings''.
SEC. 2281.Silvio O. Conte Senior Biomedical Research Service.(a) Hiring and retention authority.'--Section 228 of the Public Health Service Act (42 U.S.C. 237) is amended'--
(1) in the section heading, by inserting ''and Biomedical Product Assessment'' after ''Research'';
(2) in subsection (a)(1), by striking ''Silvio O. Conte Senior Biomedical Research Service, not to exceed 500 members'' and inserting ''Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service (in this section referred to as the 'Service'), the purpose of which is to recruit and retain competitive and qualified scientific and technical experts outstanding in the field of biomedical research, clinical research evaluation, and biomedical product assessment'';
(3) by amending subsection (a)(2) to read as follows:
''(2) The authority established in paragraph (1) may not be construed to require the Secretary to reduce the number of employees serving under any other employment system in order to offset the number of members serving in the Service.'';
(4) in subsection (b)'--
(A) in the matter preceding paragraph (1), by striking ''or clinical research evaluation'' and inserting '', clinical research evaluation or biomedical product assessment''; and
(B) in paragraph (1), by inserting ''or a master's level degree in engineering, bioinformatics, or a related or emerging field,'' after the comma;
(5) in subsection (d)(2), by striking ''and shall not exceed the rate payable for level I of the Executive Schedule unless approved by the President under section 5377(d)(2) of title 5, United States Code'' and inserting ''and shall not exceed the rate payable for the President'';
(6) by striking subsection (e); and
(7) by redesignating subsections (f) and (g) as subsections (e) and (f), respectively.
(b) Report.'--Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit, and publish on the website of the Department of Health and Human Services a report on the implementation of the amendments made by subsection (a), including whether the amendments have improved the ability of the Food and Drug Administration to hire and retain qualified experts to fulfill obligations specified under user fee agreements.
SEC. 2282.Enabling FDA scientific engagement.It is the sense of Congress that the participation in, or sponsorship of, scientific conferences and meetings is essential to the mission of the Food and Drug Administration.
SEC. 2283.Reagan-Udall Foundation for the Food and Drug Administration.(a) Board of Directors.'--
(1) COMPOSITION AND SIZE.'--Section 770(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)) is amended'--
(A) by redesignating clause (ii) as clause (iii);
(B) by inserting after clause (i) the following:
''(ii) ADDITIONAL MEMBERS.'--The Board, through amendments to the bylaws of the Foundation, may provide that the number of voting members of the Board shall be a number (to be specified in such amendment) greater than 14. Any Board positions that are established by any such amendment shall be appointed (by majority vote) by the individuals who, as of the date of such amendment, are voting members of the Board and persons so appointed may represent any of the categories specified in subclauses (I) through (V) of clause (i), so long as no more than 30 percent of the total voting members of the Board (including members whose positions are established by such amendment) are representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries.''; and
(C) in clause (iii)(I), as redesignated by subparagraph (A), by striking ''The ex officio members shall ensure'' and inserting ''The ex officio members, acting pursuant to clause (i), and the Board, acting pursuant to clause (ii), shall ensure''.
(2) FEDERAL EMPLOYEES ALLOWED TO SERVE ON BOARD.'--Clause (iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated by paragraph (1)(A), is amended by adding at the end the following: ''For purposes of this section, the term 'employee of the Federal Government' does not include a 'special Government employee', as that term is defined in section 202(a) of title 18, United States Code.''.
(3) STAGGERED TERMS.'--Subparagraph (A) of section 770(d)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(3)) is amended to read as follows:
''(A) TERM.'--The term of office of each member of the Board appointed under paragraph (1)(C)(i), and the term of office of any member of the Board whose position is established pursuant to paragraph (1)(C)(ii), shall be 4 years, except that'--
''(i) the terms of offices for the members of the Board initially appointed under paragraph (1)(C)(i) shall expire on a staggered basis as determined by the ex officio members; and
''(ii) the terms of office for the persons initially appointed to positions established pursuant to paragraph (1)(C)(ii) may be made to expire on a staggered basis, as determined by the individuals who, as of the date of the amendment establishing such positions, are members of the Board.''.
(b) Executive Director compensation.'--Section 770(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(g)(2)) is amended by striking ''but shall not be greater than the compensation of the Commissioner''.
(c) Separation of Funds.'--Section 770(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(m)) is amended by striking ''are held in separate accounts from funds received from entities under subsection (i)'' and inserting ''are managed as individual programmatic funds under subsection (i), according to best accounting practices''.
SEC. 2284.Collection of certain voluntary information exempted from Paperwork Reduction Act.Chapter VII of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 708 of such Act (21 U.S.C. 379) the following:
''SEC. 708A.Collection of certain voluntary information exempted from Paperwork Reduction Act.
''Chapter 35 of title 44, United States Code, shall not apply to the collection from patients, industry, academia, and other stakeholders, of voluntary information such as through voluntary surveys or questionnaires, initiated by the Secretary.''.
SEC. 2285.Hiring authority for scientific, technical, and professional personnel.(a) In general.'--The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 714 (21 U.S.C. 379d''3) the following:
''SEC. 714A.Additional hiring authority.
''(a) In general.'--The Secretary may, without regard to the provisions of title 5, United States Code, governing appointments in the competitive service, appoint qualified candidates to scientific, technical, or professional positions within the following centers of the Food and Drug Administration:
''(1) The Center for Drug Evaluation and Research.
''(2) The Center for Biologics Evaluation and Research.
''(3) The Center for Devices and Radiological Health.
Such positions shall be within the competitive service.''(b) Compensation.'--
''(1) IN GENERAL.'--Notwithstanding any other provision of law, including any requirement with respect to General Schedule pay rates under subchapter III of chapter 53 of title 5, United States Code, and consistent with the requirements of paragraph (2), the Secretary may determine and fix'--
''(A) the annual rate of pay of any individual appointed under subsection (a); and
''(B) for purposes of retaining qualified employees, the annual rate of pay for any highly qualified scientific, technical, or professional personnel appointed to a position at any of the centers listed under subsection (a) before the date of enactment of this section.
''(2) LIMITATION.'--The annual rate of pay established pursuant to paragraph (1) may not exceed the annual rate of pay of the President.
''(c) Report.'--
''(1) IN GENERAL.'--Not later than September 30, 2021, the Secretary shall submit a report to Congress that examines the extent to which the authority to appoint and retain personnel under this section enhanced the Food and Drug Administration's ability to meet the agency's critical need for highly qualified individuals for scientific, technical, or professional positions.
''(2) RECOMMENDATIONS.'--The report under paragraph (1) shall include the recommendations of the Secretary on'--
''(A) whether the authority to appoint personnel under this section should be reauthorized; and
''(B) other personnel authorities that would help the Food and Drug Administration to better recruit and retain highly qualified individuals for scientific, technical, or professional positions in the agency's medical product centers.''.
(b) Rule of construction.'--The authority provided by section 714A of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) shall not be construed to affect the authority provided under section 714 of such Act.
SEC. 2301.Exempting from sequestration certain user fees of Food and Drug Administration.The Balanced Budget and Emergency Deficit Control Act of 1985 is amended'--
(1) in section 255(g)(1)(A) (2 U.S.C. 905(g)(1)(A)), by inserting after the item relating to ''Financial Agent Services'' the following new item:
''Food and Drug Administration, Salaries and Expenses, but only the portion of appropriations under such account corresponding to fees collected under sections 736, 738, 740, 741, 744B, and 744H of the Federal Food, Drug, and Cosmetic Act (75''9911''0''1''554).''; and
(2) in section 256(h) (2 U.S.C. 906(h)), by adding at the end the following new paragraph:
''(5) Notwithstanding any other provision of law, this subsection shall not apply with respect to the portion of administrative expenses incurred by the Food and Drug Administration that are funded through fees collected under sections 736, 738, 740, 741, 744B, and 744H of the Federal Food, Drug, and Cosmetic Act.''.
SEC. 2321.Sense of Congress.It is the sense of the Congress that recording unique device identifiers at the point-of-care in electronic health record systems could significantly enhance the availability of medical device data for postmarket surveillance purposes.
SEC. 3001.Ensuring interoperability of health information technology.(a) Interoperability standards.'--
(1) IN GENERAL.'--Subtitle A of title XXX of the Public Health Service Act (42 U.S.C. 300jj''11 et seq.) is amended by adding at the end the following new section:
''SEC. 3010.Ensuring interoperability of health information technology.
''(a) Interoperability.'--In order for health information technology to be considered interoperable, such technology must satisfy the following criteria:
''(1) SECURE TRANSFER.'--The technology allows the secure transfer of all electronically accessible health information to and from any and all health information technology for authorized use under applicable State or Federal law.
''(2) COMPLETE ACCESS TO HEALTH INFORMATION.'--The technology allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law without special effort by the requestor of such health information.
''(3) NO INFORMATION BLOCKING.'--The technology is not configured, set up, or implemented to information block, as defined in section 3010A(d).
''(b) Categories for interoperability standards.'--The categories described in this subsection, with respect to standards and the corresponding implementation specifications for determining if health information technology is interoperable, consistent with the criteria described in subsection (a), include at least categories of standards and implementation specifications with respect to the following:
''(1) Vocabulary and terminology.
''(2) Content and structure.
''(3) Transport.
''(4) Security.
''(5) Services.
''(6) Querying and requesting health information for access, exchange, and use.
''(c) Allowing for flexibility.'--A standard and implementation specification, with respect to such standard, that is determined under section 3001(c)(5)(D) to be compatible with baseline standards and implementation specifications (as defined in clause (ii) of such section) shall be treated as in compliance with this section.''.
(2) GUIDANCE.'--Not later than January 1, 2017, the Secretary of Health and Human Services, in consultation with the National Coordinator of the Office of the National Coordinator for Health Information Technology, shall issue guidance with respect to the implementation of section 3010 of the Public Health Service Act, as added by paragraph (1), including with respect to defining and providing examples of authorized use under applicable State or Federal law of health information.
(b) Improvements to recommendation process.'--
(1) HIT POLICY COMMITTEE TO INCORPORATE POLICIES FOR UPDATES TO INTEROPERABILITY STANDARDS.'--Section 3002 of the Public Health Service Act (42 U.S.C. 300jj''12) is amended'--
(A) in subsection (a)'--
(i) by striking ''National Coordinator'' and inserting ''Secretary, in consultation with the National Coordinator,''; and
(ii) by adding at the end the following new sentence: ''The HIT Policy Committee is authorized only to provide policy and priority recommendations to the Secretary and not authorized to otherwise affect the development or modification of any standard, implementation specification, or certification criterion under this title.''; and
(B) in subsection (b)(2)'--
(i) in subparagraph (A), in the first sentence'--
(I) by striking ''The HIT Policy Committee'' and inserting ''Subject to subparagraph (D), the HIT Policy Committee''; and
(II) by inserting ''(including the areas in which modifications and additions to interoperability standards and implementation specifications, with respect to such interoperability standards, under section 3010 are needed for the electronic access, exchange, and use of health information for purposes of adoption of such modifications and additions under section 3004)'' after ''section 3004''.
(ii) by adding at the end the following new subparagraph:
''(D) SPECIAL RULE RELATED TO INTEROPERABILITY.'--Any recommendation made by the HIT Policy Committee on or after the date of the enactment of this subparagraph with respect to interoperability of health information technology shall be consistent with the criteria described in subsection (a) of section 3010.''.
(2) SUNSET OF HIT STANDARDS COMMITTEE.'--Section 3003 of the Public Health Service Act (42 U.S.C. 300jj''13) is amended by adding at the end the following new subsection:
''(f) Termination.'--The HIT Standards Committee shall terminate on the date that is 90 days after the date of the enactment of this subsection.''.
(3) STANDARDS DEVELOPMENT ORGANIZATIONS.'--Title XXX of the Public Health Service Act is amended by inserting after section 3003 the following new section:
''SEC. 3003A.Recommendations for standards through contracts with standards development organizations.
''(a) Contracts.'--
''(1) IN GENERAL.'--For purposes of activities conducted under this title, the Secretary shall enter into one or more contracts with health care standards development organizations accredited by the American National Standards Institute (or with the American National Standards Institute) to carry out, directly or through contracts with subcontractors, the duties described in subsection (b), as applicable.
''(2) TIMING FOR FIRST CONTRACT.'--As soon as practicable after the date of the enactment of this section, the Secretary shall enter into the first contracts under paragraph (1).
''(3) PERIOD OF CONTRACT.'--Each contract under paragraph (1) shall be for a period determined necessary by the Secretary, in consultation with the National Coordinator, to carry out the applicable duties described in subsection (b).
''(4) APPROPRIATE ENTITIES.'--The Secretary shall ensure the most appropriate entities described in paragraph (1) are selected for each contract under such paragraph.
''(b) Duties.'--
''(1) INITIAL CONTRACT.'--The Secretary shall initially enter into one or more contracts under subsection (a)(1) with entities described in such subsection, under which the entities'--
''(A) shall recommend to the Secretary'--
''(i) for adoption under section 3004, an initial set of interoperability standards and implementation specifications, with respect to such standards, identified or, as appropriate, developed by such entities that are consistent with the criteria described in subsection (a) of section 3010, and with respect to the categories described in subsection (b) of such section; and
''(ii) as applicable, for purposes of section 3001(c)(5)(D), methods to test if health information technology is compatible with health information technology that applies baseline standards and implementation specifications (as defined in clause (ii) of such section); and
''(B) may provide to the Secretary recommendations described in paragraph (2).
''(2) SUBSEQUENT CONTRACTS.'--Under each subsequent contract entered into under this section with entities described in subsection (a)(1) pursuant to subsection (c), the entities shall recommend to the Secretary'--
''(A) for adoption under section 3004 any standards (including interoperability standards), implementation specifications, and, to the extent necessary, certification criteria (and modifications, including additions, to such standards, specifications, and, to the extent necessary, criteria), which are in accordance with the criteria described in section 3010; and
''(B) as applicable, for purposes of section 3001(c)(5)(D), methods to test if health information technology is compatible with baseline standards and implementation specifications (as defined in clause (ii) of such section).
''(3) SUBMISSION TO NIST.'--Under each contract with an entity under this section, the entity shall submit to the Director of the National Institute of Standards and Technology each recommendation submitted to the Secretary by such entity under this section.
''(4) CONSULTATION.'--For the purposes of developing methods to test interoperability standards and implementation specifications with respect to such standards, the entities with a contract under this section may consult with the Director of the National Institute of Standards and Technology.
''(c) Modifications and subsequent contracts.'--
''(1) IN GENERAL.'--The Secretary, in consultation with the National Coordinator, shall periodically conduct hearings to evaluate and review the standards, implementation specifications, and certification criteria adopted under section 3004 for purposes of determining if modifications, including any additions, are needed with respect to such standards, specifications, and criteria.
''(2) CONTRACT TRIGGER.'--Based on the needs for standards, implementation specifications, and certification criteria (and modifications, including additions, to such standards, specifications, and criteria) under this title, as determined by the Secretary, with due consideration to section 3010(b) and in consultation with the National Coordinator, the Secretary shall, as needed, enter into contracts under subsection (a) to carry out the duties described in subsection (b)(2) in addition to any contract entered into to carry out the duties described in subsection (b)(1).
''(d) Authorization of appropriations.'--There is authorized to be appropriated $10,000,000 for contracts under subsection (a), to remain available until expended.''.
(4) MODIFICATIONS TO ROLE OF THE NATIONAL COORDINATOR.'--Section 3001(c)(1)(A) of the Public Health Service Act (42 U.S.C. 300jj''11(c)(1)(A)) is amended by inserting ''for recommendations made before the date of the enactment of the 21st Century Cures Act,'' before ''review and determine''.
(c) Adoption.'--Section 3004 of the Public Health Service Act (42 U.S.C. 300jj''14) is amended'--
(1) in subsection (a)'--
(A) in paragraph (1), by inserting after ''section 3001(c)'' the following: ''(or, subject to subsection (c), in the case of a standard, implementation specification, or criterion recommended on or after the date of the enactment of the 21st Century Cures Act, after the date of submission of the recommendation to the Secretary under section 3003A)''; and
(B) in paragraph (2)(B), by striking ''and the HIT Standards Committee'';
(2) in subsection (b)'--
(A) in paragraph (3), by striking ''with the schedule published under section 3003(b)(2)'' and inserting ''with subsection (d)''; and
(B) by adding at the end the following new paragraph:
''(4) LIMITATION.'--The Secretary may not adopt any policies, priorities, standards, implementation specifications, or certification criteria under this subsection or subsection (a) that are inconsistent with or duplicative of an interoperability standard or implementation specification with respect to such standard adopted under this section, in accordance with subsections (c) and (d). In the case of a standard, specification, or criterion that has been adopted under this section and is inconsistent or duplicative of such an interoperability standard or specification that is subsequently adopted under this section, such interoperability standard or specification shall supercede such other standard, specification, or criterion and such other standard, specification, or criterion shall no longer be considered adopted under this section beginning on the date that such interoperability standard or specification becomes effective.''; and
(3) by adding at the end the following new subsections:
''(c) Adoption of initial interoperability standards and implementation specifications.'--Notwithstanding the previous subsections of this section, the following shall apply in the case of the initial set of interoperability standards and implementation specifications with respect to such standards recommended under section 3003A:
''(1) REVIEW OF STANDARDS.'--Not later than 90 days after the date of receipt of recommendations for such interoperability standards and implementation specifications, the Secretary, in consultation with the National Coordinator and representatives of other relevant Federal agencies, such as the National Institute of Standards and Technology, shall jointly review such standards and implementation specifications and shall determine whether or not to propose adoption of such standards and implementation specifications.
