Minutes of the June 20-21, 2007 NCVHS Full Committee Meeting

Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

June 20-21, 2007

Natcher Center, National Institutes of Health
Bethesda, MD

Meeting Minutes

The National Committee on Vital and Health Statistics was convened on June 20-21, 2007 at the Natcher Center, National Institutes of Health in Bethesda, MD. The meeting was open to the public. Present:

Committee members

Simon P. Cohn, M.D., M.P.H., Chair
Justine M.Carr, M.D.
Leslie Pickering Francis, J.D., Ph.D.
Larry Green, M.D.
John P. Houston, J.D.
Garland Land, M.P.H.
Carol J. McCall, F.S.A., M.A.A.A.
J. Marc Overhage, M.D., Ph.D.
Harry Reynolds
Mark A. Rothstein, J.D.
William J. Scanlon, Ph.D.
Donald M. Steinwachs, Ph.D.
C. Eugene Steuerle, Ph.D.
Paul Tang, M.D.
Kevin C. Vigilante, M.D., M.P.H.
Judith Warren, Ph.D, R.N.
Absent: Jeffrey Blair, M.B.A.

Staff and liaisons

Marjorie Greenberg, NCHS/CDC, Executive Secretary
James Scanlon, ASPE, Executive Staff Director
Karen Trudel, CMS liaison
Steve Steindel, Ph.D., CDC liaison
Susan McAndrew, OCR, privacy liaison
Debbie Jackson, NCHS

Others (not including presenters)

Maria Friedman, Rx Hub
Carol Bickford, American Nurses Assn.
Hayley Freedman, Amer. Academy of Peds.
Douglas Boenning, ASPE
Frank Kyle, Amer. Dental Assn.
Gail Kocher, Highmark
Stanley Nachimson, Nachimson Advisors
Sheila Dwyer, Amer. Optometric Assn.
Kidus Eigu, OMH
Nancy Ferris, Government Information Group
Angela Jeansonne, AQA
Margret Amatayakul, consultant
Kraig Kinchen, Eli Lilly

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

EXECUTIVE SUMMARY

ACTIONS

The Committee approved the following letters to the Secretary:

Recommendation letter on Data Linkages to Improve Health Outcomes
Recommendations on the National Provider Identifier (NPI)
Improving the interaction of FERPA and the HIPAA Privacy Rule with regard to school health records
Update to privacy laws and regulations required to accommodate NHIN data sharing practices

Subcommittee and Workgroup Activity Scan

(See the summaries of these brief presentations in the next section.)

HIPAA 5010 Overview (A Primer)—Ms. Trudel and Mr. Reynolds

5010 is a new version of the suite of administrative transactions affecting the non-retail pharmacy sector. It was developed by X12-N. The NCVHS review process is intended to broaden the opportunities for input beyond the participants in the SDO process and to elicit comments from the general public about the transactions. The Subcommittee on Standards and Security will hold hearings starting in July, with a letter to be presented for review in September. The business impact of the anticipated changes is not yet defined; NCVHS will try to get input on this in its hearings. The document resulting from the Subcommittee’s hearings will provide input to the Secretary and CMS as they put together a proposed rule.

Actions on Letters

The Committee heard, discussed, and approved the letters listed above under Actions. They also considered another letter on which action was deferred. (See summary below.)

Data Council Update—Jim Scanlon

Mr. Scanlon reported briefly on the Secretary’s priorities, the HHS strategic plan, anticipated Bills, budgets, and three new Data Council projects.

ONC Update—Karen Bell, M.D.

Dr. Bell reported on ONC activity in three areas: privacy and security, the future of AHIC, and the ONC strategic plan. She stressed that it is important to ONC to incorporate the work of NCVHS. She was informed that the Subcommittee on Privacy and Confidentiality is developing new recommendations on consumer control of personal health information.

BRIEFINGS

The Committee heard three briefings to provide background for the forthcoming special NCVHS project on secondary uses of health information in the NHIN. The project is looking in particular at the secondary uses related to the quality use case.

AHIC Quality Workgroup Overview—Fatima Rias

The AHIC Quality Workgroup was formed in August 2006 to address how health information technology can be used for the development and use of quality measures, both ambulatory and inpatient. The Workgroup has developed a vision, a case study, and recommendations on four topics: automating data capture and reporting, establishing a unified framework and collaborations, enabling data aggregation for public reporting, and aligning quality measurement with the capabilities and limitations of HIT. It is now conducting an environmental scan to inform the next set of recommendations. It published a Federal Register notice in June with high-level questions on longitudinal measurement and the collection of information to support it, and it has taken testimony on the same questions.

