Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

November 18-19, 2008

Radisson Hotel Reagan National Airport
Arlington, VA

Meeting Minutes

The National Committee on Vital and Health Statistics was convened on November 18-19, 2008 at the Radisson Hotel Reagan National Airport, in Arlington, VA. The meeting was open to the public. Present:

Committee members

  • Harry L. Reynolds, Jr., Chair
  • Jeffrey S. Blair, M.B.A.
  • Justine M.Carr, M.D.
  • Leslie Pickering Francis, J.D., Ph.D.
  • Mark C. Hornbrook, Ph.D.
  • John P. Houston, J.D.
  • Garland Land, M.P.H.
  • Carol J. McCall, F.S.A., M.A.A.A.
  • Blackford Middleton, M.D., M.P.H.
  • Sallie H. Milam, J.D.
  • J. Marc Overhage, M.D., Ph.D. (by phone, day 1)
  • William J. Scanlon, Ph.D.
  • Donald M. Steinwachs, Ph.D.
  • Walter G. Suarez, M.D., M.P.H.
  • Paul C. Tang, M.D.
  • Judith Warren, Ph.D., R.N.
  • Absent: Larry A. Green, M.D.

Staff and liaisons

  • Marjorie Greenberg, M.B.A., NCHS/CDC, Executive Secretary
  • James Scanlon, ASPE, Executive Staff Director
  • J. Michael Fitzmaurice, Ph.D., AHRQ liaison
  • Debbie Jackson, NCHS

Others

  • Dan Rode, AHIMA
  • Allison Viola, AHIMA
  • Jeannette Thornton, AHIP
  • Sheel Pandya, Center for Democracy and Technology
  • Frank Kyle, Jr., Amer. Dental Assn.
  • Michael DeCarlo, BlueCross BlueShield Assn.
  • Laura Wooster, BlueCross BlueShield Assn.
  • Adam Birnbaum, BlueCross BlueShield Assn.

Note: The transcript of this meeting and speakers’ slides are posted on the NCVHS Web site, http://ncvhs.roseliassociates.com. Use the meeting date to locate them.

EXECUTIVE SUMMARY

ACTIONS

No actions were taken.

DEPARTMENT UPDATE

  • Data Council —Mr. Scanlon

  • CMS Update—Dr. Tony Trenkle, CMS (by phone)

Mr. Scanlon briefed the group on the current budget situation, several Data Council activities including figuring out how to make the most of scarce resources, and preparations for the transition in administrations. The Data Council is also assessing the readiness of data sources and modeling for health care reform, and trying to marshal capacities for that purpose.

Dr. Trenkle reported on the CMS PHR pilots, processing comments on the 5010 and ICD-10 NPRM’s, and an AHIMA study of the impact of ICD-10 on CMS operations. He also reported on several activities in the area of e-prescribing, including publication of the physicians’ fee schedule rate, rulemaking exercises, incentives, and standards. CMS is also working on e-prescribing standards for prior authorization and is in discussions with the Drug Enforcement Agency (DEA). He also commented on compliance reviews of covered entities on security enforcement.

Members acknowledged the Department’s lead in helping all these activities move forward.

UPDATE FROM EXECUTIVE SUBCOMMITTEE RETREAT—Mr. Reynolds

Mr. Reynolds reviewed highlights from the October 14-15 Executive Subcommittee retreat. On the cross-cutting topic of person-centered health, he stressed the importance of continuous communication and coordination. The Executive Subcommittee approved development of a primer on data stewardship, and next steps on revising the vision for 21st century health statistics. Ms. Greenberg and Ms. Jackson reported on further planning with Dr. Friedman and Dr. Parrish. Mr. Reynolds said a letter to the new Secretary is being developed to inform him about the role and accomplishments of NCVHS and to offer support.

SUBCOMMITTEE UPDATES

Subcommittee on Quality Person Centered Health Initiative—Drs. Carr and Tang

Dr. Carr described the proposed initiative and plans for a 1½-day hearing in early 2009 on person-centered health data needs. The project is centered in the importance of empowering and engaging individual Americans in their health and health care. The hearing will focus on what is needed for the next generation of health surveillance data. The goals are to better understand emerging data needs, assess current and proposed health IT certification standards, and provide recommendations to support person-centered and population health functionality in personal health IT systems.

Other Subcommittee chairs expressed interest in this topic, and the group discussed the possibility of doing some information-gathering at full Committee meetings. They also had the first of several conversations about how best to coordinate future activities. Dr. Tang suggested, as a matter of standard procedure, that the Committee begin breakout sessions with representatives of all subcommittees in a working session to identify overlaps and assign detailed agendas to individual subcommittees. Mr. Reynolds said the Executive Subcommittee would take the idea under consideration.

There was considerable discussion, as well, about the content of this project. Dr. Middleton observed that some of the uncertainty about framing and sources may be due to a failure to “explicitly address the value proposition,” and he suggested taking that perspective in the hearings. This became an important touchstone for the rest of the meeting.