''(2) DETERMINATION TO ADOPT.'--If, subject to subsection (d)(3), the Secretary determines'--
''(A) to propose adoption of such standards and implementation specifications, the Secretary shall, by regulation under section 553 of title 5, United States Code, determine whether or not to adopt such standards and implementation specifications; or
''(B) not to propose adoption of such standards and implementation specifications, the Secretary shall notify the applicable entity with a contract under section 3003A in writing of such determination and the reasons for not proposing the adoption of the recommendation for such standards and implementation specifications.
''(3) PUBLICATION.'--The Secretary shall provide for publication in the Federal Register of all determinations made by the Secretary under paragraph (1).
''(d) Rules for adoption.'--In the case of a standard (including interoperability standard), implementation specification, or certification criterion adopted under this section on or after the date of the enactment of the 21st Century Cures Act, the following shall apply:
''(1) IN GENERAL.'--Except as provided in paragraphs (2) and (3), any such standard (including interoperability standard), implementation specification, or certification criterion shall be a standard, specification, or criterion that has been recommended by the entities with which the Secretary has entered into a contract under section 3003A.
''(2) SPECIAL RULE IF NO STANDARD, SPECIFICATION, OR CRITERION RECOMMENDED.'--If no standard, implementation specification, or, to the extent necessary, certification criterion is recommended under paragraph (1)'--
''(A) in the case of interoperability standards and implementation specifications with respect to such standards, relating to a category described in section 3010(b)'--
''(i) paragraph (1) shall not apply; and
''(ii) paragraph (4) shall apply; or
''(B) in the case of any other standard, implementation specification, or, to the extent necessary, certification criterion, relating to a policy or priority to carry out this title, as determined by the Secretary, in consultation with the National Coordinator'--
''(i) paragraph (1) shall not apply; and
''(ii) paragraph (4) shall apply.
''(3) AUTHORITY TO MODIFY IMPLEMENTATION SPECIFICATIONS.'--If, following public comment pursuant to subsection (c), the Secretary would propose adoption of interoperability standards recommended under section 3003A but for the implementation specifications, with respect to such standards, so recommended, the Secretary may modify such implementation specifications and adopt such standards and specifications in accordance with subsection (c)(2).
''(4) EFFECTIVE DATE.'--In the case of a standard, implementation specification, or certification criterion for which there is a determination to adopt such standard, implementation specification, or certification criterion, such standard, implementation specification, or certification criterion shall be considered adopted under this section and shall be effective beginning on the date that is 12 months after the date of publication of the final rule to adopt such standard, implementation specification, or certification criterion.
''(5) ASSISTANCE TO THE SECRETARY.'--In complying with the requirements of this subsection, the Secretary shall give due consideration to any recommendations of the National Committee on Vital and Health Statistics established under section 306(k), and shall consult with appropriate Federal and State agencies and private organizations. The Secretary shall publish in the Federal Register any recommendation of the National Committee on Vital and Health Statistics regarding the adoption of a standard, implementation specification, or certification criterion under this section. Any standard, implementation specification, or certification criterion adopted pursuant to this paragraph shall be promulgated in accordance with the rulemaking procedures of subchapter III of chapter 5 of title 5, United States Code.
''(e) Allowing for flexibility through compatibility with baseline standards and implementation specifications.'--For purposes of this title, title XVIII of the Social Security Act, title XIX of such Act, and any other provision of law, a standard and implementation specification, with respect to such standard, that is determined under section 3001(c)(5)(D) to be compatible with baseline standards and implementation specifications (as defined in clause (ii) of such section) shall be treated as if such standard and specification were an interoperability standard and implementation specification, with respect to such interoperability standard, adopted under this section.''.
(d) Reports and notifications.'--Section 3010 of the Public Health Service Act, as added by subsection (a), is amended by adding at the end the following new subsection:
''(c) Dissemination of information.'--
''(1) INITIAL SUMMARY REPORT.'--Not later than July 1, 2017, the Secretary, after consultation with relevant stakeholders, shall submit to Congress and provide for publication in the Federal Register and the posting on the Internet website of the Office of the National Coordinator for Health Information Technology a report on the following:
''(A) The initial set of interoperability standards and implementation specifications adopted under section 3004(c).
''(B) The strategies for achieving widespread interoperability.
''(C) Any barriers that are preventing widespread interoperability.
''(D) The plan and milestones, including specific steps, to achieve widespread interoperability.
''(2) ONGOING PUBLICATION OF RECOMMENDATIONS.'--The Secretary shall provide for publication in the Federal Register, and the posting on the Internet website of the Office of the National Coordinator for Health Information Technology, of all recommendations made under this section.''.
(e) Certification and other enforcement provisions.'--
(1) CERTIFICATION OF QUALIFIED ELECTRONIC HEALTH RECORDS.'--
(A) IN GENERAL.'--Section 3007(b) of the Public Health Service Act (42 U.S.C. 300jj''17(b)) is amended by striking ''under section 3001(c)(3) to be in compliance with'' and all that follows through the period at the end and inserting ''under section 3001(c)(3)'--
''(1) for certifications made before January 1, 2018, to be in compliance with applicable standards adopted under subsections (a) and (b) of section 3004; and
''(2) for certifications made on or after January 1, 2018, to be in compliance with applicable standards adopted under subsections (a) and (b) of section 3004 and to be interoperable in accordance with section 3010 and in compliance with interoperability standards adopted under section 3004.''.
(B) REQUIREMENTS OF SECRETARY.'--Section 3001(c)(5) of the Public Health Service Act (42 U.S.C. 300jj''11(c)(5)) is amended'--
(i) in subparagraph (B), by inserting before the period at the end the following: ''and, for certifications made on or after January 1, 2018, with respect to health information technology, additional criteria to establish that the technology is interoperable, in accordance with section 3010, and in compliance with interoperability standards and implementation specifications, with respect to such standards, adopted under section 3004''; and
(ii) by adding at the end the following new subparagraphs:
''(C) ENFORCEMENT; DECERTIFICATIONS.'--
''(i) REQUIREMENTS.'--Under any program kept or recognized under subparagraph (A), the Secretary shall ensure that any vendor of or other entity offering to health care providers (as defined in section 3010A(g)) qualified electronic health records seeking a certification of such records under such program on or after January 1, 2018, shall, as a condition of certification (and maintenance of certification) of such a record under such program'--
''(I) provide to the Secretary an attestation'--
''(aa) the entity has implemented interoperability standards and implementation specifications, with respect to such standards, adopted under section 3004 (including through application of subsection (e) of such section);
''(bb) that the entity, unless for a legitimate purpose specified by the Secretary, has not taken and will not take any action that constitutes information blocking (as defined in section 3010A(d)), with respect to such qualified electronic health records;
''(cc) that includes the pricing information described in clause (iii) for purposes of inclusion under subsection (f) of such information on the Internet website of the Department of Health and Human Services; that such information will be available on a public Internet website of such entity; and that the entity will voluntarily provide such information to customers prior to offering any qualified electronic health records or related product or service (including subsequent updates, add-ons, or additional products or services to be provided during the course of an on-going contract), prospective customers (such as persons who request or receive a quotation or estimate), and other persons who request such information;
''(dd) that the technology with respect to such records has published application programming interfaces, with respect to health information within such records, for search and indexing, semantic harmonization and vocabulary translation, and user interface applications;
''(ee) that the entity has successfully and rigorously tested the real world use of the record in the type of setting in which it would be marketed; and
''(ff) that the entity has in place data sharing programs or capabilities based on common data elements through such mechanisms as application programming interfaces without the requirement for vendor-specific interfaces;
''(II) publish application programming interfaces and associated documentation, with respect to health information within such records, for search and indexing, semantic harmonization and vocabulary translation, and user interface applications; and
''(III) demonstrate to the satisfaction of the Secretary that health information from such records are able to be exchanged, accessed, and used through the use of application programming interfaces without special effort, as authorized under applicable law.
''(ii) DECERTIFICATION.'--Under any program kept or recognized under subparagraph (A), the Secretary shall ensure that beginning January 1, 2019, any qualified electronic health records that do not satisfy the certification criteria described in subparagraph (B) or with respect to which the vendor or other entity described in clause (i) does not satisfy the requirements under such clause (or is determined to be in violation of the terms of the attestation or other requirements under such clause) shall no longer be considered as certified under such program.
''(iii) PRICING INFORMATION.'--For purposes of clause (i)(I)(cc), the pricing information described in this clause, with respect to a vendor of or other entity offering a qualified electronic health record, is the following:
''(I) Additional types of costs or fees (whether fixed, recurring, transaction based, or otherwise) imposed by the entity (or any third-party from whom the entity purchases, licenses, or obtains any technology, products, or services in connection with the qualified electronic health record) to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of capabilities to which such record is to be certified under this section; or in connection with any health information generated in the course of using any capability to which the record is to be so certified.
''(II) Limitations, whether by contract or otherwise, on the use of any capability to which the record is to be certified under this section for any purpose within the scope of the record's certification; or in connection with any health information generated in the course of using any capability to which the record is to be certified under this section.
''(III) Limitations, including technical or practical limitations of technology or its capabilities, that could prevent or impair the successful implementation, configuration, customization, maintenance, support, or use of any capabilities to which the record is to be certified under this section; or that could prevent or limit the access, use, exchange, or portability of any health information generated in the course of using any capability to which the record is to be so certified.
''(D) FLEXIBILITY THROUGH COMPATIBILITY.'--
''(i) IN GENERAL.'--Under any program kept or recognized under subparagraph (A), the Secretary shall provide for a method and process by which a vendor of or other entity offering to health care providers (as defined in section 3010A(g)) qualified electronic health records seeking a certification of such records under such program on or after January 1, 2018, may demonstrate, using such mechanisms as a reference implementation model or other means, that the standards and implementation specifications applied by such entity with respect to such records are compatible with baseline standards and implementation specifications, including by demonstrating such records are able to transmit information that is compatible with qualified electronic health records that would receive such information and that apply the baseline standards and implementation specifications. Such a method and process shall ensure that any such entity using a standard or implementation specification other than a baseline standard or implementation specification demonstrates, through testing, compatibility with the baseline standard and implementation specification with respect to receiving information.
''(ii) BASELINE STANDARDS AND IMPLEMENTATION SPECIFICATIONS.'--For purposes of clause (i), the term 'baseline standards and implementation specifications' means the interoperability standards and implementation specifications, with respect to such standards, adopted under section 3004 (without application of subsection (e) of such section).''.
(2) ADDITIONAL ENFORCEMENT PROVISIONS UNDER THE PUBLIC HEALTH SERVICE ACT.'--Subtitle A of title XXX of the Public Health Service Act (42 U.S.C. 300jj''11 et seq.), as amended by subsections (a)(1) and (d), is further amended by adding at the end the following new section:
''SEC. 3010A.Enforcement mechanisms.
''(a) Inspector General authority.'--The Inspector General of the Department of Health and Human Services shall have the authority to investigate claims of'--
''(1) (A) vendors of, or other entities offering to health care providers (as defined in subsection (g)), qualified electronic health records (as defined in section 3000(13)) being in violation of an attestation (whether providing false information at the time of such attestation or by act or practice conducted after such attestation) made under section 3001(c)(5)(C)(i)(I), with respect to the use of such records by a health care provider with respect to items and services furnished under the Medicare Program under title XVIII of the Social Security Act or Medicaid program under title XIX of such Act; and
''(B) vendors of, or other entities offering to health care providers (as defined in subsection (g)), health information technology having engaged in information blocking (as defined in subsection (d)), unless for a legitimate purpose specified by the Secretary, with respect to the use of such technology by a health care provider with respect to items and services furnished under such a program;
''(2) health care providers having engaged in information blocking (as so defined), with respect to the use of health information technology with respect to items and services furnished under such a program, unless for a legitimate purpose specified by the Secretary; and
''(3) health information system providers (such as operators of health information exchanges, clinical data registries, and other systems that facilitate the exchange of information) having engaged in information blocking (as so defined), unless for a legitimate purpose specified by the Secretary, with respect to the use of health information technology with respect to items and services furnished under such a program.
''(b) Information sharing provisions.'--
''(1) IN GENERAL.'--The National Coordinator may serve as a technical consultant to the Inspector General of the Department of Health and Human Services and the Federal Trade Commission for purposes of carrying out this section. As such technical consultant, the National Coordinator may, notwithstanding any other provision of law, share information related to claims or investigations under subsection (a) with the Federal Trade Commission for purposes of such investigations and shall share information with the Inspector General, as required by law.
''(2) PROTECTION FROM DISCLOSURE OF INFORMATION.'--Any information that is received by the National Coordinator in connection with a claim or suggestion of possible information blocking and that could reasonably be expected to facilitate identification of the source of the information'--
''(A) shall not be disclosed by the National Coordinator except as may be necessary to carry out the purpose of this section; and
''(B) shall be exempt from mandatory disclosure under section 552 of title 5, United States Code, as provided by subsection (b)(3) of such section.
Such information may be used by the Inspector General of the Department of Health and Human Services or Federal Trade Commission for reporting purposes to the extent that such information could not reasonably be expected to facilitate identification of the source of such information.
''(3) NON-APPLICATION OF PAPERWORK REDUCTION ACT.'--Chapter 35 of title 44, United States Code (commonly referred to as the Paperwork Reduction Act of 1995) shall not apply to the National Coordinator or to the Office of the National Coordinator for Health Information Technology with respect to the collection of complaints relating to claims described in subsection (a).
''(4) STANDARDIZED PROCESS.'--The National Coordinator shall implement a standardized process for the public to submit reports on claims of'--
''(A) health information technology products of vendors (or other entities offering such products to health care providers (as defined in subsection (g))) not being interoperable or resulting in information blocking; or
''(B) actions by such entities, health care providers, or health information system providers that result in such technology not being interoperable or in information blocking with respect to such technology; and
''(C) any other act described in subsection (a).
The standardized process shall provide for the collection of such information as the originating institution, location, type of transaction, system and version, timestamp, terminating institution, locations, system and version, failure notice, and other related information.
''(c) Penalty.'--
''(1) IN GENERAL.'--Any person or entity described in paragraph (1), (2), or (3) of subsection (a) determined to have committed on or after January 1, 2018, an act described in such respective paragraph with respect to the use of a qualified electronic health record or health information technology, as applicable under such respective paragraph, with respect to items and services furnished under the Medicare Program under title XVIII of the Social Security Act or the Medicaid program under title XIX of such Act, shall be subject to a civil monetary penalty in such amount as determined appropriate by the Secretary through rulemaking.
''(2) APPLICATION.'--Subject to paragraph (3), the provisions of section 1128A (other than subsections (a) and (b)) of such Act (42 U.S.C. 1320a''7a) shall apply to a civil money penalty applied under this subsection in the same manner as they apply to a civil money penalty or proceeding under subsection (a) of such section 1128A.
''(3) RECOVERY OF FUNDS.'--Notwithstanding section 3302 of title 31, United States Code, or any other provision of law affecting the crediting of collections, the Inspector General of the Department of Health and Human Services may receive and retain for current use any amounts recovered under this subsection. In addition to amounts otherwise available to the Inspector General, funds received by the Inspector General under this paragraph shall be deposited, as an offsetting collection, to the credit of any appropriation available for purposes of carrying out this subsection and subsection (a) and shall be available without fiscal year limitation and without further appropriation.
''(d) Information blocking.'--
''(1) IN GENERAL.'--For purposes of this section and section 3010, subject to paragraph (3), the term 'information blocking' means, with respect to the access, use, and exchange of qualified electronic health records and other health information technology, business, technical, and organizational practices, including practices described in paragraph (2), that'--
''(A) prevent or materially discourage the access, exchange, or use of electronic health information; and
''(B) the actor knows or should know (as defined in section 1128A(i)(7) of the Social Security Act) are likely to interfere with the access, exchange, or use of electronic health information.
