Event ID: 692848
Event Started: 3/26/2007 7:46:26 AM ET
Please stand by for real-time relay captioning.and
Please stand by for real-time relay captioning.
Good morning.
My God, good morning!
Y'all better fire on up here. We have two very intense days. Let me thank everybody for being here, all the members who are in the audience, we appreciate your involvement. Everyone looking in, following on the web, it's always good to get these emergency e-mails on the Blackberry, somebody who says wait a minute, what about this? We know people are extremely attentive. This is the 12th meeting of SACGHS. I want to welcome all of you again, and for everyone's interest in the work. Members of the public who would like to testify, we urge you to sign up at the registration desk. Our committee is a little larger today, thanks to secretary's appointment of a new member, Dr. Mark Williams. You know yourself, but the rest of us may not, you are a certified board clinical jee geneticist.
Geneticist.
All those included, editor ship, chief of medical genetic services, makes you extremely important to this committee. Thank you.
I always want to welcome back two key staff, Sheila Walcoff, J.D., and our friend Dr. Greg Downing, program director of the secretary's healthcare initiative. Sheila met with us in November to talk about the commitment to improving the safety, quality and effectiveness of healthcare by leveraging advances in genomics. She told us accelerating healthcare is a top goal and there's an urgency. As of Friday of I saw the urgency in action. I represented in two extraordinary events, you will hear more from Sheila in a moment, but clearly this is a secretary who is inspired, gets it, understands it's a historical moment in being able to merge the benefits of science and health information technology to ensure better health for each individual. He gets it as far as this committee. In any history I have participated in this committee, I have never seen the extraordinary added attraction, in terms of how this secretary treats this committee. He's listening to us. The good news is you are respected. The bad news is you will have to work a lot harder. We appreciate that. You will hear a lot more. I will say a quick word about Sheila, where is she, and Greg Downing, where is he? Imnd Behind the scenes doing so much work. We have long warranted the person to -- publicly I want to say we are extremely pleased by what we are seeing and really makes the work we are putting in seem so much more real and relevant.
Following the conference, if I ever get done, we will hear from Robert Kolodner, I am really interested in hearing the national office of coordinator for health technology, and -- policy special research, about the role of technology, how this will move this agenda forward. I will tell you Robert is also just terrific and I have had a lot of time to work with him in the days past. Welcome to all of you thank you very much for coming with us.
We have a very broad charter and mandate. Within that our agenda is guided by a strategic plan. I want to put that up, everyone in the committee, and Mark, you am you will catch o I will go through laborious effort to review this strategy. It's important at the end of the day we are able to say that we have kept our commitments, that we are moving our committees and our work forward in a logical way designed to produce results. It's too much work to bring you in and have lovely conversations that go up in the eghter somewhere. Where we are, we have identified 12 issues we thought identified the attention or in-depth analysis.
Cross-cutting issues that effect all of them, always addressed in our work. Priorities on the left-hand side are checked because we have produced reports, recommendations on the issues. Priorities on the right are ones we are currently focusing our an litical efforts. As I rip through quickly, I want you to keep in mind for preparing you for tomorrow afternoon. We are going to relook at the priorities, status. I want the committee to feel comfortable that you, there's not a scent of omission on the agenda. If you feel something else is emerging we should be a tending to, something here is less important than something else, we should revisit to make sure we are Marx mally relevant to the events of our time. Keep this close in mind.
genetic discrimination, we have written a number of letters championing, and we provided a legal analysis of the add qasy of current law, compendium the size of a phone book, and a DVD documenting the concerns, public testimony from the committee. Kept close watch on congressional development and in a small way we have, within the limits of our appropriateness tried to bring folks together for a common way to resolve differences of opinion. We are thrilled to see the development in the current Congress, looking forward to an update from staff on what's going on with the new gi NA as it's called, bill. GINA. In 2004 we made recommendations to the second about the importance of genetic training and professionals, how it should be enhanced. Government has a role to play, we ask the questions, where does genetics, training, education ask training stand today, we in better shape than three years ago. We will discuss the strategic planning being developed and revisit recommendation necessary lited light of this issue.
There are developments, early disease detection, intery intervention, has an acronym, JEDI. Can head to detections to improve outcomes. CDC, NIH, collaboration, test translation project working to enhance genetic testing between providers patients and the testing laboratories. The American nursing association, to its credit, the international society of nurse s in genetics. The well-respected -- national coalition for -- in genetics continued to advance it's hard work, reaching special language pathologist, audiologists, dieticians, developing a database, providing genetics information to non-genetics -- and creating a program on pharmacogenomics, that is important.
We will see whether you are comfortable with these thing and want to move further forward on revisiting this important topic.
In 2006 we transmitted a report on coverage and reimbursement for genetic test and services, highlighted the problems in the system that we thought effected patient access and nine steps to overcome the barriers, a range of -- eferdz based covered decision making, codes for genetic tests and services
Sipedy and I had the tune the to brief Mark Mcclel an on the issue. It's was a positive meeting, expressed a strong interest in the recommendations. We will turn to Jim Rollins now, my script says he is -- Jim Rollins isn't here yet. You are going to hear later from Jim Rollins on an update on where things stand in cms concerning activity on these recommendations. Let me again say mark Mcclel an was great and his leafing out does not mean this dropped. There are activities moving forward,CMS, we will come back and hear from Jim. Whenever that happens, the thing to key esm sighs in my comments, we have been attentive that sipdzy and I did not just have a nice meeting, the key thing, we are moving forward.
We wrote letters to the consumer marketing -- genetic tests, collaboration between FDA, CDC, federal trade commission, issued a consumer alert about using at-home genetic tests not evaluated and be wary of claims made by companies marketing. It's an interagency collaboration, tremendous accomplishment in that respect. We commend HHS for its leadership in moving forward. What's the benefit? How many people did it reach? Our o fishio, for providing us data on how widely it's been disseminated 6461 so far on the website -- copies of the brochure, total distribution is around 18,000 for web and brochure. Wide covered in the media, New York Times, FDA news, medical device week. Out there, moving forward, if anyone can think of other ways to disseminate let me know.
We completed report on power issues without undertaking another large study, transmilted to the second earlier this month, copies of the printed verges are now publicly available, you have a copy in your folder and available at registration desk for the public or you can download the pdf version from the website. I happenedded a copy to the secretary in a one-on-one meeting on Friday. I know high he has it and we will quiz him on it later. Our thanks it Hunt Willard and the task force for guiding through a long difficult process. We are thankful to the experts who broaden our vision and greatly enhanced by the public comments last summer.
Bringing the report to fruition, particularly -- and in the early stages Amanda Cere at on. Pharmacogenetics -- announcement of personized healthcare initiative at the national press club. I want to thank, and appreciate our task force led by cefn fits Gerald, as well as the office of the assistant secretary for planning and evaluation, the lieu in group, and the group for getting the draft ready to release in time. It was a race to the finish, you couldn't miss the secretary announcing, having it at the press freeness conference on Friday was terrific.
We are making progress on the study of gene patents and licensing, you will recall at November meeting we developed a -- licensing practices. Our friend Jim Evans will provide foundational knowledge and how we are moving forward, the basis of the patent system, and how licensing works, and in-depth developments. We will be updated by Jim and Dr. Robert Cook-Deegan from Duke. This slide illustrates the structure of our study, components being carried out by the Duke group will revisit this later in the meeting. Jim will hold announcement, task force meeting tonight -- no basketball games. With Bob and collaborators. Committee members who wish to attend, really looking for a fun thing to do, should let Jim and Sarah know. We will be making provisions for overflow seating.
Extensive discussion about the oversight of genetic tests at our last meeting. CMS will not be moving forward with the rulemaking under cly a, after much discussion it's fair to say the committee was left with many questions about the adequaciy of the federal oversight framework for genetic tests. We decided to engage in further fact-finding at this meeting. HHS created a work group to determine where problems, and gaps lie within the federal government oversight, keeping SACGHS informed. Specific charge from the secretary's office to us. I will say this, once again, I don't want to embarrass Sheila or Greg, but I have to say it was very encouraging to me there's no question that each of you and I personally, at the end of the last meeting were confused, concerned. The responsiveness by HHS and the secretary's office to that anxiety was palpable. They are on top of their game and I am personally convinced that this issue is a high priority. I have had several meetings with them, and I will tell you that I understand that they are taking this seriously. So I just want to say to you that while there were a lot of anxieties in the commit committee at the last meeting, they are responsive and will hear more about that.
We are taking on two new topics, the economic consequences of genomics, and our good friend -- were you here? These guys have to come earlier! The -- on the evaluation of real world outcomes. We look forward to your terrific ideas. There won't be any time for it, but we are happy to have you. Before we adjourn we want to discuss developing a new long-range plan. We may have to outline new stuff, but as we do this it's useful to keep in mind that as long as as it took me to rush through, be out of breath to read all of that, it's important that we have done enough to have to read all of that and rush through. It would take that much time. You have been a busy committee and I hope when you check off your form around effectiveness and annual survey in the package you will be able to grade yourselves pretty highly by saying you guys don't fool around.
Before we go on with the meeting, and I will slow down for this, and acknowledge Joseph Hack et, who died last monthDr.Hack et participated in a income of our meetings on behalf of Steve good man and the FDA, dedicated 30 years of his life of carrying out the important mission of the FDA, an expert in methods standards, many achievements during his long ca require, one of the first to understand how important genomic testing would become, thought the first interactions with industry. The gathers were affection atly called the Hack et staff college, his appreciation to new ideas, dedication to mentoring. He was a valued colleague and friend, I know, and his passing has been a profound loss for you and your colleagues. On behalf of the committee, please accept our condolences. Terrific, thank you.
Since our last meeting there have been staff changes, terra Hurd joined in January, terra? Administrative tasks. A med a mor at a took another job, we thank her, search is under way for subject matter experts. Whoever is responsible for the Readsteer bunny joke -- we'll be speaking to you at performance appraisal review time. Finally, housekeeping matters related to lunch, to save time, order from the hotel menu, fill out the order in front of you before 9:30 or else, because of the special task force committee meeting tonight, the full commitly will not meet. We will have a dinner buffet during the meeting. Sar a time for the official ethic scare you to death comment.
Conflicts of interest: Before every meeting you provide us with information about your personal, professional, financial interests. Information we use to determine whether you have real, potential or a parnlt conflicts of interest, affecting your ability to be -- we believe your ability to be objective will not be aiveghtded we require you to be attentive to the issue arising that affects or appears to affect your interest in a specific way. We have provided you with a list of financial relationships that would become a conflict if they became a focal point. If this happens we ask you to recuse yourself and leave the room. Lobbying, you are government employees and are prohibited from lobbying -- special government employees -- we may not lobby as individuals or committee. If you lobby in professional capacity or as private citizen it's important you keep that activity separate from our activities. Keep in mind as well, as Reed has, SACGHS is advisory to the secretary, do not advise the Congress, and I thank you as I have always for being so attentive, as I know you are, to these rules.
Tuck son: Go home, tell your family you are special. If you note by your clock, it's actually 829. I have gotten through that a minute early. This is the standard we want to keep for the rest of the meeting. With that, I turn to -- I told Sheila she could have as as much time as she wants. Counselor for secretary of public health, extremely important person.