Briefings by John Loonsk, MD, ONC

National Health Information Network Health Information Exchange (NHIE) core services

The intent for the NHIN is that it be a network of networks built around health information exchanges (HIEs), which will play a critical role in advancing quality activities. ONC is trying to define core capabilities and services for the HIEs to enable them to participate in the network of networks. An HIE that implements the NHIN architecture, process and procedures and participates in the NHIN Cooperative will be called an NHIE. The next round of trial implementations will focus on fleshing out the core services and the transactions involved. Those who receive NHIN contracts will be expected to do all the core services identified and to work on two use cases. As many as 15 HIEs are to be awarded. Development of the NHIN Cooperative is a next step.

AHIC 2007 Quality Use Case

The AHIC use cases play important roles for the concrete activities of the NHIN. The key areas for the quality use case are the multiple uses of EHR data and support for quality measures based on claims-based measures, multiple entities and data sources, and longitudinal patient data. While claims are a possibility, “there is a lot of ‘to be’ expectation in this use case.” The Workgroup is striving to accommodate the world “as is,” but also to incorporate intermediate steps to the “to be” world. A practical goal is to support a core set of AQA and HQA measures. ONC is concentrating on inter-organizational standardization and information exchange and trying to ensure information flow among different architectures. There are important issues related to data stewardship, authorization and access.

In the discussion period, Dr. Loonsk heard a strong message from Committee members about the importance of advancing public health benefits through the NHIN.

International Health Terminology Standards Development Organization (IHTSDO) —Betsy Humphreys, National Library of Medicine (NLM)

The IHTSDO (also informally called “the SNOMED SDO”) was formed in March 2007 in Denmark. In April, it acquired the intellectual property in SNOMED from the College of American Pathologists (CAP). The US is among the nine countries that are charter members; it is represented by the NLM. A chief purpose of the SDO is the ongoing updating and dissemination of SNOMED. Its top priorities include documentation, defining what belongs in SNOMED, mapping to ICD-10, the SNOMED-LOINC relationship, and a medication terminology strategy. Ms. Humphreys described the IHTSDO’s organizational structure and other operational factors.

The discussion period focused on the prospects for greater clinical utility for SNOMED and the steps toward that goal.

International Classifications and Related Activities—Ms. Greenberg and Dr. Steindel

Ms. Greenberg is the Head of the WHO Collaborating Center for the Family of International Classifications for North America, based at the National Center for Health Statistics. She briefly described the WHO Family of International Classifications (WHO-FIC), the maintenance and updating process, and the WHO-FIC Network’s priorities. She and Dr. Steindel also discussed the relationship of these activities to terminological and other standards development, connecting back to Dr. Humphreys’ presentation.

Dr. Steindel, who is a member of the WHO-FIC Terminology Reference Group, said an early task of that group is to meet with the IHTSDO, first to organize principles (by early 2008) and then to figure out how to do mapping between the WHO-FIC and SNOMED.

Data Stewardship, Quality RFI—Jon White, MD, AHRQ

Dr. White observed that the secondary uses of health data loom large in the efforts to improve the quality of care. Structured information systems can be a powerful contributor, but there are many pitfalls in bringing data together in large pools. “Data stewardship” concerns the responsibilities associated with using and having access to data, and rich discussions have been taking place about it. He described the emergence of the idea of a data stewardship entity through the work of the AQA (formerly the Ambulatory Care Quality Alliance). AHRQ published an RFI on June 4, asking for answers from a broad range of stakeholders to 25 questions regarding need, funding, relationship to other entities, and other factors. Responses are due by July 27. AHRQ will then post the responses on its Website and write a summary report for AQA and the public.

Secondary Uses of Health Information: Background—Dr. Carr, Mr. Reynolds

The presenters are co-vice-chairs of the NCVHS ad hoc Workgroup on Secondary Uses of Health Information, which is to hold its first session immediately following this meeting. ONC issued a detailed request for assistance from NCVHS regarding secondary uses of health information, with particular attention to applications for quality measurement and reporting. The Committee’s tasks are to develop a framework, a taxonomy, and recommendations to the Department. The questions that will be asked of all testifiers (of whom there is a long list) concern the sources, uses and quality uses of data as well as privacy and security factors. The Workgroup has laid out a challenging schedule of meetings leading up to the September full Committee meeting, when they hope to present a product.

DETAILED SUMMARY

—DAY ONE—

Call to Order, Welcome, Introductions, Review of Agenda—Dr. Cohn

Dr. Cohn called the meeting to order, thanked the National Institutes of Health for hosting the meeting, and asked all present to introduce themselves. He then congratulated Dr. Steinwachs on his appointment as interim Provost and Academic Vice President of Johns Hopkins University, and Dr. Warren for her endowed chair at the University of Kansas. In his introductory comments, he noted the accelerating rate of HIT development, the leadership of Secretary Leavitt, the increasing utilization of NCVHS work products, and the formation of the NCVHS ad hoc Workgroup on Secondary Uses of Health Information to carry out a new assignment from HHS and the National Coordinator. He is Chair, Mr. Reynolds and Dr. Carr are co-vice-chairs, and virtually every NCVHS member is participating in some way. In addition, several agencies are sending liaisons to the Workgroup. Draft recommendations are to be presented at the September meeting. (See presentation below.)