''(2) PRACTICES DESCRIBED.'--For purposes of paragraph (1), the practices described in this paragraph shall include the following:
''(A) Contract terms, policies, or business or organizational practices that restrict authorized use under applicable State or Federal law of electronic health information or restrict the authorized exchange under applicable State or Federal law of such information for treatment and other permitted purposes under such applicable law, including transitions between certified EHR technologies.
''(B) Charging unreasonable prices or fees (such as for health information exchange, portability, interfaces, and full export of health information) that make accessing, exchanging, or using electronic health information cost prohibitive.
''(C) Developing or implementing health information technology in nonstandard ways that are likely to substantially increase the costs, complexity, or burden of sharing electronic health information, especially in cases in which relevant interoperability standards or methods to measure interoperability have been adopted by the Secretary.
''(D) Developing or implementing health information technology in ways that are likely to lock in users or electronic health information, such as not allowing for the full export of health information; lead to fraud, waste, or abuse; or impede innovations and advancements in health information access, exchange, and use, including health information technology-enabled care delivery.
''(3) EXCEPTIONS.'--
''(A) IN GENERAL.'--The term 'information blocking' shall not include practices that'--
''(i) are required by applicable law; or
''(ii) that the Secretary, through regulation, identifies as necessary to protect patient safety, to maintain the privacy or security of individuals' health information, or to promote competition and consumer welfare.
''(B) PROCESS.'--For purposes of subparagraph (A)(ii), not later than 12 months after the date of the enactment of this section, the Secretary shall issue regulations following the notice and comment procedures of section 553 of title 5, United States Code, except that the Secretary may issue the first such regulation as an interim final regulation.
''(C) NO ENFORCEMENT BEFORE EXCEPTIONS IDENTIFIED.'--The term 'information blocking' shall not include any practice or conduct occurring before the date that is 30 days after the date on which the first regulation (as described in subparagraph (B)) is issued under such subparagraph.
''(D) CONSULTATION.'--To the extent that regulations issued under this paragraph define practices that are necessary to promote competition and consumer welfare, the Secretary may consult with the Federal Trade Commission in issuing such regulations.
''(E) APPLICATION.'--The term 'information blocking', with respect to an individual or entity, shall not include an act or practice other than an act or practice committed by such individual or entity.
''(e) Treatment of vendors with respect to patient safety organizations.'--In applying part C of title IX'--
''(1) vendors shall be treated as a provider (as defined in section 921) for purposes of reporting requirements under such part, to the extent that such reports are related to attestation requirements under section 3001(c)(5)(C)(i)(I);
''(2) claims of information blocking described in subsection (a) shall be treated as a patient safety activity under such part for purposes of reporting requirements under such part; and
''(3) health care providers that are not members of patient safety organizations shall be treated in the same manner as health care providers that are such members for purposes of such reporting requirements with respect to claims of information blocking described in subsection (a).
''(f) Rulemaking and guidance.'--
''(1) IN GENERAL.'--Not later than 12 months after the date of the enactment of this section, the Secretary, in consultation with the National Coordinator and the Inspector General of the Department of Health and Human Services, shall, through rulemaking, implement the provisions of section 3001 of the 21st Century Cures Act, including amendments made by such section, relating to information blocking.
''(2) NON-DUPLICATION OF PENALTY STRUCTURES.'--In carrying out paragraph (1), in determining the scope of penalties, assessments, or exclusions under such section 3001, including amendments made by such section, relating to information blocking, the Secretary shall ensure to the extent possible that such penalties, assessments, and exclusions do not duplicate penalty, assessment, and exclusion structures that would otherwise apply with respect to information blocking and the type of individual or entity involved as of the day before the date of the enactment of this section.
''(3) CLARIFICATION.'--In carrying out paragraph (1), the Secretary shall ensure that health care providers are not penalized for actions of vendor of, and other entities offering to such providers, health information technology for the failure of such technology to meet requirements for such technology to be certified under this title.
''(4) GUIDANCE RELATING TO HIPAA.'--Not later than January 1, 2017, the National Coordinator shall publish guidance to clarify the relationship of the provisions of the HIPAA privacy and security law, as defined in section 3009(a)(2) to information blocking, including'--
''(A) examples of how such provisions may result in information blocking; and
''(B) clarifying that a health care provider (as defined in subsection (g)) who discloses health information as allowed under applicable State and Federal law is not liable for unlawful actions, including breaches that occur in the custody of the recipient unless the disclosure proximately cause the breach.
''(g) Health care provider defined.'--For purposes of this section, the term 'health care provider' means a provider of services under subsection (u) of section 1861 of the Social Security Act and a supplier under subsection (d) of such section.
''(h) Authorization of appropriations.'--In addition to amounts made available under subsection (c)(3), there is authorized to be appropriated $10,000,000 for fiscal year 2017 to carry out subsection (a), to remain available until expended.''.
(3) POSTINGS RELATING TO ENFORCEMENT ON HHS INTERNET WEBSITE.'--Section 3001 of the Public Health Service Act (42 U.S.C. 300jj''11) is amended by adding at the end the following new subsection:
''(f) Enforcement information posted on HHS Internet website.'--
''(1) PRICING INFORMATION.'--Not later than January 1, 2019, the National Coordinator shall post the information described in subsection (c)(5)(C)(I)(i)(cc) on the public Internet website of the Office of the National Coordinator for Health Information Technology in a manner that allows for comparison of functionality, price information, and other features among health information technology products that aids in making informed decisions for purchasing such a product.
''(2) ANNUAL POSTING.'--For 2019 and each subsequent year, the Secretary shall post on the public Internet website of the Department of Health and Human Services a list of any qualified electronic health records with respect to which certification has been withdrawn under subsection (c)(5)(C)(ii) during such year and the vendor of or other entity offering to health care providers (as defined in section 3010A(g)) such qualified electronic health records.
''(3) PERIODIC REVIEW.'--The Secretary shall periodically review and confirm that vendors of and other entities offering to health care providers (as defined in section 3010A(g)) qualified electronic health records have publicly published application programming interfaces and associated documentation as required by subsection (c)(5)(C)(i)(II) for purposes of certification and maintaining certification under any program kept or recognized under subsection (c)(5)(A).''.
(4) DEMONSTRATION REQUIRED FOR MEANINGFUL EHR USE UNDER MEDICARE.'--
(A) ELIGIBLE PROFESSIONALS.'--
(i) IN GENERAL.'--Section 1848(o)(2)(A) of the Social Security Act (42 U.S.C. 1395w''4(o)(2)(A)) is amended by inserting after clause (iii) the following new clause:
''(iv) INTEROPERABILITY.'--With respect to EHR reporting periods for payment years beginning with 2020, the eligible professional demonstrates to the satisfaction of the Secretary, in accordance with subparagraph (C)(i), that during such period the professional has not taken any action described in subsection (a)(2) of section 3010A of the Public Health Service Act, with respect to the use of any certified EHR technology.''.
(ii) HARDSHIP EXEMPTION IN CASE OF DECERTIFIED EHR.'--Subparagraph (B) of section 1848(a)(7) of the Social Security Act (42 U.S.C. 1395w''4(a)(7)) is amended to read as follows:
''(B) SIGNIFICANT HARDSHIP EXCEPTION.'--
''(i) IN GENERAL.'--The Secretary may, on a case-by-case basis, exempt an eligible professional from the application of the payment adjustment under subparagraph (A) if the Secretary determines, subject to annual renewal, that compliance with the requirement for being a meaningful EHR user would result in a significant hardship, such as in the case of an eligible professional who practices in a rural area without sufficient Internet access.
''(ii) DECERTIFICATION.'--The Secretary shall exempt an eligible professional from the application of the payment adjustment under subparagraph (A) if the Secretary determines that such professional was determined to not be a meaningful EHR user because the certified EHR technology used by such professional is decertified under section 3001(c)(5)(C) of the Public Health Service Act. An exemption under the previous sentence may be applied to an eligible professional only, subject to clause (iii), during the first payment year with respect to the first EHR reporting period to which such decertification applies.
''(iii) DURATION OF DECERTIFICATION.'--
''(I) IN GENERAL.'--Notwithstanding clause (iv)(I), in no case shall an exemption by reason of clause (ii) be for a period of less than 12 months.
''(II) EXTENSION.'--An exemption under clause (ii) may be extended, on a case-by-case basis, for a period of an additional 12 months subject to the limitation described in clause (iv)(I).
''(iv) LIMITATION.'--
''(I) IN GENERAL.'--Subject to subclause (II), in no case may an eligible professional be granted an exemption under this subparagraph for more than 5 years.
''(II) EXCEPTION.'--Subclause (I) shall not apply to an exemption by reason of clause (ii) to the extent necessary to satisfy clause (iii)(I).''.
(iii) FURTHER APPLICATION.'--Section 1848(o)(2) of the Social Security Act (42 U.S.C. 1395w''4(o)(2)) is amended by adding at the end the following new subparagraph:
''(E) HARDSHIP EXEMPTION IN CASE OF DECERTIFIED EHR.'--In the case of certified EHR technology used by an eligible professional that is decertified under section 3001(c)(5)(C), during the first payment year with respect to the first EHR reporting period to which such decertification applies, the Secretary shall not treat the professional as not being a meaningful EHR user solely because the technology used by such professional was so decertified. The treatment of a professional under the previous sentence shall be for a period of at least 12 months and may, on a case-by-case basis, be for a period of an additional 12 months.''.
(B) ELIGIBLE HOSPITALS.'--
(i) IN GENERAL.'--Section 1886(n)(3)(A) of the Social Security Act (42 U.S.C. 1395ww(n)(3)(A)) is amended by inserting after clause (iii) the following new clause:
''(iv) INTEROPERABILITY.'--With respect to EHR reporting periods for payment years beginning with 2020, the hospital demonstrates to the satisfaction of the Secretary, in accordance with subparagraph (C)(i), that during such period the hospital has not taken any action described in subsection (a)(2) of section 3010A of the Public Health Service Act, with respect to the use of any certified EHR technology.''.
(ii) HARDSHIP EXEMPTION IN CASE OF DECERTIFIED EHR.'--Subclause (II) of section 1886(b)(3)(B)(ix) of the Social Security Act (42 U.S.C. 1395ww(b)(3)(B)(ix)) is amended to read as follows:
''(II) (aa) The Secretary may, on a case-by-case basis, exempt a subsection (d) hospital from the application of subclause (I) with respect to a fiscal year if the Secretary determines, subject to annual renewal, that requiring such hospital to be a meaningful EHR user during such fiscal year would result in a significant hardship, such as in the case of a hospital in a rural area without sufficient Internet access.
''(bb) The Secretary shall exempt a subsection (d) hospital from the application of subclause (I) with respect to a fiscal year if the Secretary determines that such hospital was determined to not be a meaningful EHR user because the certified EHR technology used by such hospital is decertified under section 3001(c)(5)(C) of the Public Health Service Act. An exemption under the previous sentence may be applied to a subsection (d) hospital only, subject to items (cc) and (dd), during the first payment year with respect to the first EHR reporting period to which such decertification applies.
''(cc) Notwithstanding item (ee), in no case shall an exemption by reason of item (bb) be for a period of less than 12 months.
''(dd) An exemption under item (bb) may, on a case-by-case basis, be extended for a period of an additional 12 months subject to the limitation described in item (ee).
''(ee) Subject to item (ff), in no case may a hospital be granted an exemption under this subclause for more than 5 years.
''(ff) Item (ee) shall not apply to an exemption by reason of item (bb) to the extent necessary to satisfy item (cc).''.
(C) DEMONSTRATION REQUIRED FOR MEANINGFUL EHR USE UNDER MEDICAID.'--Section 1903(t)(2) of the Social Security Act (42 U.S.C. 1396b(t)(2)) is amended by adding at the end the following: ''An eligible professional shall not qualify as a Medicaid provider under this subsection, with respect to a year beginning with 2020, unless such provider demonstrates to the Secretary, through means such as an attestation, that the provider has not taken any action described in subsection (a)(2) of section 3010A of the Public Health Service Act, with respect to the use of any certified EHR technology.''.
(5) GUIDANCE.'--Not later than January 1, 2018, the Secretary of Health and Human Services shall issue guidance to further the voluntary transition of health care providers between different certified EHR technology (as defined in section 3000(1) of the Public Health Service Act (42 U.S.C. 300jj(1)) by removing disincentives to such transition, which may include applying to instances of such a transition the hardship exemption authority under section 1848(a)(7) of the Social Security Act (42 U.S.C. 1395w''4(a)(7)), section 1886(b)(3)(B)(ix) of such Act (42 U.S.C. 1395ww(b)(3)(B)(ix)), and other provisions of law in existence as of the date of the enactment of this Act. In developing such guidance, the Secretary may consult with the relevant Federal agencies.
(f) Definitions.'--
(1) CERTIFIED EHR TECHNOLOGY.'--Paragraph (1) of section 3000 of the Public Health Service Act (42 U.S.C. 300jj) is amended to read as follows:
''(1) CERTIFIED EHR TECHNOLOGY.'--The term 'certified EHR technology' means a qualified electronic health record that is certified pursuant to section 3001(c)(5) as meeting the certification criteria defined in subparagraph (B) of such section that are applicable to the type of record involved (as determined by the Secretary, such as an ambulatory electronic health record for office-based physicians or an inpatient hospital electronic health record for hospitals) including, beginning January 1, 2018, with respect to which the vendor or other entity offering such technology is in compliance with the requirements under section 3001(c)(5)(C)(i).''.
(2) WIDESPREAD INTEROPERABILITY.'--Section 3000 of the Public Health Service Act (42 U.S.C. 300jj) is amended by adding at the end the following new paragraph:
''(15) WIDESPREAD INTEROPERABILITY.'--The term 'widespread interoperability' means that, on a nationwide basis'--
''(A) health information technology is interoperable, in accordance with section 3010; and
''(B) such technology is employed by meaningful EHR users under the Medicare Program under title XVIII of the Social Security Act and the Medicaid program under title XIX of such Act and by other clinicians and health care providers.''.
(g) Conforming amendments.'--
(1) VOLUNTARY USE OF STANDARDS.'--Section 3006 of the Public Health Service Act (42 U.S.C. 300jj''16) is amended'--
(A) in subsection (a)(1), by inserting '', including an interoperability standard or implementation specification, with respect to such interoperability standard, adopted under such section'' after ''section 3004''.
(B) in subsection (b), by inserting '', including the interoperability standards and implementation specifications, with respect to such interoperability standards, adopted under such section'' after ''section 3004''.
(2) HIPAA PRIVACY AND SECURITY LAW DEFINITION CORRECTION.'--Section 3009(a)(2)(A) of the Public Health Service Act (42 U.S.C. 300jj''19(a)(2)(A)) is amended by striking ''title IV'' and inserting ''title XIII''.
(3) COORDINATION OF FEDERAL ACTIVITIES.'--Section 13111 of the HITECH Act is amended'--
(A) in subsection (a), by inserting before the period at the end the following: ''(and, beginning on January 1, 2018, that are also interoperable under section 3010 of such Act and in compliance with interoperability standards and implementation specifications, with respect to such interoperability standards, adopted under section 3004 of such Act )''; and
(B) in subsection (b), by inserting ''(and, beginning on January 1, 2018, including an interoperability standard or implementation specification, with respect to such interoperability standard, adopted under section 3004 of such Act)'' before ''the President''.
(4) APPLICATION TO PRIVATE ENTITIES.'--Section 13112 of the HITECH Act is amended by inserting before the period at the end the following: ''(and, beginning on January 1, 2018, that are also interoperable under section 3010 of such Act and in compliance with interoperability standards and implementation specifications, with respect to such interoperability standards, adopted under section 3004 of such Act)''.
(5) NIST TESTING.'--Section 13201 of the HITECH Act (42 U.S.C. 17911) is amended'--
(A) in subsection (a), by inserting ''(or, beginning January 1, 2018, in coordination with the entities with contracts under section 3003A, with respect to standards, and implementation specifications under section 3004) '' before '', the Director'';
(B) in subsection (b), by inserting ''(or, beginning January 1, 2018, in coordination with the entities with contracts under section 3003A, with respect to standards and implementation specifications under section 3004)'' before '', the Director''; and
(C) by adding at the end the following new subsection:
''(c) Funding.'--For purposes of carrying out this section, in addition to any other funds made available to carry out this section, there is authorized to be appropriated $15,000,000, to remain available until expended.''.
(6) COORDINATION WITH RECOMMENDATIONS FOR ACHIEVING WIDESPREAD EHR INTEROPERABILITY.'--Section 106 of the Medicare Access and CHIP Reauthorization Act of 2015 (Public Law 114''10) is amended by striking subsection (b).