Sheila Walcoff, J.D.: I am wondering if today is National Compliment Day. I appreciate the opportunity to return to the SACGHS to update the committee on the department's work on accelerating personalized healthcare. I noticed the bunny, I admire Reid's energy so much, it makes me feel like wlofer is not here is probably going to suffer the consequences of the bunny sometime later on today. I have a few slides I think I would like to outline, to reiterate what reed said. On Friday the secretary outlined the personalized medicine coalition, the healthcare initiative. I would like to provide a brief overview of his remarks, discuss steps under way to develop the important information, as well as steps to build foundation for personalized healthcare and make sure gene based technology are used appropriately.
About a year ago secretary Leavitt defined 10 priorities on which he in10eded to spent personal leadership. Personalized healthcare is, we always put it at the top, but delve definitely on the top 10.
The secretary understands the advances present opportunities for enabling healthcare practices to take into account differences -- the desired outcome, safety, and -- noted a number of times, increased value and transparency for patients.
Up here you will see the secretary's visions, the secretary's words, personalized healthcare describes the approaches across the healthcare enterprise, high value on consumer focused health by using modern technologies to improve safety and health. We have a healthcare sector in the United States, not a healthcare system. You will hear Dr. Kolodner later, focused on as well. Incorporated new methods of analysis to better manage disease or predisposition toward disease, facilitate the testing of new products, getting the right treatmentment or approach to the right patient at the right time every time.
Some of our long-term goals, and the secretary looks at this as a long-term vision, project of our generation we refer to it sometimes, and very specific short-term goals. He understands, and I believe we have 666 days left with the secretary at the wheel of HHS, we have countdown clocks and are very aware with the limited time we have to make a significant difference, accelerating personalized health and moving forward.
Some of our long-term objectives of the next five or 10 years are to promote connectivity, the hetle care information network. Access oversight approaches, develop incentives across the healthcare system, genetic information. Develop -- pharmaceutical -- industries. Encourage participation in healthcare management, prevention, consulting support and incentives, and establish real-time -- for disease management strategies using health --
Short-term goals, to prevent AHEC with what we are calling -- genomic medical testing and family medical history for electronic health records.
In parallel with infrastructure and capacity development, encouraging development of validated -- as Reed mentioned, and to establish networks of interactive data sources.
You will see on the slide a diagram we use pretty consistently to describe the overall vision we have. This pyramid really captures where we are. At the base is health information technology and knowledge development, underring pinning this development, two global forces shaping consumer care. Information technology and knowledge management. The foundation. The full potential cannot be realized unless the electronic systems and repositories under development are based on a common set of definitions and standards. Moving up the pyramid, intervention development and review, need to integrated data sets, higher quality information about efficacy and safety outcomes. Using integrated databases the ability to assimilate, relate experiences is incredible power for disease management. As capabilities develop better information based on individual differences will aid in future medical product evaluation and post-marketing assessments of safety and efficacy. Health measurement tools will foster measures to -- preventive approaches. Finally, translation into clinical practice. The key players in this transformation are healthcare providers, doctors will play new roles, rnldzing the unique aspects of each of us had healthcare pljment, continued advancement and biomedical research, particularly evident as need for better bridges for healthcare delivery. We wlak lack the infrastructure at this time for data management across biomedical research and health delivery. Formats can enable among willing partners in healthcare, hoping to create a healthcare system. We envision a continuum of transfor mages to support integration of discovery delivery in the healthcare enterprise, pave the way for a more modern Dr. Patient relationship where value in the ultimate objective.
Basically, we describe the secretary's role in this initiative as being two parallel tracks moving along quickly together, technology development and appropriate policies to support that technology. You will see outline of the first set of goals, technology goals including establishing the foundation for networking partnership to enable researchers to research clinical data in an almost google-like system. You will look in the small document, the president's FY 08 budget, includes $15 million for the personalized healthcare initiative to begin the distributed network, genomic and clinical data to add efficiencies, clinical best practices and better method of tracing adverse events, right at the starting line for that, excited about having that money. That will be coordinated through Dr. Clancy's office at -- ARC. I know Dr. Kolodner will give you a greater understanding, but tracking standards are genomic health information, personal history, and health records. Established a special working group to advise the AHEC on these issues.
Our secretary track is support appropriate use of genetic information. Because genomic information is immutable, the public is concerned about issues of privacy. It's definitely in the news now as well, with the genetic information on discrimination act. People fear discrimination in health experience, employment, public attitude. The secretary as a number of times said he supports passage of legislation to prohibit discrimination. Before the secretary stepped to the podium on Friday we received word the GINA bill had, and is soon headed to the House floor. The president inned KATEed a willingness to sign such a bill, and -- I think we cannot ever get past the discussion on this legislation without turning to Dr. Francis Collins, instead of call it fing it GINA we should call it FRANCIS. Couldn't get the acronym to work. Analytical, clinical validity of -- reed touch odd earlier, the validity of genetic testing, the usefulness, making important clinical medical decisions, there's a lack of clarity in the regulatory oversight system.
Finally, the initiative seeks to standardized -- policies, the sequence database by public funding, create many new opportunities that will benefit public health. Currently policies for accessing are inconsistent about who has access to specific information and the time frame in which this information will be made public, and the level to come it will be made public. The initiative is working to harmonize, bring consistency to the policies move forward effectively, efficiently in that kind of research.
As I noted earlier, the AHEC established healthcare working group, broad section of stakeholders, listed here to get a sense of where we are going on that. We recently had a meeting, two weeks ago. Really encouraged by the comments I heard while there, ex10 the to which folks are taking this extremely seriously, taking time and effort to work through the issues.
Currently there's a lack of consensus on policies surrounding genetic testing, family history information in the electronic health record. That could impede further systematic and useful adoption of the technology. Genetic tests are being used in -- no standards edge bedded, certified for genetic family history, to ensure information in the health records. You will see other work the group will take a look at over the next two years. The standards are not widely cap accepted, a patch work of ideas -- exchange of useful information.
The healthcare acceptance and understanding of new medical technology is not keeping up with the rapid pace of research, the charge of the work group, something very much a part of the healthcare initiative, and Dr. Downing should have a bunny because he never sleeps, working on all these issues so hard, really the string of continuity through the various issues happening at the department that will promote the secretary's initiative.
I would like to wrap up my remarks with focus on an area we believe the SACGHS could assist us in developing knowledge to support some of the work I just referenced. Fortunately, since my system was not working very well last night we still have glitches in technology, Reed doesn't have this in advance, but I will outline the charge referenced earlier and leave a copy so the committee has a chance to look over that, consider whether it would like to take that up. As part of the personalized healthcare initiative, oversight of genetic test suggest a tarn concern for many stakeholders. It's a concern, the SACGHS heard over the last few meetings a range of testimony on the subject, many, not all of the agencies involved in oversight of this important technology have participated in the discussions you have heard. Through this proationz the committee identified a number of unresolved issues. We understand and recognize the prnsz of this discussion and also see the complexity as the use of genetic technology expands, plays a larger role in the personalization of the healthcare. The secretary is committed to supporting advances and appropriate regulation without stifling innovation. As we look back we have been carefully reviewing your work, still relevant in today's conversation of the many important topics, recommendations were covered in the report, enhancing oversight of genetic tests. We agree with the principle stated, the public is best seferd by -- continued developed of such tests. Subsequent to the report, you are a very very busy committee reed, in September of 2001, clarification of -- genetic tests, the committee found the feasibility of categorizing based on limited set of elements, simple linear fashion was not possible. Closely following the information gathered by a broad cross-section of stakeholders to bet are understand the issues and discuss internally how the department should -- to that end, we are interested in the work of this committee and ask you to continue to provide valuable information to inform the secretary's initiative. We specifically appreciate your input on several questions critical to -- the secretary announced the personalized healthcare initiate is -- regulatory policies concerning genetic tests to identify the scientific information and oversight needed to be sure tests are being developed and properly used to encourage patient access to better genetic test and improve transparency of the system of oversight over all. We suggest this committee undertake the development of comprehensive map of steps needed for eferdz development and oversight for genomic tests with improvement of health quality as the primary goal. The following questions: The pathways examining the analytical validity, clinical validity, what organization are responsible for, and what are they doing to address the issues, and the potential pathways to get clear information and treatment selection by providers. We would like infuts on the -- and clinical validity such as what evidence of human harm exists regarding genetic tests. The validity, clinical valid ID -- if evidence does not exeft exist -- what resources, such as standard -- or materials are needed to develop po proefficiency testing requirements, what information is provided by proficiency testing. What new approaches or models for public, private or public/private engagement in -- for developing effectiveness measures for use of genetic tests and what should be considered and why?
Finally, if where and how additional revised government oversight would add value for patients. On behalf of secretary Leavitt I appreciate your time and attention and look forward to receiving input on these and the broad rage range of issues you went over earlier.
Reed V. Tuckson: We appreciate -- in the spirit of almost always true dictum, be half careful of what you asked for. We asked for an assignment, I think we got one. We got a pretty big one. Pretty powerful one. What we will do, and I am well-aware of the anxiety that goes with someone trying to present a report on Sunday night, and your compute commer doesn't work, you are running around with the senior people at 6:00 Sunday night, that's no fun. We will take a copy of what you have, I will have it copied for the committee, curn return to the issue tomorrow, start to think about it. The charge is important, while we have Sheila here, she has to get back downtown. I will say I am comfortable, excited by the charge. Especially because I think it is important the committee understand the context of the charge. I want Sheila to comment specifically, you have to hear it from her. I, through a series of meetings, am convinced that hh system understands the importance of protecting the public, and they are doing their work to coordinate the federal agencies and are looking carefully themselves at what Clia and CMS and FDA and all are supposed to do. I want the Committee to be confident that as we look to take on the assignments we have, it is within a context of an overarching activity at HHS.
Sheila Walcoff, J.D.: That is exactly right. It's the secretary's initiative, one of the policy areas we identified pretty early on, a number of folks here are very engaged in this from the department's perspective. But it's something we think in the next two years we would really like to move forward on and try to establish some clarity and consistency so that the area of personalized healthcare isn't stalled. Promote innovation with an eye out on the issue of public trust.
Reed V. Tuckson: You ended exactly where I wanted you to end, that is the sense that one of the things that impressed me about the secretary's comment, his realization of the public's anxiety about privacy, confidentiality, the sister of this issue of trust, of oversight. It's pretty clear to me this movement is not going to go very far, very fast if the public is not assures there's confidentiality, trust, and on the regulation side has to be addressed, it's keenly important.
Sheila Walcoff, J.D.: And Dr. Kolodner will talk more about what AHEC is doing in that area, something moving along as part of that track I spoke about earlier, right along with technology and the other policy areas we are trying to develop.
Reed V. Tuckson: I am buying time for your computer brains to figure the question you want to ask Sheila, but let me say the other thing that -- this is the second meeting Sheila has come before us and mentioned "the clock."the one, again, one thing I like about the way the secretary does his business, he's keenly aware he's only there for a certain period of time, he's not interested in a lot of yammer yammer yammer. He wants to see something happen. We have to think carefully about the things we can deliver to him in time for his watch in these areas, as that committee process goes forward. Maybe through Greg Downing we can have a way of continuing to keep track of, maybe help us Greg, think about, as we organize and respond to the challenges the timeline for us on this. Something we have to consider. Sheila Walcoff, J.D.: I have an assignment also, have to provide the secretary for not one, but two quizzes, may have to start traveling with him on overseas travel to have time for that. I am happy to take questions before I head back to Washington if anybody has any.
