ckabee makes his announcement -- who will have the biggest impact? 8 they all bring something to the table. the battle with hillary clinton is joined in that fashion and she can strike at hillary in a way the other republican candidates cannot. carson is the only other african-american and we saw him in 2008, winning the iowa caucuses. mike huckabee is an old face. the question is whether he can capture that evangelical vote and do really well. host: who of three fiorina carsons and huckabee are the other candidates most afraid of? caller: i think there isn't a question that huckabee poses the biggest threat. he is the only of the three who

has won states. he won and the south and iowa. he followed bill clinton into office. he can win the evangelical voters which are really important in iowa and south carolina. four people who are fresher faces going after the same voters, ted cruz and mike huckabee are very much a threat to take a wait the first early states -- take away the first early states. host: mike huckabee announcing today. we will show that announcement life on c-span at 11:00 a.m. he will make that announcement from hope, arkansas and rollout into a weeklong iowa and south carolina trip. all of the candidates making their appearances in the early primary states. talk about ben carson. who does he take the most votes

away from? caller:guest: he is very popular with young voters. at cpac he was one of the more popular candidates. this is a big deal for the republicans, attracting younger voters. he is important for them. he is somebody who burst onto the scene two years ago at the prayer breakfast and really caught everybody by surprise when he went after obama sitting a few feet away from him. he showed a willingness to go after the president had on. -- head on. even though the president isn't on the ballot, his former secretary of state will be. he knows how to get attention. he is very articulate and revered as a world-renowned neurosurgeon.

all of these questions about whether his lack of political experience will hurt him, but i think, one question is whether people are looking for a fresh face. he is certainly one of them. host: those two announcements coming this week already. mike huckabee expected to announce. you have been writing a lot about jed bush. one of the things you wrote about is he was out early and flex his financial muscles. he was trying to raise money to scare others out of the race. has anybody been scared out of the race? guest: it doesn't look like it. a couple weeks ago there were 19 people giving speeches about running for president. he is raising a lot of money. he will top $100 million in his first few months, but more are getting in the race and more are considering it. one who is considering and is

not scared by jed bush is the governor of ohio. if jed bush was scaring people, he would not be getting into the race or considering it. he knows how much bush money can scare you out of the presidential race because he was scared out of the race by george w but he is looking at running this year. guest: i would argue that mitt romney was scared out of the race by jed bush. two establishment titans owing against each other and romney looked at the reality and decided he could not make it work. host: we are talking about the 20 sixteen rd to the white house. the lines are open -- 2016 road to the white house. democrats call (202) 748-8000 republicans (202) 748-8001 and independents (202) 748-8002.

we're the next 45 or 50 minutes to talk about this topic. as we said yesterday, ben carson made it official. he talked about his announcement sunday night but at his event in detroit he made his presidential campaign official. here is a bit of ben carson's speech from the event. [video clip] >> that is what we have to start doing. opening our mouths for the values and principles of america. [applause] i have to tell you something. i am not politically correct. [cheers] [applause] i am probably never going to be politically correct, because i am not a politician.

i don't want to be a politician. politicians do what is politically expedient. i want to do what is right. host: i am not a politician. will we be hearing this refrain a lot? guest: absolutely. there are so many real politicians running including hillary clinton who is as political as they get. they are all political. all of these non-politicians who run for president are instantly politicians. you have to look at it from a meta-perspective. here is ben carson's saying i am not politically correct. that is a political message. he is saying i will hear things -- say things you do not normally hear from someone like me. the reality is, it is extremely

difficult for them to win. carly fiorina is another non-politician in the race. she was working on the mccain campaign as a surrogate spokeswoman and said something she shouldn't, she would veer off message and was taken off tv. it is great to be a nonpolitician, the public likes that, but the reality is that they make mistakes. if you have never run for anything, she actually ran for senate in california and does have that experience. but has never held elective office. it is extremely difficult to pull that off. the last time we elected a nonpolitician was dwight allen -- dwight eisenhower. he was the supreme allied commander for world war ii. that gives him a pass. host: "the washington post," writes enter the nonpoliticians. a grand tradition of thinking they can do politics better.

it is easy to disparage public servants, much harder to reshape the forces pushing them away from solutions and harder still to fashion compromise without abandoning principle. ms. furia and mr. carson's are politicians on the national stage. shane, your thoughts on the un-politician versus the politicians already in republican primaries. some members of the united states senate and former governors as well. guest: one of the questions you asked earlier is who takes votes from whom? it is really interesting that ben carson and carly fiorina got into the race on the same day. there was kind of an gentleman's agreement not to step on each other's announcements. they were spaced out one week apart between rand paul and marco rubio -- these two got in on the same day. one of the reasons is they are competing with each other. everybody else in this field has

held elected office. if they are not part of washington they are part of the establishment in some fashion. even if your ted cruz and are antiestablishment or rand paul wanting to defeat the washington machine, you are part of it. these to him are competing for that vote. there is a long tradition of people getting into races and a longer tradition of them losing. host: shane goldmacher of "the washington caller: thanks for taking my call. caller:i think campaign finances distorted the politics to where unless you are a corporation you're not going to get any representation. bernie sanders is probably the only credible candidate, and i

don't think he is going to get elected because of money. if they didn't have money pushing against it, they could get immigration reform and make it work. you can make it if l.a. to hire an undocumented worker. you can send the criminals back to mexico and legalize the people that are here and paying taxes. it you wouldn't have the problems in the hospitals that you've got by the border states. it's a mess down there. host: there are several topics. start with bernie sanders. guest: his entry into the race makes the democratic nomination battle more interesting. hillary clinton is way ahead and the chances are high she gets the nomination. his voice will be elevated in

the debate about the democratic party. it the progressive wing of the party was wanting elizabeth warren to get in. and away, he is a surrogate for elizabeth warren. he has been an independent for decade and has succeeded politically in that way. he is a very rare bird in washington. he and hillary differ on health care, he once single-payer. she wants to make obamacare better. on trade, huge split in the party. hillary clinton as secretary of state was instrumental in the asia-pacific trade deal that the president wants and some democrats are against it. the unions don't like it and bernie sanders is dead set against it. i also want to respond to the

collar on the question of money. it's true that he is not going to raise the money hillary will, i don't think that ceiling reason he can't get the nomination. the reality is that when of the party is not big enough. host: the wall street journal and pollsters all of the country are making the general election comparison between hillary clinton and potential republican candidates. it's not like they are matching bernie sanders up with any of these potential republicans. this is the latest poll. hillary clinton against jeb bush, she leads him 49-43. the closest is rand paul. fossum is pulling numbers?

-- pulling numbers? guest: it doesn't mean she is going to stay there. an interesting argument rand paul makes is he says he is the guy that gets closest to her. he is trying to run as mr. electable. it's one of those interesting dynamics. he has been talking about expanding the republican party reaching out to young people minorities. in that poll, some of the other figures were about who could you potentially support. there is a lot of potential for marco rubio. very few say that about chris christie and jeb bush. marco rubio is second place. look down the road to the next

announcement. host: where is mitch daniels? who is next? guest: that's a good question. i don't know. do we have any actual dates? mitch daniels is not going to run it. i think he is the president of purdue university. guest: they have not picked dates. host:guest: i would not say this is a joke, these people are all running. they are raising as much money as they can before they officially announce and trigger legal requirements. they are effectively candidates. host: do you think chris christie is going to be a candidate? guest: i think it was really bad for him. i don't know. these indictments this week, his

people are spinning furiously that this was good news for him. it doesn't look like he was any -- in any legal jeopardy, but when your legal aides are indicted, the story has long legs. i don't see how he can mount anything close to a successful campaign. if he thinks otherwise. guest: they are talking about decamping to new hampshire and do town halls. chris christie has got a similar name. tell the truth town halls, this is what he is trying to do in new hampshire. he is from the northeast. he has human skills. he can deal with people. that everybody has that. host: we have lots of talk about this morning. michael is up next on the line