(h) Patient engagement and empowerment.'--It is the sense of Congress that'--
(1) if the strategic goals that Congress set forth in the HITECH Act are to be achieved, interoperability is best achieved with individuals and authorized representatives having equal access to the health information of such individuals in electronic format;
(2) patients have the right to the entirety of the health information of such individuals, including such information contained in an electronic health record of such individuals;
(3) such right extends to both structured and unstructured data;
(4) such right extends to authorized representatives of the individual involved, such as caretakers of such individual, family members of such individual, and guardians of such individual; and
(5) to further facilitate access of an individual to health information of such individual'--
(A) health care providers should not have the ability to deny a request of the individual for access to the entirety of such health information of such individual;
(B) health care providers do not need the consent of individuals to share personal health information of such individuals with other covered entities, in compliance with the HIPAA privacy regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 for the purposes of supporting patient care, except in situations where consent is specifically required under such regulations, such as in cases related to the psychiatric records of the individual involved;
(C) mechanisms should be utilized that allow for the bidirectional exchange of information through such mechanisms as web portals, appointments, and prescription refills, for the purpose of patients partnering with providers to assist in managing health and care;
(D) mechanisms described in subparagraph (C) should allow for connecting individuals across the continuum of care;
(E) an individual has the right to access the health information of the individual without cost to the individual;
(F) mechanisms described in subparagraph (C) should allow for data of an individual generated by the individual to be integrated into such platforms as electronic health records;
(G) such access should be timely, in accordance with the HIPAA privacy regulations described in subparagraph (B), and take into account communications preferences of the individual involved;
(H) an individual should have the right to be confident that the data in the electronic health record of the individual pertains to such individual; and
(I) the right described in subparagraph (H) will promote safety and care coordination for individuals.
SEC. 3021.Telehealth services under the Medicare Program.(a) Provision of information by Centers for Medicare & Medicaid Services.'--Not later than 1 year after the date of the enactment of this Act, the Administrator of the Centers for Medicare & Medicaid Services shall provide to the committees of jurisdiction of the House of Representatives and the Senate information on the following:
(1) The populations of Medicare beneficiaries, such as those who are dually eligible for the Medicare Program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) and the Medicaid program under title XIX of such Act (42 U.S.C. 1396 et seq.) and those with chronic conditions, whose care may be improved most in terms of quality and efficiency by the expansion, in a manner that meets or exceeds the existing in-person standard of care under the Medicare Program under title XVIII of such Act, of telehealth services under section 1834(m)(4) of such Act (42 U.S.C. 1395m(m)(4)).
(2) Activities by the Center for Medicare and Medicaid Innovation which examine the use of telehealth services in models, projects, or initiatives funded through section 1115A of the Social Security Act (42 U.S.C. 1315a).
(3) The types of high-volume services (and related diagnoses) under such title XVIII which might be suitable to the furnishing of services via telehealth.
(4) Barriers that might prevent the expansion of telehealth services under section 1834(m)(4) of the Social Security Act (42 U.S.C. 1395m(m)(4)) beyond such services that are in effect as of the date of the enactment of this Act.
(b) Provision of information by MedPAC.'--Not later than March 15, 2017, the Medicare Payment Advisory Commission established under section 1805 of the Social Security Act (42 U.S.C. 1395b''6) shall, using quantitative and qualitative research methods, provide information to the committees of jurisdiction of the House of Representatives and the Senate that identifies'--
(1) the telehealth services for which payment can be made, as of the date of the enactment of this Act, under the fee-for-service program under parts A and B of title XVIII of such Act;
(2) the telehealth services for which payment can be made, as of such date, under private health insurance plans;
(3) with respect to services identified under paragraph (2) but not under paragraph (1), ways in which payment for such services might be incorporated into such fee-for-service program (including any recommendations for ways to accomplish this incorporation).
(c) Sense of Congress.'--It is the sense of Congress that'--
(1) eligible originating sites should be expanded beyond those originating sites described in section 1834(m)(4)(C) of the Social Security Act (42 U.S.C. 1395m(m)(4)(C)); and
(2) any expansion of telehealth services under the Medicare Program should'--
(A) recognize that telemedicine is the delivery of safe, effective, quality health care services, by a health care provider, using technology as the mode of care delivery;
(B) meet or exceed the conditions of coverage and payment with respect to the Medicare Program under title XVIII unless specifically address in subsequent statute, of such Act if the service were furnished in person, including standards of care; and
(C) involve clinically appropriate means to furnish such services.
SEC. 3041.Exempting from manufacturer transparency reporting certain transfers used for educational purposes.(a) In general.'--Section 1128G(e)(10)(B) of the Social Security Act (42 U.S.C. 1320a''7h(e)(10)(B)) is amended'--
(1) in clause (iii), by inserting '', including peer-reviewed journals, journal reprints, journal supplements, medical conference reports, and medical textbooks'' after ''patient use''; and
(2) by adding at the end the following new clause:
''(xiii) In the case of a covered recipient who is a physician, an indirect payment or transfer of value to the covered recipient'--
''(I) for speaking at, or preparing educational materials for, an educational event for physicians or other health care professionals that does not commercially promote a covered drug, device, biological, or medical supply; or
''(II) that serves the sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event.''.
(b) Effective date.'--The amendments made by this section shall apply with respect to transfers of value made on or after the date of the enactment of this Act.
SEC. 3061.Treatment of certain items and devices.(a) In general.'--Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:
''(r) Payment for certain disposable devices.'--
''(1) IN GENERAL.'--The Secretary shall make separate payment in the amount established under paragraph (3) to a home health agency for a device described in paragraph (2) when furnished to an individual who receives home health services for which payment is made under section 1895(b).
''(2) DEVICE DESCRIBED.'--For purposes of paragraph (1), a device described in this paragraph is a disposable device for which, as of January 1, 2015, there is'--
''(A) a Level I Healthcare Common Procedure Coding System (HCPCS) code for which the description for a professional service includes the furnishing of such device; and
''(B) a separate Level I HCPCS code for a professional service that uses durable medical equipment instead of such device.
''(3) PAYMENT AMOUNT.'--The Secretary shall establish the separate payment amount for such a device such that such amount does not exceed the payment that would be made for the HCPCS code described in paragraph (2)(A) under section 1833(t) (relating to payment for covered OPD services).''.
(b) Conforming amendment.'--Section 1861(m)(5) of the Social Security Act (42 U.S.C. 1395x(m)(5)) is amended by inserting ''and devices described in section 1834(r)(2)'' after ''durable medical equipment''.
(c) Effective date.'--The amendments made by this section shall apply to devices furnished on or after January 1, 2017.
SEC. 3081.Improvements in the Medicare local coverage determination (LCD) process.(a) In general.'--Section 1862(l)(5) of the Social Security Act (42 U.S.C. 1395y(l)(5)) is amended by adding at the end the following new subparagraph:
''(D) LOCAL COVERAGE DETERMINATIONS.'--The Secretary shall require each Medicare administrative contractor that develops a local coverage determination to make available on the website of such contractor and on the Medicare website, at least 45 days before the effective date of such determination, the following information:
''(i) Such determination in its entirety.
''(ii) Where and when the proposed determination was first made public.
''(iii) Hyperlinks to the proposed determination and a response to comments submitted to the contractor with respect to such proposed determination.
''(iv) A summary of evidence that was considered by the contractor during the development of such determination and a list of the sources of such evidence.
''(v) An explanation of the rationale that supports such determination.''.
(b) Effective date.'--The amendment made by subsection (a) shall apply with respect to local coverage determinations that are proposed or revised on or after the date that is 180 days after the date of the enactment of this Act.
SEC. 3101.Medicare pharmaceutical and technology ombudsman.Section 1808(c) of the Social Security Act (42 U.S.C. 1395b''9(c)) is amended by adding at the end the following new paragraph:
''(4) PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.'--Not later than 12 months after the date of the enactment of this paragraph, the Secretary shall provide for a pharmaceutical and technology ombudsman within the Centers for Medicare & Medicaid Services who shall receive and respond to complaints, grievances, and requests that'--
''(A) are from entities that manufacture pharmaceutical, biotechnology, medical device, or diagnostic products that are covered or for which coverage is being sought under this title; and
''(B) are with respect to coverage, coding, or payment under this title for such products.
The second sentence of paragraph (2) shall apply to this paragraph in the same manner as such sentence applies to paragraph (2).''.
SEC. 3121.Medicare site-of-Service price transparency.Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended by section 3061, is further amended by adding at the end the following new subsection:
''(s) Site-of-Service price transparency.'--
''(1) IN GENERAL.'--In order to facilitate price transparency with respect to items and services for which payment may be made either to a hospital outpatient department or to an ambulatory surgical center under this title, the Secretary shall, for 2017 and each year thereafter, make available to the public via a searchable website, with respect to an appropriate number of such items and services'--
''(A) the estimated payment amount for the item or service under the outpatient department fee schedule under subsection (t) of section 1833 and the ambulatory surgical center payment system under subsection (i) of such section; and
''(B) the estimated amount of beneficiary liability applicable to the item or service.
''(2) CALCULATION OF ESTIMATED BENEFICIARY LIABILITY.'--For purposes of paragraph (1)(B), the estimated amount of beneficiary liability, with respect to an item or service, is the amount for such item or service for which an individual who does not have coverage under a Medicare supplemental policy certified under section 1882 or any other supplemental insurance coverage is responsible.
''(3) IMPLEMENTATION.'--In carrying out this subsection, the Secretary'--
''(A) shall include in the notice described in section 1804(a) a notification of the availability of the estimated amounts made available under paragraph (1); and
''(B) may utilize mechanisms in existence on the date of the enactment of this subsection, such as the portion of the website of the Centers for Medicare & Medicaid Services on which information comparing physician performance is posted (commonly referred to as the Physician Compare website), to make available such estimated amounts under such paragraph.
''(4) FUNDING.'--For purposes of implementing this subsection, the Secretary shall provide for the transfer, from the Supplemental Medical Insurance Trust Fund under section 1841 to the Centers for Medicare & Medicaid Services Program Management Account, of $6,000,000 for fiscal year 2015, to remain available until expended.''.
SEC. 3141.Programs to prevent prescription drug abuse under Medicare parts C and D.(a) Drug management program for at-Risk beneficiaries.'--
(1) IN GENERAL.'--Section 1860D''4(c) of the Social Security Act (42 U.S.C. 1395w''10(c)) is amended by adding at the end the following:
''(5) DRUG MANAGEMENT PROGRAM FOR AT-RISK BENEFICIARIES.'--
''(A) AUTHORITY TO ESTABLISH.'--A PDP sponsor may establish a drug management program for at-risk beneficiaries under which, subject to subparagraph (B), the PDP sponsor may, in the case of an at-risk beneficiary for prescription drug abuse who is an enrollee in a prescription drug plan of such PDP sponsor, limit such beneficiary's access to coverage for frequently abused drugs under such plan to frequently abused drugs that are prescribed for such beneficiary by one or more prescribers selected under subparagraph (D), and dispensed for such beneficiary by one or more pharmacies selected under such subparagraph.
''(B) REQUIREMENT FOR NOTICES.'--
''(i) IN GENERAL.'--A PDP sponsor may not limit the access of an at-risk beneficiary for prescription drug abuse to coverage for frequently abused drugs under a prescription drug plan until such sponsor'--
''(I) provides to the beneficiary an initial notice described in clause (ii) and a second notice described in clause (iii); and
''(II) verifies with the providers of the beneficiary that the beneficiary is an at-risk beneficiary for prescription drug abuse.
''(ii) INITIAL NOTICE.'--An initial notice described in this clause is a notice that provides to the beneficiary'--
''(I) notice that the PDP sponsor has identified the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse;
''(II) information describing all State and Federal public health resources that are designed to address prescription drug abuse to which the beneficiary has access, including mental health services and other counseling services;
''(III) notice of, and information about, the right of the beneficiary to appeal such identification under subsection (h) and the option of an automatic escalation to external review;
''(IV) a request for the beneficiary to submit to the PDP sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the PDP sponsor to select under subparagraph (D) in the case that the beneficiary is identified as an at-risk beneficiary for prescription drug abuse as described in clause (iii)(I);
''(V) an explanation of the meaning and consequences of the identification of the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse, including an explanation of the drug management program established by the PDP sponsor pursuant to subparagraph (A);
''(VI) clear instructions that explain how the beneficiary can contact the PDP sponsor in order to submit to the PDP sponsor the preferences described in subclause (IV) and any other communications relating to the drug management program for at-risk beneficiaries established by the PDP sponsor; and
''(VII) contact information for other organizations that can provide the beneficiary with assistance regarding such drug management program (similar to the information provided by the Secretary in other standardized notices provided to part D eligible individuals enrolled in prescription drug plans under this part).
''(iii) SECOND NOTICE.'--A second notice described in this clause is a notice that provides to the beneficiary notice'--
''(I) that the PDP sponsor has identified the beneficiary as an at-risk beneficiary for prescription drug abuse;
''(II) that such beneficiary is subject to the requirements of the drug management program for at-risk beneficiaries established by such PDP sponsor for such plan;
''(III) of the prescriber (or prescribers) and pharmacy (or pharmacies) selected for such individual under subparagraph (D);
''(IV) of, and information about, the beneficiary's right to appeal such identification under subsection (h) and the option of an automatic escalation to external review;
''(V) that the beneficiary can, in the case that the beneficiary has not previously submitted to the PDP sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the PDP sponsor select under subparagraph (D), submit such preferences to the PDP sponsor; and
''(VI) that includes clear instructions that explain how the beneficiary can contact the PDP sponsor.
''(iv) TIMING OF NOTICES.'--
''(I) IN GENERAL.'--Subject to subclause (II), a second notice described in clause (iii) shall be provided to the beneficiary on a date that is not less than 60 days after an initial notice described in clause (ii) is provided to the beneficiary.
''(II) EXCEPTION.'--In the case that the PDP sponsor, in conjunction with the Secretary, determines that concerns identified through rulemaking by the Secretary regarding the health or safety of the beneficiary or regarding significant drug diversion activities require the PDP sponsor to provide a second notice described in clause (iii) to the beneficiary on a date that is earlier than the date described in subclause (I), the PDP sponsor may provide such second notice on such earlier date.
''(C) AT-RISK BENEFICIARY FOR PRESCRIPTION DRUG ABUSE.'--
''(i) IN GENERAL.'--For purposes of this paragraph, the term 'at-risk beneficiary for prescription drug abuse' means a part D eligible individual who is not an exempted individual described in clause (ii) and'--
''(I) who is identified as such an at-risk beneficiary through the use of clinical guidelines developed by the Secretary in consultation with PDP sponsors and other stakeholders described in section 3141(f)(2)(A) of the 21st Century Cures Act; or
''(II) with respect to whom the PDP sponsor of a prescription drug plan, upon enrolling such individual in such plan, received notice from the Secretary that such individual was identified under this paragraph to be an at-risk beneficiary for prescription drug abuse under the prescription drug plan in which such individual was most recently previously enrolled and such identification has not been terminated under subparagraph (F).
''(ii) EXEMPTED INDIVIDUAL DESCRIBED.'--An exempted individual described in this clause is an individual who'--
''(I) receives hospice care under this title;
''(II) is a resident of a long-term care facility, of an intermediate care facility for the mentally retarded, or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or
''(III) the Secretary elects to treat as an exempted individual for purposes of clause (i).
''(D) SELECTION OF PRESCRIBERS AND PHARMACIES.'--
''(i) IN GENERAL.'--With respect to each at-risk beneficiary for prescription drug abuse enrolled in a prescription drug plan offered by such sponsor, a PDP sponsor shall, based on the preferences submitted to the PDP sponsor by the beneficiary pursuant to clauses (ii)(IV) and (iii)(V) of subparagraph (B) (except as otherwise provided in this subparagraph), select'--
''(I) one or more individuals who are authorized to prescribe frequently abused drugs (referred to in this paragraph as 'prescribers') who may write prescriptions for such drugs for such beneficiary; and
''(II) one or more pharmacies that may dispense such drugs to such beneficiary.
''(ii) REASONABLE ACCESS.'--In making the selections under this subparagraph'--
''(I) a PDP sponsor shall ensure that the beneficiary continues to have reasonable access to frequently abused drugs (as defined in subparagraph (G)), taking into account geographic location, beneficiary preference, impact on costsharing, and reasonable travel time; and
''(II) a PDP sponsor shall ensure such access (including access to prescribers and pharmacies with respect to frequently abused drugs) in the case of individuals with multiple residences and in the case of natural disasters and similar emergency situations.
''(iii) BENEFICIARY PREFERENCES.'--If an at-risk beneficiary for prescription drug abuse submits preferences for which in-network prescribers and pharmacies the beneficiary would prefer the PDP sponsor select in response to a notice under subparagraph (B), the PDP sponsor shall'--
''(I) review such preferences;
''(II) select or change the selection of prescribers and pharmacies for the beneficiary based on such preferences; and
''(III) inform the beneficiary of such selection or change of selection.