Questions?
Joe?
Good morning, thank you for that presentation. I have, if you could speak briefly on the initiative, if you can say a little about financing and access issues, one. Secondly, consumer and public education and engagement as it relates to the rolling out of this. I know on the committee you have listed some of that, in the presentation you didn't discuss it that much. Maybe say a little more.
You are asking about reimimursment policy and education?
Well, reimbursement policy is one thig, but the literal access to whatever comes out of the work itself by those it directly effects, more than reimbursement. Education as engagement. One thing to be aware, oork the to be educated, another to be involved. Speaking of the part, an outcome of the work, but have there been discussions, thoughts around that? So far, we are just getting started.
Sheila Walcoff, J.D.: Exactly. Across the department, looking to try to figure out what we can do, he can do, as a focus of this initiative. In that we looked at a pretty big vision, long vision, generational, tried to narrow down, direct leadership over the next couple of years. In those discussions we talked about transparency, education of not just providers, but consumers, researchers, spectrum of stakeholders, reimbursement policies. That list we have on the AHEC slide is really a brief snapshot of, I think, a broader number of issues that will certainly touch on there and are worthy of discussion as we continue to go through.
We haven't identified some of those as priority issues mainly because we have limited time and to some extent limited resources, although I don't think Greg Downing ever sleeps. We are, I can let you know, we are engaged in those kinds of discussions and continue to seek input and discussion on those, they inform our other policy processes, as you noted.
Terrific.
Any last questions? Is
Yes?
Thank you very much for that presentation, the secretary's comment, charge to issues of oversight. I haven't seen the chart in detail or had time to look over, there are a couple of things I would like you to go further if today, maybe at later time, as we go more into the charge to provide us more detail, specifically what you are looking for. In the area of oversight, the role of the states and the federal government, could you tell us more about that? Do you want us to actually look at the role of the federal government, the states, the private sector, of genetic testing?
Sheila Walcoff, J.D.: We have left the charge in some respects purposely ly broad, we noted to get the best look, broad spectrum look from the variety of stakeholders on this committee. Our focus certainly would be more on the federal side, our ability to impact, but we would like an understanding of what private sector sees, public/private partnerships, and where the federal government is on this with the extreme importance of it. In terms of state reelingulation, issues, there's work done by the committee in the past, but I think we would be looking more broad, federal look to try to identify specific areas we can take action.
Question: The clinical -- with regard to the analytical and clinical validity, if you can provide more specifics of what the secretary is looking for.
Sheila Walcoff, J.D.: Sure. This is the first lout line of the charm and charge and we will continue to work with you, and discussion will come out as we move forward. An initial look at how committee feels about the charge, we can further develop from there, have more specific discussions.
Reed V. Tuckson: What we will probably do then, Sheila, Greg will you be around for much of the meeting? The whole time, unbelievable. When we get to the discussion and agenda on this topic we will have a chance to engage at that level of granularity. Sort of negotiate out a little in terms of how much we can get done on the timeline available. I think this idea of the relationship between the public and private sector is one that particularly engaged me intellectually. We are uniquely able to do something with this. That will be important. Sheila, your question was really important in terms of helping them to understand a better, if I understand the charge at this level, really clearly trying to understand when it comes to clinical, analytical validity, if there's evidence of harm, what the large speaks to, or threats.
With that, I want to again, amazingly, it's like one minute of! Gosh. That's why I am calling the question here, saying thank you again for this, and we look forwards to responding back to you, and the secretary, with the results of this meetings deliberations, and we will shape that between ure committee and the secretary 's office within the next couple of weeks.
Sheila Walcoff, J.D.: Sha sounds great. I didn't mention timeline, I left that for more discussion, but our clock is ticking and we are anxious to put you on a fairly accelerated timeline for this. Fortunately you have already done a good amount of work on this to date, focusing in on the specific questions that help the policy process will be extremely helpful. Thank you very much. Don't eat too many bunnies.
We are all about the deliverables. Thank you very much. Right on time, look who's here, it's Dr. Kolodner and Jodi G. Daniel. The key to many meetings is how important the health information technology infrastructure is going to be to the transformation of healthcare, and in particular personalized care, particularly in the noigz notion of genetics. Dr. Kolodner stepped in to try to be the leader of 18 different task forces, I am on half of themwhy I really know that Dr. Kolodner is on his game, believe me. Thank you very much for joining us, giving us this background. I hope the committee will get from this, not only the overview of what's going on in HIT, seeing, thinking about how this infrastructure is available to advance the interests we have. Thank you Jodie for joining as well.
Dr. Kolodner: Thank you very much, it's a pleasure to be with you today. Look forward to, not the presentation as much as the Question and Answer afterwards. I will do part of the presentation, Jodie Daniel will be doing the second part. As you know, there are multiple challenges to the advancement of the genomics, and we heard about a number of the issues of discrimination on the basis of static information we need to protect against, genetic information is unique to the individual, predictive of future health and immutable once disclosed. Unique among information really does not only effect information about individual, but other rlghted family members. While we had that with family history it what you want as powerful as it is seen with genetic information itself. Finally, the challenge that genetic information by then being supplemented with other types of data by noncovered entities could be relinked and that we need to do the protection to make sure that sort of violation of privacy does not occur. Health IT itself, as mentioned earlier on, can really add to genomics, helping advance the adoption, huge amount of information to bring to the forefront, frontline clinicians to make a difference to the individual themselves, we need IT to enable that. This issue of trust in the privacy and security is fundamental in order for individuals, you and I and our friends and colleagues, as well as family, to allow that information to be used and captured now and into the future.
There are a number of drivers for health IT adoption and one of those that is pushing us is that rising cost of healthcare in the U.S., the fact that in the U.S. healthcare is double the -- and we are frankly not getting value of the dollars we are investing. If it continues to rise it will fundamentally undermine our economy in the neuter even now as it's challenging the global competitiveness of the corporations. There are positive drivers, the fact consumers, economy begin to see the substantial benefits that can come from it, and some organization showing where health IT can help improve care. We will sigh see that.
Administration leadership, both in the executive branch, president, secretary Leavitt, as well as on the Hill, there's real bipartisan support for the health IT agenda. Finally, the strong endorsement from industry and commercial leaders who will be able to benefit in terms of their global competitiveness, in the fact so much of our current costs going to market, services, products overseas are tied into the cost of supporting health care.
Now, when I talked about the health IT there are several components I would like to address. At the top of the screen you see the end points, electronic health record, information, systems that are where that information gets used, either by providers, individuals or by the community and nation. Underpinning that are standards we need for data, technical standards and security. Without that we have a tower of babel. In order to get the benefit we need to link them together securely, robustly, in order to flow the information among the different islands, users in a way that honors the privacy, security of the individual r but advances knowledge, the health of the communities. That network is what we talked about as the nation-wide health information network we are seeking to foster, not a single network, but a network of networks at the community and national level.
For those who aren't familiar, the President did issue executive order in April of 2004 establishing the office of the national coordinator, to advance division for developing this nation-wide interoperable health structure,le as well as achievingwide spread adoption. The key for ONC is to provide then leadership to achieve this goal. To improve the quality and efficiency of healthcare, as well as ability of consumers to manage health. By that we mean the national health IT agenda. Let me emphasize the purpose of that national health IT agenda is what you see highlighted at the bottom. It's not to achieve technology. It's about the outcome, it's about improving the quality, efficiency, safety of healthcare, enabling consumers to manage their health.
So health IT is a critical component for a transformation to occur. The transformation is not the adoption of health IT. The transform ation is in the individual and population health, not just incrementally improving based on what we are doing today, but bringing about a change in how we support the health of individuals and the nation.
The framework we have builds from that would 2004 charge to 2014 when there's a widespread use of a variety of things, the network, public infrastructure, other things, home telehealth, even beyond the home, continuous monitoring of one's health so, people talk about the fact you pick up the cell phone, make a call, it's monitoring your vital signs, using ailing algorithms to determine if something is going on, recording who to notify, you, your significant other, primary care doctor, if something is abnormal. It's really very different way of thinking as opposed to now where we have the episode where you have to go to a provider, have that small snapshot where you are getting care. This allows you to actually have a monitoring of your health in real-time throughout the day and night.
We have set up four goals to support this charge that we have. Things about informing the healthcare professional, interconnecting healthcare, personalizing that health management, and improving population health. You can see there's a real overlap between the areas that you are focused on as a committee, and the activities that we have; because the things you are doing cut across multiple goals there we are charged with.
We also have a federal advisory committee, the American health information committee, community. This community, this AHEC, is one chaired by secretary Leavitt himself, public/private collaboration, and serves to provide input with regard to our advance towards the digital health records and interoperability. A lot of this is also how we a sure that privacy and security of the records and how we enable the market forces, because frankly in the area of health IT the market forces, the market processes did not work. Our role is not to replace those, but to set certain boundaries, certain targets to remove barrier and provide incentives in order for the market forces to work, for creativity of the community, the providers, the nation, to move forward and to advance us so that we achieve that interoperability, and the transformation of the health arena.
Our work is done in work groups, and so we have a variety of work groups that have been set up. We have been fairly busy, last year we had over 50 meetings involved 120 stakeholders. The focus is to make recommendations to AHEC regarding policies, technical, policy and social issues so the AHEC then, as you do, can make recommend gzs appropriately to the secretary and the department. We start ed in November of 2005 -- for example, the electronic health records established we wanted to make laboratory results available to front-line providers, even if that provider didn't order it. Sometimes that's an issue. We wanted to make sure consumers had a medication profile to pull up, make available to whoever they want to make it available to. We established two other groups in May of 2006, because each of those groups identified the confidentiality, security issues, rather than dealing separately in each group we brought them together into a group that would discuss and advance those and Jody will talk about that in the future, in a little bit. We had a work group on quality. Finally, the most recent work group established in October 2006, the personalized work group Sheila talked about previously. Of these groups you can see there are two particularly relevant to the work you are doing here.
We use the collaboration to advance our agenda; and that term national coordinator is important, because my role is to help coordinate the activities. We have public/private initiatives to do so. There were three contracts established, the first two are meant to foster the establishment of organization that will go on and have a regular role to serve the nation. The first is a standards harmonization, hitsbe. We like a lot of alphabet soup as well. This group is looking to take standards in areas, harmonize, which will we use going forward? The problem is having so many to choose from. If we are going beyond the tower of babel, we have to decide as a nation which we will use to speak the same language. We have a verification commission certification commission, moving forward on personal health records in order to provide certification for those. Two-fold, first to help, push forward adoption of standards that have been identified, and secondly, to help reduce the risk for the frontline providers, coming to electronic health record, so they aren't having to decide does a product meet my needs, the standards? They will have certification there to depend on, in the first year we have 55 inventoried e HRs, get to over 70, and that represents over 25% of the products on the market, and over 75% of the installed base already. That's the good news. The bad news is the installed base of really significant electronic health records being used is only at 10% of the provider community, whether in-patient or out-patient. We have a long ways to go to move that forward, but that is what our charge is.