for democrats. good morning. caller: -- host: let's go to sand in kentucky. caller: good morning. i would like to hear the panel put their thoughts forward as far as why is there a difference in the media scrutiny requiring democratic versus republican candidates? hillary clinton was secretary of state and all of these deals done, bill clinton's speeches. i don't see them going after hillary clinton much like they will go after governor christie from new jersey. why is that? why is there such a difference in how the media will go after

the facts and the truth about these candidates? bernie sanders is a european socialist and nobody is talking about that. they don't really delve into what he supports and what he advocates. why is that? guest: i was going to say on the hillary discussion, she had a brutal month of media press. this book is coming out. it hits shelves today. nbc news followed bill clinton to africa this week and spoke with him about the fundraising and the speeches. they got him to say he has to pay the bills. host: usa today, the lead editorial. guest: it is true that there is

more action on the republican side, so there is more coverage of their field. there is nobody running for president getting more scrutiny right now than hillary clinton. guest: i agree. when you look at the headlines it's been the clintons on defense. host: it's not where they expect to start in may of the year before the election. erica is an michigan. caller: good morning. i have a comment about ben carson. the reason i would support him is the fact that him being an outsider and something that the president of united states set about how we deal with cuba. we've been doing the same thing for 50 years and it doesn't work. let's make a change.

we have had politicians running this country for the past 50 some years. the debt is increased. let's make a change. let's put a non-politician in who is going to fix the problem and be done with it. host: what are your thoughts on carly fiorina? caller: i can see them teaming up. if she can make it to michigan i would support her. that's the way i would look at it. we are getting sick of these same old same old and nothing changes. i have seen detroit deteriorate to nothing and now all the rich people are coming in to build up the inner part of the city, but the average person can't get a job.

it's being outsourced out of michigan. host: on the call for non-politicians to unite. guest: this is a common refrain in every cycle. people have this negative reaction to professional politicians. the reality is you are better at something when you have experience doing it. the reality is to be elected president, you have to be a politician. ben carson is now a politician. he does not have the experience fielding questions and being caught off guard on things and the range of issues that you have to address. it's a real crucible. it's no bigger crucible than running for president. it sounds good to say we when

outsider, the reality is it's nearly impossible. host: here is carly fiorina's announcement from yesterday. >> our founders never intended for us to have a professional political class. they believe that citizens and leaders needed to step forward. we know the only way to reimagine our government is to reimagine who is leading it. i'm carly fiorina and i am running for president. if you're tired of the soundbites, the vitriol, the ego, the corruption, if you believe that it's time to declare the end of identity politics and you believe it's time to declare the end of lowered expectations, if you believe it's time for citizens to stand up to the political class and say enough, then join us. it's time for us to empower our citizens and give them a voice

in government and come together to fix what has been broken about our politics and our government for too long. we can do this. together. host: your thoughts? guest: there is no question that she is bringing something to the field, her gender, business experience in she was the first woman to run a fortune 20 custom -- camping. it did not and will. she is a voice. one of the challenges is going to be how to manage this field when it comes to the debates. they are low in polling. how my other people meet that threshold? that is a tough thing for the republicans to have to say.

you are talking about 16 people on that stage. host: an african-american in the field, a female and two hispanics. are you surprised the diversity of the republican field? guest: the party is not all white men, there is diversity in the party. not as much as the democratic party, but it's important to have this diversity in the field. you can also add bobby jindal to the mix. i don't know when he is going to get in, but he is indian-american. another point, i think in some circumstances, people like that run knowing in their heart of hearts that they are not going to win, but it positions them to be selected for the ticket and raises their national profile.

it raises their speaking fees and gives them new life. they are retired from their original careers. host: carol, good morning. caller: good morning. regarding bernie sanders i am 82. i left wisconsin 40 years ago. i went from the frying pan into the fire because i moved to florida. they have a rotten governor, too. for the first time i contributed to the campaign it, bernie sanders. i do not care what you call him but he offers hope to people below the poverty line. he sees what needs to be done getting rid of citizens united for one. money has to be taken out of politics. he is running on campaign money he gets from people like me. i wish i had more to give.

i think he can straighten out our country. thank you. host: do you think he can win? could he defeat hillary clinton? guest: if enough of the people that have been living in poverty can't get jobs get out and vote and contribute something to him yes, i think he can win. he is a politician it, but he sees what needs to be done for this country. guest: there is an interesting tagline at the bottom of his website. he wants to tell people give me money and i will talk about your issues. i will talk about income inequality. they are courting the wealthiest class to run for president. his challenge, are there enough of them?

it's not the base of the democratic party. that is what he brings to the debate. the role of money in politics is growing cycle over cycle. with citizens united, it's not necessarily written large all the money, it's the super pac's that you are not directly soliciting. can you find a billionaire who will underwrite your campaign. host: bernie sanders is willing to take questions from the media. after his announcement, he has taken more press questions than hillary clinton. can you talk about the relationship of bernie sanders with the press? guest: the press loves bernie sanders. not because of his positions but because he is willing to engage.

hillary clinton has felt that the presses out to get her. she is leery of the press. she wants to do a reset of her relationship with the press. host: has that happened? guest: hard to say. guest: a reset comes from the top. that is hillary clinton, does she want that? it's not clear. most of the questions she has taken were shouted at her. the number of questions you are taking. then carson is doing interviews. bernie sanders can't get off the phone. hillary clinton won't take any questions at all. jeb bush has been fairly available.

scott walker less so. guest: where they are placing in the polls, there isn't inverse proportion. i think rubio is fairly accessible. he is doing well in the polls. host: let's go to laura in pennsylvania. caller: good morning. i want to say rush limbaugh made a very good point about the first black president. i think republicans need to make a big deal about being the first female or the first hispanic which is the largest minority out there. i

they never include why we don't have china making changes. we need a debate. host: i will let you take the first part of the question about marco rubio and republicans appealing to hispanic voters. guest: i think that's going to

be a big part of the campaign, and there's already a subterranean cycle between democratic groups trying to organize the latino vote and republican groups. there's an initiative funded by the koch brothers called the libre initiative trying to reach out to hispanic voters and mobilize and organize them and turn them on to republican principles. hillary clinton maybe even today headed out to nevada talking about embracing a pathway to citizenship or those who are already here illegally. this is going to be a big fight, and the democratic party has moved to the left on this over time. this is not wish he was when she ran against barack obama when drivers licenses for illegal immigrants trip her up. this is really a dividing line. democrats believe in the latino community this has helped them win support. host: let's talk issues on the campaign trail -- specifically climate change and the obama

administration's action on the issue of climate change and how much they will play into a republican presidential run. guest: i think this will be a very big issue in democratic debates. bernie sanders has been -- has said this has been one of his top three issues. hillary clinton has been very vague on that. she is not been willing to state her issue before the president makes a decision. on the left, she could be a little vulnerable, but keystone is not the biggest issue out there regarding climate change when you have the president with his epa regulations on greenhouse gases, and important part of his legacy and his policy on the environment. host: does it make it into the top tier of issues on the campaign trail? guest: i think it's more pocketbook issues, and the republican argument is that all this regulation hurts the economy, hurts business, heard jobs. -- hurts jobs.

in the republican primary, an assurance the biggest issue, but in the general, it could be very big. host: from our twitter page -- david is up next from beachwood ohio. line for independents. caller: i want to comment on lend' that bernie sanders would bring debate for the soul of the democrat party into place -- i want to comment on linda's remark. who of the republicans is likely to find that soul of the republican party? either one, if you would respond. guest: this is what is so great about the huge republican field. you have some diversity of views, and you do have a debate for the soul, the establishment

wing. people like jeb bush, john kasich if he runs. scott walker has a foot in the establishment as well. people going to the social conservative vote, the libertarian leaning. you've got questions about where the party is on foreign policy, defense -- immigration is a big internal debate with republicans. education -- i mean, if john kasich gets in the debate, that really helps jeb bush, i think in a way because they both favor the common core educational standards. jeb bush is kind of dangling out there all alone on this, but if casey is in there, that kind of gets them covered. these are two serious governors -- x-governor, -- ex-governor, current governor -- of donald brown states -- of battleground states. if one of them could catch fire, that would say a lot about the future of the party.