Subcommittee on Population Health—Dr. Steinwachs

Dr. Quinn has been helping on a use case on the patient-centered medical home. The Subcommittee will coordinate with the Subcommittee on Quality after the hearings described above. Meanwhile, it is holding hearings on November 19 on government data sources related to insurance coverage and access to care. It will hold another hearing on modeling for policy. The Subcommittee is also interested in the implications of CTSAs (see below) for health statistics and for information on community health. Dr. Scanlon, the liaison to the NCHS BSC, highlighted concerns about inadequate funding for vital statistics and the consequences for the quality of the statistics.

Subcommittee on Privacy and Security—Dr. Francis and Mr. Houston

The Subcommittee has put together a kind of briefing book on what NCVHS has said to date and resources available on PHRs. It is planning to study the privacy practices of PHR vendors, examples of employer use of PHRs in wellness programs, data flow in current uses of PHRs, and privacy and security issues in those settings. In addition, it plans to look at privacy aspects of the Medicare PHR demonstration projects, and at what governance structures are in place for PHRs as their use evolves.

Subcommittee on Standards—Mr. Blair and Dr. Warren

In what it is calling “The NCVHS Standards Initiative,” the Subcommittee plans a series of hearings and written communications to examine how well health IT standards are being developed, selected, coordinated, implemented, and used. The question “What do we need to do to improve things?” is the focus of the effort.

CLINICAL AND TRANSLATIONAL SCIENCE AWARDS (CTSA) BRIEFING—

Jody Sachs, D.P.M.

Dr. Sachs is the Scientific Project Officer for the National Center for Research Resources (NCRR) at NIH, a trans-NIH program that is heavily involved in re-engineering the clinical research enterprise. The CTSA program, funded in 2006, is aimed at decreasing the delays in moving from research to implementation in communities. It develops interdisciplinary teams in order to break silos and catalyze change. The CTSA Consortium Steering Committee, composed of other program awardees, is at the center of an extensive governance structure. In 2008, the program had 14 awardees. CTSA wants to create regional networking opportunities, and there are three regional organizations. Dr. Sachs discussed the priorities of the Community Engagement Steering Committee, one of six “key function committees,” which works to broaden community outreach at the CTSA sites. Leveraging funding partnerships is a high priority. Finally, she reviewed the CTSA Steering Committee’s National Consortium Strategic plan.

NCVHS members talked with Dr. Sachs about potential enhancements to population-based data, synergies with existing community-based research models, interoperability issues and the possibility of NCVHS guidance in this area, and the need for cultural change in the biomedical research world. The importance of linking the CTSA program to national health statistics was also stressed.

ONC UPDATE—Charles Friedman, Ph.D.

Dr. Friedman distributed copies of a synopsis of the Health IT Strategic Plan and gave brief updates on the final AHIC meeting (November 12), progress in interoperability and standards, the State Alliance for E-Health, and the NHIN. Standards and interoperability activities are progressing, based on priorities and process set by AHIC. He reviewed recent activities related to the NHIN, notably the September 23 live demo involving 20 organizations, which worked very well.

In their comments, NCVHS members primarily expressed praise for ONC’s leadership and congratulations for the successful trial implementation.

AHIC SUCCESSOR ORGANIZATION—Laura Miller, FACHE, Interim Executive Director

The AHIC Successor (not its final name) is designed to become the focal point for harmonization activities and a way of engaging a broad range of stakeholders in a sustainable organization. The goals for it include accelerating adoption of interoperable health IT, prioritizing stakeholder requirements, advancing policies and technical approaches, and overseeing and facilitating the NHIN. Noting the caliber of people involved, Ms. Miller showed a series of slides listing the members of the Governance, Membership, Sustainability and Transition Planning Groups and of the Board of Directors (including NCVHS member Dr. Paul Tang and former NCVHS Chair Dr. Simon Cohn). The Board is currently actively recruiting a president/CEO. There are four board-level committees. The Transition Workgroup identified several priorities for the AHIC Successor, leading to a list of 17 “key opportunities” for consideration. The ONC use case process will continue through 2009, and a new use case process will begin in 2010. Ms. Miller explained the concept of “value case,” which is to be “the primary artifact of the AHIC Successor.” To begin this process, the Successor will call for the submission of value cases, ultimately leading to interoperability specifications. Value cases that pass due diligence will be recommended for recognition as a nationwide priority. The idea is to accelerate adoption of interoperable health IT through broader stakeholder input and a collaborative process, and to stress that the Successor exists for individual and consumer benefit..

In the discussion period, Mr. Reynolds stressed the tremendous diversity among HIEs and the need for ONC and the AHIC Successor to help define and model what a good organization looks like. Mr. Houston urged that the Successor facilitate a more “scientific approach” to deciding what to focus on than seemed to exist for AHIC’s workgroups.

REPORT ON WORKSHOP ON DE-IDENTIFICATION OF HEALTH DATA—Dr. Carr

Dr. Carr was on a panel at this September 26 workshop, hosted by the Center for Democracy and Technology. The Center is a highly respected public interest group that works on issues of technology policy, with a strong focus on emerging technology and keeping the Internet open and free. There were panels on facts and methodologies, data uses, and policy implications, and a discussion of next steps. The key discussion points included these: it may be easier now to re-identify anonymous data than it was in 2000; even if not re-identified, de-identified data still carry privacy risks; re-identification is often easy, but there are solutions; and de-identification must go beyond technical safeguards to include trusted personnel and sound policies. The workshop also identified six issues for further exploration.