Now the final contract is not to establish an organization, but to foster the development of that network, and we started last year by issuing contracts to electronic consortia to develop prototypes to develop the test ideas. We drew from that, demonstrated on AHEC in January, and our next round is to go not to the technology companies, but to the health information exchange communities that are out there in the regions, local, state, in order for them to contract for the services. We will be defining certain capabilities that need to be there, particularly with regard to enabling individuals to control the information that flows over the networks. The reasons for doing the latter is not to say that's the policy, but to say as this technology moves out, the technology doesn't limit or define the policy, but that in fact support what ever policies we adopt moving forward as a nation.
The other collaborative activities are at the state level, because the state and communities are where the real action is occurring, not the federal level. We can foster development of standards and certification, but the true implementations occur locally. Two activities there, the first is activity within the privacy and security which was a collaboration at the state level to identify where the variations in state laws occurred that might act as barriers to the movement of information. The one at bottom is state alliance for e-health, contract with the national governors association committee, one of many Dr. Tuckson is engaged in. That's really looking at establishing, has established executive level advisory body, into the governor, legislative levels at the state in order to develop consensus solutions for state policy.
Another state activity we had went out through AHIMA to work and identify some of the top leading edge health information exchanges to identify best practices and to advance those, cull them out so others that are proceeding to establish the health information exchanges can learn from them, see what issues, strategies were addressed by those early-adopters.
One way of looking at this is that health IT supports the transforming healthcare, and that like a tree, it, privacy, security and confidentiality are at the basis of all we do in transforming healthcare. The health IT activities feed the roots of the tree, you see a number of them there, a few of which I talked about. The governance process, the AHEC, the real purpose of it is not the tree trunk or roots, it's the foiliage, you see the providers, improving public health. Three of them, individuals managing health in a safer, healthier nation, not just transforming healthcare, but health and care, goes beyond the healthcare arena or sector itself.
The issue of privacy is critical in terms of policies, principles, and transitioning the a tech unlike what you would be doing, transitioning to a public/private entity, the real governance will move to an entity that is a public/private entity in the private sector. We are in the process of starting that movement.
You heard from Sheila about the personalized healthcare group, a broad charge there, I am highlighting here about the issue of common standards, the incorporation of clinical useful genetic laboratory test data, electronic health records, the specific charge having to do, highlighting establishing the standards for recording a corporation, medical genomic test data, and providing incentives for adoption.
The standards will -- we will be fostering. We need to be managing the systems, to generate the knowledge by having better -- give us better information on the individual differences, we will be able to draw the information, standardized information so we can do closed market surveillance, get better evidence development, what we need to do is figure out how to do that, honor the privacy of the individuals and do this in a manner that all of us as a society can benefit from.
We need to move -- automating the revenue side to automating the core activities that are the delivery of care. You look across any industry it's when you automate the core processes you get the benefits from the auto mages. For the last 30 year necessary healthcare we have been automating the edges, the revenue, not the healthcare delivery.
Health IT, again, is not the end point, it's the means to improve health by supporting the physician, and the care provider, keeping up-to-date with medical information, making sure they have access to the nsmtionz, all the information about an individual to give that better care, improving the diagnoses, decision support at their fingertips, point of care, being able to know, various parameters, genetic tests, results, what the anticipated curious of the illness might be for that individual. It supports the researcher by making available a variety of tools and providing access to a wealth of information that goes beyond what we can achieve with our normal randomized control studies where we have to refine the population in a very tight manner and where most of the individuals that we care for actually have multiple diseases and will be we'll be able to draw that information from the databases. Supporting the consumer, the real beneficiary of all this, by helping them to receive the bested care possible, personalized health; so they get the right diagnosis and treatment the first time, every time. As I say, it's really beyond healthcare itself, it's transforming health and care. So not only do we deal with improving the diagnosis and treatment, the healthcare delivery portion; but it's really about moving to anticipate and prevent illness, and by that really transforming to healthcare health.
With that let me turn it over to Jodie, she will talk in more detail about the privacy, security aspects and we will take questions at the end.
Terrific, Jodie is director, office of policy and research in the office of national coordinator for health information and fecknology, known as a U.K.
Jodi G. Daniel: Used to be -- so we shortened it, not a perfect acronym, but better than the alternative. Good morning everyone. I will drill down on some of the issues related to privacy, security, that Rob touched on. To highlight a up tole of things Reed and Sheila talked about, privacy is one of if not the most important issue we face with respect to health IT. Trust is the key. If we don't have patients trusting the -- if providers don't trust the information is reliable, protected, then we will have a real problem in achieving health IT goals. This really is the key policy issue that I face and that we face in trying to roll out health IT goal and initiatives.
Two things to highlight. I think the technology clearly does provide some added risks for health information to be disclosed. There's greater ability to aggregate, greater ability for a large amount of information to be shared, and also provides really great opportunities to protect data in a way much more secure than in the paper world. You can build in protections that might be administratively purden some in a paper world. You can identify when there's been a breach where in a paper world you can't necessarily, real opportunities to, and trying to look at how to minimize the risks and increase the protections that are available with technology.
Rob mentioned the executive order establishing our office, one goal is about privacy, security, nation-wide health information technology infrastructure must ensure patients identify information is secure and protected, key tenet of everything we are doing, part of our mission of the office. One thing I like to highlight, there's always debate, policies in place before the technology? Technology ahead of policy? Issues addressed in medical technology and health information technology, and we really see these as having to work hand in hand. These cannot develop in the abstract. The policies have to be built as the technology is being developed. The technology will provide insights on how best the policy goals can be achieved. For instance, particularly as technology is being developed you can come up with great policies, but if they are difficult to use, people will find work-arounds and will have less protection than different policy incorporated, for example, I know everything has different passwords, you have to change every few months, more and more difficult for people to be able to figure out. Because of that people always have a little sticky note with their password on the computer, which make its less protective than if they had a simpler password to remember. Developing policies, technology that fits well together.
Rob also mentioned the NHI N, nation ride -wide health information network, the technology architecture standards are being developed, tried out, incorporating the ability for different privacy policies to be developed and be incorporated into the technology. The trial implementations have control capability, as developed there's the ability to work those into the technology, rather than technology being developed without considering those at the onset.
So where does this all start? When we are looking at privacy and security issues hip a always comes up as the issue and the foundation for everything we are talking about. And I think some of the challenges we face with respect to health IT and genetics, some similarities here based on the HIPAA baseline. The roles are strong foundation for protection, first nation-wide protection of health information, and they allow, federal floor, allow for state protections greater than federal protechs, and some of those provide greater protections for specific kinds of information, including genetic information. As looking for privacy, security policies, not only federal policies, but state policies and how the two can work together. That's why we are doing so much work with the states, as Rob mentioned, both federal and state level, to address those issues.
There's some things though where health IT may pose additional privacy or security issues that may not have been considered by HIPAA. There are opportunities for greater data sharing, aggregation, and so these raise questions as to do we have the right policies based on these greater abilities to share and aggregate information. New entities entered the market, in the relght realm of health IT and technologies, exchange technologies, regional oceans oceans and the like not necessarily covered, may be through contracts, and raise questions when those entities are holding a lot of information, aggregating a lot of information, does that raise new challenges, policy questions we need toe think about in order to make sure the information is private, secure, and can be trusted and safe.
Sheila mentioned the ability to aggregate a lot of genetic information, have genetic databases, the entities holding this may or may not be covered directly by federal or state laws currently existing, new opportunities and challenges to look at those areas.
Some of these issues are being raised by the privacy and security levels, also things looking at internally and have been talking with the office for civil rights about, office of civil rights at HHS, and as we get new information from the states, both state and federal level, of what are challenges faced, we are taking those to heart and looking at how to best develop approximately sees to policies to address those concerns.
At the state level we have the health information security and privacy collaboration. This was an effort to look at a state level, state laws, 34 states and territories are working within their states, collaborating across states through regional and national meetings, to look at their state privacy laws and business practics. Groups to identify how things really work in the real world with respect to privacy, scoter security poll policies and practices, entities more protective, variations in laws, and those states are each identifying variations and policies, practices, laws, looking at state solutions, developing implementation plans in their own state to address legal or policy barriers at a state level with respect to privacy, security. Where we are going with this, we want, have 34 states looking at issues, cost discussions at meetings, and in the future we want to find opportunities where there are issues overlapping across the states to bring those states together to have regional or multi-state collaboration to look at challenging issues that come up at a state level, organizational level that really require collaboration across jurisdictions. Patients don't stay in lines, crootionz cross to states, people travel, from rural may go outside, to cities, and we want to make sure we don't end up with 50 state stove pipes but have collaboration across the states on privacy, security issues, legal issues.
Because the -- identified the need for the cross-state collaboration it was one of the drivers for the state alliance for e-health, by the national governor's association, council for state legislatures, national association of attorneys general, and -- to build consensus by state leaders, alliance made up of governors, insurance commissioners, folks from their health agencies and the like, as well as technical advisers, including Reed V. Tuckson, to look at these issues coming up in various different manners and to try to see if there's consensus that can be drawn across the states, promoted across the states so as they take on these issues they have a baseline to work from, understand what other state s are doing, and Harmonization of policy discussions and decisions.
Particularly with respect to privacy and security there are three task forces providing information up to the state alliance. One of theme is health information protection task forced, focused on issues of privacy and security at the state level, taking information from the collaboration, as well as doing their own work and research, testimony to try to identify where there are issues, opportunity for cross-state collaboration on privacy and security policies.
Then, at a federal level, one of the biggest things we have, one of the biggest sources of policy development we have is the confidentiality and privacy work group of the American health -- the broad charge of this work group is to make recommendations to the community regarding the protection it of personal health information in orders to secure trust and support appropriate interoperable health exchange. The specific charge is the break through areas Rob mentioned. This work group was formed by a recommendation of the first set of work groups, focused on the break through areas, electronic health areas, consumer empowerment, they were replicating the same discussions in all of those, not necessarily having a means of coordinating, experts at the table who really understood the privacy and security issues. They made the recommendation to have a specific work group focused in the area. We start indeed ed in August of last year, operating about 7 months at this point. Have come up with recommendations on securities -- how entities would identity-proof a patient, make sure the patient is who they claim to be, advanced by the American health information community to the secretary based on their January meeting.
They are trying to now go a little broader and look more at some of the privacy focused issues, and are looking at the implications of having some entities within health IT and electronic health information exchange being covered by federal and state laws, whereas others new and emerging are not covered by federal and state laws, trying to figure out the implications of that, to ensure appropriate protections, and just started down this road the last meeting, few weeks ago, will continue to have hearings on those topics this month.
The other thing they are very focused on, interested in, personal health record privacy policies. The consumer can put information in a health record they control, as opposed to the doctor's health record. Many of those personalized health records are not necessarily covered by state or federal laws, new entities, the consumer empowerment identified this as area to focus working with them to identify policies for personal health records.
As I mentioned, a sort of summary of how all these things work together. Everything we are looking at, security and policies, the legal framework we are focused on. The CP S work group, and the phase two, how does the work of the CP s cans work group fit in with the -- the informational, and solider direct link. We see the work of the group feeding our verification activities for electronic health records and for network. We see it providing some input into the state alliance, state level issues raised, and we see a direct link with the trial implesmations, policies developed, we want them incorporated, requiring contractors to look at policies. Clearly their work will effect our federal policy development and thinking on how to protect information from a federal perspective. Then it will help with standards efforts, as the hitsby group is -- and other AHEC work groups. We see them working closely with consumer empowerment, electronic health records, and personalized healthcare work group, we have talked to them, about our activities and Greg and I are in constant dialogue on how to make sure the groups work together.