guest: i think there are two candidates in this party who are willing to make a bet that the republican party has changed in recent years. one is ted cruz, who believes the party has moved to the right. no more pale pastels, bold colors. this is his bed. he thinks the soul of the party has moved in his direction. the other is rand paul, who think the party has become less interventionist. talk about dangling alone on the stage. rand paul is going to be alone on foreign policy. the fight for rand paul is definitely a fight for the foreign policy soul of the gop. if he moves in this direction it's going to be a pretty dramatic shift. host: walter waiting in cincinnati ohio, line for democrats. good morning. caller: my question is these

last candidates who put their hat in the ring for president -- could you tell me what state stands behind carly and then -- ben? realizing that these people bring a lot of baggage to the political arena. carly being higher from her job -- carly being fired from her job. ben has no political experience whatsoever. chris christie possibly about to get indicted on answering questions he has been avoiding for years. the credibility really doesn't make any sense. host: is your question what states they could pick up in a primary? caller: what states do they represent, not pick up? guest: i don't think we look at it in terms of what states a candidate would represent. it's more which voters they represent. in the early going with such a huge field of republican

candidates, they will be trying to pick up different elements of the electorate. he is right. who is a carly fiorina voter? it might be a republican woman. her candidacy is not just about being a woman, but that's obviously part of it in a way that she goes after hillary clinton, but then, carson has young support. he's got people who like his conservative message for low income people to not get trapped on public assistance. i look at it more in terms of voters and not states. guest: ben carson, we can forget was a famed neurosurgeon best-selling author separated conjoined twins, and really a hero in the black community. he lived in baltimore for a very long time, made a huge impact there. he announced in detroit, which is his hometown, and now he is in detroit. -- now he is in south carolina.

the community knows him as an inspirational surgeon. the most interactions about 10 carson were in african-american-heavy southern states. that's not his base as a republican candidate for president, but those are the people who know him. these are the people who saw him as a heroic or gift the black community, not as a republican politician, even if he claims he's not one. host: interesting tweet -- tony north providence, rhode island line four republicans. caller: i'm totally disgusted

with this discussion. the rich people are running the country, the lobbyists, and half of your politicians go there they tell you what they are going to do, and they do what they want to do. i always thought when i was younger woman would be great in politics. even they used up on the lines where they end up going with democrats or republicans. mom is that the point were i didn't want to vote no more. host: before you go, if you did go vote, is there anybody right now you did trust? caller: that jenna lynn from i think new hampshire up there. host: -- that gentleman from i think new hampshire up there. but congress still runs the country, and they don't give a

damn. host: bernie sanders was on one of the sunday shows this week over the weekend, and he responded to a question he got about if it's really popular -- possible for a socialist to be elected president of the united states. video clip] bernie sanders: in countries where they have a lot of turnout, health care is provided all people come college education is free. in those countries by a large government works for ordinary people in the middle class rather than is the case right now in our country, for the billionaires. >> i can hear the attack and right now -- he wants america to

look more like scandinavia? bernie sanders: that's right. what's wrong with more income inequality? what's wrong with having a stronger middle class than we do higher minimum wage that we do and they are stronger on the environment? we do a lot in our country which is good, but we can learn from other countries. host: in your piece, you wrote that he fills a void left vacant by war and -- war and -- warren . guest: they would love for her to get in, and a think they are realizing that is not going to happen, so i think bernie will fill that void. the protest vote against hillary clinton. the thing about bernie sanders is he will talk a lot about the

billionaire class. billionaires billionaires, billionaires, and americans are fighting about wealth. they don't like this idea of candidates appearing to be bought and paid for by billionaires, but at the same time, if you turn this race into a big class warfare festival that can turn people off in some ways because everybody wants to do well. everybody wants to get ahead so it ultimately might backfire on the democrats if that becomes too much a part of the race, bashing billionaires. host: let's go to houston, texas, where reginald's rating -- waiting. good morning, sir. caller: america needs overhaul. she needs a new emancipator, and i think ernie sanders is it. making sure that american pays back on the social security she has borrowed. he has talked about the patriot

act, reauthorizing that and we need somebody to talk about the racism going on -- >> please come to order this morning. we are holding a hearing on realizing the promise of precision medicine for patients. senator murray and i will each have an opening statement, and then we will introduce our panel who are getting to be very familiar to us. we are grateful to you for coming. after that, we will have time to ask five-minute rounds of questions or two come depending how many senators are here. we're here to discuss an exciting new direction in our health care called precision medicine. what does that mean? the centers for disease control and prevention estimates nearly one in 10 of us would have diabetes. if doctors could use precision medicine -- that is if they could look at the dna and

genetic and molecular makeup of our disease, perhaps then they could tailor treatments to each individual rather than to the more general category of diabetes. i was visited this morning by the head of the littlefield children's hospital. who talked about their work and identifying a defective gene or mutating genetic defect that causes blindness and how they have developed a repeat -- therapy that restores the side in a child -- sight in a child because of the therapy for that specific genetic defect. this is happening with cancer treatment. this week, reports that genetic testing on tumors is already starting to become the norm in big cancer hospitals.

all incoming patients automatically have their tumors sequenced. this is possible because of an extraordinary achievement by a great many individuals on sequencing the human genome, none more important than dr. collins, who is here with us today. we are grateful or that. today, we want to discuss what the national institutes of health and private industry are doing in precision medicine, how the fda will regulate those innovations, how electronic health records can affect our ability to innovate, and what this means for the american patient in our health system. it's one of the most exciting new frontiers in medicine. senator murray and i are working on an initiative to ensure our facilities are able to utilize the processes by this kind of cutting-edge medicine so americans are not waiting on the sidelines because regulatory science cannot keep up. it's not just about precision medicine, but precision medicine

is an important part of our initiative. president obama announced a precision measurement -- medicine initiative in the state of the union this year detailing his lands -- plans in the white house. i attended that to demonstrate my support for it. the president has proposed masking the genomes -- mapping the genomes of one million individuals and making that information accessible across the country. i know there are similar private efforts under way and i'm interested in hearing about that competition and possible collaboration. for example, the children's hospital of fill it up you has 250,000 individual children genomes sequenced there -- the children's hospital of philadelphia. i wonder how that relates to the

president's proposal for one million individuals. i look forward to hearing about the potential cost of precision medicine. we know the costs of sequencing the human genome have been reduced significantly in the last two decades. dr. collins testified -- i believe he said 15 years ago, a customer or hundred million dollars to sequenced human genome, whereas today, it's about $1000. often, health care initiative increases our costs. that does not mean we should not innovate. innovative costs that increase over the short term can decrease over the long term. if we could use precision medicine to delay onset or cure disease, we could save precious dollars in the health-care system and alleviate some of the grief and pain associated with it. the committee has also spent time and will spend more on

improving electronic health records. the edible government has spent 28 billion -- the federal government has spent $28 billion, and the result is that doctors do not like the systems. many say they disrupt workflow and interrupt the doctor/patient relationship and have not been worth the effort. senator murray and i have begun a working group to identify the five or six things we can do to help make the promise of electronic health records something that is issues and providers look forward to in that of something they enter -- indoor -- endure. we look forward to working with you on that and being able to report maybe early next year some results. we have to get to a place where the systems can talk to one another, interoperability and doctors offices can afford the cost and can be confident their investment will be of value.