Members discussed possible ways to learn from, support, and/or collaborate with the Center around common concerns, and they agreed to ask for a presentation from Center staffer Deven McGraw. The Subcommittee on Privacy and Security will provide a framework for addressing these issues.

WHO FAMILY OF INTERNATIONAL CLASSIFICATIONS (FIC) UPDATE—Ms. Greenberg

Ms. Greenberg, who recently returned from two WHO meetings, briefed the Committee on the WHO FIC Network and its priority activities, and highlights of the recent meetings, and commented on synergies with Global Partnerships in Public Health Informatics. The topic of the annual WHO Classifications meeting was public health informatics. This was followed by an Asia-Pacific conference on the same topic. Ms. Greenberg noted that even with its full plate of activities, it is good for NCVHS to be reminded that “it’s a very small world,” and there are many synergies between its work and the international work on classification and public health informatics.

After reviewing the main classifications in the WHO FIC, the structure and mission of the WHO Collaborating Centres, and the committee and reference group structure, she described its major activities, which center on updating ICD-10, developing ICD-11, and starting a revision and update of the International Classification of Functioning, Disability and Health (ICF). The tentative theme for the 2009 annual WHO FIC meeting is primary care classification, which synergizes with NCVHS interests. In the Asia Pacific Region, the highest priority identified for health IT was monitoring patient safety. Ms. Greenberg outlined the major barriers and commitments in this region, many of which are the same as those in the U.S.

Mr. Reynolds commended Ms. Greenberg for the work she is doing worldwide with WHO.

COMMITTEE DISCUSSION

Subcommittee chairs reported briefly on new discussions and decisions in their breakout sessions. (See the short summaries at the end of the detailed minutes, below.) Mr. Reynolds reminded the group to watch for ways to include the value concept.

The effort to accommodate all the desired hearings stimulated a discussion of how subcommittees should collaborate and communicate. The main thing emphasized was that the chairs need to keep each other informed of their respective activities and plans. In addition, Mr. Reynolds said it would be necessary to work out hearing schedules once all desires are known.

OTHER BRIEF AGENDA ITEMS

Also see the brief summaries at the end of the detailed minutes, below, for the following agenda items:

  • NCHS/BSC Update—Dr. Scanlon

  • First Meeting of CDC Advisory Committee Chairs and Designated Federal Officials—Ms. Jackson


DETAILED SUMMARY

—Day One—

CALL TO ORDER, WELCOME, INTRODUCTIONS, REVIEW OF AGENDA

Mr. Reynolds called the meeting to order and asked all present to introduce themselves.

DEPARTMENT UPDATE

Data Council —Mr. Scanlon

After noting the election of a new President, Mr. Scanlon noted that former NCVHS chair Simon Cohn and current NCVHS member Paul Tang are both members of the Board of Directors of the AHIC successor organization. The Hill is focusing on the economy, and its attention to health IT is of interest to many. On the budget front, most Federal agencies have a continuing resolution, which creates uncertainties for population health statistics. NCHS was slated for an $11 million increase, but this was delayed by the continuing resolution. The issue now is to get through the first 4-5 months of FY2009. The Data Council is looking at the impact of the budget on population statistics programs and how to minimize the effect on that and other programs. FY2010 is in the hands of the new President; it will be a very compressed process.

The Data Council is also assessing the readiness of data sources and modeling for health care reform, and trying to marshal capacities for that purpose. The NCVHS Subcommittee on Population Health will be doing this on a broader scale. In addition, the Department is undertaking evaluations and demonstrations in the PHR area, including a pilot study of PHRs in South Carolina and others, along with a Medicare ambulatory EHR demonstration program and evaluation. ASPE is working with NCHS to use the NHIS to assess how consumers use HIT to get health information. The NHIS questions will be asked in January, with data about six months to a year later. He promised to try to give NCVHS a sense of the findings sooner than that.

ASPE is in a transition process in anticipation of Inauguration Day, preparing briefing books and space for the transition team, with a designated person in charge when others leave to preserve continuity. The transition team that knows the health IT area, as well as other issues, has begun to arrive.

Dr. Hornbrook suggested using the NHIS to survey vendors and managed care systems about how many people are using their PHRs and portals. Mr. Scanlon said HHS plans to monitor this dynamic area on an industry basis and to attempt a more systematic survey at a later time. Dr. Francis noted the Privacy Subcommittee’s interest in this topic. Dr. Tang asked about evaluating the quality of the data housed in PHRs. The importance of comparing and assessing different approaches to privacy was also noted. There were also comments about using non-traditional sources of health information such as Google to monitor public health trends.

CMS Update—Dr. Tony Trenkle, CMS

On PHR pilots, Dr. Trenkle noted that CMS has specific privacy requirements in the PHR pilot for Arizona and Utah, and it is also looking at its entire data use. The South Carolina pilot has expanded to include an agreement with DoD to send Tricare data on active medications.