Dr. Cohn noted that the Executive Subcommittee had met on May 2-3 to review recent activities and plans for the near future, and to review Committee operations. The Subcommittee agreed on several measures to encourage synergy and integration among the areas of NCVHS activity and free up more time in full Committee meetings for substantive discussion.

Subcommittee and Workgroup Activity Scan

Quality Workgroup—Dr. Carr

The Workgroup held a hearing on June 19 to hear from speakers on the transition from paper to hybrid data sources for quality measurement, including some electronic elements. It learned that in several leading-edge quality initiatives, clinical outcomes are getting better, transparency is increasing, the public is becoming engaged, metrics are being refined by blending administrative data with clinical elements, physicians and other clinicians and stakeholders are getting involved, and public reporting is stimulating participation and quality improvement. The Workgroup also heard about the administrative burden and costs of data abstraction and reporting.

The Workgroup will prepare a report summarizing the themes from the hearing, possibly also revisiting some of the candidate quality recommendations in a 2004 NCVHS report.

Subcommittee on Populations—Dr. Steinwachs and Dr. Scanlon

The Subcommittee has been looking at data linkages, and later in this meeting will bring forward a letter on how to improve access to linked data sets for outside researchers. In the near future, it will address how to facilitate access within and across government agencies. Dr. Steinwachs said he would like to engage the Subcommittee on Privacy and Confidentiality in looking at the privacy issues involved in data linkage.

The Populations Subcommittee had a hearing on surge capacity in January. Dr. Scanlon noted the breadth of the issue, which encompasses hospital capacity, emergency response systems, supply availability and more with respect to multiple possible crises and catastrophes. The Subcommittee plans to have a follow up hearing to focus on the information policy issues in this area.

Dr. Steinwachs said the Subcommittee is continuing to collaborate with the NCHS Board of Scientific Counselors, for example on concerns about funding for national surveys. The Subcommittee also plans to revisit the report on health statistics for the 21^st century, to see what kind of updating it needs.

Subcommittee on Standards and Security—Mr. Reynolds

The Subcommittee will bring two letters before the Committee today and will brief the Committee on the 5010, an area of future work on HIPAA standards (see below). Its future work also will address claims attachments, ICD-10, monitoring NPI implementation, and streamlining administrative simplification.

Subcommittee on Privacy and Confidentiality—Mr. Rothstein

The Subcommittee will present two letters to the Committee today (see below). Its major activity now is studying the topic of individual control over access to the content of personal health records, which Mr. Rothstein called “the fundamental privacy issue in the NHIN.” The Committee addressed it briefly in its June 2006 letter and advised HHS to assess it in greater depth. The Subcommittee held a hearing on the subject in April and heard from many who would be affected by an NCVHS recommendation. It has since agreed in principle on directions to go. It will circulate a draft letter among Subcommittee members in mid-July, then hold a series of conference calls, with the aim of having a letter to present to the full Committee in September. Mr. Rothstein encouraged all Committee members to participate in the conference calls, if possible, to gain familiarity with the issue and the evolving thinking of the Subcommittee. Ms. Greenberg suggested alerting the Secretary and ONC to the fact that the Committee is developing recommendations on this issue.

Dr. Steindel noted the relevant activity by the HITSP Technical Committee on how to encapsulate privacy issues in the present security IT infrastructure. He, Mr. Rothstein and others discussed at some length how communication and collaboration might be fostered between NCVHS, HITSP and other bodies working in this area. Mr. Rothstein stressed the importance of ensuring that there is “policy behind the articulation of standards.” Mr. Houston observed that there seems to be a general “disjoint” in terms of “who is doing what and how everything works together.” The group discussed at length these communication and coordination issues and the possibility of a joint meeting involving NCVHS, HITSP and other relevant actors in this arena, possibly convened by NCVHS.

It was noted that AHIC workgroups are focused relatively narrowly, and NCVHS is the body to develop broad principles that inform policies. For example, the ONC RFP stipulates that new work on the NHIN should proceed in the framework of NCVHS recommendations on privacy and functional requirements. Dr. Overhage expressed concern, however, about “the cacophony of voices the Secretary is hearing” and the possibility of any synthesis.