''(iv) EXCEPTION REGARDING BENEFICIARY PREFERENCES.'--In the case that the PDP sponsor determines that a change to the selection of prescriber or pharmacy under clause (iii)(II) by the PDP sponsor is contributing or would contribute to prescription drug abuse or drug diversion by the beneficiary, the PDP sponsor may change the selection of prescriber or pharmacy for the beneficiary without regard to the preferences of the beneficiary described in clause (iii).
''(v) CONFIRMATION.'--Before selecting a prescriber (or prescribers) or pharmacy (or pharmacies) under this subparagraph, a PDP sponsor must request and receive confirmation from such a prescriber or pharmacy acknowledging and accepting that the beneficiary involved is in the drug management program for at-risk beneficiaries.
''(E) TERMINATIONS AND APPEALS.'--The identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph, a coverage determination made under a drug management program for at-risk beneficiaries, and the selection of prescriber or pharmacy under subparagraph (D) with respect to such individual shall be subject to reconsideration and appeal under subsection (h) and the option of an automatic escalation to external review to the extent provided by the Secretary.
''(F) TERMINATION OF IDENTIFICATION.'--
''(i) IN GENERAL.'--The Secretary shall develop standards for the termination of identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph. Under such standards such identification shall terminate as of the earlier of'--
''(I) the date the individual demonstrates that the individual is no longer likely, in the absence of the restrictions under this paragraph, to be an at-risk beneficiary for prescription drug abuse described in subparagraph (C)(i); and
''(II) the end of such maximum period of identification as the Secretary may specify.
''(ii) RULE OF CONSTRUCTION.'--Nothing in clause (i) shall be construed as preventing a plan from identifying an individual as an at-risk beneficiary for prescription drug abuse under subparagraph (C)(i) after such termination on the basis of additional information on drug use occurring after the date of notice of such termination.
''(G) FREQUENTLY ABUSED DRUG.'--For purposes of this subsection, the term 'frequently abused drug' means a drug that is a controlled substance that the Secretary determines to be frequently abused or diverted.
''(H) DATA DISCLOSURE.'--In the case of an at-risk beneficiary for prescription drug abuse whose access to coverage for frequently abused drugs under a prescription drug plan has been limited by a PDP sponsor under this paragraph, such PDP sponsor shall disclose data, including any necessary individually identifiable health information, in a form and manner specified by the Secretary, about the decision to impose such limitations and the limitations imposed by the sponsor under this part to other PDP sponsors that request such data.
''(I) EDUCATION.'--The Secretary shall provide education to enrollees in prescription drug plans of PDP sponsors and providers regarding the drug management program for at-risk beneficiaries described in this paragraph, including education'--
''(i) provided by Medicare administrative contractors through the improper payment outreach and education program described in section 1874A(h); and
''(ii) through current education efforts (such as State health insurance assistance programs described in subsection (a)(1)(A) of section 119 of the Medicare Improvements for Patients and Providers Act of 2008 (42 U.S.C. 1395b''3 note)) and materials directed toward such enrollees.
''(J) APPLICATION UNDER MA''PD PLANS.'--Pursuant to section 1860D''21(c)(1), the provisions of this paragraph apply under part D to MA organizations offering MA''PD plans to MA eligible individuals in the same manner as such provisions apply under this part to a PDP sponsor offering a prescription drug plan to a part D eligible individual.''.
(2) INFORMATION FOR CONSUMERS.'--Section 1860D''4(a)(1)(B) of the Social Security Act (42 U.S.C. 1395w''104(a)(1)(B)) is amended by adding at the end the following:
''(v) The drug management program for at-risk beneficiaries under subsection (c)(5).''.
(b) Utilization management programs.'--Section 1860D''4(c) of the Social Security Act (42 U.S.C. 1395w''104(c)), as amended by subsection (a)(1), is further amended'--
(1) in paragraph (1), by inserting after subparagraph (D) the following new subparagraph:
''(E) A utilization management tool to prevent drug abuse (as described in paragraph (6)(A)).''; and
(2) by adding at the end the following new paragraph:
''(6) UTILIZATION MANAGEMENT TOOL TO PREVENT DRUG ABUSE.'--
''(A) IN GENERAL.'--A tool described in this paragraph is any of the following:
''(i) A utilization tool designed to prevent the abuse of frequently abused drugs by individuals and to prevent the diversion of such drugs at pharmacies.
''(ii) Retrospective utilization review to identify'--
''(I) individuals that receive frequently abused drugs at a frequency or in amounts that are not clinically appropriate; and
''(II) providers of services or suppliers that may facilitate the abuse or diversion of frequently abused drugs by beneficiaries.
''(iii) Consultation with the contractor described in subparagraph (B) to verify if an individual enrolling in a prescription drug plan offered by a PDP sponsor has been previously identified by another PDP sponsor as an individual described in clause (ii)(I).
''(B) REPORTING.'--A PDP sponsor offering a prescription drug plan (and an MA organization offering an MA''PD plan) in a State shall submit to the Secretary and the Medicare drug integrity contractor with which the Secretary has entered into a contract under section 1893 with respect to such State a report, on a monthly basis, containing information on'--
''(i) any provider of services or supplier described in subparagraph (A)(ii)(II) that is identified by such plan sponsor (or organization) during the 30-day period before such report is submitted; and
''(ii) the name and prescription records of individuals described in paragraph (5)(C).''.
(c) Expanding Activities of Medicare Drug Integrity Contractors (MEDICs).'--
(1) IN GENERAL.'--Section 1893 of the Social Security Act (42 U.S.C. 1395ddd) is amended by adding at the end the following new subsection:
''(j) Expanding Activities of Medicare Drug Integrity Contractors (MEDICs).'--
''(1) ACCESS TO INFORMATION.'--Under contracts entered into under this section with Medicare drug integrity contractors (including any successor entity to a Medicare drug integrity contractor), the Secretary shall authorize such contractors to directly accept prescription and necessary medical records from entities such as pharmacies, prescription drug plans, MA''PD plans, and physicians with respect to an individual in order for such contractors to provide information relevant to the determination of whether such individual is an at-risk beneficiary for prescription drug abuse, as defined in section 1860D''4(c)(5)(C).
''(2) REQUIREMENT FOR ACKNOWLEDGMENT OF REFERRALS.'--If a PDP sponsor or MA organization refers information to a contractor described in paragraph (1) in order for such contractor to assist in the determination described in such paragraph, the contractor shall'--
''(A) acknowledge to the sponsor or organization receipt of the referral; and
''(B) in the case that any PDP sponsor or MA organization contacts the contractor requesting to know the determination by the contractor of whether or not an individual has been determined to be an individual described such paragraph, shall inform such sponsor or organization of such determination on a date that is not later than 15 days after the date on which the sponsor or organization contacts the contractor.
''(3) MAKING DATA AVAILABLE TO OTHER ENTITIES.'--
''(A) IN GENERAL.'--For purposes of carrying out this subsection, subject to subparagraph (B), the Secretary shall authorize MEDICs to respond to requests for information from PDP sponsors and MA organizations, State prescription drug monitoring programs, and other entities delegated by such sponsors or organizations using available programs and systems in the effort to prevent fraud, waste, and abuse.
''(B) HIPAA COMPLIANT INFORMATION ONLY.'--Information may only be disclosed by a MEDIC under subparagraph (A) if the disclosure of such information is permitted under the Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d''2 note).''.
(2) OIG STUDY AND REPORT ON EFFECTIVENESS OF MEDICS.'--
(A) STUDY.'--The Inspector General of the Department of Health and Human Services shall conduct a study on the effectiveness of Medicare drug integrity contractors with which the Secretary of Health and Human Services has entered into a contract under section 1893 of the Social Security Act (42 U.S.C. 1395ddd) in identifying, combating, and preventing fraud under the Medicare Program, including under the authority provided under section 1893(j) of the Social Security Act, added by paragraph (1).
(B) REPORT.'--Not later than 1 year after the date of the enactment of this Act, the Inspector General shall submit to Congress a report on the study conducted under subparagraph (A). Such report shall include such recommendations for improvements in the effectiveness of such contractors as the Inspector General determines appropriate.
(d) Treatment of certain complaints for purposes of quality or performance assessment.'--Section 1860D''42 of the Social Security Act (42 U.S.C. 1395w''152) is amended by adding at the end the following new subsection:
''(d) Treatment of certain complaints for purposes of quality or performance assessment.'--In conducting a quality or performance assessment of a PDP sponsor, the Secretary shall develop or utilize existing screening methods for reviewing and considering complaints that are received from enrollees in a prescription drug plan offered by such PDP sponsor and that are complaints regarding the lack of access by the individual to prescription drugs due to a drug management program for at-risk beneficiaries.''.
(e) Sense of congress regarding use of technology tools To combat fraud.'--It is the sense of Congress that MA organizations and PDP sponsors should consider using e-prescribing and other health information technology tools to support combating fraud under MA''PD plans and prescription drug plans under parts C and D of the Medicare Program.
(f) Effective date.'--
(1) IN GENERAL.'--The amendments made by this section shall apply to prescription drug plans (and MA''PD plans) for plan years beginning more than 1 year after the date of the enactment of this Act.
(2) STAKEHOLDER MEETINGS PRIOR TO EFFECTIVE DATE.'--
(A) IN GENERAL.'--Not later than January 1, 2016, the Secretary of Health and Human Services shall convene stakeholders, including individuals entitled to benefits under part A of title XVIII of the Social Security Act or enrolled under part B of such title of such Act, advocacy groups representing such individuals, physicians, pharmacists, and other clinicians, retail pharmacies, plan sponsors, entities delegated by plan sponsors, and biopharmaceutical manufacturers for input regarding the topics described in subparagraph (B).
(B) TOPICS DESCRIBED.'--The topics described in this subparagraph are the topics of'--
(i) the anticipated impact of drug management programs for at-risk beneficiaries under paragraph (5) of section 1860D''4(c) of the Social Security Act (42 U.S.C. 1395w''104(c)) on cost-sharing and ensuring accessibility to prescription drugs for enrollees in prescription drug plans of PDP sponsors, and enrollees in MA''PD plans, who are at-risk beneficiaries for prescription drug abuse (as defined in subparagraph (C) of such paragraph);
(ii) the use of an expedited appeals process under which such an enrollee may appeal an identification of such enrollee as an at-risk beneficiary for prescription drug abuse under such paragraph (similar to the processes established under the Medicare Advantage program under part C of title XVIII of the Social Security Act that allow an automatic escalation to external review of claims submitted under such part);
(iii) the types of enrollees that should be treated as exempted individuals, as described in subparagraph (C)(ii) of such paragraph;
(iv) the manner in which terms and definitions in such paragraph should be applied, such as the use of clinical appropriateness in determining whether an enrollee is an at-risk beneficiary for prescription drug abuse as defined in subparagraph (C) of such paragraph;
(v) the information to be included in the notices described in subparagraph (B) of such paragraph and the standardization of such notices; and
(vi) with respect to a PDP sponsor (or Medicare Advantage organization) that establishes a drug management program for at-risk beneficiaries under such paragraph, the responsibilities of such PDP sponsor (or organization) with respect to the implementation of such program.
(g) Rulemaking.'--The Secretary of Health and Human Services shall promulgate regulations based on the input gathered pursuant to subsection (f)(2)(A).
SEC. 4001.Limiting Federal Medicaid reimbursement to States for durable medical equipment (DME) to Medicare payment rates.(a) Medicaid reimbursement.'--
(1) IN GENERAL.'--Section 1903(i) of the Social Security Act (42 U.S.C. 1396b(i)) is amended'--
(A) in paragraph (25), by striking ''or'' at the end;
(B) in paragraph (26), by striking the period at the end and inserting ''; or''; and
(C) by inserting after paragraph (26) the following new paragraph:
''(27) with respect to any amounts expended by the State on the basis of a fee schedule for items described in section 1861(n), as determined in the aggregate with respect to each class of such items as defined by the Secretary, in excess of the aggregate amount, if any, that would be paid for such items within such class on a fee-for-service basis under the program under part B of title XVIII, including, as applicable, under a competitive acquisition program under section 1847 in an area of the State.''.
(2) EFFECTIVE DATE.'--The amendments made by this subsection shall be effective with respect to payments for items furnished on or after January 1, 2020.
(b) Medicare ombudsman.'--Section 1808(c) of the Social Security Act (42 U.S.C. 1395b(c)), as amended by section 3101, is further amended by adding at the end the following new paragraph:
''(5) MONITORING DME REIMBURSEMENT UNDER MEDICAID.'--The ombudsmen under each of paragraphs (1) and (4) shall evaluate the impact of the competitive acquisition program under section 1847, including as applied under section 1903(i)(27), on beneficiary health status and health outcomes.''.
SEC. 4002.Excluding authorized generics from calculation of average manufacturer price.(a) In general.'--Subparagraph (C) of section 1927(k)(1) of the Social Security Act (42 U.S.C. 1396r''8(k)(1)) is amended'--
(1) in the subparagraph heading, by striking ''Inclusion'' and inserting ''Exclusion'';
(2) by striking ''a new drug application'' and inserting ''the manufacturer's new drug application''; and
(3) by striking ''inclusive'' and inserting ''exclusive''.
(b) Effective date.'--The amendments made by this section take effect on October 1, 2015.
SEC. 4003.Medicare payment incentive for the transition from traditional x-ray imaging to digital radiography and other Medicare imaging payment provision.(a) Physician fee schedule.'--
(1) PAYMENT INCENTIVE FOR TRANSITION.'--
(A) IN GENERAL.'--Section 1848(b) of the Social Security Act (42 U.S.C. 1395w''4(b)) is amended by adding at the end the following new paragraph:
''(9) SPECIAL RULE TO INCENTIVIZE TRANSITION FROM TRADITIONAL X-RAY IMAGING TO DIGITAL RADIOGRAPHY.'--
''(A) LIMITATION ON PAYMENT FOR FILM X-RAY IMAGING SERVICES.'--In the case of an imaging service (including the imaging portion of a service) that is an X-ray taken using film and that is furnished during 2017 or a subsequent year, the payment amount for the technical component (including the technical component portion of a global service) of such service that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this section) for such year shall be reduced by 20 percent.
''(B) PHASED-IN LIMITATION ON PAYMENT FOR COMPUTED RADIOGRAPHY IMAGING SERVICES.'--In the case of an imaging service (including the imaging portion of a service) that is an X-ray taken using computed radiography technology'--
''(i) in the case of such a service furnished during 2018, 2019, 2020, 2021, or 2022, the payment amount for the technical component (including the technical component portion of a global service) of such service that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this section) for such year shall be reduced by 7 percent; and
''(ii) in the case of such a service furnished during 2023 or a subsequent year, the payment amount for the technical component (including the technical component portion of a global service) of such service that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this section) for such year shall be reduced by 10 percent.
''(C) COMPUTED RADIOGRAPHY TECHNOLOGY DEFINED.'--For purposes of this paragraph, the term 'computed radiography technology' means cassette-based imaging which utilizes an imaging plate to create the image involved.
''(D) IMPLEMENTATION.'--In order to implement this paragraph, the Secretary shall adopt appropriate mechanisms which may include use of modifiers.''.
(B) EXEMPTION FROM BUDGET NEUTRALITY.'--Section 1848(c)(2)(B)(v) of the Social Security Act (42 U.S.C. 1395w''4(c)(2)(B)(v)) is amended by adding at the end the following new subclause:
''(X) REDUCED EXPENDITURES ATTRIBUTABLE TO INCENTIVES TO TRANSITION TO DIGITAL RADIOGRAPHY.'--Effective for fee schedules established beginning with 2017, reduced expenditures attributable to subparagraph (A) of subsection (b)(9) and effective for fee schedules established beginning with 2018, reduced expenditures attributable to subparagraph (B) of such subsection.''.
(2) ELIMINATION OF APPLICATION OF MULTIPLE PROCEDURE PAYMENT REDUCTION.'--
(A) IN GENERAL.'--Section 1848(b)(4) of the Social Security Act (42 U.S.C. 1395w''4(b)(4)) is amended by adding at the end the following new subparagraph:
''(E) ELIMINATION OF APPLICATION OF MULTIPLE PROCEDURE PAYMENT REDUCTION.'--
''(i) IN GENERAL.'--For services furnished on or after January 1, 2017, the Secretary shall not apply a multiple procedure payment reduction to the professional component of imaging services unless the Secretary has published as part of a Medicare Physician Fee Schedule Proposed Rule the empirical analysis described in clause (ii) with tables made available on the website of the Centers for Medicare & Medicaid Services.