dr. collins has told us and i've heard from many others that are properly functioning electronic medical records system is tremendously important to the president's precision medicine initiative. it can help to assemble the genomes of the one million individuals, and, second if we want to make genetic information useful, this is complex stuff. it's going to take computers that operate easily and with a clique of the mouse to help make it possible or doctors to actually prescribed prescriptions for individual patients. i also would like to hear, if we know, dr. desalvo, at some point how the $11 billion by the defense department on electronic medical records would relate to the 28 billion dollars we've already spent and if those would be compatible.

there's a lot to talk about today. this is a tremendously interesting and important effort , and i look forward to the witnesses' comments. senator murray: thank you for being here today. each of your agency's plays a critical role in the topic will be talking about, and i'm grateful to share your expertise. i've approached our bipartisan effort to advance medical innovation focused on one question in particular -- what can congress do to help all patience and emily's get the safest, most effective treatments and cures more quickly? our conversation today is about the promise of precision medicine, and it is a crucial and truly exciting piece of the puzzle. there's no question we are at a critical moment in the medical field. researchers and medical experts are increasingly finding ways to treat patients, not just the average patient, but instead

based on their own unique characteristics in history. this is like the difference between getting eyeglasses based on the average prescription and getting eyeglasses based on your own prescription. it's huge. especially for those across the country waiting and hoping for better treatments and cures. i'm proud my home state of washington is home to several institutions that have been pioneers in this area, including two that are using this precision medicine technology to tackle breast cancer, i disease and alzheimer's disease among others. i'm glad we have the opportunity today to discuss the ways in which precision medicine is changing and improving lives and how congress can help advance this new frontier in biomedical innovation for patients and family. the president has proposed making significant investments in precision medicine. his fiscal year 2016 budget supports a bowl no initiative to exploit the recent advances in

genomics, molecular biology, and data management to support the shift away from this one-size-fits-all medicine and towards treatment tailored to specific individuals -- a bold new initiative. this produces in a norma's amount to accelerate -- enormous amount to accelerate procedures medicine -- precision medicine. i'm deeply disturbed by the erosion of nih's purchasing power over the last decade. democrats and republicans were able to come together to replace the harmful sequestration cuts to the investments in nih and other critical priorities like education infrastructure. i am really hopeful that this year despite the budget proposals put forward by our republican colleagues, we will be able to work across the aisle and find a way to prevent these shortsighted cuts from seeking and again. this is critical to the kind of investments we need to help our

families. one of my top priorities on this committee is looking for ways to continue improving the quality of care patients receive, and supporting precision medicine is essential to that goal. by offering patients and providers more and better health information, patients in consultation with their doctors will be empowered to make informed decisions about their care, and our health care system will be better equipped to bear fruit. i do note that protecting privacy will be an important challenge throughout the process. in the last few months, we've seen serious security breaches impacting amylase' -- families' personal health information, and that's unacceptable. we need to be aware that data is being created that cyber criminals will want to exploit and that means we will need to

develop strategy to protect privacy that meets today's challenges. chair alexander and i are investigating the current state of security in the health sector, and it's clear this needs to be an all hands on deck effort for providers and insurers and government working together. again, thank you to all of our witnesses for being here today, and i want to thank chairman alexander for holding this hearing on such an important topic for patients in my state, and i look forward to working with you and other members of this committee to support this initiative. chairman alexander: thank you. this specific topic is an initiative of the president in which the committee is very interested. we expect to get a result, and we welcome expert advice. we have three witnesses. senator cassidy: dr. desalvo

have known each other since way back. i told her that just in her honor, we may be spread -- we made the spread two-lane greene today. dr. desalvo is the coordinator at the national office of health information technology. charged with coordinating federal health i.t. strategy and coordinating federal health i.t. policy standards, programs, and investments. i have been impressed. dr. disalvo has come to me personally. she has a friend back home who has had problems with adapting to her electronic medical record . she clearly recognizes interoperability is key. she is working and listening to physicians and developers of these products before joining hhs, dr. desalvo was a health commissioner for the city of new orleans, including and after hurricane katrina. chairman alexander: dr. dassault will, we look forward to your

testimony. we expect to know you pretty well because all of us are interested in fixing the electronic medical records system, and you are on the point for that according to secretary burwell. we look forward to that. the other two witnesses are here about every other day, it seems like, and we are grateful or that. dr. collins, director of the national institutes for health who oversees the largest department of medical research in the world. he has been director since 2009. he is known among other things for his leadership of the international human genome project, completely sequencing the human genome in 2003. dr. jeffrey shuren was here last week. he's been director of the center for devices and radiological health at the road and drug administration or more than five years -- the fda for more than five years. they are responsible for sharing the safety of radiation-admitting products. he has had a lot of experience.

one year of that has been detailed to this committee. we welcome him back. if the witnesses would summarize their remarks in about five minutes, we would appreciate it. we have senators here who want to have a conversation with you so let's start with dr. collins. dr. collins: good afternoon, chairman alexander ranking member murray, and distinguished committee members. it's an honor to appear before you today to discuss how we can advance america's health by accelerating progress towards a new era of precision medicine. earlier this year, the ministration unveiled the precision medicine initiative able to research effort to change how we diagnose and treat disease. we believe the time is right. -- a bold, new research effort. historically physicians that have to make most recommendations about disease

prevention and treatment based on the expected response of the average patient. this one-size-fits-all approach works for some patients and some conditions but not others. precision medicine is an innovative approach that takes into account individual differences in patient's genes, environments, and lifestyles. the concept is not entirely new. blood typing, for example, has been used to guide blood transfusions for almost a century. dedications have made it possible to provide options for women at high risk of breast or ovarian cancer, and the genes indicated in cystic fibrosis, discovered in my own laboratory 25 years ago has led to widespread availability and carrier screening and targeted therapeutics. the prospect of applying this concept broadly has been dramatically improved by the development of powerful and affordable methods for characterizing personal, biological information including genomics. the widespread adoption of electronic health records, the

recent revolution in mobile health technology, and the emergence of computational tools for analyzing large biomedical data sets. furthermore, patients are increasingly interested in taking part in research. all these developments will help make possible to dream of personalizing a wide range of health applications. with this in mind, we are thrilled to take a lead role in this initiative. in the near term, this initiative will focus on cancer, accelerating efforts to develop strategies for a wide range of adults and pediatric answers. it will include large numbers -- an analysis of large numbers of individual tumors to see what gene mutations are driving the malignancy and matching that information with available targets and therapeutics provided by pharmaceutical industry partners to optimize responses for the individual. simple blood tests will be developed that can detect early response or resistance to drug therapy.

a combination of targeted drugs will be tested to see how best to achieve not just a remission but a cure. to put a human face on this, i would like to paint you a forward-looking picture of what the precision medicine initiative can deliver for medicine in a few years. consider the hypothetical case of lily, a 50 two-year-old woman of asian descent. in 2018 -- this is a hypothetical case -- after battling bronchitis and a persistent cough routine of months, she goes to a doctor and orders a ct scan along with a new blood test developed with the research supported by the precision medicine initiative to look for dna of biomarkers circulating in her blood. the c.t. scan detects a tiny spot that could be either inflammation from bronchitis or cancer -- not clear -- but the biomarker test clinches the diagnosis, revealing a genetic mutation that occurs only in patients with cancer. in 2015, today, her prognosis

from this cancer would likely be pretty grim. but in 2018, that could all change. lily would have surgery to remove the tumor and that tumor would undergo molecular analysis. based on those results, lily is treated with a targeted drug that wasthere. lily remains cancer free. within think of what the cancer component initiative could achieve. as a goal, nih will launch a cohort of one million or more volunteers will play an active role in how their information is used to manage a broad array of diseases. participants will be centrally involved in design and

instrumentation. they will be true partners. with appropriate privacy protections, they will share genomic data come and biological samples. participants will be able to have access to their own health-related information. new approaches in detecting a wide array of variables will be tested in small pilot studies. the most promising approaches will be utilized in greater numbers of people over longer times to collect viable data that will be of great benefit. let me give an example of how this could fit a specific participant in the precision medicine initiative, it could provide evidence for a new strategy for health maintenance. consider the case of carla. carla feels perfectly healthy.