The goal isn't to have the activities, but to make sure we end up with a nationwide health information system, to make sure they are incorporated. As we start moving we hope to see the circles get closer and closer, vearn will have an overlap so privacy policies and -- are in harmony. With that we will take your questions and comments.
Reed V. Tuckson: As colleagues begin to think about questions, I will reemphasize for those of you who don't live in the world day-to-day of AHEC, again, the reason that this stuff is being presented to you is, from where I sit, I can't think of anything that is currently more transformative in the real life of healthcare delivery than what's going on in these committees. This is absolutely fundamentally redefining the mechanisms for the infrastructure of care delivery at every level. All the stuff going into electronic record, everything that will be standardized, expectations for how the electronic record will work, not only collecting information, but providing the prompts for information, evidence-based guidance that will effect care at the point of delivery. Everything on the task force's agenda around how to you educate fission physicians, other professionals, around appropriate stuff. This is one of the incomes to dump those informations into a point of access care record delivery. It's how we're going to evaluate physician's performance around are they doing the right stuff? That's what's going on in this space, the personal health record for the patient, how they will accumulate family history, genetic based information, so a patient can take that from one care setting to another across the fragmented healthcare delivery system. That's what this stuff is essentially all about. . So I want you to keep in your mind, this is transformative. The question I would have as my colleagues think through, two things, one, how can we influence or at least ascertain that genetics is in fact a priority in the electronic record committees, in the personalized -- patient health record committee. Is it only or specifically through the personalized healthcare work group we ought to follow-up, but how do we say genetics -- the committees are making decisions every day about what they can do, what they can't do. Certain things are more important than others in a timeline. This committee may need to understand where are we in the line? Our interests in the line. Secondly, if you can remember a second one after that long first one, for us to start thinking, trying to understand better the privacy, confidentiality, how the natural linkages occur in antidiscrimination. I am trying to get to -- try to keep both of these in your head, I know I am killing you here. The concern around discrimination is one thing, legitimate, real. On the other hand, of all the people in healthcare that will require an infrastructure for coordination of care, complex illnesses requiring lots of interaction with the healthcare system, so the ability to have information about that person put forward into the healthcare delivery system in a way that allows the coordination of cross-care settings, having that protected, but used, not discriminated if it ever get out, fundamental issues. I put both of those before you.
Robert Kolodner: I will take the first easy question. We are balancing a lot of priorities as we move forward in the agenda. The AHEC has a lot of things that its identified, moving forward. Everybody's particular interest is number one, we have a few number ones. This, however, because it is part of that transformation of healthcare and health, has to be built in at the foundation as well. So personalized health group is certainly the main vehicle for connection and Greg Downing helps to foster that, as this one, and is a direct link. In addition to that, as with your meetings, all of our meetings are broadcast, widely available. Whether it's monitoring the AHEC meeting itself or reading the transcript, which they go faster than listening to the meeting, or the work groups, which are also broadcast, where there are issues, you can see what we have for agenda, if there are issues you think either touch on your area of interest, or should touch on your area of interest, first of all, through Greg you can make sure if it should but it's not clear that it has, get the message to Greg, that is something that put its on our plate at the time of the meeting.
But by monitoring those things you can see where we need to add, pay attention to something that we may not be paying attention to. I encourage you to use those means, but you have a primary channel. The AHEC will be considering those things and for the next 666 days, if that's right, secretary Leavitt has this as a top priority. You have an advocate, as chair of AHEC, and the separate hat, in his role as secretary.
Reed V. Tuckson: As Jodie gets to my other question, I would like to make a specific request. I would like to acknowledge Greg , who expends a lot of energy, and as you considering new candidates for the personnellized healthcare work group, you consider someone from this group to be formally on it, I understand how complex it is, populating the committees, if you notice the Carol way careful way I phrased it, I would like you to consider someone from this committee. I would like secondly, to have as a standard part of our -- our n briefing, meeting, perhaps several to come, a formal update from the personalized health group, either a member of that committee to come brief us or staff function, however you best decide, Robert, but somebody to brief us as to what's going on. We will monitor. My thing is, you gave the right answer, but unfortunately these folks are so darn busy on this committee, with their regular lives, I think they need that going forwards. If we can do that, I see Mark --
Too late. There are two of us already on the personalized healthcare work group. Steve -- and myself, I can't speak for Steve, but I will anyway, I think we would be most interested in formally liasing with this committee, doing that. Yeah.
Reed V. Tuckson: I wasn't too late. I was pressing it. No, great, Mark. Why don't we do this, we have a committee of the committee. You are connecting it. We will hear from you as a team report. I think what we ought to do, when we get to the discussion about next steps, tomorrow, let's see if we can't give our team a little sense of guidance about what we see as some of the issues, go forward. This needs to become one of our strategic goals. Basically one we can claim since we are already doing it, we are in perfect shape.
Glad to put the check mark next to the -- there's another one with the box, no check mark, might be worth having the same connection to the CP S work group, confidentiality, privacy, security, somebody sensitized to this, we would entertain that if there's another member who would like to sacrifice their time, ob multiple committees.
Reed V. Tuckson: The connection between this stuff and the electronic -- certification committee, and the health record crew. Jodie, in terms of my question on the confidentiality, privacy --
Jodi G. Daniel: If we would be open to including more folks, and we have, I have talked with Greg Downing on trying to find somebody with research and genetic background to join the work group, haven't identified a person, so we would be open to suggestions at least. In addition, we have been internally, Greg and I, talking about how to make sure genetic and privacy issues, as well as health IT issues are considered simultaneously. As I mentioned, the CP S work group is starting to look at the landscape of some entities covered, some not, looking at those aggregating data from a health IT perspective, but also the same thing with genetic information, similar issues that are being raised. We were talking and are open to input on how to inthe great those.
Reed V. Tuckson: The thing I want to tee up, the antidiscrimination legislation, it really is this extremely sensitive and specific point, that there are lots of effort being done to coordinate, have information that allows you to coordinate care for chronically ill complex people. The genetic discrimination stuff is clearly trying to make sure that you, again, not able to harm, misuse that. There's a dynamic tension between how do you solve that equation and so I just want to keep that in front of the committee as we go forth. Let us take other questions.
Francis?
Thanks for a very interesting presentation, obviously a critical topic for the future of all medicine and personalized medicine. In terms of the charge to the personalized healthcare work group you outlined, it seems heavily focused on the use of genetic laboratory tests as a means of making sure the information is properly standardized, integrated, so it's possible for all communication priorities to be achievable in terms of physicians and other healthcare providers to have information, using it to benefit healthcare. I was surprised not to see any reference to family history, given that at the present time it's a strong driver of whether genetic testing will ever be -- and independent predictor of -- it's poorly collected, poorly represented in any kind of electronic record. There's a great opportunity here to optimize that part of personalized medicine, effortses under way by many groups over the years to provide the tools to make that possible, including the work with the surgeon general and the work of CDC. I would like to be reassured the charge here, by focusing on genetic tests is not missing the chance to take advantage of use of family history in a more effective way than we do.
Fortunately, the work group, like many advisory work groups isn't limited by the charge. One of the first activities they looked at as we identified areas to work on family history, one of those areas they are focusing on, and I expect it will have a recommendation coming forward on that, which will then form the basis in the way we flow, forms the basis of scenario, technically a use case, we then give to the standards group, to identify standards to use, and can be put into the certification process. The work group has corrected that shortcoming and we will be moving that forward.
Reed V. Tuckson: The list we have, Kevin, mark --
Kevin?
Question: Thank you for the presentation and esm size emphasis both of you gave, to occur, there will have to be public trust. We want to reassure the public there will not be harms coming out of this, at the same time, I am wondering, in order to get the public trust we will have to engage segments of population who unfortunately, but justifiably already don't trust the system. Instead of just reassuring people they will not be harmed by this, how can we engage them in such a way as to say this is actually going to give you greater empowerment, control, on a policy level and technology level.
Excellent question to come I can't say I have the answer, but as we move forward, ferret out what policy should be, we need to think about our experience in other realms, and specifically to me raise the issue of Internet, use of credit card information on the Internet. On any issue we have, we have early adopters, taking risks, people on the other end who may never adopt that technology, never trust it, certainly more risk averse. We need to figure out how to allow the population to develop that trust, and to -- for them to choose when to be a part of it, how fast we move it forwardI think those are the challenges with the policy development, because on the other hand, and this gets to things labeled as opt-in, opt-out, you allow it to be a part, opt out if you don't trust it, pros and cons to each of those. It will be exploring and discussing in great depth in a variety of forums, but this issue of recognizing that there are different levels of trust, different levels of risk taking, no matter how much assurance I give, or the department gives, there are people who are going to take a long time to develop that trust, and how do we address that, how do we -- what sort of policies do we do in the meantime?
If I could add also; I think the personalized health records can go a long way in gaining the consumer trust. It is a place the consumers can gather their own health information, have greater control in disseminating. That's something new where now a consumer's health information is basically held by the healthcare provider and -- not them. The consumer driver of trust and involvement that can help us. A couple of other things, we are very much including consumers in all of our different collaborative efforts, consumer advocacy groups in work groups, as well as the health information security and privacy. We are trying to get consumer engagement up front as policies are being developed, many have recommended consumer education, part vert state implementation programs, and again, opportunities for consumer control so that if folks aren't comfortable with sharing some information, there may be opportunities create policies if that area, not at this point, but there are opportunity to get more consumer engagement and trust.
Reed V. Tuckson: We will do real quick questions, quick answers. This has been terrific, but we have to get a break in here and we have to be back in here at 10:15, all these important people call nothing for the next part.
Mark?
Question: Brief comments, to reinforce what Francis said, moving ahead to family history, have a draft use case to take forward since that information is available, unfortunately, unusable form in electronic health records, trying to see if we can convert to something useful. The second point, interaction between the different use groups, excellent vehicle, reviewing those out of other work groups I see where pieces of what our charge is would fit into others. Using those as a point to be able to interact, suggest perhaps we include something from our work group to enhance the use case could be quite powerful. And the thing Reed mentioned, the harm from privacy violations which for most cases still represent a theoretical rather than tajible harm, against the tangible harms from the inability to use what we have. The information is already in the medical record, available for anybody who wants to look at the medical record, but if if we can take it, put it into usable form we can prevent tangible harm.
Let's come back to that in the discussions that will come. It's important.
Question: I would like to find out -- provider, provider b, they are from different -- where a patient goes to two different providers and how they would be connected, and how they are being protected.
At the heart of our agenda, standardized information, usable within each, not just text turl information, and then developing a network that is secure, how do we authenticate the user, know they are authorized to receive the information and how we move it across the systems themselves, receiving the information, what we are challenged with doing. We have examples of that on small scales, how do we foster the widespread use.
This will be important for patients that do not have insurance, just going from provider a to provider b, and just for a specific treatment, that's it, how these are going to be connected, and how they are going to be followed through.
You got to the heart of the matter, just then, the heart of the issue.