On the regulations front, the NPRM comment period closed October 21, with 3,105 comments on ICD-10 and 150 comments on 5010. CMS is reviewing the comments and moving toward final rules. There is an AHIMA report on internal CMS operations and how they will be impacted by ICD-10, a summary of which is posted on the Website. CMS has signed a contract with Noblis to pursue this work in greater detail.

He reported on several activities in the area of e-prescribing,, including publication of the physicians’ fee schedule rate, rulemaking exercises, incentives, and standards. CMS is continuing to look at RXNorm and codified sig. It expects to begin a 9-month pilot test in December. Prior authorization is another major standard that CMS is working on with AHRQ and industry. Also, an HHS team has been meeting with DEA on key areas of common concern, and they are hopeful about a final rule within a year.

CMS is doing compliance reviews of covered entities on security enforcement and expects to have completed about 20 by the end of the fiscal year. It was critiqued by the OIG in this area, but it regards compliance review as only one piece of an enforcement program, along with outreach and education. Also, it lacks the resources to do large-scale compliance review.

In response to questions, Dr. Trenkle said CMS would take a look at pilot testing for ICD-10, and that negotiation with DEA has “three pillars”: integration with industry’s e-prescribing practices; scalability; and promoting e-prescribing adoption. Dr. Francis noted that governance is a dimension of the compliance issue. Members acknowledged the Department’s lead in helping all these activities move forward.

UPDATE FROM EXECUTIVE SUBCOMMITTEE RETREAT—Mr. Reynolds

Mr. Reynolds reviewed highlights from the October 14-15 Executive Subcommittee retreat. On the cross-cutting topic of person-centered health, he stressed the interconnections between all NCVHS domains and subgroups and the importance of continuous communication and coordination. The retreat also featured discussions with NCHS and Board of Scientific Counselors (BSC) representatives. Dr. Lepkowski expressed interest in the new NCVHS initiative on person-centered health. Members were also aware of potential collaborations with AHIC 2.0, NQF, and other bodies. The Executive Subcommittee approved development of a compendium (primer) on key data stewardship principles and background documents.

They also agreed to move forward on revising the vision for 21st century health statistics. As follow-up, Ms. Greenberg and Ms. Jackson reported that they have developed a rough plan with Dr. Parrish and Dr. Friedman, in two phases over two fiscal years. In phase one, the contractors (who will attend the February meeting) will pull together status reports; in phase two, there will be hearings or workshops to look at what revisions are needed in view of changes in Health IT and other key factors.

Mr. Reynolds said that at Dr. Fitzmaurice’s suggestion, a letter to the new Secretary is being developed to inform him about the role and accomplishments of NCVHS and offer support. He invited members’ inputs and suggestions.

SUBCOMMITTEE UPDATES

Subcommittee on Quality Person Centered Health Initiative—Drs. Carr and Tang

Dr. Carr described the proposed initiative and plans for a 1½-day hearing on person-centered health data needs in early 2009. The project is centered in the importance of empowering and engaging individual Americans in their health and health care. The hearing will focus on what is needed for the next generation of health surveillance data. The goals are to better understand emerging data needs, assess current and proposed certification standards, and provide recommendations to support person-centered and population health functionality in personal health IT systems. Dr. Tang added that the hearing schedule is designed to invite the participation of other subcommittees.

Dr. Francis said the Subcommittee on Privacy and Security will be interested in coordinating around this effort, to economize on hearings on areas of common interest. Dr. Warren expressed a similar interest on the part of the Subcommittee on Standards, and that of the Subcommittee on Population Health was noted as well. The group discussed the possibility of doing some information-gathering in the context of one or more full Committee meetings; more broadly, they considered ways to coordinate their future activities.

Mr. Reynolds proposed that this project explicitly consider what tools people are or will be given, beyond health care, to monitor and optimize their health. In that vein, Ms. McCall suggested looking at what activities will generate data. Dr. Tang noted that the Subcommittee on Quality is initially focusing on population health and reporting. He raised the question of the scope of NCVHS and how it can incorporate ideas of wellness. Mr. Scanlon noted that the focus is on measures, metrics, data, and the systems thereof. Some information is clinically based, some population-based, and some employer-based. Ms. Greenberg suggested hearing from consumer groups to clarify what information people feel is most important about health.

Dr. Middleton cited Dr. Green’s observations in the NEJM on the most important determinants of mortality as help in defining the data scope and perspectives for this project. He added that some of the uncertainty about framing and sources may be due to a failure to “explicitly address the value proposition,” and he suggested taking that perspective in the hearings because it brings in multiple perspectives. Dr. Steinwachs suggested tapping into the developmental process for the 2020 Health Objectives.

Mr. Reynolds stressed that the purpose of this preliminary discussion of the Subcommittee’s plans is to generate as many ideas and perspectives as possible in a full Committee setting, to further the process of figuring out how to do this cross-cutting project.