she welcomes the chance to try out a wearable sensor that monitors her pulse, blood pressure, activity can in sleep patterns. she discovers her blood pressure usually runs 150/100 too high. carl is not alone. nationwide, about 78 million americans have high blood pressure. many like carla do not even know it. 50% of those diagnosed with hypertension to not have it under control. carla consults with her doctor who suggests she take an inexpensive drug. the precision medicine initiative will bring many other types of health care monitoring into this new century.

evidence suggests the physical exam and associated screening lab test may not be as useful as one would hope, but new opportunities to incorporate more indicators of enjoyable -- individual health are in merging. this will provide an opportunity to assess strategy rigorously to see if they provide clinically viable intervention -- information. in closing, let me decide the impact of the precision medicine initiative will extend beyond individuals who volunteer to participate. it will push the frontiers of discovery across the entire spectrum of biomedical research, from basic science to translational science intent on moving discoveries into practice for maximum benefit. given the size of the project and it's real-world nature, evidence of improved health outcomes derived from the initiative will be attractive for the application across u.s.

medical care. with sufficient resources and a strong, sustained commitment of time energy, and ingenuity run the participant communities can the future of precision medicine appears bright. look forward to working together to make stories like those of lily and carla a reality. it's my testimony. i look forward to answer your question. senator alexander: thank you dr. collins. dr. desalvo, welcome. dr. desalvo: thank you for the opportunity to be here today . i am the national coordinator for health information and technology at the department of health and human services. when a student i could never imagine in my career i would medicine on the frontier of such significant transformation. as a still practicing doctor, it

is thrilling to know we on the cusp of being able to customize treatment for the patient in front of me based on their genetics, preferences, and other information instead of having to treat them as an average patient. more exciting is precision medicine is not just a theory. it is already changing practice and save lives. we would not be on this cusp but for health information technology which is foundational to the precision medicine initiative. office of the national corner desk coordinator -- and it is to hope against the structure for what is a six of the u.s. coming health care. we do this work through a mix of programs come meeting some assistance aimed at catalyzing the marketplace. we seek to spur and support innovation to help address advancements like precision medicine. we want to provide clear and steady direction. onc also has responsibility to

ensure consumers are engaged in a protected. covers created significant momentum in when it passed the high-tech act in 2000 hundred act provided funding to support the doctrine of electronic health records and support for doctors and hospitals on the line as they made the transition to use them. as a result of programs and the hardware providers we're bringing health care into the digital age and we have reached a tipping point. strong foundation of technology makes it possible to bring to the best -- personalized treatment. the data in electronic health records married with analytics information for mobile health devices, and other data will provide the full some picture of a person's health and needs. this data picture is necessary to identify the right convention and treatment that is not only the most effective, but also most desired by the patient. this is not a decision about

what might come, but a reality. in places like tennessee maryland nebraska, i could go on. doctors are able to tailor treatment today. i spoke to folks at the university of florida, where a agent's cardiologist can order a test. test will help cardiologists know if they can give the best medicine to prevent clots. a critical time someone's life a doctor is choosing the right life-saving led thinner tailored for them. though this kind of treatment is exciting to him it is only the beginning. we have much work to do head. -- to do ahead. onc stands ready to undertake this work. to get there, we went to stay the course in adoption to see that every american has an electronic health record. we need to go beyond the pockets

of data exchange and achieve true interoperability as prescribed in our nationwide road that. we will need to establish standards for the most fundamental information shared by all. we will need to establish standards for new data necessary for precision medicine can including genomics, but also patient-generated information. we will build a trust framework that respects individual privacy and establishes strong security protections. we will work with the private sector to establish openly available api's. we will remember what i hear consistently for consumers who are our principal customers. they want to be able to access and share the health information, including with scientists without blocking or delay. the president's initiative is one of the most excited ways we can ring the right care, the right prevention to the right patient. only imagine a few years ago

because of advances like this and the underlying technology we have to support it that we are on the cusp of realizing better care for everyone. onc stands ready to help further precision medicine with colleagues at hhs and congress. thank you, and we look forward to your questions. senator alexander: dr. shuren? dr. shuren: thank you for the opportunity to testify regarding fda possible. the success of precision medicine depends on: having meaningful tests. because it is the result of the test that determine which patients get which drugs or treatment and whether or not they get them. in precise medicine, results from bad test misdiagnosis, you get the wrong treatment or you get no treatment at all when you should come in as a result of patients get harmed in health

care costs go up. fda's role in the precision medicine initiative is primarily focused on advancing an emerging technology called next -generation sequencing. ngs test can sequence long summits of dna or the entire genome. as result, we are moving away from the model of one test, when disease, but a test of can identify one of many different diseases or the risk of developing that disease. today it is significant barriers in place for advancing technology that affects research develop, and affects our ability to use it optimally in health care. let me tell you what some of those barriers are and what we are doing about it. you are making a test and you want if it is accurate and reliable meaningful, two things you need to know. does it accurately measure what you are trying to measure, in

this case, genetic variance can recall that analytical validity. secondly, you want to know is there a good relationship between what you measure in the particular disease. if you say it is a test for breast cancer, is that variant in fact associated with breast cancer? we call that clinical validity. today that is difficult for next-generation sequencing. here is why. think about the human genome. you have 3 million variants and genes are made up with components called base pairs. yet 3 billion of them. now you want to know how accurate is next generation sequencing test and measure that. you look at each of the variance . you cannot access the accuracy of 3 million variants. there are good standards other to assess it so people are struggling to make sure our their test cricket you want to know is a clinically meaningful, you need data for that. the problem is many of these variants are,. -- are uncommon.

it is difficult to do legal studies can and that the density siloed in institutions doing the testing. in december we propose an entirely different framework for the oversight of next-generation sequencing tests. we and the developers struggle among to do with it. for analytical validity can we need that reference standards subset of genetic variance that if you can show accuracy in measuring those can it is reasonable to infer you are good measuring the other variants. in fact, he gave $2 million to an institute to work with the scientific community come up with a very first reference standard for the genome and they just released that last week under this initiative, and with additional funding support from he will continue to work with nist anj in developing reference later.

the developers will not have to come to the state to show their validation. we need to leverage databases where we get all that siloed genetic information and make sure it is standardized and it is of sufficient quality where we can make decisions on it. they're partnering with francis. working with them and scientific community to develop standards and best practices for having these databases for doing the cure ration and then having consistent interpretation, because you can send your blood to different testing labs and get different results. that is what happens. it may be because you missed a particular genetic variant or you interpreted it fairly. those standards in place, we can now consistent accuracy testing and consistent interpretation to reduce the time and cost to spur research, to advance technology

development, and ultimately to achieve better health outcomes. thank you. senator alexander: thank you. we will now have a round of five minutes. questioning dr. d esalvo, in 1980i had the big idea all eighth-graders would become computer literate. i met with the jobs and bought enough mac computers to put in all the middle schools. it was a great idea. good. forgot something. forgot teacher training. so nobody really knew how to do it. i did not think it all the way through to the end. we have something of the same problem with our electronic health care records system. we spent 28 billion dollars, a great id, holds great progress but it is not working the way it is supposed to. the current standards for

meaningful use are not clear. upgrades are expensive. systems do not work well enough to share the data. we hear it is expensive to share the data because of the relationships between vendors and doctors. some of the doctors call this data blocking. you just released a report on data blocking describing these concerns. senator murray and i have set up a group working on is because of the large amount of interest in our committee on the subject. i question -- my question is, will you work with us, this committee, to identify the five or six steps we could take to get our electronic medical records system functioning well enough so that it supports not just the precision medicine effort that we have come but so that it functions and it is something that physicians and providers can look forward to using instead of enduring? dr. desalvo: yes, i look forward

to working with you to make sure this works on the ground, where workflows are not the way that ought to be. so we look forward to that. you can count on our participation actively. we have some efforts underway, at the senator is aware. we have been working to our rules, certification but there is work to be done, and we look forward to that. senator alexander: and talking about beginning to get results identifying the steps we should take. you should know them better than we. and then going step-by-step to get them done. if you could do them by illustrative order, turning. we will include them as part of our initiative and begin to do what we ought to do. dr. collins, one million genomes.