We are working with -- to make sure we don't increase the gap, actually address safety net provider needs, rural, underserved. That's key. Joe? Is
Question: INAUDIBLE I have to keep it short, I will cut down on the number of questions I had.
Sorry.
You're the boss.
If you could speak to the maintenance, sustainment, of the system itself, how you anticipate, long-term issue, you have a lot of development pieces, but -- development piece, now what, how do you maintain that?
First question. Second is what do you have in place aits the current time to address issues related to monitoring the policy and work group process? There are a lot of those. I am wondering, know everyone in the group has goals, objectives, but how do you get a sense that they are moving in the direction that's consistent with the overall intent of the effort itself? Because that to me will have a lot to do with your outcome.
With regard to the system, part of what I mentioned, our focus is to enable the farkt forces to work so it isn't we are developing systems, fostering development. The electronic health records have to be self sustainable within the provider setting. The personal health record, Jodie mentioned, may impact, disruptive technology, may be the thing when the consumer gets it, understands the value of it, may take off faster than the providers who are adopting may actually push that forwards. We will see whether that happens. It's certainly possible.
Those will be ones, right now a number of efforts, employer based, insurer based, individual based, types of personal health records, each of those -- need to occur, need to look at how we have governance process, looking at having AHEC move to public, private process to oversee and foster that. You look at other examples, other networks, not sources of profit, but by-products.
How inefficient healthcare is today, a small portion of that, would more than sustain the infrastructure.
Question: My point, I wonder whether or not any of your groups are actually developing the -- concrete, adoptable recommendations about the intent. The wish side of we hope this occurs, there's the side that history may play itself out, then there is the aspect of will they actually get this done, given, given what we know about the way our healthcare dollars and decision-making around the dollars are actually spent, how that information is influenced. I am try lging to get to the point this is a very good system, for both of y'all, very good system. Butted always falls apart when the rubber hits the road. Particularly around those who are trying to access this, and if you are talking about working with states lorksicallities, that's pretty much what they're really concerned about. Given that, do you have groups focusing on concrete usable recommendations for both sustainment and assessment of the process? Is
Jodi G. Daniel: Almost all of the contracts we have with the standards folks, certification comigdz, state alliance, others, we have asked them as part of their one tract to identify sustainable business models, and with our NHI prototype contracts one of their requirements was to develop sustainable business models that could be used to sustain nation-wide health network. They presented those at a public forum we held for them to display prototypes, as well as business model for sustaining those networks, it's something we are -- understanding it's one of the biggest challenges we face, making sure as folks look at technology, policy issues, they are looking at those as well.
Reed V. Tuckson: You have to realize, Joe, a lot of this stuff is, may be a model we need to think about for the roadmap, challenge from Sheila a moment ago around public/private partnerships. It will be difficult for a software venders to put forward a product without cchit certification in it, just hard to do business. Certain things are built in. Let me do this, here's the deal, this committee is in training, we are in shape, we are an in-shape committee. I think we can probably manage to know when you need to slip out quietly to do a bathroom break, grab a cup of cough see. We don't need no darn breaks, this is a hard core committee. You have four important people about to call in at 10:15, we asked these people to stop their work to do t. we won't worry about the break. We are going to keep asking questions to 10:15.
Question: I admire your firm leadership on this. I will try to be quick.
[]Captioner transition]
[Replacement captioner attempting connection to audio line 1-301-985-4641. Line is ringing busy. Will continue to attempt connection.]
[Replacement captioner needs somebody to disconnect phone line so that I can call into audio. Cannot resume captions until audio line is freed and replacement captioner is allowed connection.]
[Captioner still getting busy signal on line 1-301-985-4641. If this information is incorrect of assistance is required, please contact Caption Colorado at 1-800-590-4197. Captioner will continue to attempt connection.] to what I know is an extremely thorny issue over the years which is the definition of what constitutes a genetic task. And reading through the language it refers to, of course, DNA and RNA, but I believe the language is analysis of proteins that metabolites that would also allow detection of a genotype. That, I know, has caused some concern, as that could be broadly interpreted and terms of what you mean by detecting a genotype. You know, so would a blood pressure measurements, could that be interpreted by some as detecting a genotype? And I did not know if that had received any attention in the markups in how that was addressed and whether that can be further clarified its rulemaking or whether we are ultimately going to come to a test case law once the bill is out.
I guess I will make a brief comment on that. I would kind of at least like to hear Chris' opinion upon the regulatory side of things as it relates to that. Number one, I think you saw in the committee an effort by a number of Republicans. Mr.Stern's amendment is the highlight Of an attempt to narrow the scope of the definition of genetic information in such a way in the definition of to the tests that would be rather problematic. And this concerns the amendments in an attempt to amend the definition of genetic tests to basically force the services to create a master list. So in a sense we are only protecting tested information that is always under this list maintained by the Secretary of Health and Human services. So I think that is a huge regulatory burden for Secretary of Health and Human Services and also not very functionally efficient as well. So obviously there have been some attempts to narrow the scope of the bill like that, but I would say those attempts have been more problematic than anything else. I would be happy to hear what the shall have to say on the subject or anything Chris had to say about how the current version functions and whether or not they think it will be able to provide the regulatory guidance to make sure these are properly addressed.
Thank you, Francis.
Just to add onto what Bryan to but this is Michelle. The attempts to change the definition were defeated. We are moving ahead with the definition that is in the bill.
As far as regulation goes, we will work with congress. We do have a regulatory process. The regulatory process usually works with public comment. It is something that we are prepared to address. So we would look forward to seeing what comes out of the house as a final bill after reconciling after recess.
Thank you, Francis.
Thanks, I certainly would like to compliment those of you who have taken time to be on the telephone with us this morning, Chris, Michelle and Bryan efforts you all have been putting into getting this bill as part at it is. After 12 years of trying to see this happen it is truly gratified to see this come together in a bipartisan way that as real momentum and I particularly would like to recognize the important efforts of representatives of slot and beer in the house and rating at so by their strong of the ship and many other it to others who have endorsed it as well. I would also like to recognize the Coalition for genetic fairness, an organization that has come together to support this legislation and has become a very important voice in that effort led by Sharon Terri is here this morning. And I think they have brought together many different constituencies that all see the need for this particular form of protection in a very detailed way. I think they assisted in the process of trying to be sure that the bill is crafted and put forward in a way that will provide what the public needs and deserves. A lot of people are putting a lot of effort into what now appears to be a very encouraging series of events. But we are not quite there yet, of course. There are still some obstacles that could get in the way. The Rules Committee will have to figure out what to do with these three different versions and then we will have to figure out in terms of the house and Senate version. In terms of the question that was just asked, that was of the I wanted to bring up. There was this proposal that, in fact, the definition of a genetic test might be something which would require it ongoing list to be carried by the secretary. I'd just want to comment from a purely scientific perspective what a really bad idea that would be because but the ability to define on any given moment what has actually worked it could be potentially useful is such a moving target that I don't know how anybody on the planet would have the ability to do that, especially as we are now seeing in the course of this year and a couple of years to come we will have all of these discoveries about genetic risk factors and common disease and diabetes and heart disease and asthma. Each one of those discoveries is relegated and many of them will potentially be a useful topic for research to figure out try to use that information in their own personal medical agenda. But we wish to do that in research before but the practice. But what of the great risks right now in the absence of a federal legislation to protect against genetic discrimination is that research is being impeded. We have very good evidence of that at NIH, that lets the people that would like to be part of projects opt out because of their fear of this kind of discrimination. But up the things we ought to be able to say to them very soon is that there is now that at a press -- protection and they need not fear participating in a NIH study because of that risk that the static information might be used against them. If we had to also fold into that this sort of on going to ration minute by minute that might fall into a research study somewhere, we would be totally impracticable. So as difficult and challenging as this test and [ indiscernible ] are and have been developed a course over many years, I think one should not try to impose upon that the responsibility of any person to try to say what is on the list and what is not. It just simply won't work.
By the way, that is very important. I have asked Sharon Terri to come up. She was going to be quiet there in the audience, but, Sharon, it is so important to hear from you, especially with our legislative colleagues on the phone. We need your response to how you see things and any issues that from your point of view, in charge of barriers to getting this done. And by the way, let me in doing this explicitly second Francis' comments about not only your personal leadership will be or as this is leadership in moving this forward.
Thanks very much, and as you know I have had many visits to this committee where I was not able to be smiling all the time to say that we are actually moving the ball forward. And I would second or third the thanks for the huge effort made, especially by Michelle Adams and Bryan Peterson. They have really worked day and night and literally day and night on this bill, especially over the last few weeks. I am really thrilled to be where we are. It is remarkable to me to think that this early in a session we have this number of co-sponsors, to 15 or 19, a starter exactly what today to be able to have gotten the bill through all three committees as quickly. And there were brought many hearings at markups over the last few weeks. It has been enormous. It has not been easy with those on the outside say, is a fabulous how this is flying through? I think Michelle and Bryan will agree with me that it did not fly and was a big rock that we pull up a very steep hill. It was not without bumps. And there were certainly a lot of special interest groups interested along the way including other interests that I learned as it as the bill started to move fast. I joked that only the beef lobby did not jump on the bill. So have -- we are really pleased to have it in this shape and this place. But my concern is that we are clear in the reconciliation of the three different sets of issues around the bill. I know that Michelle working with others will be very careful about making sure that the bill is the start of that can be and that it does what it need to do. And around that I think the issues around genetic testing or worrisome throughout the process, and I think it might even be good for Francis to make another comment about the issue of the definition, particularly since the issue that Mark brought up about whether or not metabolize and proteins that indicated to the site should be included. I think Francis made that quite clear in his testimony in the testified twice. I think that would be good for him to come on. The last thing I would say is something I did not get to say in the hearings. This has been fabulous with industry and patient groups working together. I think that we should as a patient should think about, what have we lost? Not only in the numbers of people who have been discriminated against but in the number of people who did not enroll in research, in clinical trials and where we might be as a nation today had we not had this implement the other countries don't have and that other countries look at us as an advanced nation and say, we can't even protect our peoples genetic information. So set that is very significant as we move forward in that think both Republicans and Democrats patients can stand together when we finish this bill and say what a great thing we did for people. It is late in coming, but here it is.
Before Francis engages your question, let me just -- I don't know whether you work in the room earlier but we talked about the health information technology discussion, but I don't expect that you do, but in case you do I want to give you the opportunity if you have any thoughts on the privacy Alliance and the discussion and a relationship that you see. I tried to underline that issue and don't know what you wanted to comment.
I appreciate your underlying that and I heard Secretary talk about the press on Friday and he was quite clear as we're the people here today about the importance of the health privacy issue. I cannot imagine that without this bill passing any of that can go forward. I wish we came again to this center and had more forethought several years ago from the secretary on down [ indiscernible ] had to push hard to get this done quicker. I am glad that there are practical issues on the table so that we can get real about how fast we need to make this implanted. At the best things are totally married and without it it would not be very effective.
Thank you so much. Francis?