Mr. Blair urged an effort to quantify the benefits. Dr. Hornbrook said Kaiser is trying to figure out how to build a measure of output, which is an issue for this project, as well. He proposed that in data system design, thinking about “detecting the implosion of the health care system” must take precedence over “thinking about the 21st century.” Ms. McCall commented on the links among the 21st century vision, the concept of health determinants, and the concept of value. She suggested asking testifiers how they are handling these factors and introducing value into the process. Dr. Middleton noted that a large policy question is the use and goals to which the increasingly scarce health care dollars will be put, a question that calls for information to inform decisions.

Dr. Tang suggested, as a matter of standard procedure, that the Committee begin breakout sessions with representatives of all subcommittees in a working session to identify overlaps and assign detailed agendas to individual subcommittees. Mr. Reynolds said the Executive Subcommittee would take the idea under consideration.

Subcommittee on Population Health—Dr. Steinwachs and Dr. Scanlon

Dr. Quinn has been helping on a use case on the patient-centered medical home. The Subcommittee will coordinate with the Subcommittee on Quality after the hearings described above. Meanwhile, it is holding hearings on November 19 on government data sources related to insurance coverage and access to care. It will hold another hearing on modeling for policy. The Subcommittee is also interested in the implications of CTSAs (see below) for health statistics and information on community health. It anticipates getting greater clarity about next steps from the presentation later in this meeting. The Subcommittee is also working on plans for updating the 21st century health statistics vision (see below).

Dr. Scanlon, the liaison to the NCHS BSC, highlighted concerns about inadequate funding for vital statistics and the consequences for the quality of the statistics. The BSC wrote the Secretary expressing this concern, and has created a workgroup to look into it further. The Subcommittee on Population Health plans to coordinate with them.

Mr. Land called attention in particular to the ramifications of 1) the proposal to reduce the number of data elements collected on birth and death certificates, and 2) a proposal to cut funding by at least 30 percent to states that provide the data to NCHS.

Dr. Middleton asked whether NCVHS could adopt a stronger advocacy stance on these issues. Mr. Scanlon said that while the Committee cannot lobby Congress, it can assess the impact and send recommendations to the Secretary. He noted that an increase in funds for NCHS was requested, but got caught in the budget process.

Subcommittee on Privacy and Security—Dr. Francis and Mr. Houston

The Subcommittee has put together a kind of briefing book on what has been said to date and resources available on PHRs. It is planning to study the privacy practices of PHR vendors, examples of employer use of them in wellness programs, data flow in current uses of PHRs, and privacy and security issues in those settings. In addition, it plans to look at privacy aspects of the Medicare PHR demonstration projects, and at what governance structures are in place for PHRs as their use evolves. These issues will be addressed in hearings. Mr. Houston added that governance related to EHRs will also be reviewed. He added that the greatest governance issues relate to when data cross RHIO or state boundaries.

Dr. Hornbrook pointed out that integrated delivery systems have unique characteristics in this regard. Ms. Milan suggested looking at the PHR at the NHIN level, among others. Ms. McCall suggested that what people expect and find valuable provide the reference point for the project. She also advised that the Committee bear in mind as it plans its projects that it cannot anticipate what technology will be capable of. The rapidly evolving nature of PHRs was noted in this context.

Subcommittee on Standards—Mr. Blair and Dr. Warren

In what it is calling “The NCVHS Standards Initiative,” the Subcommittee plans a series of hearings and written communications to examine how well health IT standards are being developed, selected, coordinated, implemented, and used. It will ask 4 basic questions to organizations. The last, “What do we need to do to improve things?” is the focus of the effort. The Subcommittee will ask for written testimony, select a representative group of people to testify, conduct a series of hearings, and then develop recommendations.

CLINICAL AND TRANSLATIONAL SCIENCE AWARDS (CTSA) BRIEFING—

Jody Sachs, D.P.M.

Dr. Sachs is the Scientific Project Officer for the National Center for Research Resources (NCRR) at NIH, a trans-NIH program that is heavily involved in re-engineering the clinical research enterprise. The CTSA program started in 2005 and was funded in 2006, aimed at decreasing the delays in getting from research to implementation in communities. The traditional system favored independent investigators in discrete institutional settings. This program develops interdisciplinary teams in order to break silos and catalyze change. It uses a complex mechanism of coordinative agreements between the awardee, academic institution, and NIH, for 5-year awards.

Dr. Sachs described the extensive governance structure for cooperative agreement. The CTSA Consortium Steering Committee, composed of other program awardees, is at the center. The program grew from 12 to 14 awardees in 2008. She showed a chart of the Emory University site as an example of the complexity of the partnership, with 11 different entities participating. Similarly, UC Davis has 9 collaborators. The program’s Website, <CTSAweb.org>, is a public site. CTSA wants to create regional networking opportunities, and there are three regional organizations. The NIH Roadmap program, which identified clinical research networks, found that 271 exist, 60 percent of which are government funded. They can be found at <clinicalresearchnetworks.org>. This program has been leveraged through the CTSA program, with a new RFA for CTSA investigators to work in existing clinical research networks but form new partnerships.