HIPAA 5010 Overview (A Primer)—Ms. Trudel and Mr. Reynolds

5010 is a new version of the suite of administrative transactions affecting the non-retail pharmacy sector—i.e., physicians, hospitals, other institutions with whom they communicate, vendors, and clearinghouses. It was developed by X12-N. This is the first time the transactions have been updated since May 2000. The NCVHS review process is intended to broaden the opportunities for input beyond the participants in the SDO process and to elicit comments from the general public about the transactions. NCVHS is responsible for receiving and distilling that input and making recommendations to the Secretary. The Subcommittee on Standards and Security will hold hearings starting in July, with a letter to be presented for review in September.

The 5010 is a prerequisite for ICD-10 implementation. There are nine transactions, covering most of the information flow related to HIPAA. Each transaction has a lengthy implementation guide. The changes may relate to logic, wording, adding or eliminating content, or other variables. Every entity will have to look at all the implementation guides to determine the business impact for itself. They also will have to change their systems and processes, test them internally, and test them with trading partners. The business impact of the anticipated changes is not yet defined; NCVHS will try to get input on this in its hearings. The document resulting from the Subcommittee’s hearings will provide input to the Secretary and CMS as they put together a proposed rule.

In the discussion period, when asked to comment on the business impact, Mr. Reynolds said that in the industry, everyone knows the 5010 is coming and has been working on it. The Subcommittee has asked WEDI to identify the real business changes, especially in terms of business process among players, as distinct from cosmetic changes and corrections.

Ms. Greenberg noted that all the speakers at the previous day’s Quality Workgroup hearing had prominently mentioned the present-on-admission (POA) qualifier, which is accommodated by the 5010.

Dr. Tang commented that this primer provides a good model of a way to prepare Committee members for action on a complex topic.

Subcommittee on Privacy and Confidentiality Letters—Mr. Rothstein

Mr. Rothstein presented two letters for review and action, starting with one on improving the interaction of FERPA and the HIPAA Privacy Rule with regard to school health records. The letter was read aloud and discussed. Ms. McAndrew described the Department’s responses to a previous NCVHS letter on this topic, noting that the Secretaries of HHS and the Education Department had gotten together with the Attorney General and released a report on information sharing on June 13. (This was precipitated by the Virginia Tech tragedy, and the report is on the HHS Website.)

Members proposed formatting and presentation changes to strengthen the letter’s impact. They agreed that henceforth, all NCVHS letters should start with a heading stating the subject they address. The Committee then passed a motion approving the letter and allowing wordsmithing as needed. As with all approved letters, the final version is posted on the NCVHS Website.

The second letter deals with non-covered entities, following up on a recommendation (#R-12) made in the Committee’s June 2006 letter to the Secretary. Mr. Rothstein read it aloud, pausing periodically for discussion (which was extensive on some points). The Committee then passed a motion approving the letter, as revised.

Subcommittee on Standards and Security Letters—Mr. Reynolds

Mr. Reynolds presented a letter on the National Provider Identifier (NPI) and the need for UPIN enumeration and access during the contingency period. He read the draft aloud and discussed it with Committee members and staff. The Subcommittee will revise the letter based on the discussion and present the revision on day two.

The second draft letter addressed the streamlining of updates to the HIPAA transaction standards. The Committee heard the letter and extensively discussed the issues it addresses. A pivotal issue is that the rulemaking process often can take more than seven years, though experience shows it is possible to develop and ultimately move to a final rule in less than a year. The slowness of the process is troubling for the industry. In response to input from the industry, the Committee is seeking ways to play a role in accelerating the rulemaking process. The timing and nature of a mechanism for public participation is one of the issues involved. Based on the Committees discussion of the issue and the draft letter, Mr. Reynolds withdrew the request for immediate action on the letter. Committee members affirmed the importance of streamlining the process and of an eventual NCVHS contribution to that effort.

Subcommittee on Populations Letter on Data Linkages—Dr. Steinwachs

The review of this letter followed the usual NCVHS practice. The group’s discussion focused on ways to clarify the document and what heading to use for it. The latter question provided a context for examining the key message(s) and purpose of the letter. A revised version of the letter will be presented for approval in day two.

Committee members then recessed, to reconvene in subcommittee and workgroup sessions.

—DAY TWO—

The second day of this NCVHS meeting, after updates from the Department, featured a series of high-level briefings. Three briefings provided background for the forthcoming special NCVHS project on secondary uses of health information in the NHIN; two others concerned international activities. (The slides for several of the presentations are available on the NCVHS Website.)

Data Council Update—Jim Scanlon

Mr. Scanlon circulated an updated version of the Secretary’s top nine priorities. A new one is “affordable choices,” which relates to the President’s proposal for tax credits, coupled with state efforts to link individuals without health insurance to existing groups to reduce the cost of coverage. He also mentioned each of the other priorities.

He then briefly reviewed the updated HHS strategic plan, whose goals relate to health care safety, quality, affordability and accessibility; prevention; economic wellbeing; and scientific biomedical research and development. The June 2007 version of the strategic plan is now out for public comment.