Well, this issue up the definition of genetic tests and genetic information has certainly been a challenging one to try to put down in a limited number of words what exactly is intended. Again, the goal is to protect people against discrimination based upon that type of information. One recognizes that the ways that you detect genotypes are not always limited just to DNA and RNA. Essentially there are indications that times were one can do that using the measurement of a protein or of a metabolite, and it would be unfortunate, therefore, if you intended to protect somebody but it just happened that the test is being used at that point was not a DNA or RNA test, but was a protein test. For a sense that you wish to protest people with sickle cell trait from discrimination and that they would want to [ indiscernible ] of the state bills that have been in place the longest or for that very purpose. That is truly not detected by DNA or RNA but by hemoglobin. It is measure of proteins. You would want to have that under the umbrella of protection. Similarly a [ indiscernible ] carrier, that is usually done with an analysis to see if the is of his present at 50% of the normal level and if it is that essentially infers rather directly what the that individual must be with that actually going to the level. It is that kind of circumstance covered under the way the definition is written about what is protected. But in terms of other kinds of metabolic measurements were perhaps teams are playing a role, but a very complicated one key are just not to use [ indiscernible ] to also want your calcium, all of those are of course that vary over time. The art since the top defect it's a desolate by diets and other circumstances of what is going on in your environment. The intent of this bill is not to shoot those under the umbrella of protection given that that what you are measuring their -- while it has some relationship to a long list of genotypes is influenced by many other factors. At the it would be very helpful. I think what I have to [ indiscernible ] is the consensus view of all the people who have been commenting upon the definition. It will be good to have that the corporate and to report language and the bill when it is altogether brought to its conclusion and that will assist the process of figuring out the regulations which of course have to be implemented after passage to be sure that this bill is to interpretable by those who need to enforce it.
Terrific.
I appreciate that, and I certainly am completely with you in terms of where that is. I think the concern that I have is that as much as the genesis of this bill has been from the perspective of the harm that could accrue from the discrimination that can result from genetic information, there is also the realization that there are interested parties that would look to bring as much under this bill as they could possibly bring under to essentially protect all information under this rubric of genetic discrimination which would be equally harmful in terms of the ability to do things such as quality improvement and disease management and things that I think we would all agree are good things. Again, it is a tension issue and an interpretation. What reasonable people would consider to be the intent versus what unreasonable people on either side of the debate would consider to be how they could use the language to foster an agenda.
So I appreciate your clarification also what some of those concerns. There are two issues here. One really is, which part of information is protected under this legislation in terms of it not being something that can be used by health insurer or an employer to make a discriminatory decision? And the separate issue about will this get in the way of actual delivery of health care. And as has already been touched on this morning The intent of this bill is in no way to damage that relationship. The bill is written with the understanding that it is health care providers to make those patient care it [ indiscernible ] decisions, not health insurance companies. Health insurance companies are in a great position to encourage well as programs and to put out affirmation about what is now available that might be valuable for individuals to take advantage of as far as personalized medicine, but not to request or require that someone actually undergo that kind of a genetic test. That really, we felt, was a conversation that ought to be between the provider and the patient. The bill has been very careful to try to make that distinction.
Members of the committee, do you have any other questions? Well, this is just fantastic, and on behalf of all of us, let me thank Chris, Michelle, Bryan, not only for your willingness to be on the phone with us today, but for the efforts to have been through behind-the-scenes to make this a real opportunity to actually deliver something. Thank you again for coming up. Any the last comments from Members on the telephone?
Thank you for inviting me?
Yes, thank you for inviting us as well.
Well, take care and let us know if there is anything we can appropriately to from our role at this late stage to move this board. Thank you everybody.
As for the committee members, you see if you are a disciplined and tough and strong you get a reward. So the reward is you actually will get a break until 11:00. So you do get that 10 minutes. There you go. We will see you exactly in 10 minutes and if you are late, oh, my God, the sorrow that you will experience.
[10 minute break until 11:00 a.m. ET]
We actually are going to start on time. We are actually trying to start. Sarah, did we find Gregg? Did we ever find Gregg? Did we find Gregg? Yes, we will have to do it that way. Does everybody have a copy of the hand out?
I am going to go get them now.
Are the public comment people here? Good. Deborah is here? Okay. All right. We are ready to begin, if you could close the door. All right. Here is what we are going to do. We are going to ask Gregg who does not know that we are asking him -- Gregg, we are calling to ask you to come on up to the table for a second if you could and help us out a little bit. Those of you, by the way, we were right to come to you for public comment in a minute. We are way early. So we are doing good. If you look at your schedules that after we come back from lunch we are scheduled to go into our discussions on the oversight of genetic testing, we were very pleased to have gotten the guidance this morning from Sheila. So what we want to do is put up on the board, on the slide the summary of those recommendations, the charge that we got this morning. So what I want to do so we make sure that we have a focused oversight discussion when we come back from lunch, I want to just review with you those recommendations, those charges to us to see whether or not there are any questions or if we have any issues there as we start to look at things going forward. And I asked if Gregg would be here in case we had questions that we wanted to ask him about helping us to understand intent or anything that was unclear. So if you look at the -- at what was presented, we developed a comprehensive map of the steps needed for evidence development and oversight of genetic and genomic tests to improve overall health quality. Next slide. Good. So if you start out with, we are being asked to describe the existing pathways that examine the analytic validity, clinical validity and clinical utility of genetic testing. And then to define the responsible organizations who are, in fact, responsible for those three things. Let me stop there. Is there any question or issue about our taking up this descriptive assignment? So it is really describing or documenting the existing pathways that examine and analytical validity, clinical validity and clinical utility and then defining the organization is currently responsible for each of those.
I mean, that is a very good question. Actually, this job should be made much easier given all of the work that has been done over the past three years. So, I mean, it is just pulling out these old documents and looking at them.
Right. It is the defining of reality.
When you mean organizations, can you be a little more explicit?
That would be from sponsors to federal regulatory agencies, research organizations and professional organizations. And we are looking -- and that may be different depending upon where you are in the development of this from political validity to clinical utility or cost effectiveness, we could include that last parameters, but there are conduits of information aggregation and analysis that we think could be useful if you wind up in terms of the responsibility and question of what evidence is needed. This would enable certain tests to be performed. We would like to see some sort of categorization, if you will, of the types of information that are needed at various steps.
Is this limited to the critical issues or are we looking at things that relate to the public health utility of these tests? Or is this limited to the clinical side.
If you could clarify the distinction is on how you would see as being separate, maybe we can help with the answer.
I think we understand how it could be used [ indiscernible ] and at the individual level, but to the extent that what is right to have this information out there, the teddy information will be used for population Health that may be related to exposures and the environment or recommendations for nutrition Policy or you could think of a lot of things were these tests might have population health impact for specific ethnic groups.
I think the question would be -- and really it has been thought about all but I am try to understand your question. I don't think that this first question that are raising is depending upon to but this simply any test for whatever purpose as to have some utility and validity. And therefore, if you put it in that context, regardless of the ultimate application of it, does this thing work? That is the fundamental question. So if you are saying that you can think of some tests that you would want to see that which could be used at the world population base, then you should I think think about putting that in this mix.
It is exactly what it is intended to do.
So in other words, you are diving -- you are taking a higher level you here for the minute moving from the specific to an overarching thing saying -- let me to see if I can we interpret your question or if I am listening to you correctly. You are saying, is a generic purpose of the oversight of genetic testing -- should it be that it would be for clinical individual use and in addition testing used in population based environments as well? Should it be that the oversight is both from a generic point of view? And I think that, Gregg, your expectation from the department is, yes, it would be both.
Yes.
So that is good. Now, what I am doing now to talk where I am now on querying the committee is I am combining, as you can tell, the first and second bullets, essentially which is one thought in my mind. Again, it is saying to us that they would like us to document and define the existing pathways for analytic validity, clinical validity and clinical utility and define the organizations that are currently responsible. What we have heard in his opinion is that this is pretty much a fact-finding activity. There is a lot of work that has been done and we have got some clarity from Gregg that that would include almost all of the domains of organizations that may be relevant to this, whether they are the Academy, whether it is, you know, Private Sector initiatives, whether the government regulatory agencies. It is really to try to lay out a road map that says, here are all the relevant organizations that are involved in this oversight in definition of acceptability. Are there any other questions on this first point?
We have heard this morning that Secretary is actually looking very closely at the oversight issues with the independent agencies, and I was just wondering as we go through these different questions that cover not only the public sector, but the private sector, how do you think we should focus our work on this issue since the HHS of this is already looking at this issue? Should we just first to focus first on the private sector? What is your take on that?
The bulk of the efforts as far as looking at -- as you know each of the agencies that play in this space with regard to genetic tests have a lot of different authorities designed and how it was aligned. How they are applied whether it be in the sections of them. That has been the focus of trying to develop more comprehensive testing. Internally that is one of the rules of the department, To ensure that the communications and interactions of various regular this to the real story aspects and the Department of their policies are cleared and are understood what the other organizations and aspects of the duties of the other agencies perform which are done in concert and understanding of that. So our efforts to this point have been trying to, in an exploratory way, look to see where those intersections are and see where the authorities of one agency aligned or perhaps intercept or not in terms of gaps or overlap of a particular policy or regulation.One element, I would like to interject here also is on the aspect of [ indiscernible ] whether it is the performance of them or the ways which the information is required and delivered to those that use it, there is many types of technologies involved now, and I would think that looking historically at the documents from 2000 and 2001 -- I realize many people have moved on from the committees to work on that. One aspect of the be of interest for this group is to look at specific requirements for different types of genetic tests, whether we are specifically talking about PCR or complex [ indiscernible ] or are rate analyses and how the information from that is developed may have some differences in terms of the clinical validity as well as analytical validity and how that information is developed. So we would ask that the interpretation and defining genetic test take into consideration methodologies and the types of information that is developed, how it is processed and presented which is to be utilized.
Let me make sure. We have a couple of issues here. On the first point, Gregg, as we to look at putting together the map that has public and private sector initiatives that are involved in political and clinical validity and clinical utility, you are saying that even while the government efforts are going forward to look at its domain we ought to be looking at this comprehensively. And pointing out from our map where those gaps are and that sort of thing. So I think that is the assignment that we are being given. Secondly, you are saying that that you want us to be sensitive to the methodological -- the methodology is that are driving these tests and how information is processed and disseminated as subtleties that we should be thinking about in case there are issues that are obtained there, and that is something we would add to this first mix. All right. Related to this, then -- this is what I see as .1. Set it is the first to hash marks there. I am combining that into one as a sign it. Can we move the slide to one mix done? Yes?
One thing of the second bullet, and this is maybe the second portion. This is an import distinction. The second bullet says [ indiscernible ] also which implies that somebody is actually taking the possibility. The terms you are using are currently involved with, and I think that is better like it because there is a lot of this taking place in a very informal or ad hoc way as opposed to a formal way in at the we need to capture all of that a formality.
Well then let's try to do both points in them and we get to the recommendation part, should be explicitly responsible for. So somebody can capture that and at the Mark is onto something here. We want to say, are currently involved with. When we get to the end of the exercises should [ indiscernible ] are making recommendations as to who should be accountable for, responsible for. Unless that informality is working as it should. Will we move please to the slides. I would like to skip down to the one that says what new models or approaches for private, solely and public-private sector. Could you move to that one? What I would like to do is I would like to -- yes, sir?
I know I am interrupting, but you covered the first two bullets on that first one. Did you literally not cover the last one?