i mentioned i was visited by the head of the w's children's -- head of philadelphia's children's hospital. i have two questions. one question -- how many of these are already out there? you want to assemble a million. they have 250,000 in philadelphia. a doctor wants to assemble a million to can you get your one million genomes to going to places like the philadelphia children's hospital in using some of theirs? dr. collins: a great question, and we are trying to come up with every possible way to assemble this cohort by taking advantage of things that have 40 been done instead of having to start from scratch. we will in fact having major meeting in your state on may 20 7, 28, with a number of those who have been managing those large-scale cohorts gathering together to see if there's a way to put them together in a way that would prevent -- senator alexander the number of

genomes that have been sequenced ? dr. collins: some people are referring to the sampling. some are talking about sequencing just the parts of the genome that code for protein. to do a whole genome see grant -- sequence, it is not quite affordable. both of the courts of their desk cohorts have not done their wyhuohole sequencing. a doctor has the intention in his human longevity to do a lot of whole genome sequencing. we believe to get the maximum information, you want that. senator alexander: senator murray has emphasized the importance of making everyone or a representative group of everyone is included. what about children? the suggestion was made that

sequencing the genome of a child for a genetic defect leading to a particular disease can be less collocated than for an older person who may have a more complex disease. will you include children -- and a single gene therapy treatment as part of what you do? dr. collins: that is an active area and the -- of investigation. we've assembled a group on this question. they had met once last week. they were meeting again to specifically talk about what should the constitution of this cohort. should children be included what should we do about individuals who may not otherwise be asked to participate. we want to be sure this covers diversity of our population as well, and some of the cohorts out there may not be as diverse

as needy. he will figure this out. there's a desire to have this be something that represents the broad swath of our country, so there will be a strong motivation for many people to include children. senator alexander: thank you senator murray. senator murray: we've heard about how precision medicine is revolutionizing the practice of medicine allowing for development of targeted cures for individuals. i am interested in the economic impact of this work. we know precision medicine is not only about treatment, but about prevention, and we have a lot to learn about how factors like environment nutrition impact individual health outcomes. how might these discoveries impact self-care costs? dr. collins: i appreciate that question, because we agreed that health care costs need to be brought under control and a lot of the concern i think about our current system is that it is more a desk system here than a

health care system. if we had the opportunity for permission, we would improve -- for chris -- for prevention. to find out what actually works. i mentioned in my companies they been something of the fact that our annual physicals probably do not collect the kind of data that ultimately you would like to that might be a tipoff to something that needs attention. and the opportunity to begin to use many of these new tools as well as these wearable sensors that are reported on the environmental exposures and performance under situations should put us in a better situation to monitor individual health before an illness strikes. i do not want overpromise the value that this will result in as far as cutting health care costs and bending the curve we want to see start downward. it is a longer-term initiative.

i would over the course of time is one of the best opportunities we will have to cut our health care costs. editor murray: -- senator murray: one of the exciting things is it is empowering people to participate and be full partners in discovery of new treatments. you mentioned the new mobile and wearable health technologies out there. this allows researchers to collect data on how participants' behavior effects their health outcomes. i know all your agencies are working to find ways to engage patients on their health and sustain participation among people who are involved in research studies. what are the best practices in patient engagement to ensure sustained participation throughout these precision medicine studies? dr. collins: another great christian. it are a number of cohorts already engaged in a lot of patients that we will be consulting with about what their experience has been. kaiser permanente has a large

cohort. mayo clinic others in pennsylvania. all these done a lot of work to figure out what it is that people are looking for if they are going to participate. i think an important part of what we're trying to do with this initiative is not to think of the individuals who take part as patients, they are really partners, and we want to have them at the table. we will have a workshop july 1 and which is focused specifically trying to get inputs of individuals. what we can already say is people expect that their information will help people. there's a lot of chores and in taking part -- a lot of our truism -- altruism in taking part. what has the study learned? they want to be informed. they want to be at the table. he promised that it is the attitude will bring to this. senator murray: let me ask you dr. desalvo, we've seen of

health care organizations over the last few months. americans expect providers and researchers are taking the necessary precautions to protect their data. that is why mentioned working with senator alexander on the current state of cyber security in the health care industry. and you tell us what steps onc is taking to help researchers keep the larger map of genetic and other health information that they are collecting secure? dr. desalvo: thank you for the question. it is a major issue. in some of our mind everyday. the steps we've taken recently for example are to require in the electronic health records that data is encrypted at rest and in motion, so as you move interoperability data needs to be secure and encrypted. networking with the department of homeland security, national

security council, and others to ramp up the additional security expectations because as data begins to move and be more liquid, there's more opportunity for there to be issues. it is a top priority. we have taken actions, and we have additional ones that are underway. senator murray: dr. collins what is nih doing? we have initiated -- dr. collins: the conditions under which that data can be shared is carefully overseen. qualified researchers can apply to see that they did because we think much is it by having it accessible, but it has to be overseen in a way to make sure the individuals looking at the data are appropriately signing on to their various frustrations, such as not sharing it with third parties technology where it came from.

that has been very successful over several years. i think we have a good framework. are some things that are needed to protect genetic privacy can make sure that it is not acquired by individuals who do not have the right to do so, that are to be something to avoid surreptitious genetic testing of individuals without their consent. senator murray: thank you very much. senator alexander: thank you senator murray. senator hatch? senator hatch: we appreciate the work you are doing. we have a big database, too, and i am wondering if i could be the part of the million-person cohort, because as i recall, the database is the world's largest database of computerized image histories, and it is linked public health and critical records. scientists at the university of youutah have identified g

enes responsible for jeans readgenes. utah has discovered news disease-causing disease and conditions like obesity and cancer. these large families accelerate the pace of genetic discovery by magnifying ability to identify disease-causing genes. harnessing these advantages it seems to me, using these large families and large cohorts, i think our folks in utah to make significant divisions to what you are trying to do here, and i would just like to know if you think they would be useful and if i can play a role in getting university of utah -- i think

they are already working together, but i think you need to work with that group. dr. collins: we are, and thank you for the question. utah has been in a wonderful place for us the ability to do remarkable research in human genetics over many decades. i personally have benefited from collaborating with this over decades of my own research career. you have an unprecedented level of depth in terms of family collections. one of the things we are going to be wrestling with in terms of this cohort is exactly what on to be the involvement of multi-generation pedigrees. it brings considerable strengths to the effort. that will be a topic of discussion. also at this workshop later this month in nashville. i would say the intermountain health care system which involves lots of folks in utah i should have mentioned it on my list of folks who have already generated cohorts. they have a strong presence in this is what. i'm sure when the dust settles this precision medicine initiative have a utah

connection. i saw a wonderful piece is morning talking about some of this and i could there's a lot of excitement across the scientific community across the country in what this might be to create a appreciate your volunteering to help us. senator hatch: the university of utah has a genetics department that is as good as their can be -- as can be had. i think the people at harvard like the mountains and the ski we would love to be of great assistance to you. i would appreciate all three of you. i know about what each of you do come and have taken a great interest in what you do over these many years. i have not had as much time to spend in this committee, which i used to chair. want to compliment the chair and a vice-chairman for the good work they're doing.