In other news, several HIT bills are anticipated in the Fall. The 2008 budget is now under development in Congress. The FY2007 budget, now approved, provides funding for three Data Council projects. The Council held a workshop on the potential use of EHRs and health information exchange as a resource for national health provider surveys. Its other projects are new PHR pilots and updating an NCHS survey of emergency departments regarding preparedness.

Action on Subcommittee on Populations Letter

Dr. Steinwachs presented the revised version of the letter on data linkages. There was further discussion, particularly about the title for the document and about the importance of monitoring progress in this area. Later in the meeting, after being presented with a clean, updated version, the Committee passed a motion approving the letter as revised. A separate vote was taken on whether to include a reference in the title to protecting confidentiality, with the majority favoring its inclusion.

Mr. Land asked whether NCVHS had a protocol for revisiting the status of Departmental responses to the Committee’s letters and recommendations after a year or so; discussion of this question was deferred.

ONC Update—Karen Bell, M.D.

Dr. Bell reported on ONC activity in three areas: privacy and security, the future of AHIC, and the ONC strategic plan. In the first area, ONC plans to look at the entire federal structure of laws and regulations and at the variations in state policies and laws. It regards NCVHS as “a primary source” in this area, notably its June 2006 recommendations on privacy and security in the NHIN. ONC is looking forward to the Committee’s recommendations on the secondary uses of data, as well. It is trying to harmonize a set of principles on privacy from a wide array of sources to provide a framework. The AHIC work group is another arena of ONC activity on privacy, security and confidentiality. It will bring forward recommendations to the Secretary, emphasizing security and dovetailing with HITSP’s work on standards.

Dr. Bell said “the AHIC successor organization” is envisioned as “a public-private partnership in the private sector” and will be a decision-making body. On the strategic plan, she said it is intended not just for ONC or HHS but also for the nation. The idea is to articulate how all the building blocks should be put together to create an effective and efficient health information infrastructure.

In the discussion period, Dr. Pickering informed Dr. Bell that “by the summer,” NCVHS hoped to submit new recommendations on privacy and confidentiality. Mr. Scanlon added that Ms. Bernstein, who staffs the NCVHS Subcommittee on Privacy and Confidentiality, has been made available to help the AHIC Workgroup.

Dr. Cohn expressed appreciation that the NCVHS recommendations on privacy in the NHIN are being treated as an ONC resource and are built into its recent RFPs. Dr. Bell stressed that it is important to ONC to incorporate the Committee’s work. Dr. Cohn also praised Dr. Kolodner’s efforts to coordinate the many activities in this arena.

Action on the Letter on the NPI

Mr. Reynolds presented a revised version of the letter on the NPI, discussed the previous day. The Committee approved the letter, as revised, subject to further wordsmithing as needed.

Introduction to the Briefings—Dr. Cohn

Dr. Cohn explained that the briefings by Ms. Rias, Dr. Loonsk and Dr. White are all meant to set context as the Committee moves into its work on secondary uses. The emphasis of that project is the quality use case, as defined by AHIC.

AHIC Quality Workgroup Overview—Fatima Rias

Ms. Rias, who works with Booz Allen, presented on behalf of Ms. Cronin of ONC. Booz Allen is supporting ONC’s efforts related to the AHIC Quality Workgroup. The AHIC Quality Workgroup was formed in August 2006 to address how health information technology can be used for the development and use of quality measures, both ambulatory and inpatient. Based on its charge, the Workgroup developed a vision to guide its recommendations to AHIC and the Secretary. There are seven points, including that stakeholders will rely on transparent reporting of quality performance and quality improvement to inform their decision-making about care. The data are to be useful to providers, consumers, and policy-makers. The vision is based on building blocks and characteristics of the national Quality Enterprise, including information dissemination and sharing, population health management, consensus metrics, EHR adoption, and data stewardship, among others.

Ms. Rias showed a slide depicting a case study of the future vision from the perspective of a patient with congestive heart failure. After developing the vision, AHIC developed its first set of recommendations, focused on improving information flow during the health care encounter to ensure the delivery of quality of care and enable automated quality measurement. The four recommendations (which address automating data capture and reporting, establishing a unified framework and collaborations, enabling data aggregation for public reporting, and aligning quality measurement with the capabilities and limitations of HIT) did not address the area of privacy and security, which Ms. Rias noted is a requirement of the Quality Enterprise.

The AHIC Quality Workgroup is now conducting an environmental scan to inform the next set of recommendations. It is using longitudinal measurement as the framework because of the recognition that “measurement from a longitudinal perspective is the future.” Looking across care settings and over time will give a well-rounded view of the patient. The longitudinal focus also addresses the issues around the integration of multiple data sources to inform measures. The AHIC Quality Workgroup hopes to define a path from predominantly sole-source measurement to multi-source measurement, with increasing reliance on EHRs and other networked clinical data such as labs.