Exactly, for the moment. I have tried to make logic of this because I am not as smart as you. I cannot do quantum mechanics with permutations. I have deliberately lumped together what I see as one coherent idea and am now moving quickly to a related idea as part of the first idea. But believe this question of what new model or approach for private sector versus Private public-sector engagement and to [ indiscernible ] this chemical validity and utility for developing effective use. So I am trying to see, at and work with Gregg here, I am interpreting this, and I may be interpreting it to nearly to get to the point that Mark is to around, responsible for. What I think it is getting to is, you have got some of these things which can be -- this responsibility is government whether it is CLEA, FDA, who should be what. Some of this may be that you can work out a responsible public private partnerships and accomplish the goal. So it is not always done by government regulation. And I think what they are asking here is for us to think about a legitimate role for public private sort of partnership as a solution to some of these problems. So let me just ask Gregg, am I over reading the intent of this one or not?
No, I think that what we have been trying to do is to understand, much like was discussed earlier this morning with the use case scenarios, at what point -- where is the information hand of? Who needs what information to do what with? That has not been clear in some of the earlier meetings in terms of where does that information come from, how is it applied in the decision making process. And from a standpoint of effecting critical care or population based approaches, what are the key political questions that have to be framed and answered in order to develop that information as necessary to use the test and use it in such a way where there is transparency about the results. What it would take in terms of organization input and medical and put, the health systems and put in terms of the deployment of these technologies and information necessary to make the process in which information continues to recruit and there is refinement about the use of those tools and their applications. So we don't have a concept in mind specifically, but we think that it will take more than just the better a government role in defining.
So what I think you have clarified is the reason I wanted to engage this discussion as part of the clinical validity and utility definition was whether the challenge was more focused on public-private partnership role for clinical validity and utility versus the appropriateness of the use of the test in chemical practice. I hear you emphasizing more the latter, more on the clinical use of the test and not as much on the former. Or is it both?
I think it is clearly both, and that is one of the intersections we are trying to cross here. Where are those responsibilities currently falling and what are better ways to recruit that information as we go forward?
Kevin, your hand.
Just also for clarification, Gregg, in the pharmaco genomic report we also identified a medical outcomes as a important part of this whole formula. Now it is not in here specifically but I am presuming you also be that.
I think that is probably certainly useful if the [ indiscernible ] can stretch to that point to look at those efforts. And I think again, there are various stages of technology development and deployment. There is more and more [ indiscernible ] about that. There is inside and expertise of this group to deal with that, great. If not, certainly the evidence that we are working for more partially is listed too analytical validity and the oversight of the test kits themselves and materials that are bought and, performance of this test. Those things are permanent concerns of this committee has been debated in the last few meetings. You would like to try to get more clarity. But those logger more difficult aspects of it, I think, if there are insights about bodies or authorities or ways to agree that information, obviously we see the help of these -- the future of help IT facilitating that which is why we were working on that downtown. We would certainly be eager to do that and I know a number of the other agencies here today are also quite interested in does.
So let me do this in just so the folks -- the logic of where my head is event is what I think we are being asked to do -- and you guys are going to be to track this here. On point one, this describing the pathways that exists now for analytical and political utility and defying the responsible organizations, the people that are involved to build, to talk ultimately is possible and accountable, as a cold part of that charge it also includes to look at -- to look at the appropriateness and need for public/private activities in terms of this base. It's basically saying, let's look and see if there are roles there was be laid out this road map for whether or not it is all government regulation, government oversight and also the role of public private partnerships in this regard. So just as a point we are putting all that together as a bundle. If we will now go back to -- and while [ indiscernible ] I just did not want to always best your name up. You are from now on GR.
Just G.
Wow, man, G. Would you -- while we do that I want to scroll back up of the slides back to be -- they will begin by of the third bullet. That is where I am headed. Go ahead.
I just wanted to reinforce the idea before we get to this because those public-private partnership discussions have already occurred on the deliberations of British committees. I think, you know, the clinical validity and the utility of tests and over such as it exists right now would never allow for the complete type proof, so to speak, of testing seeping from research to practice so that it will always have to be this public-private collaboration moving gone. I think we discussed it at length at previous Committees. I think part of the existing pathway discussion could be existing in suggested pathways. So that leads you into I guess number three.
That is where I am headed. Dr.G.?
Thank you. A point of clarification. I am reading the [ indiscernible ] and it is developing effectiveness measures. Is it developing new measures or is it just collecting measures we already know and synthesizing them appropriately? I was not quite sure what the intent of that bullet was.
I think, if Greg will answer that, but let me ask you to restate that again. We ask it one more time.
Sure. Two parts to this question. One, inherentlwhy is chemical validity for developing effective this measures. The two parts I am getting stuck on are developing effectiveness. So in terms of developments thinking of new measures, we already know many existing effected displeasures. Are we developing measures or are we to synthesizing?
Okay. So I think that, if I understand the very important question -- I do not think that the charge to this committee is to be concerned about the adequacy or how to stimulate more measures per say. It is the oversight of whether or not new measures are being developed or promulgated appropriately, that they are rational. There is some accountability for the oversight of it. I don't think we are being encouraged to get more stuff the, genetic testing done, more tests. It is more of a sense of being clear that there this a relationship in science to the measures that are being developed and that they are connected to science so that the public can feel confident that just as in the tests themselves, that there is someone who involved whether public or private sector, involved in making sure that it is not just snake oil. Now let me just double check that.
Yes. And we could [ indiscernible ] terms of evidence developments but you would like to use the terms of how do we know that the test is providing the kinds of information that questions and health care providers and consumers want and need and can trust and reliably use and other what parameters is it useful and those conditions. If you're thinking about new ways in developing that information that would be insightful and useful to whomever carries of us as possibilities. I am not suggesting on the technical or scientific level that we need guidance. The size should carry forward and the science involved. We are not looking for -- we need more specific ways to measure our RNA and the sort of thing. Is that kind of to your point?
That helps. The other part was the effectiveness? Are we considering efficacy as a product effectiveness or are we focusing only on the effectiveness?
No, I would combine those two approaches. As Sheila mentioned this morning am giving some latitude to how this committee wants to frame these issues.
By the way, I did a poor job of introducing this topic and moderating it. I think that last, is extremely important. By the that what we are, in fact, doing here is that the secretary's office is trying to give us a sense of what they think they need. And we are trying to get clear here. The secretary's office recognizes that the committee is its own ego. This is a pretty headstrong group, and they are trying hard, I think, to say to us to but they are not trying to -- and I should not have made it this way. They are not trying to dictate to us what we do, but we ask them, how could we be most helpful. So you are right, within sort of the terms of latitude I think what they are trying to do is come back to us and say respectfully to the committee, if you want to know what we need to go to look this agenda forward within the department, here are the issues that are on our mind. We are trying to get down to the levels of regularity and what it is you think you need help on. So Dr. G. raises an important question which I had not fully understood. There is a subtlety here. We are moving from the actual over set of tests which we have been fanatically working on to now introducing in addition, to the test the measures of effectiveness which is a step outside of our normal box which is something we are going to have to think about whether we want to engage. And I think that we clearly have that in front of us. So your question has actually been very helpful. All right. Now we are going back to bullet number three on slide number one. So far we have stayed, you know -- we took the first bullet, second bullet and this last thing. We took half of whatever but this was down in the bowels of the thing and brought that up into one giant mish. Technical term, mish Now we are moving to topic number two which is the potential pathway to communicate clear information to guide tests and treatments selection by the provider. So what we have just done is to take the second half of the stuff we just went through with public-private partnership stuff and we are now bringing that up and grafting that half to this. So now we are saying, we understand that we are being asked as part of this one to talk about the role of public, private partnership, and that means the academy and professional societies and to those but in terms of being able to communicate their information to guide. I am grafting that are to this number two. Do we have any further comments around this number two in clarifying this bowl?
Gregg, as this where you think we can look at assistive technology at how we can communicate clear information to guide critical treatment?
Can you repeat your question?
You mentioned earlier that you wanted us to look at how we can do testing in the different technologies, how you go about looking at the different technology and the thing that information to the decisions and how they get interpreted and ultimately tested. The do you think that we can, within this number two, I guess, something that we can address?
I think that, as mentioned earlier, we are not looking for a complete inventory of every test that can be done and categorize it as a genetic test and what is needed for it, but surely from -- some framework for understanding particularly those cases where it is not just a positive and negative result, but we are talking about something like PCR. But where there are cognitive and sort of the interpretive skills and analysis that are needed and what levels of the parties and then how is that result interpreted and what is the affirmation that is passed to whoever is going to be making decisions. Reflecting on some of the earlier reports, a lot was focus become on the test performance. We think that is still a very important question. Is the test performed by the particles which are required and the evidence supporting the analytical validity of that instrument or the reasons that are used to perform that test? But I think as we are moving onto more and more complex areas that we use in some of the earlier reports art in those cases in which there are an interpreter's site who is providing the information in what the levels of evidence that the test results are benchmarks against. And if that is utilizing other datasets and me, how is that performed and what are the datasets capabilities that are needed to make the accurate determination? So I think perhaps there are some means of an ad hoc basis beyond this group that would be important in performing those processes. I think to step up to what we are backing down on all of this is that one aspect is that, we have found it particularly difficult to start from the very beginning problem a specimen it's a laboratory or when it will be used or a method is developed. All of this steps to go through in terms of developing information for a commission or consumer or whoever is during the test and making decisions about it, lining all of that up and expanding it to someone. It is a very challenging thing to do and I am not sure I can do it yet. That does not mean that there are others in the person who cannot. What we are trying to do is say where it does the information flow go. That is at the foremost of importance. It is difficult for me in looking at the kinds of cases and are units that have been made its way to go to the abstract and describe a genetic test. It does not help us [ indiscernible ] and we are not able to put it into some context of saying, here is the kind of information accrued in here is how the tests are performed. Whether it is a number of a piece of paper that is taxed somewhere or put into some protocol that are able to develop numbers and probably statement. And long-term wise what we are trying to get to is a world in which that information is part of a critical decision making process. So we are certainly not quite keeping their yet, but the -- all of those steps required different pieces of information to line up to make the assumption at the end of the pathway that their number has passed through all the processes and has about me.
By the way, that is something we'll discuss when we come back from lunch in terms of the oversight committee, but one way to get at this is to actually take a few examples and start from beginning all the way through and trace it and say, okay, what happens? Some real use case scenarios might be the way to get added. I really like what you are trying to do. Let me move quickly to the next slide. I probably should have and am thinking now that what we might want to do is to make the first bullet, the first - there, the very first question and make that at the very top of the whole thing and make that number one. Because at the end of the day that is the fundamental question. What is the point? It is like buying out, what evidence of harm exists regarding genetics. Do we have any sense that there are real harm being done because of the gap? I think it is important to identify -- and if we don't -- if I understand the question, it is identifying other what are the harms or what to be the likely harm that will exist through various development of case scenario. Let me tell you there is a whole you Can Drive a truck through that allows maniac test number three to be inflicted on the public. Whether it is actually occurring or not to buy and we have to define actual harm examples and potential.
Just for clarification, are these all interconnected? To ask it another way, what if -- and I not suggesting we will find this, but what if we got there is no harm, no potential for harm, no gaps, current regulatory schemes are working --
[ indiscernible ]
Everything is great. You recommend that we still go to that the bullet under general questions which is, what are the potential pathways to communicate clear -- I become are they connected? To we ha