''(ii) EMPIRICAL ANALYSIS DESCRIBED.'--The empirical analysis described in this clause is an analysis of the Resource-Based Relative Value Scale Data Manager information or other information that is used to determine what, if any, efficiencies exist within the professional component of imaging services when two or more studies are furnished to the same individual on the same day. Such empirical analysis shall include'--
''(I) information detailing which physician work activities overlap and the reductions applicable to such overlap;
''(II) a discussion of the clinical aspects that informed the assignment of the reduction percentages described in subclause (I);
''(III) to the extent that such reductions are used for proposed payment reductions, an explanation of how the percentage reductions for pre-service, intra-service, and post-service work were determined and calculated;
''(IV) other data used to determine a reduction; and
''(V) a demonstration that the Secretary has consulted with practicing radiologists to gain knowledge of how radiologists interpret studies of multiple body parts on the same individual on the same day.''.
(B) CONFORMING AMENDMENT.'--Section 220(i) of the Protecting Access to Medicare Act of 2014 (42 U.S.C. 1395w''4 note) is repealed.
(b) Payment incentive for transition under hospital outpatient prospective payment system.'--Section 1833(t)(16) of the Social Security Act (42 U.S.C. 1395(t)(16)) is amended by adding at the end the following new subparagraph:
''(F) PAYMENT INCENTIVE FOR THE TRANSITION FROM TRADITIONAL X-RAY IMAGING TO DIGITAL RADIOGRAPHY.'--Notwithstanding the previous provisions of this subsection:
''(i) LIMITATION ON PAYMENT FOR FILM X-RAY IMAGING SERVICES.'--In the case of an imaging service that is an X-ray taken using film and that is furnished during 2017 or a subsequent year, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 20 percent.
''(ii) PHASED-IN LIMITATION ON PAYMENT FOR COMPUTED RADIOGRAPHY IMAGING SERVICES.'--In the case of an imaging service that is an X-ray taken using computed radiography technology (as defined in section 1848(b)(9)(C))'--
''(I) in the case of such a service furnished during 2018, 2019, 2020, 2021, or 2022, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 7 percent; and
''(II) in the case of such a service furnished during 2023 or a subsequent year, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 10 percent.
''(iii) APPLICATION WITHOUT REGARD TO BUDGET NEUTRALITY.'--The reductions made under this paragraph'--
''(I) shall not be considered an adjustment under paragraph (2)(E); and
''(II) shall not be implemented in a budget neutral manner.
''(iv) IMPLEMENTATION.'--In order to implement this subparagraph, the Secretary shall adopt appropriate mechanisms which may include use of modifiers.''.
SEC. 4004.Treatment of infusion drugs furnished through durable medical equipment.Section 1842(o)(1) of the Social Security Act (42 U.S.C. 1395u(o)(1)) is amended'--
(1) in subparagraph (C), by inserting ''(and including a drug or biological described in subparagraph (D)(i) furnished on or after January 1, 2017)'' after ''2005''; and
(2) in subparagraph (D)'--
(A) by striking ''infusion drugs'' and inserting ''infusion drugs or biologicals'' each place it appears; and
(B) in clause (i)'--
(i) by striking ''2004'' and inserting ''2004, and before January 1, 2017''; and
(ii) by striking ''for such drug''.
SEC. 4005.Extension and expansion of prior authorization for power mobility devices (PMDs) and accessories and prior authorization audit limitations.Section 1834(a) of the Social Security Act (42 U.S.C. 1395m(a)) is amended'--
(1) in paragraph (15), by adding at the end the following new subparagraph:
''(D) LIMITATION ON AUDITS AFTER ADVANCE DETERMINATION.'--A claim for an item that has received a provisional affirmation under an advance determination under this paragraph or a prior authorization under paragraph (23) shall not be subject to review under section 1893(h) but may be subject to audits for potential fraud, inappropriate utilization, changes in billing patterns, or information that could not have been considered during the advance determination (such as proof of item delivery).''; and
(2) by adding at the end the following new paragraph:
''(23) PRIOR AUTHORIZATION FOR POWER MOBILITY DEVICES (PMDS) AND ACCESSORIES.'--Not later than 90 days after the date of the enactment of this paragraph, the Secretary shall, using funds provided under paragraph (2) of section 402(a) of the Social Security Amendments of 1967 and other funds available to the Secretary'--
''(A) extend at least through August 31, 2018, the PMD Prior Authorization Demonstration (being conducted under paragraph (1)(J) of such section);
''(B) begin to expand, as appropriate, such demonstration to include additional power mobility devices and accessories as part of initial claims for payment under this part for such devices; and
''(C) begin to expand such demonstration to such additional States or geographic areas as may be appropriate.''.
SEC. 4006.Civil monetary penalties for violations related to grants, contracts, and other agreements.(a) In general.'--Section 1128A of the Social Security Act (42 U.S.C. 1320a''7a) is amended by adding at the end the following new subsection:
''(o) Any person (including an organization, agency, or other entity, but excluding a program beneficiary, as defined in subsection (r)(4)) that, with respect to a grant, contract, or other agreement for which the Secretary of Health and Human Services provides funding'--
''(1) knowingly presents or causes to be presented a specified claim (as defined in subsection (r)(6)) under such grant, contract, or other agreement that the person knows or should know is false or fraudulent;
''(2) knowingly makes, uses, or causes to be made or used any false statement, omission, or misrepresentation of a material fact in any application, proposal, bid, progress report, or other document that is required to be submitted in order to directly or indirectly receive or retain funds provided in whole or in part by such Secretary pursuant to such grant, contract, or other agreement;
''(3) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent specified claim under such grant, contract, or other agreement;
''(4) knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement; or
''(5) fails to grant timely access, upon reasonable request (as defined by such Secretary in regulations), to the Inspector General of the Department, for the purpose of audits, investigations, evaluations, or other statutory functions of such Inspector General in matters involving such grants, contracts, or other agreements;
shall be subject, in addition to any other penalties that may be prescribed by law, to a civil money penalty in cases under paragraph (1), of not more than $10,000 for each specified claim; in cases under paragraph (2), not more than $50,000 for each false statement, omission, or misrepresentation of a material fact; in cases under paragraph (3), not more than $50,000 for each false record or statement; in cases under paragraph (4), not more than $50,000 for each false record or statement or $10,000 for each day that the person knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay; or in cases under paragraph (5), not more than $15,000 for each day of the failure described in such paragraph. In addition, in cases under paragraphs (1) and (3), such a person shall be subject to an assessment of not more than 3 times the amount claimed in the specified claim described in such paragraph in lieu of damages sustained by the United States or a specified State agency because of such specified claim, and in cases under paragraphs (2) and (4), such a person shall be subject to an assessment of not more than 3 times the total amount of the funds described in paragraph (2) or (4), respectively (or, in the case of an obligation to transmit property to the Secretary Health and Human Services described in paragraph (4), of the value of the property described in such paragraph) in lieu of damages sustained by the United States or a specified State agency because of such case. In addition, the Secretary of Health and Human Services may make a determination in the same proceeding to exclude the person from participation in the Federal health care programs (as defined in section 1128B(f)(1)) and to direct the appropriate State agency to exclude the person from participation in any State health care program.''(p) The provisions of subsections (c), (d), and (g) shall apply to a civil money penalty or assessment under subsection (o) in the same manner as such provisions apply to a penalty, assessment, or proceeding under subsection (a).
''(q) With respect to a penalty or assessment under subsection (o), the Inspector General of the Department is authorized to receive, and to retain for current use, such amounts of such penalty or assessment as are necessary to provide reimbursement for the costs of conducting investigations and audits with respect to such subsection and for monitoring compliance plans with respect to such subsection when such penalty or assessment is ordered by a court, voluntarily agreed to by the payor, or otherwise. Funds received by such Inspector General as reimbursement under the preceding sentence shall be deposited to the credit of the appropriations from which initially paid, or to appropriations for similar purposes currently available at the time of deposit, and shall remain available for obligation for 1 year from the date of the deposit of such funds.
''(r) For purposes of this subsection and subsections (o), (p), and (q):
''(1) The term 'Department' means the Department of Health and Human Services.
''(2) The term 'material' means having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.
''(3) The term 'other agreement' includes a cooperative agreement, scholarship, fellowship, loan, subsidy, payment for a specified use, donation agreement, award, or sub-award (regardless of whether one or more of the persons entering into the agreement is a contractor or sub-contractor).
''(4) The term 'program beneficiary' means, in the case of a grant, contract, or other agreement designed to accomplish the objective of awarding or otherwise furnishing benefits or assistance to individuals and for which the Secretary of Health and Human Services provides funding, an individual who applies for, or who receives, such benefits or assistance from such grant, contract, or other agreement. Such term does not include, with respect to such grant, contract, or other agreement, an officer, employee, or agent of a person or entity that receives such grant or that enters into such contract or other agreement.
''(5) The term 'recipient' includes a sub-recipient or subcontractor.
''(6) The term 'specified claim' means any application, request, or demand under a grant, contract, or other agreement for money or property, whether or not the United States or a specified State agency has title to the money or property, that is not a claim (as defined in subsection (i)(2)) and that'--
''(A) is presented or caused to be presented to an officer, employee, or agent of the Department or agency thereof, or of any specified State agency; or
''(B) is made to a contractor, grantee, or any other recipient if the money or property is to be spent or used on the Department's behalf or to advance a Department program or interest, and if the Department'--
''(i) provides or has provided any portion of the money or property requested or demanded; or
''(ii) will reimburse such contractor, grantee or other recipient for any portion of the money or property which is requested or demanded.
''(7) The term 'specified State agency' means an agency of a State government established or designated to administer or supervise the administration of a grant, contract, or other agreement funded in whole or in part by the Secretary of Health and Human Services.
''(s) For purposes of subsection (o), the term 'obligation' means an established duty, whether or not fixed, arising from an express or implied contractual, grantor-grantee, or licensor-licensee relationship, for a fee-based or similar relationship, from statute or regulation, or from the retention of any overpayment.''.
(b) Conforming amendments.'--Section 1128A of the Social Security Act (42 U.S.C. 1320a''7a) is amended'--
(1) in subsection (d)'--
(A) in paragraph (1), by inserting ''or specified claims'' after ''claims''; and
(B) in paragraph (2), by inserting ''or specified claims'' after ''claims'';
(2) in subsection (e), by inserting ''or specified claim'' after ''claim''; and
(3) in subsection (f)'--
(A) by inserting ''or specified claim (as defined in subsection (r)(6))'' after ''district where the claim'';
(B) by inserting ''(or, with respect to a person described in subsection (o), the person)'' after ''claimant'';
(C) by inserting ''that are not received by the Inspector General of the Department of Health and Human Services under subsection (q) as reimbursement'' after ''amounts recovered''; and
(D) by inserting ''(or, in the case of a penalty or assessment under subsection (o), by a specified State agency (as defined in subsection (r)(7))'' after ''or a State agency''.
(a) Drawdown and sale.'--Notwithstanding section 161 of the Energy Policy and Conservation Act (42 U.S.C. 6241), except as provided in subsection (b) the Secretary of Energy shall draw down and sell'--
(1) 4 million barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2018;
(2) 5 million barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2019;
(3) 8 million barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2020;
(4) 8 million barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2021;
(5) 10 million barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2022;
(6) 15 million barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2023;
(7) 15 million barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2024; and
(8) 15 million barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2025.
Amounts received for a sale under this subsection shall be deposited in the General Fund of the Treasury during the fiscal year in which the sale occurs.(b) Emergency protection.'--The Secretary shall not draw down and sell crude oil under this section in amounts that would result in a Strategic Petroleum Reserve that contains an inventory of petroleum products representing less than 90 days of emergency reserves, based on the average daily level of net imports of crude oil and petroleum products in the previous calendar year.
(c) Proceeds.'--Proceeds from a sale under this section shall be deposited into the general fund of the Treasury of the United States.
SEC. 4061.Lyme disease and other tick-borne diseases.(a) In general.'--Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the end the following new part:
''PART W'--Lyme disease and other tick-borne diseases
''SEC. 399OO.Research.
''(a) In general.'--The Secretary shall conduct or support epidemiological, basic, translational, and clinical research regarding Lyme disease and other tick-borne diseases.
''(b) Biennial reports.'--The Secretary shall ensure that each biennial report under section 403 includes information on actions undertaken by the National Institutes of Health to carry out subsection (a) with respect to Lyme disease and other tick-borne diseases, including an assessment of the progress made in improving the outcomes of Lyme disease and such other tick-borne diseases.
''SEC. 399OO''1.Working Group.
''(a) Establishment.'--The Secretary shall establish a permanent working group, to be known as the Interagency Lyme and Tick-Borne Disease Working Group (in this section and section 399OO''2 referred to as the 'Working Group'), to review all efforts within the Department of Health and Human Services concerning Lyme disease and other tick-borne diseases to ensure interagency coordination, minimize overlap, and examine research priorities.
''(b) Responsibilities.'--The Working Group shall'--
''(1) not later than 24 months after the date of enactment of this part, and every 24 months thereafter, develop or update a summary of'--
''(A) ongoing Lyme disease and other tick-borne disease research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, intervention, and access to services and supports for individuals with Lyme disease or other tick-borne diseases;
''(B) advances made pursuant to such research;
''(C) the engagement of the Department of Health and Human Services with persons that participate at the public meetings required by paragraph (5); and
''(D) the comments received by the Working Group at such public meetings and the Secretary's response to such comments;
''(2) ensure that a broad spectrum of scientific viewpoints is represented in each such summary;
''(3) monitor Federal activities with respect to Lyme disease and other tick-borne diseases;
''(4) make recommendations to the Secretary regarding any appropriate changes to such activities; and
''(5) ensure public input by holding annual public meetings that address scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms.
''(c) Membership.'--
''(1) IN GENERAL.'--The Working Group shall be composed of a total of 14 members as follows:
''(A) FEDERAL MEMBERS.'--Seven Federal members, consisting of one or more representatives of each of'--
''(i) the Office of the Assistant Secretary for Health;
''(ii) the Food and Drug Administration;
''(iii) the Centers for Disease Control and Prevention;
''(iv) the National Institutes of Health; and
''(v) such other agencies and offices of the Department of Health and Human Services as the Secretary determines appropriate.
''(B) NON-FEDERAL PUBLIC MEMBERS.'--Seven non-Federal public members, consisting of representatives of the following categories:
''(i) Physicians and other medical providers with experience in diagnosing and treating Lyme disease and other tick-borne diseases.
''(ii) Scientists or researchers with expertise.
''(iii) Patients and their family members.
''(iv) Nonprofit organizations that advocate for patients with respect to Lyme disease and other tick-borne diseases.
''(v) Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group.
''(2) APPOINTMENT.'--The members of the Working Group shall be appointed by the Secretary, except that of the non-Federal public members under paragraph (1)(B)'--
''(A) one shall be appointed by the Speaker of the House of Representatives; and
''(B) one shall be appointed by the majority leader of the Senate.
''(3) DIVERSITY OF SCIENTIFIC PERSPECTIVES.'--In making appointments under paragraph (2), the Secretary, the Speaker of the House of Representatives, and the majority leader of the Senate shall ensure that the non-Federal public members of the Working Group represent a diversity of scientific perspectives.
''(4) TERMS.'--The non-Federal public members of the Working Group shall each be appointed to serve a 4-year term and may be reappointed at the end of such term.
''(d) Meetings.'--The Working Group shall meet as often as necessary, as determined by the Secretary, but not less than twice each year.
''(e) Applicability of FACA.'--The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act.
''(f) Reporting.'--Not later than 24 months after the date of enactment of this part, and every 24 months thereafter, the Working Group'--
''(1) shall submit a report on its activities, including an up-to-date summary under subsection (b)(1) and any recommendations under subsection (b)(4), to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate;
''(2) shall make each such report publicly available on the website of the Department of Health and Human Services; and
''(3) shall allow any member of the Working Group to include in any such report minority views.
''SEC. 399OO''2.Strategic plan.
''Not later than 3 years after the date of enactment of this section, and every 5 years thereafter, the Secretary shall submit to the Congress a strategic plan, informed by the most recent summary under section 399OO''1(b)(1), for the conduct and support of Lyme disease and tick-borne disease research, including'--
''(1) proposed budgetary requirements;
''(2) a plan for improving outcomes of Lyme disease and other tick-borne diseases, including progress related to chronic or persistent symptoms and chronic or persistent infection and co-infections;
''(3) a plan for improving diagnosis, treatment, and prevention;
''(4) appropriate benchmarks to measure progress on achieving the improvements described in paragraphs (2) and (3); and
''(5) a plan to disseminate each summary under section 399OO''1(b)(1) and other relevant information developed by the Working Group to the public, including health care providers, public health departments, and other relevant medical groups.''.