The AHIC Quality Workgroup published a Federal Register notice in June with high-level questions on longitudinal measurement and the collection of information to support it. Additional testimony about strategies will be taken at the June 22 AHIC Quality Workgroup meeting. There will be five to nine stakeholder interviews to gather more information. The questions are in eight categories, including business and financial drivers, privacy and security, and provider feedback.

Ms. Rias noted that there are many intersections between the AHIC Quality Workgroup and NCVHS, and she looks forward to future collaborations.

Briefings by John Loonsk, MD, ONC

Dr. Loonsk briefed the Committee on two activities.

National Health Information Network Health Information Exchange (NHIE) Core Services

The intent for the NHIN, he said, is that it be a network of networks built around health information exchanges (HIEs). The exchanges will play a critical role in advancing quality activities. ONC is trying to define core capabilities and services for the HIEs to enable them to participate in the network of networks. An HIE that implements the NHIN architecture, process and procedures and participates in the NHIN Cooperative will be called an NHIE. The next round of trial implementations will focus on fleshing out the core services and the transactions involved. An organization that supports one or more HIE through operational and technical health exchange services is to be called an Health Information Service Provider (HSP).

ONC took the prototype architectures developed in the first year and built them into the latest RFPs. A number of specific products from 2006 provide guidance for the 2007 trial implementations, along with the 2006 NCVHS privacy and confidentiality recommendations and functional requirement recommendations. A contract vehicle is being used to develop the capabilities desired for the eventual network of networks. The NHIE core services are in four areas, each with multiple components: data services, user and subject identity management services, management services, and consumer services. The services are being used to help define what an NHIE will be in the coming trial implementations period. (See slides for details.)

The activities described above will encompass the seven use cases now on the table. Those who receive NHIN contracts will be expected to do all the core services identified and to work on two use cases. As many as 15 HIEs are to be awarded. Development of the NHIN Cooperative is a next step.

AHIC 2007 Quality Use Case

The AHIC use cases play important roles for the concrete activities of the NHIN. Although the use cases are largely self-contained, they are also synergistic and should be understood in relation to each other. The new AHIC Quality Workgroup has received input from the other AHIC priorities and working groups. Its key areas are the multiple uses of EHR data and support for quality measures based on claims-based measures, multiple entities and data sources, and longitudinal patient data. While claims are a possibility, “there is a lot of ‘to be’ expectation in this use case.” The Workgroup is striving to accommodate the world “as is,” but also to incorporate intermediate steps to the “to be” world. A practical goal is to support a core set of AQA and HQA measures.

Dr. Loonsk showed a graphic depicting multiple functional roles, with the health information exchange at the center. ONC is concentrating on inter-organizational standardization and information exchange, trying to ensure information flow among different architectures. There are important issues related to data stewardship, authorization and access, some of which he discussed.

Transitioning to a discussion period, Dr. Cohn thanked Dr. Loonsk for his presentation and his anticipated role in the secondary use project, which the Committee will approach in the context of the developing NHIN.

Mr. Reynolds asked where the CCD fits in ONC’s scenarios. Dr. Loonsk said ONC sees a useful role for the CCD as a harmonized summary record, while recognizing that it does not represent all the data that need to flow nor meet all data needs.

In response to another question, he said the definition of an HIE is inclusive of a RHIO, and he went on to explain the theoretical relationships among different information exchange entities. Dr. Loonsk then discussed consumer control of the content of the medical record with Dr. Francis. He said the assumption is that consumers will be able to have access to and express some controls over their data. Other NCVHS members asked about ONC’s conception of the personal health record and its variants. Dr. Loonsk said the NHIN envisions “a connected personal health record,” not a stand-alone, but he acknowledged that there are many different conceptions of the PHR.

Dr. Land asked about any public health role in determining how the networks will meet public health information needs. Dr. Loonsk said CDC has participated in the work, on the biosurveillance use case and other issues. There is an effort to keep the HIE projects “knitted together” with public health needs. Dr. Green asked what we would know when the experiments are finished, and he stated his sense of urgency about being sure that they would produce valid vital and health statistics. Dr. Loonsk explained that the activity to date had supported “situational awareness and biosurveillance purposes, not traditional public health reporting,” though other aspects of public health reporting are “on deck” for AHIC. He predicted that EHRs would ultimately represent “an overwhelming improvement to public health information access and reporting.”

Dr. Vigilante noted the merits of being “measure-agnostic” about what information will provide the most meaningful quality indicators in the long term. Dr. Loonsk pointed to the work of a Workgroup led by Dr. Tang, which is identifying a core set of quality measures for EHRs; in contrast, the quality use case is largely measure-agnostic. Dr. Carr noted the likely need for structured data in EHRs along with ways to extract information from unstructured text, and Dr. Loonsk described the current thinking about those issues.