Dr. Sachs then discussed the priorities of the Community Engagement Steering Committee, one of six “key function committees,” which works to broaden community outreach at the CTSA sites. Leveraging funding partnerships is a high priority for them. Finally, she reviewed the CTSA Steering Committee’s National Consortium Strategic plan, which has goals to enhance translational research capabilities, training and career development, consortium-wide collaborations, and community and population health.

Discussion

Dr. Steinwachs commented on the potential to generate health-related data with relevance for national health statistics. Dr. Sachs said the focus is on research, not healthcare; but the goals for a data-sharing network, a national resource inventory, and a national model for community engagement have some potential in the latter area. Dr. Warren asked about the impact of funding cuts, and whether reduced funding to centers would be accompanied by reduced expectations; Dr. Sachs said there is flexibility for projects to reduce their scope. Dr. Suarez called attention to the model of community-based participatory research (CBPR). Dr. Sachs said the intention is to work with CBPR people to develop a common model, and in general to consider work that has already been accomplished.

Dr. Middleton asked about expectations for interoperability at individual sites; Dr. Sachs said the Bioinformatics Committee is working on defining systems, and all Consortium applicants are asked to work together. However, it will take more money to create an interoperable system. She hopes the Goals Committees, which are just meeting for the first time, will come to grips with this problem. Dr. Middleton noted that NCVHS might offer guidance to the CTSAs about the standard data set and the process, perhaps modeling the process going on in HITSP for other clinical information systems. There is a mechanism in place that CTSAs could piggyback onto.

Dr. Hornbrook, who is part of the Northwest CTSA Consortium, observed that the major obstacles and opportunities for the kind of system change being envisioned depend on “human culture.” CTSAs, he said, are not strong enough yet to “break through the old cultures of biomedical research”; this culture has to be changed, and merged with health services research. He explained that his purpose in proposing this presentation was to enable NCVHS to provide “symbolic leadership” by linking the CTSA program to national health statistics, thus “showing the accountability of NIH to the nation’s health” by creating the expectation that the CTSA program will “show in our health statistics sometime, somewhere.”

ONC UPDATE—Charles Friedman, Ph.D.

Dr. Friedman distributed copies of a synopsis of the Health IT Strategic Plan and gave brief updates on the final AHIC meeting (November 12), progress in interoperability and standards, the State Alliance for E-Health, and the NHIN.

At its final meeting, AHIC was briefed on the CMS PHR demo in Utah and Arizona, which involves four vendors, it heard reports on the AHIC successor (see below), workgroups gave their final reports, and Secretary Leavitt recognized the contributions of the AHIC members.

Standards and interoperability activities are progressing, based on priorities and a process set by AHIC. As of November 2008, HITSP was working on interoperability specifications for six use cases for AHIC’s 2008 priorities. It is anticipated that as of January 2009, the full set of interoperability specifications will have been “accepted” from 2006 use cases, and the full set will have been “recognized” from 2007 use cases. Dr. Friedman used the AHIC Priorities Roadmap to show the use cases for each year from 2006 to 2009.

The State Alliance for E-Health, created by the National Governors Association in 2006, addresses the role of states in facilitating adoption of interoperable health IT. It has three task forces, which align with the national health IT strategic plan. The Alliance has just released a report, “Accelerating Progress,” containing six state-level recommendations and a set of strategies. It is posted on the web. Dr. Friedman described some of the proposed strategies.

Finally, he reviewed recent activities related to the NHIN, notably the September 23 live demo involving 20 organizations, which worked very well. For example, one set of demonstrations illustrated real-time information transfer related to emergency care, transfer of care, and the wounded warrior; another showed how patients could control the flow of information about them. Dr. Friedman showed the wounded warrior scenario in some detail. The next big event is December 15-16, with a public demonstration of interoperability.

In their comments, NCVHS members primarily expressed praise for ONC’s leadership and congratulations for the successful trial implementation. In addition, Dr. Scanlon asked about getting CMS on the NHIN chart, and was told that discussions are underway with CMS about implementing a software called NHIN Connect, a gateway to the NHIN for Federal agencies.

Dr. Deering observed that the linkages and activities described by Dr. Friedman are the beginning of movement in the direction envisioned by NCVHS years ago and laid out in its report, Information for Health.

AHIC SUCCESSOR ORGANIZATION—Laura Miller, FACHE, Interim Executive Director

Ms. Miller ended her government career in health care as Deputy Under Secretary of Health for VA. She noted that “AHIC Successor,” of which she is the Interim Executive Director, will not be the permanent name of the organization. She described it as “one of a series of spin-offs” from AHIC; the others in the infrastructure created by ONC are CCHIT, HITSP, HISPC, and the NHIN. The Successor is designed to become the focal point for harmonization activities and a way of engaging a broad range of stakeholders in a sustainable organization. The goals developed for it include accelerating adoption of interoperable health IT, prioritizing stakeholder requirements, advancing policies and technical approaches, and overseeing and facilitating the NHIN. Noting the caliber of people involved, she showed a series of slides listing the members of the Governance, Membership, Sustainability and Transition Planning Groups and of the Board of Directors (including NCVHS member Dr. Paul Tang and former NCVHS Chair Dr. Simon Cohn). The Board, which has 15 members and is designed to have strong Federal participation with three Federal liaisons, has fiduciary responsibilities, oversees strategies, and selects, oversees and evaluates the AHIC 2.0 president. The organization is currently actively recruiting a president/CEO. There are four board-level committees. Members will set priorities, identify opportunities for standards adoption, and help develop and govern the NHIN. The Successor has start-up Federal funding; the aim is to generate most revenue from membership dues and other sources within a few years.