(b) No additional authorization of appropriations.'--No additional funds are authorized to be appropriated for the purpose of carrying out this section and the amendment made by this section, and this section and such amendment shall be carried out using amounts otherwise available for such purpose.
SEC. 4062.Outreach to historically black colleges and universities.The Secretary of Health and Human Services shall conduct outreach to historically Black colleges and universities, Hispanic-serving institutions, Native American colleges, and rural colleges to ensure that health professionals from underrepresented populations are aware of research opportunities under this Act.
Passed the House of Representatives July 10, 2015.
Armageddon
ALERT: Former Soros Associate Just Warned 'A Thousand Lehmans' Event Is Going To Plunge The World Into Total Chaos
Sun, 11 Dec 2016 03:20
In the aftermath of what has been a wild couple of weeks of trading, today a former associate of George Soros told King World News that ''A thousand Lehmans'' event is going to plunge the world into total chaos.
Victor Sperandeo oversees over $3 billion, has been in the business 45 years, and has worked with famous individuals such as Leon Cooperman and George Soros. Below is what Sperandeo had to say.
Victor Sperandeo: ''The big story for 2017 will be the breakup of the euro and it will unleash total chaos'...
Victor Sperandeo continues: ''Individual currencies such as the lira will come back in Europe and everybody will write-off the debt. This will unleash total chaos and Europe will go into depression.
If Marin Le Pen wins in France, the euro is toast. France will pull out of the euro and other countries will follow. The world will witness the destruction of the euro and money will flee into hard assets such as gold and silver. But it will be chaos. It will be destruction. It will be a depression.
Italy will leave the euro as well. Beppe Grillo, leader of the Five Start Movement, is going to be the next Premier of Italy and he wants out of the euro. And as soon as Italy leaves and they have control of their own currency, they will have their own central banks buy their own bonds and write them off and print the lira. Just look at Britain. The plunge in the pound is not hurting them at all. Britain is selling more goods. That's the purpose of being able to control your own currency.''
Eric King: ''How will this ricochet across global markets?''
''It's A Thousand Lehmans'' EventVictor Sperandeo: ''Look at what happened after Lehman, and ask yourself, 'What is the euro relative to Lehman?' Answer: It's a thousand Lehman's.
All of these Italian banks '-- the big ones '-- are bankrupt. They have 400 billion euros of non-performing loans. Where is Italy going to get the money to pay that back? They are going to have to print it. They will get the Italian central bank to print the money and give it to the banks. But what happened when Lehman folded and before Bernanke and Paulson could get the TARP money? The markets crashed. They had to come in with one trillion dollars and that saved the game.
So this will be catastrophic. Assuming countries leave the euro, that's where we're headed. When Renzi lost in Italy, it pointed to the fact that Italians also want to leave the European Union.''
Eric King: ''As this unfolds and 'it's a thousand Lehmans' event, what happens to the United States?''
A Bad Moon RisingVictor Sperandeo: ''The global banking system is interconnected and Deutsche Bank has over $45 trillion in derivatives and JP Morgan has now overtaken Deutsche Bank as the leader in total derivatives exposure. So this will be horrible and I don't even think I can describe how horrible it will be because I don't even know all the negatives that are being hidden by the governments. People should get the lyrics to the song Bad Moon Rising and read them carefully.
I will just close by saying that grains, gold, silver and platinum are the most undervalued objects in the world. And as the financial system begins to implode, some of the money will flow into those metals as the panic into hard assets really takes hold.''
___http://kingworldnews.com/alert-former-soros-associate-just-warned-a-thousand-lehmans-event-is-going-to-plunge-the-world-into-total-chaos/
Second Half of Show
grebennikov flying box - Google Search
Sat, 10 Dec 2016 16:35
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Ottomania
29 Dead, 10 Detained in Turkey Attacks Aimed at Police: Updates | News | teleSUR English
Sun, 11 Dec 2016 07:58
Turkey's Interior Minister Suleyman Soylu has confirmed that 10 people have been detained in relation to the two bombings that left 29 dead and 166 wounded on Tuesday.
The two blasts happened shortly after a soccer match between the country's top teams ended in Istanbul and were directed at police.
Soylu said the people had been detained based on evidence from the first blast '' a vehicle that had detonated at a riot-police rallying point just outside the Vodafone Arena, home to Istanbul's Besiktas soccer team. However, there is no clear indication as to whom was behind the attacks, he added, and no one has claimed responsibility yet.
RELATED:Suicide Bomber Kills at Least 50 at Kurdish Wedding in Turkey
Nevertheless, the attacks come only a week after the Islamic State group called for attacks on the country's "security, military, economic and media establishment," leading many to suspect the extremist group.
Soylu said one of the explosions hit directly outside the stadium, while the suspected suicide bomber struck in the adjacent Macka park less than a minute later.
President Tayyip Erdogan described the blasts as a terrorist attack on police and civilians. He said the aim had been to cause the maximum number of casualties.
"As a result of these attacks unfortunately we have martyrs and wounded," Erdogan said in a statement.
"Nobody should doubt that with God's will, we as a country and a nation will overcome terror, terrorist organizations ... and the forces behind them."
Describing the blasts to Reuters, Omer Yilmaz, who works as a cleaner at the nearby Dolmabahce mosque, directly across the road from the stadium, said: "It was like hell. The flames went all the way up to the sky."
"People ducked under the tables, women began crying," he continued. "Football fans drinking tea at the cafe sought shelter, it was horrible."
Islamic State group, Kurdish and far-leftist militants have all carried out bomb attacks in recent years including in Istanbul and the capital Ankara.
Turkey, a NATO member, is part of the U.S.-led coalition fighting Islamic State group in Syria, and is battling an insurgency by Kurdish militants in its southeast.
Casualties Mainly Police
The first blast came about two hours after the end of the match between Besiktas and Bursaspor, at an assembly point for riot police, according to minister Soylu. The second one came as remaining police surrounded the suicide bomber.
As a result, reported a Reuters photographer, many riot police officers were seriously wounded and two civilians lost their lives.
Armed police sealed off streets and a police water cannon doused the wreckage of a burned-out car as two separate fires burned on the road outside the stadium, he reported.
According to Soylu, 27 police officers were killed in the explosions, which have been described as "horrific acts of terror" by NATO Secretary General Jens Stoltenberg. Another 17 were wounded and undergoing surgery, and six more were in intensive care, Soylu added.
Both soccer teams have condemned the attacks, with Bursaspor representatives saying none of their fans appeared to have been harmed.
OPINION: Europe Can No Longer Pretend to Respect Human Rights
"Those attacking our nation's unity and solidarity will never win," Sports Minister Akif Cagatay Kilic said on Twitter. Transport Minister Ahmet Arslan, also writing on Twitter, described it as a terrorist attack.
Turkey has been hit by a series of bombings in recent years, some blamed on Islamic State group militants, others claimed by Kurdish and far-leftist militant groups.
In June, around 45 people were killed and hundreds wounded when three suspected Islamic State group militants carried out a gun and bomb attack on Istanbul's Ataturk airport.
Nukes
Should we be worried about Fukushima radiation?
Sun, 11 Dec 2016 07:20
USA Today NetworkMary Bowerman and Tracy Loew, USA TODAY NETWORK2:51 p.m. EST December 9, 2016
Scientists have detected radiation from Japan's 2011 nuclear disaster on the West Coast. USA TODAY NETWORK
This Jan. 12, 2016 photo, shows No. 3 nuclear reactor, bottom, at Takahama nuclear power station in Takahama town in Fukui prefecture, northwestern Japan. Japan has restarted a nuclear reactor that burns plutonium-based fuel for power generation, first under the post-Fukushima safety rules. The No. 3 reactor at Takahama nuclear plant in western Japan, operated by Kansai Electric Power Co., becomes the first one using plutonium-uranium hybrid fuel known as MOX to go back online since the 2011 meltdowns at Fukushima.(Photo: AP)
For the first time, seaborne radiation from Japan's Fukushima nuclear disaster has been detected on the West Coast of the United States.
The levels are very low and shouldn't harm people eating fish from the West Coast or swimming in the ocean, according to Ken Buesseler, a senior scientist at Woods Hole Oceanographic Institution.
"To put it in context, if you were to swim everyday for six hours a day in those waters for a year, that additional radiation from the addressed cesium from Japan ... is 1000 times smaller than one dental x-ray," Buesseler said in a phone interview.
But while people make a choice to be exposed to x-ray radiation, they don't choose to be exposed to Japanese radiation, he said.
Cesium-134, the so-called fingerprint of Fukushima, was measured in seawater samples taken from Tillamook Bay and Gold Beach in Oregon, according to researchers from the Woods Hole Oceanographic Institution.
Celsium-134 was also detected in a Canadian salmon, according to the Fukushima InFORM project, led by University of Victoria chemical oceanographer Jay Cullen.
USA TODAY
Fukushima radiation has reached U.S. shores
Massive amounts of contaminated water were released from the crippled nuclear plant following a 9.0 magnitude earthquake and tsunami in March 2011. More radiation was released to the air, then fell to the sea.
"In Japan, at its peak [celsium-134 levels] it was 10 million times higher than what we are seeing today on the West Coast," he said.
Buesseler, who runs a crowd-funded, citizen science seawater sampling project that has tracked the radiation plume as it slowly makes its way across the Pacific Ocean, said the samples, were taken in January and February of 2016 and later analyzed. They each measured 0.3 becquerels per cubic meter of cesium-134.
He said scientists have turned to crowdfunding to measure the radiation from the Fukushima nuclear disaster because federal agencies are not funding research on ocean radioactive studies stemming from the 2011 event.
"We don't expect to see health concerns from swimming or fish consumption, but we would like to continue monitoring until (the radiation level) goes back down again," he said.
Learn more about Ken Beusseler's crowd-funded, citizen-science seawater sampling project at http://www.ourradioactiveocean.org/.
Read or Share this story: http://usat.ly/2htNGW1
ANTS!
Fire ants could become Australia's worst pest, experts warn - BBC News
Sun, 11 Dec 2016 14:23
Image copyrightBiosecurity QueenslandImage caption Time is running out to eradicate the red imported fire ant, experts say Red fire ants could wreak more damage in Australia than feral rabbits, cane toads and foxes combined, experts have warned in a new report.
Originally from South America, the red imported fire ant is feared for its burning and potentially lethal sting.
If not eradicated, it is estimated the insect could trigger up to 3,000 anaphylactic reactions in Australia each year.
An independent review called for urgent action before it spread nationwide.
The analysis of the National Red Imported Fire Ant Eradication Program recommended spending A$380m (£225m; $284m) over 10 years to stop the ant's rapid march, the ABC reported.
Red ant colonies entered Australia through the Port of Brisbane in 2001. Since then, they have flourished in south-east Queensland and are now estimated to be within 50km (30 miles) of the New South Wales border.
Image caption Experts fear the ant could spread from Queensland to New South Wales The aggressive insect is known to bite humans and livestock en masse. Its venomous sting can cause blistered spots or even trigger a deadly allergic reaction.
In the United States, more than 80 deaths have been attributed to the species.
Invasive Species Council CEO Andrew Cox said unless Australia ramped up its eradication programme, it could suffer a damage bill worth billions of dollars.
"Fire ants will be a massive hit to our economy, our environment, our healthcare system and our outdoor lifestyle if we do not act now," he said in a statement.
"Eradication is still possible and in our nation's interest but the time to act is rapidly diminishing."
The species could become more damaging than any other feral animal, he said.
Image copyrightBiosecurity QueenslandState and federal authorities have faced criticism for not doing more to control the outbreak.
A spokesman for federal Agricultural Minister Barnaby Joyce said $328m had already been spent on eradication efforts. Further investment would be considered at the next ministers' meeting in May.
"The Agricultural Ministers' Forum has agreed with the findings of independent review that eradication remains technically feasible, cost-beneficial and in the national interest," he said in a statement to the BBC.
Which is the most notorious ant species on earth?
CYBER
NATIVE AD-700 Pages of Terrorism Data Stolen and Leaked from Europol - Deep Dot Web
Sun, 11 Dec 2016 01:14
It has recently been found that an officer working for the Europol agency has leaked sensitive material about the agency's online investigations.
A televised documentary stated that it had found over 700 pages of confidential data which included terrorism investigations. The data was found on a hard drive that had been linked to the internet. The program also stated that the hard drive containing the information was not password protected. Before the documentary aired, Europol released a statement acknowledging the leak and that an investigation has been launched to find out how, and why the data became public:
Although this case relates to Europol sensitive information dating from around 10 years ago, Europol immediately informed the concerned member states. As of today, there is no indication that an investigation has been jeopardized, due to the compromise of this historical data. Europol will continue to assess the impact of the data in question, together with the concerned member states.
A reporter for the program that was aired stated that he found the information via a search engine called Shodan; a search engine that searches the Internet of Things. He also stated that there was no password needed to access the hard drive; which he did remotely through the internet.
It was also reported that the documents contained names and telephone numbers of terrorism suspects, and associates. Most of the data was from 2006 to 2008. It included the Madrid train bombing investigations, a Netherlands based Islamist terror cell called The Hofstad Network, as well as information about attacks that have been successfully stopped aboard several flights. The reporter also said that the hard drive contained information on investigations that were never made public.
Europol claims that the officer responsible for the leak had copied the files to a separate, personal hard drive against Europol's rules; but that the officer no longer worked for the agency.
The hard drive in question was a Lenovo Lomega and the Chinese based company had released a statement saying that it is up to the owner of the drive to make it secure. Older models such as this one require the user to input a password before they can be used securely.
Dr. Bibi van Ginkel, a senior researcher with the Netherlands Institute of International Relations, thinks a leak containing data such as this one could have negative consequences:
Police organizations never want to reveal how much they know to prevent bad guys from understanding how the police operate and infiltrate them. In times that better international-cooperation and data exchange is needed, this leak might jeopardize the trust between states.
Europol Director Rob Wainwright announced that in light of this investigation he will be attending a seminar in London this January to learn more about data protection and online privacy practices.
Secret Europol terror data found online - BBC News
Sun, 11 Dec 2016 01:13
Image copyrightLenovoImage caption The classified documents had been saved to an Iomega drive A police officer working for Europol exposed sensitive data about security investigations to the internet.
The European Union's law enforcement agency acknowledged the error ahead of a Dutch documentary's broadcast.
The TV programme Zembla said it had found more than 700 pages of confidential dossiers, including details of terrorism probes, on a hard drive linked to the net.
It said the networked drive was not password protected.
Europol said it had launched an investigation into the matter.
"Although this case relates to Europol sensitive information dating from around 10 years ago, Europol immediately informed the concerned member states," a spokesman for the law agency said.
"As of today, there is no indication that an investigation has been jeopardised, due to the compromise of this historical data.
"Europol will continue to assess the impact of the data in question, together with concerned member states."
Image copyrightShodanImage caption The Dutch TV show made its discovery via an online search engine A reporter for Zembla told the BBC that it found the documents via a service that specialises in finding internet-connected kit.
"We found the disk online through a search engine called Shodan," said Vincent Verweij.
"We were able to remotely access the disk through the internet. It didn't require a password."
Zembla reported that documents contained the names and telephone numbers of hundreds of people associated with terrorism.
It added that they mostly dated from 2006 to 2008 and included investigations into the Madrid train bombings, the Hofstad Network - a Netherlands-based Islamist terror network - and foiled attacks on several flights.
In addition, it said, other investigations that had never been made public were revealed.
Europol confirmed that the officer had copied the data to a personal drive in "clear contravention" of its rules, but had since left its staff.
The BBC understands that after working for the agency for more than a decade, she now works for the Dutch police.
The hard drive in question was one of Lenovo's Iomega models. The Chinese company has said that it is the responsibility of owners to make them secure. Later models required that a password needed to be set before their use.
One counter-terrorism specialist said the apparent mistake could have serious consequences.
Image copyrightGetty ImagesImage caption A British civil servant, Rob Wainwright, currently heads up Europol "Police organisations never want to reveal how much they know to prevent bad guys understanding how the police operate and infiltrate [them]," Dr Bibi van Ginkel, a senior research fellow at the Netherlands Institute of International Relations, said.
"In times that better international co-operation and data exchange is needed, this leak might jeopardise trust between states."
The revelation coincides with an announcement that Europol's current director, Rob Wainwright, will take part in a seminar in London in January dedicated to data protection and online privacy.
John Matherly-US intelligence chief: we might use the internet of things to spy on you | Technology | The Guardian
Sun, 11 Dec 2016 01:20
'In the future, intelligence services might use the internet of things for identification, surveillance, monitoring, location tracking, and targeting for recruitment', says James Clapper, US director of national intelligence. Photograph: Alex Brandon/AP
The US intelligence chief has acknowledged for the first time that agencies might use a new generation of smart household devices to increase their surveillance capabilities.