perfect leaders in the united states senate. i appreciate you being here and appreciate the work you are doing. senator out xander -- senator out xander -- senator alexander: the order i am using is who was in terms of the gavel. senator franken. senator franken: thank you to the ranking member. thank you, dr. collins, because mayo and university of minnesota have been doing a genomic

project funded. very smart on your part. this is exciting because there has been a paradigm shift in the way we think of health care in this country. in some part due to the health care reform law from health care providers and insurers are moving more toward person-centered care. talking about coordinating care, medical homes to help doctors tailor their treatment, therapy needs of individual patients. precision medicine is all about, making for the right patient gets the right to end the right treatment does not necessarily

mean -- it is not treating people when they are sick, it is about health care, not care, and using personal and ms. -- personalized medicine should improve prevention so we are doing health care, not sick care. dr. desalvo, >> we are at a tipping point with electronic health records and i want to talk about that -- we have -- had a hearing on that not long ago. there are some barriers to adoption by some sort of medical providers. some because of doctors that feel like, i have 20 minutes

with this station and i don't want to spend a of it -- eight minutes of it and putting data. but this is where we are going and what do you do to adjust that and what are good models? we need to get there, what are we doing to get there? dr. desalvo: i hear similar things when i travel and talk. we are going forward folks want to go there, however the systems are not part of the workload and the way that we want or expect in clinical practice. the opportunities there include giving more time for providers to be able to implement the system on the frontline you may

be aware that in the last year we have put forward rolls to provide additional flexibility in timing of the adoption of records or upgrading to new ones. and also to propose a new set of rules giving doctors the option of a more streamlined approach to the ways that they have to report, reducing the burden or expectation on the amount of clicks they must do to show that they are functionally using the records. we are working toward a goal of a shared expectation that this will enable and support the non-committed to continue on that path. your point about successes on the ground and tools that doctors have used that otherwise are important, we collect those. we share those and it is -- it varies by dr. and office. what will work for them. sometimes using indication systems and having assistance of

transcribers over it. sometimes they are working with electronic health records and they have had so much time that they have been able to make the systems seamless for them. in minnesota, they are so far advanced in i.t.. they have had many more years and to make sure that systems are working. senator franken: we can talk about this for a long time, i don't mean to interrupt you. i want to get one quick question. i have a question about how the tests at the fda, about those tests they will be assessing. one thing that concerns me is that some tasks may get expensive and i want to make sure that i understand how they and how the personalized care and precision medicine can provide -- provided it will

benefit everyone and will not contribute to disparities in the country. so, my questions are, will these tests he considered diagnostic tests or preventive tests and who is going to be paying for them? dr. shuren: they can be used for both protecting and diagnostic purposes. they need to show that that test can perform in such a way. in terms of reducing cost, there is an opportunity for reducing cross -- costs for those technologies, because we have standards that i talked about. we have information. it will be less expensive to do these. in the past, if you do a clinical study to show that does the test actually predict or diagnose that disease, but now with databases you may be able to point to that data. essentially, this is a clinical community crowdsourcing the

evidence and we just did that. we did that recently two years ago with a test for cystic fibrosis, where we proved that based on a subset variance they were able to use data in a database at johns hopkins that was supported by the cystic fibrosis foundation and they didn't have to do a clinical study, they reduced the cost of that test. who pays for it? hopefully the insurers at the and of the day, because if you have good technology -- senator franken: there's no question that technology and medicine can bring down costs, i just worry about a brave new world where certain people have access to certain things. i would just, i'm out of time, i'm just asking for a senate to

make a record of this. >> it will be done. >> dr. desalvo, we have had a report in the past where the fda needs to do much better to courtney records. electronic medical records are important to precision medicine, now there is an $11 billion contract going out and i'm not quite sure that it is coordinating with the v.a. and we have a testimony recently about how there is a lack of operability, one of the systems being considered by dod are those mentioned with the and operability. i feel like we are in a thicket and we can't get out. all we know about this is that we were going to spend $11 billion on this that is an operable. please tell me i am wrong. dr. desalvo: the dod's

acquisition of electronic medical records is one of the most important things on the medical landscape. we are involved in that. we have embedded staff to see that we are communicating with the department of defense. they have agreed to lead the way and pointing to the standards -- we were asked earlier about the steps we would take. if i could for a second. i only have 3.5 minutes. one of the first things we need to do is move away from party standards which are getting in the way of standards. >> epic is one of them, they are not open source? dr. desalvo: those vendors will have to agree to use the standards that the dod wants to use. we are very pleased that we are moving in a direction to have a course of standards that

everyone will agree to so that we don't run into problems. >> the v.a. will be able to share records with local hospitals and records of the dod? >> the v eight and dod is a different issue, they have different technology's. but that is the goal, the exchange and operability. >> again, i talk to medical students all the time, but when you mention the goals, i accept it as a goal, but how likely is it to happen. it seems like you would go room. the dod has a different system and they may not indicate with v.a.. dr. desalvo: what they have done is they have found a solution to exchange information, so that if you are with a patient you can see records from the ba and dod, they have taken the first step. the integrating of the data requires having the same core elements, that is a technology issue, that is probable. there is a culture issue, which is the harder one and that is what we are facing in

circumstances like information blocking, one thing getting an a way of offered ability and the broader community -- operability in the broader community. >> so who is blocking? dr. desalvo: it can happen from technology, but what we see commonly is that the vendor system will charge -- >> we have had those hearings about the vendors of blocking so we are back where we started. my fear is that the vendors of blocking data are the ones of hitting and then you mention it will be open source, but you return to the fact that it could be blocking. i guess i am not clear on the final $11 billion project, will it be something that people can access data, or will there be vendor blocking? dr. desalvo: the dod confirms they will answer, but what i will share with you, since we described blocking and put out that report of vendors to make

this problem go away we have to keep putting on pressure. i don't think that the work is done. >> i'm already over time, but i guess is it part of the initial rfp that can they cannot block and the v.a. has to be able to share as it does the community hospital? dr. desalvo: that is the intention of the dod. >> is it part of the rfp? dr. desalvo: that is what i understand, that is what we have recommended, so i would have to refer to the dod. >> do the recommendations are not adopted? dr. desalvo: i can get back to you on that. >> i am almost out of time. dr. desalvo: thank you. >> thank you senator cassidy senator bennett. senator bennett: thank you to

the panel. dr. shurman there is a movement of molecular diagnostics on the way. thank you to the human genome project, there are a number of colorado companies which are developing remarkable new diagnostic scenarios, like ebola, cardiovascular disease, lung cancer and the fda recently released a chaff on how to regulate lab tests. as i wrote in a letter a couple of weeks ago, as always we need to balance innovation and safety to make sure that we create a workable process. there is some concern that the draft work could require the fda to it prove -- to approve thousands of labs and test. can you speak to this given the

spoke -- scope of the problem are you open to congressional action, without be useful and how to we get a handle on this and create predictability for the people doing this work? dr. shuren: lab tests plate an important role, we do not want to shut down lab tests but make sure that we are both facilitating innovation and that these tests are accurate, and reliable. we try to strike that balance in our proposal and i don't know if we will actually receive thousands of tests, because what we have heard from the lab community is that a lot of the tests they make are to address on met needs. we want to put out that if you're making a truly lab test, the health care system is doing this and treating patients and there is no test out there like that that the fda has approved. you do not come in the door for

premarket review. if someone has a test, they send us the data and we know that this test works, then our expectation is, other people making the test should do the same, because we now have data that is test in fact is accurate, reliable, and clinically meaningful. i don't know that we will receive thousands, that said we have received comments on the proposal that we are working on. we will be making changes before we have the final policy. senator bennett: i hope you'll will let the committee know if there is anything to do about this. and i also want to turn to another topic around innovation dr. collins mentioned earlier about how important mobile technologies have become. really and the blank -- in the blink of an eye the changes the way that doctors treat patients and monitor their well-being. as you know, i reintroduce the med tech act yesterday to make