International Health Terminology Standards Development Organization (IHTSDO) —Betsy Humphreys, National Library of Medicine (NLM)

The IHTSDO (also informally called “the SNOMED SDO”) was formed in March 2007 in Denmark; and in April it acquired the intellectual property in SNOMED from the College of American Pathologists (CAP). The US is among the nine countries that are charter members; it is represented by the NLM. A chief purpose of the SDO is the ongoing updating and dissemination of SNOMED. It has contracted with the CAP for three years to be the support organization carrying out these duties, under the direction of the SDO. The IHTSDO principles include openness and transparency, mutual accountability, ethical conduct, collaboration to facilitate interoperability, and encouragement of shared intellectual contributions. Several NCVHS members are involved in aspects of the process, along with CDC liaison Dr. Steve Steindel.

There are three tiers of participation in the IHTSDO: member countries, sponsored countries, and non-member countries. The annual fee for membership is based on the ability to pay, with the U.S. paying the most. The idea is to encourage as many countries as possible to become members. The members of the IHTSDO are the organizations representing their countries, and they have both rights and responsibilities. The governing and management structure of IHTSDO includes a General Assembly, a Management Board, and executive officers. The goal is to get a permanent CEO as soon as possible. There will be four standing committees: Content, Technical, Quality Assurance, and Research and Innovation, chaired by Board members. Committee members are elected by the General Assembly, starting on June 30 2007. The NLM solicited US nominations broadly, received 43 suggestions, and forwarded 12 names (three for each committee) in consultation with Dr. Cohn, Dr. Kolodner, and HITSP Chair John Halamka. Each committee will have working groups. The SDO also has Harmonization Boards to provide a mechanism for working with other standards organizations to align their activities. The Affiliates Forum is a users’ group open to all SNOMED licensees. There is only one license.

The top priorities of IHTSDO include documentation, defining what belongs in SNOMED, mapping to ICD-10, the SNOMED-LOINC relationship, and a medication terminology strategy. Finally, Ms. Humphreys noted that none of this would have happened without US buy-in. The IHTSDO Website is accessible through the NLM Website.

In the discussion period, members talked with Ms. Humphreys about the anticipated evolution and contributions of SNOMED, particularly in terms of increasing its clinical usefulness. Several noted that there is a feedback loop between clinical use and refinement of the terminology; Ms. Humphreys predicted that after five years, SNOMED will have achieved a level of use and refinement to be easier to implement and use. Asked how the IHTSDO activities are pertinent to the NCVHS mission and charge, she predicted that the Committee might be asked to advise on key issues, especially to help stakeholders in the US reach consensus on their position (and single vote) on issues to be decided by this international body. Coordination with other standards bodies is another way the Committee could be helpful. Dr. Cohn added that the Committee will want to be involved with the medication terminology strategy, as well. On that subject, Ms. McCall suggested that the group working on secondary uses consider the possible links between pharmacovigilance and an international medication terminology.

International Classifications and Related Activities—Ms. Greenberg and Dr. Steindel

Ms. Greenberg is the Head of the WHO Collaborating Center for the Family of International Classifications for North America, based at the National Center for Health Statistics. Her presentation, which followed one to the Committee in November, 2006, briefly described the WHO Family of International Classifications (WHO-FIC), the maintenance and updating process, and the WHO-FIC Network’s priorities. She and Dr. Steindel also discussed the relationship of these activities to terminological and other standards development, connecting back to Dr. Humphreys’ presentation.

The Family includes the International Classification of Diseases (ICD) and the International Classification of Functioning, Disability and Health (ICF) as reference classifications plus a growing list of “derived and related” classifications. Ms. Greenberg stressed that the ICD doesn’t just provide billing codes; it has many other uses and is a health statistics tool. While it is not a clinical terminology tool, the goal is to align it with clinical terminology, with SNOMED as the central partner. There is a formal process for updating ICD. It has been almost 25 years since ICD-10 was updated, in contrast with the usual 10 years.

Structurally, there are 12 fully designated WHO Collaborating Centers for International Classifications, established based on language and geography. Besides developing, disseminating and implementing the WHO-FIC, the Centers are working to establish more Collaborating Centers in Southeast Asia, Africa and the Eastern Mediterranean and to make the case internationally for the importance of health information. The Education Committee, chaired by Ms. Greenberg, is developing training tools and tool kits, which could include helping to develop national committees such as NCVHS (which was established in 1949 in response to a WHO recommendation).