The Transition Workgroup identified several priorities for the AHIC Successor, leading to a list of 17 “key opportunities” for consideration. The ONC use case process will continue through 2009, and a new use case process will begin in 2010. Ms. Miller explained the concept of “value case,” which is to be “the primary artifact of the AHIC Successor.” For each identified need, it presents the costs, value, and risks of implementing a scenario and the measurement of actual impact on care improvement, and commits the submitting organization to implementing the case. To begin this process, the Successor will set a framework for a strategic direction and then call for the submission of value cases, ultimately leading to interoperability specifications. The point of using a value case is to stress that the Successor exists for individual and consumer benefit. A mechanism will be developed to support value cases for underserved populations, and there may be a scholarship fund for application fees. Criteria will be published to determine value factors. Value cases that pass due diligence will be recommended for recognition as a nationwide priority. The idea is to accelerate adoption of interoperable health IT through broader stakeholder input and a collaborative process. Ms. Miller gave examples of a value case in the areas of clinical research and radiology.

Finally, she said that in the next three months, the Successor would finalize bylaws and strategic plan, complete formation of the Board and management, finalize the value case approach, determine next steps for proposals, and launch a membership program.

In the discussion period, Mr. Reynolds asked about the relationship between ONC and the Successor, and was told that they will be less “tightly coupled” than with AHIC. The Successor will be more self-reliant in developing value cases, and so on, with ONC as one of the players—an active one, Dr. Friedman added. He stressed that there will be an emphasis on creating a single infrastructure that serves many purposes. Mr. Reynolds stressed the tremendous diversity among HIEs and the need for ONC and the AHIC Successor to help define and model what a good organization looks like.

Mr. Houston urged that the Successor facilitate a more “scientific approach” to deciding what to focus on than seemed to exist for AHIC’s workgroups. Dr. Suarez expressed concern about a business model for AHIC 2.0 that depends on “whoever needs a use case to put money and time into it.” He urged an approach that avoids competition between use cases.

This concluded the day-one plenary session, and NCVHS members moved into Subcommittee breakout sessions.

—Day Two—

Mr. Reynolds began the meeting by highlighting the idea of “using value as a differentiator in all the Committee’s planning,” following on Dr. Middleton’s suggestion the previous day. He noted that Subcommittee charges were being revised, and Ms. Greenberg reviewed the process for finalizing them.

REPORT ON WORKSHOP ON DE-IDENTIFICATION OF HEALTH DATA—Dr. Carr

Dr. Carr was on a panel at this September 26 workshop, which was hosted by the Center for Democracy and Technology. She described it as a “one-day think tank.” There were panels on facts and methodologies, data uses, and policy implications, and a discussion of next steps. A summary has been created of the eight key discussion points. Four key ones are that it may be easier now to re-identify anonymous data than it was in 2000; that even if not re-identified, de-identified data still carry privacy risks; that re-identification is often easy, but there are solutions; and that de-identification must go beyond technical safeguards to include trusted personnel and sound policies. The workshop also identified six issues for further exploration, including creating stronger requirements for data use agreements, integrating a system of patient notice, establishing certified data stewardship entities, and fashioning potent remedies for violations of data use agreements.

Ms. Bernstein explained that the Center for Democracy and Technology is a highly respected public interest group that works on issues of technology policy, with a strong focus on emerging technology. Its stated mission concerns keeping the Internet open and free. It has a new interest in healthcare issues and technology and is considered an honest broker.

Members discussed the possible ways to learn from, support, and/or collaborate with the Center around common concerns, and they agreed to ask for a presentation from Deven McGraw, formerly with AHIC and now with the Center. Ms. Bernstein noted that while some of the Center’s work is “incredibly technical,” other facets have policy implications that align with NCVHS’s work. (Former Subcommittee on Privacy and Security Chair Mark Rothstein was also on a workshop panel.)

Dr. Steinwachs proposed that the Committee “grapple with the bridging issue” related to the tension between the growing need to use data in the public interest and moves to make it less and less accessible because of re-identification issues. At Mr. Reynolds’ request, the co-chairs of the Subcommittee on Privacy and Security said they would provide a framework for addressing this set of issues.

NEW STEPS BY SUBCOMMITTEES

Subcommittee chairs then gave brief summaries of the new decisions taken in their breakout sessions. Mr. Reynolds reminded the group to watch for ways to include the value concept.

  • Subcommittee on Population Health—Dr. Steinwachs

In addition to discussing the plans reviewed on day one, the Subcommittee agreed to develop a brief response to the presentation on CTSA, focusing on how NCVHS could help build bridges between what NIH is doing and health statistics for the country.