sure that lower risk software are not related by the fda. i think we share the same goals on this and i want to thank your team for giving us technical advise all the way through. can you talk about the fda and their thinking in this area. dr. shuren: thank you for the opportunity to work together on the med tech act. we were lookingand device functions and we have the right leading this for a long time. some of them are being put on mobile platforms and what we found is that when we look at it, some of these lower risk functions, we may better serve by no longer actively regulate in them and to spur innovation. there is low risk, so we do not have to provide fda oversight. instead, focus on higher risk functions in this space. that is a nice balance on that, we facilitate innovation and

ensure patient safety. senator bennett: i don't know if you have anything you want to add, dr. collins. dr. collins: the proliferation of exciting opportunities is happening all around us and we see the precision medicine initiative as an opportunity to test those out, because you don't only want to have an application that is cool and gives you an firm -- information, but you want to know that it improves health and changes outcomes. if we have a million individuals excited about participating and volunteering to become users of these kinds of technologies come a whether it is the next version of a watch that measures aspects of your body physiology and or something that protects you this would be a great opportunity to find out what works and what improves health care and what should be extrapolated and utilize across

medical care for the whole country. senator bennett: thank you. mr. chairman: senator collins? senator collins: i met with people in maine who are pushing for research in brain cancer. you mentioned in your written testimony that oncology is a clear choice for enhancing the impact of precision medicine and that important advances have already been made in this area. i look forward to sharing your testimony with ms. group of people from maine who are concerned about such devastating brain cancers as glioblastoma. i'm wondering if you also see a role for precision medicine in

neurodegenerative diseases like alzheimer's, parkinson's, als. our investments in these areas also been considered as part of the precision medicine initiative? dr. collins: thank you senator collins, absolutely. we are look -- learning that disorders like these do in fact have multiple contributions to whether they happen or not to a given individual. for alzheimer's, we all know that 45 individual places in the genome where variations place an individual at higher risk. and we know about one or two where individual variations are protective, which is even more of a finding, because he want to understand that to develop the next generation of definitive strategies for those who are not

as lucky. so especially for any disease that is common enough that you will have dozens of individuals and your one million strong cohort, there is an opportunity to study those on a scale that has not previously been learned and try to put together all the things that we learn about the genetic inheritance and also their environmental exposures. anything we can about their electronic health record experience and also using mobile health. the ways that we can come up with with a better detection systems, cognitive changes, that is an intention. an exciting aspect of having this very large cohort is that it does not have to be about heart disease, or just about diabetes or just about alzheimer's, it can be about all of those things. it will have the skill to do so. we have waited a long time to reach the point where we can -- or the technology makes that possible and the time is it now.

we have reached a remarkable point in the potential of medical research and we should not let this moment passed. senator collins: i could not agree more. it is truly so exciting. dr. disalvo, despite the federal support that you mentioned in your testimony, i can -- i continue to hear from smaller health care providers about the barriers that they face with electronic health record implementation. just yesterday i met with a physician from maine who shared with me that putting in place a conference of electronic -- comprehensive electronic system for his small practice would cost in excess of $230,000. this was just for the software, not for the hardware. that is no small amount, particularly for a smaller

independent practice that is not hospital owned. to access information about individuals to improve diagnosis , treatment, and prevention of diseases, you discussed the important roles of health information technology and an operability, including standards and technology that will be needed. as you work to build these health i.t. systems, for precision medicine, how can we assure that we are not leaving out rural america, smaller practices, rural hospitals health clinics, because of the cost? dr. desalvo: thank you for the question. it particularly spotlights one of the challenges of smaller

practices. there was a particular focus that we had early on in the discussion, prior to me joining the administration, that team wanted to see that rural america was not left behind. there was excess and adopting it in many communities across the country. they are now facing a challenge of upgrading technologies and it is a reason that last year, some challenges that they were having , that we put out the flexibility role -- rule, so that they could do with the cost that you are describing. i would be very happy to follow up with your staff on that position to see if we can understand what is happening there and perhaps the extension centers in your community can follow up. you are correct, it is critical that we get this, that nobody is left behind and we find a way to make it successful for everyone. senator collins: i will take you up on that offer. mr. cham and -- chairman:

senator warren. senator warren: this could be a big step forward for therapies for any number of conditions. it is a great idea. we should've started years ago. dr. collins, you advocated for a national genetic study to examine how people's genes and environment contribute to diseases over a decade ago. is that right? dr. collins: exactly right, it landed with the -- at that point. that is the article on the screen that a published in 2004. in retrospect, this was probably ahead of its time, because we did not have the technology at the point where this could have been affordable or practical but it is now. senator warren: if we had only

started pushing back then -- over the past decade, funding has not helped deal with inflation, so we are years behind in doing this work. if we are serious about speeding up biomedical innovation, improving health, reducing long-term costs, we start by investing in an ih. the house has a proposal called point for century cures that is supposed to accelerate biomedical innovation and when it was first released by the republicans a few months ago, it did not include a single dime of new nih funding for congress. last week, the bipartisan draft of this bill isn't moving into the right direction. it has to billion dollars in new mandatory funding for the nih for every year, in the next five years. i applaud the house republicans for a technology this.

nih is critical to accelerating cures. let's be clear, a few billion dollars in temporary funding will not solve a decade of neglect, much less build a future that we need. so dr. collins, in the late 1990's, congress doubled the budget of nih and agency funding was left to shrink that down. if congress had never doubled the budget and had simply kept pace with prior investments where would the nih budget be today? dr. collins: i keep a graph in front of me all the time on this very check, i will put it up on the screen, because this is a documentation of the problems we are facing. what you see is -- the yellow line is what nih has had for purchasing power, it is adjusted by the effects of inflation.

the dotted green line is in the trajectory of it, going back to 1970. we had that wonderful doubling, but have gone down ever since. we could have stayed on that smoother trajectory and would have been higher up in the neighborhood of $40 billion. senator warren: to reverse the damage of the last decade, if i'm reading this right nih would need more than $12 billion in just the first year and the house proposal does not even put that much in over the space of five years. so let me ask, based on what you have here. in your expert judgment, what is the annual rate of increase the nih needs to get back on track on funding. dr. collins: let me see that -- let me say that we were thrilled to see that $2 billion

mandatory, he gave us excitement and relief to a community that has been stressed over the past 12 years as we have been losing ground. to get back on a stable trajectory that would result in a healthy biomedical research ecosystem which our country is depending on, i would estimate in my professional judgment that we would need to be in the space of inflation plus 4-5% per year. that is a healthy way to be sure that all the talent and capabilities of this country in terms of biomedical research where we have led the world for decades, could be sustained encourage, and innovation could go forward and the ways that we wanted to. senator warren: $2 billion a year for five years is certainly better than nothing. but as not pretend that a small investment that falls short of what we need to do -- there is a gaping hole in our budget and we

need serious plans to fix it. there are many ways to make that happen, i have a medical innovation act for example that could add another $6 billion per year and it would not cost taxpayers a dime. whatever we do this committee have to get serious about medical innovation and that means we have to do better than the house proposal on this. mr. chairman: thank you senator warren, senator whitehouse. senator whitehouse: let me start by echoing the chairman's interest in having a review of where we are in health information technology. i read the wall street journal piece by dr. to solve a -- this although and i think that it makes a lot of sense and provides information for us to work forward. i think that the meaningful use

a has become obsolete and needs to be -- obsolete and needs to be tuned up since it was passed. thank thank you for agreeing to work with the chairman and the committee on the key goals that we should be achieving. i would encourage you to think big in encouraging completing that. let's get this right. to follow up on what senator warren was saying, i'm interested in what you have been able to document by way of consequences for failures to adequately fund our scientific and medical research. it strikes me that you could probably tell