She then discussed the revision of ICD-10. The Revision Steering Group, chaired by Dr. Chris Chute of the Mayo Clinic, held its first meeting in April 2007. She suggested that Dr. Chute be invited to brief the Committee on these activities at a future meeting. (Dr. Cohn later affirmed that this would happen, perhaps for the November meeting.) Work on the ICD-11 process was launched with funding by the Japan Hospital Association, which encountered difficulties using ICD-10 for clinical purposes and decided to support the revision process instead of creating its own clinical modification. The alphanumeric structure of ICD-10 will be maintained, and there is also a WHO commitment to create a version that is usable for primary care. The hope is to present the ICD-11 to the World Health Assembly for approval by 2015, which would make its implementation happen by 2018 – 2020; but progress is dependent on the availability of funding (there is no WHO funding specifically for the revision). Ms. Greenberg stressed that “ICD-10-CM is the pathway to ICD-11 … and ICD-9-CM is a pathway to nowhere…. It is time to move on.” For the first time, the revision process is open to everyone, thanks partly to an Internet platform funded by the Japan Hospital Association. Stakeholders are invited to participate. Ms. Greenberg asked Committee members to consider what role NCVHS might play in the process.

Dr. Green asked about “the payoff for doing all that mapping” and was told that those working on it are not sure yet, but they want to explore it. Ms. Greenberg added that there is recognition of a continuum between terminologies and classifications, and ways need to be found for them to work together.

In response to another question about why and how globalization of the kind described above is important, Dr. Steindel pointed out that many public health threats come from outside the US, and it is important to be able to exchange data with international partners. “There is no such thing as domestic health care,” added Dr. Tang.

Data Stewardship, Quality RFI—Jon White, MD, AHRQ

Dr. White observed that the secondary uses of health data loom large in the efforts to improve the quality of care through measurement, evidence-based decision support, and rapid learning networks. Structured information systems can be a powerful contributor, but there are many pitfalls in bringing data together in large pools. “Data stewardship” concerns the responsibilities associated with using and having access to data, and rich discussions have been taking place about it.

The Ambulatory Care Quality Alliance (later AQA) formed in 2005 to measure physician-level performance. It created workgroups on the measures, sharing and aggregation, and reporting. Eventually there was a decision to start with claims data. In 2006, AQA pilots became CMS’s Better Quality Improvement Initiative.

While these activities were going on, a discussion was unfolding about how to know if data are being handled responsibly. Two years of a “robust discussion” led to the idea of a national health data stewardship entity to help AQA oversee what they are doing with the data. There is awareness that several initiatives are talking about secondary uses, including NCVHS, so it is a timely issue and they concluded that they needed broader input about it. An RFI developed by AQA and others was published by AHRQ in the Federal Register on June 4.

Dr. White read the proposed mission of the proposed entity, noting that it is very broad. The RFI asks for responses to 25 questions concerning such topics as need, funding, and relation to other initiatives. AHRQ and AQA hope to hear from a broad range of stakeholders. Responses are due by July 27. The intended result of the RFI is not an RFP or proposed legislation, but a summary report to AQA and the public. In addition, all responses will be scanned into a PDF and posted on the AHRQ Website.

Dr. White then invited comments and questions from the Committee. Dr. Cohn noted that Dr. White would be participating in the secondary use project, and he said the Committee would not respond to the RFI. In response to questions, Dr. White acknowledged that there could be many entities, not just one. He will wait for the RFI responses before forming an opinion on how to deal with data stewardship issues not related to quality. Members suggested that HITSP, CCHIT and IRBs are all possible models of a stewardship entity, and rules and functions represent another approach.

Secondary Uses of Health Information: Background—Dr. Carr, Mr. Reynolds

Both presenters, who are co-vice-chairs of the ad hoc Workgroup, stressed that this is a work in progress as the Committee is just getting started with the project. (The first session immediately followed this meeting.)

ONC issued a detailed request for assistance from NCVHS regarding secondary uses of health information, with particular attention to applications for quality measurement and reporting. The Committee’s tasks are to develop a framework, a taxonomy, and recommendations to the Department. It has outlined two premises for the work: that health information technology should serve quality well, and that for this to happen, there must be adherence to standards and appropriate privacy and confidentiality protections.

The questions that will be asked of all testifiers (of whom there is a long list) concern the sources, uses and quality uses of data as well as privacy and security factors. Mr. Reynolds invited Committee members to help think through the questions and to suggest other testifiers. The Workgroup has laid out a challenging schedule of meetings leading up to the September full Committee meeting, when they hope to present a product. Committee members were encouraged to listen to and participate in any of the hearings in which they have special interest or expertise.

Concluding Comments—Dr. Cohn

Dr. Cohn outlined the Committee’s many activities and tasks throughout the summer and the detailed agenda in store for the September meeting.

The group briefly reviewed the foregoing meeting, agreeing that the restructuring to allow more dialogue was successful and that the presentations were timely and well orchestrated.

Dr. Cohn then adjourned the meeting.

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

/s/ 9/25/07

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Chair Date