  • Subcommittee on Quality—Drs. Tang and Carr

The Subcommittee tightened its hearing concept, to focus on novel uses and reuses of data for assessing and influencing individual health that could be reused for population reporting. The deliberations will include ways to protect and standardize the data, areas in which input is needed from other NCVHS subcommittees.

  • Subcommittee on Privacy and Security—Dr. Francis and Mr. Houston

The hearing on the evolving role of PHRs in the personal health space could be the day before the February full Committee meeting, with four panels. Much of the discussion will center on where PHRs will go over a five- to ten-year period, with the intent of developing a privacy roadmap. The Subcommittee also plans to monitor governance issues and vet any recommendations that come forward in this area.

The effort to accommodate all the desired hearings stimulated a discussion of how subcommittees should collaborate and communicate. The main thing emphasized was that the chairs need to keep each other informed of their respective activities and plans. In addition, Mr. Reynolds said it would be necessary to work out hearing schedules once all desires are known.

  • Subcommittee on Standards —Mr. Blair and Dr. Warren

The Subcommittee has put aside until a later time a number of the other elements it wants to address. It also worked out a specific process for eliciting written testimony and choosing in-person testifiers, and it planned a tentative hearing schedule for the first six months of 2009. It will probably ask a question about value among its queries.

NCHS/BSC UPDATE—Dr. Scanlon

Dr. Scanlon reviewed the magnitude and scope of the data limitations resulting from the longstanding budget problems of NCHS. He reported that in addition to creating a task force on vital statistics, the BSC has created a task force on the NCHS vision for the future. It is taking an innovative approach to the uses of administrative data to substitute for things not collected in surveys, and looking at data needs from a policy perspective and the most efficient way to collect information to fulfill those needs. In addition, the BSC is continuing its review of NCHS programs and has begun discussions of informed consent issues related to uses of NHANES data.

FIRST MEETING OF CDC ADVISORY COMMITTEE CHAIRS AND DESIGNATED FEDERAL OFFICIALS—Ms. Jackson

Ms. Jackson represented NCHS at this meeting, where she became more aware of the intersections between the interests of NCVHS and of CDC. One purpose of the meeting was to introduce people to CDC’s Healthiest Nation Initiative, which reflects its intention to “burst out of its silos of disease…into an expanded mission.” The meeting laid the groundwork for keeping everyone informed about what is happening at CDC, and how cross-cutting communication can be continued.

WORLD HEALTH ORGANIZATION (WHO) FAMILY OF INTERNATIONAL CLASSIFICATIONS (FIC) UPDATE—Ms. Greenberg

Ms. Greenberg, who recently returned from two WHO meetings, briefed the Committee on the WHO FIC Network and its priority activities and highlights of recent meetings, and commented on synergies with the Global Partnership in Public Health Informatics. The topic of the annual WHO Classifications meeting was public health informatics. This was followed by an Asia-Pacific conference on the same topic. Ms. Greenberg noted that even with its full plate of activities, it is good for NCVHS to be reminded that “it’s a very small world,” and there are many synergies between its work and the international work on classification and public health informatics.

She reviewed the main classifications in the WHO FIC, the structure and mission of the WHO Collaborating Centres, and the committee and reference group structure. WHO FIC lists 14 priorities, of which the first is to implement ICD-10. There are annual updates and major updates every three years. ICD-11, which is under development, is expected to be a “very major update to ICD-10.” They are also starting to update and eventually revise the International Classification of Functioning, Disability and Health (ICF) and have expanded the update platform for this purpose. (Anyone can recommend updates to ICD-10 and ICF, once they register.) They are looking at implementation of ICF in censuses and surveys, and several countries are looking at using an ICF framework for redesigning their disability eligibility systems and otherwise informing social policy. Ms. Greenberg co-chairs the Education Committee, and has been working on an International Training and Certification Program for coders and trainers, currently focused on ICD.

At the recent meetings, held outside Delhi, 133 updates to ICD-10 were approved. The next major update will be in 2010. After deliberation, it was decided to continue to update it in 2013, 2016, and until ICD-11 is available for implementation. In addition, the updating platform was expanded to include updating for ICF, starting next year.

The tentative theme for the 2009 annual WHO FIC meeting is primary care classification, which synergizes with NCVHS interests.

In the Asia Pacific Region, the highest priority identified for health IT was monitoring patient safety. Their major barriers are in the areas of funding, human resources, technical capacity, and political will, including limited appreciation of the importance of the work. They hold in common with NCVHS and others around the world a commitment to standards. Capacity building was a major topic of discussion.

Dr. Warren commented that “there was joy in Mudville, or I should say Nursingville,” when WHO FIC accepted the International Classification of Nursing Practice (ICMP) as a related classification this year. This was very important from a nursing perspective, she said. Finally, to a question about the convergence of SNOMED and ICD, Ms. Greenberg said this is now a high priority for both the International Health Terminology Standard Development Organization (IHTSDO) and WHO. She is involved in harmonization efforts and will keep the Committee posted.

Mr. Reynolds commended Ms. Greenberg for the work she is doing worldwide with WHO.

He then adjourned the meeting.


I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.

/s/ February 25, 2009

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Chair Date