As increasing numbers of devices connect to the internet and to one another, the so-called internet of things promises consumers increased convenience '' the remotely operated thermostat from Google-owned Nest is a leading example. But as home computing migrates away from the laptop, the tablet and the smartphone, experts warn that the security features on the coming wave of automobiles, dishwashers and alarm systems lag far behind.
In an appearance at a Washington thinktank last month, the director of the National Security Agency, Adm Michael Rogers, said that it was time to consider making the home devices ''more defensible'', but did not address the opportunities that increased numbers and even categories of connected devices provide to his surveillance agency.
However, James Clapper, the US director of national intelligence, was more direct in testimony submitted to the Senate on Tuesday as part of an assessment of threats facing the United States.
''In the future, intelligence services might use the [internet of things] for identification, surveillance, monitoring, location tracking, and targeting for recruitment, or to gain access to networks or user credentials,'' Clapper said.
Clapper did not specifically name any intelligence agency as involved in household-device surveillance. But security experts examining the internet of things take as a given that the US and other surveillance services will intercept the signals the newly networked devices emit, much as they do with those from cellphones. Amateurs are already interested in easily compromised hardware; computer programmer John Matherly's search engine Shodan indexes thousands of completely unsecured web-connected devices.
Online threats again topped the intelligence chief's list of ''worldwide threats'' the US faces, with the mutating threat of low-intensity terrorism quickly following. While Clapper has for years used the equivocal term ''evolving'' when asked about the scope of the threat, he said Tuesday that Sunni violent extremism ''has more groups, members, and safe havens than at any other point in history''.
The Islamic State topped the threat index, but Clapper also warned that the US-backed Saudi war in Yemen was redounding to the benefit of al-Qaida's local affiliate.
Domestically, ''homegrown extremists'' are the greatest terrorist threat, rather than Islamic State or al-Qaida attacks planned from overseas. Clapper cited the San Bernardino and Chattanooga shootings as examples of lethal operations emanating from self-starting extremists ''without direct guidance from [Isis] leadership''.
US intelligence officials did not foresee Isis suffering significant setbacks in 2016 despite a war in Syria and Iraq that the Pentagon has pledged to escalate. The chief of defense intelligence, Marine Lt Gen Vincent Stewart, said the jihadist army would ''probably retain Sunni Arab urban centers'' in 2016, even as military leaders pledged to wrest the key cities of Raqqa and Mosul from it.
Contradicting the US defense secretary, Ashton Carter, Stewart said he was ''less optimistic in the near term about Mosul'', saying the US and Iraqi government would ''certainly not'' retake it in 2016.
The negative outlook comes as Carter traveled on Tuesday to meet with his fellow defense chiefs in Brussels for a discussion on increasing their contributions against Isis.
On the Iran nuclear deal, Clapper said intelligence agencies were in a ''distrust and verify mode'', but added: ''We have no evidence thus far that they're moving toward violation.''
Clapper's admission about the surveillance potential for networked home devices is rare for a US official. But in an overlooked 2012 speech, the then CIA director David Petraeus called the surveillance implications of the internet of things ''transformational '... particularly to their effect on clandestine tradecraft''.
During testimony to both the Senate armed services committee and the intelligence panel, Clapper cited Russia, China, Iran, North Korea and the Islamic State as bolstering their online espionage, disinformation, theft, propaganda and data-destruction capabilities. He warned that the US's ability to correctly attribute the culprits of those actions would probably diminish with ''improving offensive tradecraft, the use of proxies, and the creation of cover organizations''.
Clapper suggested that US adversaries had overtaken its online capabilities: ''Russia and China continue to have the most sophisticated cyber programs.''
The White House's new cybersecurity initiative, unveiled on Tuesday, pledged increased security for nontraditional networked home devices. It tasked the Department of Homeland Security to ''test and certify networked devices within the 'Internet of Things'.'' It did not discuss any tension between the US's twin cybersecurity and surveillance priorities.
Connected household devices are a potential treasure trove to intelligence agencies seeking unobtrusive ways to listen and watch a target, according to a study that Harvard's Berkman Center for Internet and Society released last week. The study found that the signals explosion represented by the internet of things would overwhelm any privacy benefits by users of commercial encryption '' even as Clapper in his testimony again alleged that the growth of encryption was having a ''negative effect on intelligence gathering''.
The report's authors cited a 2001 case in which the FBI had sought to compel a company that makes emergency communications hardware for automobiles '' similar by description to OnStar, though the company was not named '' to assist agents in Nevada in listening in on conversations in a client's car.
In February 2015, news reports revealed that microphones on Samsung ''smart'' televisions were ''always on'' so as to receive any audio that it could interpret as an instruction.
''Law enforcement or intelligence agencies may start to seek orders compelling Samsung, Google, Mattel, Nest or vendors of other networked devices to push an update or flip a digital switch to intercept the ambient communications of a target,'' the authors wrote.
CLIPS AND DOCS
VIDEO - Rep. Tulsi Gabbard Hits Back at Obama Foreign Policy Cronies and Neocons!! - 12/8/16 - YouTube
Sun, 11 Dec 2016 15:07
VIDEO - CNN Anchor Shakes in Fear Over American Generals Being in Trump's Cabinet - YouTube
Sun, 11 Dec 2016 15:00
VIDEO - Bipartisan group of senators calls for probe of Russian role in 2016 US elections - CNNPolitics.com
Sun, 11 Dec 2016 14:39
The group -- two Republicans and two Democrats -- called for an investigation into American intelligence agencies' conclusion that Russian hacking was intended to help President-elect Donald Trump defeat Hillary Clinton.
"Congress's national security committees have worked diligently to address the complex challenge of cybersecurity, but recent events show that more must be done," said Sens. Chuck Schumer, the incoming Senate Democratic leader, Sen. John McCain, the Armed Services Committee chairman, fellow Republican Sen. Lindsey Graham, and Sen. Jack Reed, the top Armed Services Committee Democrat, in a Sunday morning statement.
"While protecting classified material, we have an obligation to inform the public about recent cyberattacks that have cut to the heart of our free society. Democrats and Republicans must work together, and across the jurisdictional lines of the Congress, to examine these recent incidents thoroughly and devise comprehensive solutions to deter and defend against further cyber-attacks."
The letter is an implicit rebuke of Trump, who has questioned whether Russia actually interfered with the election, including with hacks of Democratic operatives, and came two days after Trump sided with Russia over the CIA and attacked the US intelligence assessment of Russia's role.
"These are the same people that said Saddam Hussein had weapons of mass destruction," Trump's transition team said in a terse, unsigned statement targeting the CIA on Friday.
"The election ended a long time ago in one of the biggest Electoral College victories in history. It's now time to move on and 'Make America Great Again.'"
The transition team's reference to the agency's most humiliating recent intelligence misfire -- over its conclusion that Iraq under Saddam Hussein had weapons of mass destruction -- threatens to cast an early cloud over relations between the Trump White House and the CIA, whose assessments he'll need to make monumental decisions.
The top leadership of the agency that presided over the Iraq failure during the Bush administration has long since been replaced. But the comments from Trump's camp will cause concern in the Intelligence community about the incoming President's attitude to America's spy agencies. CNN reported last week that Trump is getting intelligence briefings only once a week. Several previous presidents preparing for the inauguration had a more intense briefing schedule.
VIDEO - Obama orders review of 2016 election cyber attacks | Reuters
Sun, 11 Dec 2016 08:08
Fri Dec 9, 2016 | 3:59 PM EST
ByJeff Mason|WASHINGTON
WASHINGTON U.S. President Barack Obama has ordered intelligence agencies to review cyber attacks and foreign intervention into the 2016 election and deliver a report before he leaves office on Jan. 20, the White House said on Friday.
In October, the U.S. government formally accused Russia of a campaign of cyber attacks against Democratic Party organizations ahead of the Nov. 8 presidential election, and Obama has said he warned Russian President Vladimir Putin about consequences for the attacks.
The review and its timeline are a signal that Obama wants the issue addressed before he hands power to President-elect Donald Trump, who cast doubt on Russia's hacking role and praised Putin during the campaign.
Obama's homeland security adviser, Lisa Monaco, told reporters the report's results would be shared with lawmakers and others.
"The president has directed the intelligence community to conduct a full review of what happened during the 2016 election process ... and to capture lessons learned from that and to report to a range of stakeholders, to include the Congress," she said during an event hosted by the Christian Science Monitor.
White House spokesman Eric Schultz said the review would be a "deep dive" that would look for a pattern of such behavior over several years during election time, dating as far back as the 2008 presidential election.
He noted that Obama wanted the review completed under his watch. "This is a major priority," Schultz said.
During his campaign for the White House, Trump called on Russia to dig up missing emails from his opponent, Hillary Clinton, from her time as secretary of state under Obama, a fellow Democrat. That move prompted critics to accuse him of encouraging foreign actors to conduct espionage.
The New York businessman has said he is not convinced Russia was behind the attacks.
"I don't believe they interfered," Trump told Time magazine about Russia in an interview published this week. "That became a laughing point, not a talking point, a laughing point. Any time I do something, they say, 'Oh, Russia interfered.'"
People Trump has nominated for top national security posts in his new administration have taken a harsher stance toward Moscow.
Russian officials have denied all accusations of interference in the U.S. election.
Obama has come under pressure from Democratic lawmakers to declassify more intelligence on the alleged hackings.
A government source said the review was sparked in part to respond to those demands as well as to determine how much material related to the subject could be made public.
''Given President-elect Trump's disturbing refusal to listen to our intelligence community and accept that the hacking was orchestrated by the Kremlin, there is an added urgency to the need for a thorough review before President Obama leaves office next month,'' Rep. Adam Schiff of California, the senior Democrat on the House Intelligence Committee, said in a statement.
Monaco said cyber attacks were not new but might have crossed a "new threshold" this year.
When she was working as a senior Federal Bureau of Investigation official in 2008, she said, the agency alerted the presidential campaigns of then-Senator Obama and Republican Senator John McCain that China had infiltrated their respective systems.
"We've seen in 2008 and in this last election system malicious cyber activity," Monaco said.
Asked if Trump's transition team was not concerned enough about Russia's influence on the election or about other threats to the United States such as infectious disease outbreaks, Monaco said it was too soon to say. She noted that she had not met with her successor because the Trump team had yet to name one.
(Reporting by Jeff Mason in Washington; Additional reporting by Mark Hosenball and Jonathan Landay in Washington; Editing by Jonathan Oatis)
VIDEO - Radiation from Japan Fukushima nuclear disaster reaches Oregon - CBS News
Sun, 11 Dec 2016 07:17
SALEM, Ore. - Seaborne radiation from Japan's Fukushima nuclear disaster has been detected on Oregon shores, researchers say.
Seawater samples from Tillamook Bay and Gold Beach indicate radiation from the nuclear disaster but at extremely low levels not harmful to humans or the environment.
Citing the Woods Hole Oceanographic Institution, the Statesman Journal newspaper reports the samples were taken last winter and later analyzed.
Massive amounts of contaminated water were released from the crippled Japan nuclear plant following a 9.0 magnitude earthquake and tsunami in March 2011.
Woods Hole chemical oceanographer Ken Buesseler runs a crowdfunded, citizen-science seawater sampling project that has tracked the radiation plume as it makes its way across the Pacific Ocean.
(C) 2016 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.
VIDEO - Transgendered traffic lights
Sun, 11 Dec 2016 07:06
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VIDEO - The best Martin Shkreli interview to date - YouTube
Sun, 11 Dec 2016 06:13
VIDEO - Clinton campaign tried to silence Mika Brzezinski for trivial statements - YouTube
Sun, 11 Dec 2016 06:08
VIDEO - Congresswoman Tulsi Gabbard Says The U.S. Government Is Directly Funding ISIS And Al Qaeda! - YouTube
Sun, 11 Dec 2016 05:57
VIDEO - Rep. Schiff Said Carlson Holds Water for Putin, Then Tells Him Not to Resort to Personal Insults - YouTube
Sun, 11 Dec 2016 05:40
VIDEO - Rep. Tulsi Gabbard Defends Trump Nominating Generals to His Cabinet - YouTube
Sun, 11 Dec 2016 05:34
VIDEO - Chris Cuomo Sneers: Climate Skepticism Like Opposing Interracial Marriage | MRCTV
Sun, 11 Dec 2016 05:30
[See NewsBusters for more.] New Day co-anchor Chris Cuomo on Thursday continued the media freak out over Donald Trump picking a climate change doubter to run the Environmental Protection Agency. He even outrageously compared those with similar beliefs to past opposition of interracial marriage. While discussing the appointment of Oklahoma Attorney General Scott Pruitt to run the EPA, Cuomo ranted to CNN co-anchor Alisyn Camerota, ''People thought the world was flat.'' He continued, ''People thought blacks and whites shouldn't marry. People thought blacks shouldn't be equal. It doesn't mean you accept it as fact as a leader.''
VIDEO - Behar Blames 'Horrible' Scott Pruitt on 907 Earthquakes in Oklahoma | MRCTV
Sun, 11 Dec 2016 05:04
With each conservative cabinet pick, the media freaks out and does their best to characterize each person as a radical extremist instead of just, well, a consistent conservative. Oklahoma Attorney General Scott Pruitt was next in line for the media to attack, as Trump picked the critic of excessive government regulation to head the Environmental Protection Agency. The liberal women at the View were quick to bash the ''horrible pick'' as someone who was going to leave the United States in an apocalyptic wasteland filled with polluted air and dirty water.
Read more of the blog at Newsbusters, here.
VIDEO - NBC Warns: Trump Tweets Could Wreck Your 401K! | MRCTV
Sun, 11 Dec 2016 04:17
More in the cross-post on the MRC's NewsBusters blog.
On Friday, NBC's Today devoted a full report to stoking fears that Donald Trump's criticism of businesses could ruin people's investments. MSNBC host Stephanie Ruhle appeared on the morning show to warn viewers: ''Imagine a tweet, a single tweet losing you money. 140 characters could cost you 140 bucks maybe 1,400, maybe more. That is how powerful the president's voice is, it can move markets.''
She took aim at the President-elect: ''And whether you know it or not, that offhanded tweet from Donald Trump blasting the CEO, hitting up this industry, it could send your 401k up or down '' maybe it already has.'' Moments later, Ruhle noted that ''Trump's intervention in business has some CEOs nervous.''
VIDEO - Little Caesars Commercial Compliation - YouTube
Sun, 11 Dec 2016 03:32
VIDEO - Hillary Clinton calls fake news a 'danger'
Sun, 11 Dec 2016 03:30
Hillary Clinton calls fake news a 'danger'Hillary Clinton said fake news is an "epidemic" and "a danger that must be addressed and addressed quickly" while speaking on Capitol Hill for a portrait unveiling in honor of retiring Senate Minority Leader Harry Reid. (Dec. 8)
VIDEO - Slate's Michelle Goldberg: Trump Post-Election Rallies Designed To "Menace And Threaten" Those Who Didn't Vote For Him | Video | RealClearPolitics
Sun, 11 Dec 2016 03:22
MSNBC'S Chris Hayes and Slate's Michelle Goldberg talk about how they are uncomfortable with Donald Trump's decision to hold post-election "thank you" rallies. Donald Trump made the third stop on his 'Victory Tour' Thursday night in Iowa.
Goldberg notes that Donald Trump's "menacing" statements are only menacing "because [they are] coming from the mouth of Donald Trump."
She referred to Trump's menacing statements, such as: "They're on our side, they just don't know it yet," and: "You're going to like what we have in store."
"I don't think I am reading too much into this," she said. "Because it is coming from the mouth of Donald Trump. Who is going to turn our country into a racist police state."
CHRIS HAYES: I have a sort of instinctual aversion to the mode of the Trump rally --particularly after he won. It feels like, it feels not that far from "Rallies For The Leader," which don't have a great history in politics across the world.
MICHELLE GOLDBERG, SLATE: The whole posture is one of kind of both rallying the people who voted for him, and also kind of menacing and threatening the majority who didn't -- with these kind of menacing asides. "They're on our side, they just don't know it yet." "You're going to like what we have in store."
It is -- I don't think I am reading too much into this.
HAYES: That's the question, right? Like, in the words of Barack Obama: Are you saying that is menacing because of the words, or because it is coming from the mouth of Donald Trump?
GOLDBERG: Because it is coming from the mouth of Donald Trump. Who is going to turn our country into a racist police state.
CHRISTINA GREER, FORDHAM UNIVERSITY: Well, that is what he ran on, and here we are.
Goldberg also warned that Trump will turn the U.S. into a "racist police state" on Thursday's broadcast of All In:
VIDEO - Ex-CIA operative: We may need a new vote
Sun, 11 Dec 2016 02:08
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