Minutes of the November 28-29, 2006 NCVHS Full Committee Meeting

Note: The transcript of this meeting and links to presenters’ slides are posted on the NCVHS Web site, http://ncvhs.hhs.gov/lastmntr.htm

Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

November 28-29, 2006

Hubert H. Humphrey Building
Washington, D.C.

MEETING MINUTES

The National Committee on Vital and Health Statistics was convened on November 28-29, 2006 at the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:

Committee members

Simon P. Cohn, M.D., M.P.H., Chair
Jeffrey Blair, M.B.A.
Justine M.Carr, M.D.
John P. Houston, J.D.
Stanley M. Huff, M.D.
Robert W. Hungate
A. Russell Localio, Esq., M.A., M.P.H., M.S.
Carol J. McCall, F.S.A., M.A.A.A.
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.
Judith Warren, Ph.D, R.N.

Absent:

Kevin C. Vigilante, M.D., M.P.H.

Staff and liaisons

Marjorie Greenberg, NCHS/CDC, Executive Secretary
James Scanlon, ASPE, Executive Staff Director
Michael Fitzmaurice, Ph.D., AHRQ liaison
Karen Trudel, CMS liaison
Steve Steindel, Ph.D., CDC liaison

Others

Garland Land, NAPHSIS (incoming NCVHS member)
Roger Blauwet, Canfield & Assoc.
Jamila Marcus, AAP
Michael DeCarlo, BlueCross BlueShield Assn. (BCBS)
Jack Swenson, Keane Worldzen
Linda Creps, Mitre
Elizabeth Halley, Mitre
Meryl Bloomrosen, AMIA
Gail Kocher, Highmark
Charlene Honeycutt, Mitre
Suzie Burke Bebee, ASPE
David Slaughter, Thompson Publishing
Sheila Dwyer, American Optometric Assn. (AOA)
John Hough, NCHS
Carol Bickford, American Nurses Assn.
Miryam Granthon, OMH
Andrew Krug, Academy of Managed Care Pharmacy (AMPC)
Mark Brueckl, AMCP
Jodi Chappell, AOA
Angela Franklin, Amer. College of Emergency Physicians
Randy Levin, FDA
Bill Alfano, BCBS
Matthew Dobias, Modern Healthcare, Modern Physician
Marilyn Zigmund Luke, AHIP
Jim Schuping, WEDI
James Ferguson, Kaiser Permanente
Allison Viola, AHIMA

EXECUTIVE SUMMARY

ACTIONS:

Dr. Cohn officially dissolved the Ad Hoc Workgroup on NHIN Functional Requirements, following successful completion of its work.
On the retirement of Mr. Hungate, Dr. Cohn announced the appointment of Dr. Carr as the new Chair of the Quality Workgroup.
On behalf of the Secretary, Mr. Scanlon presented retiring members Hungate, Huff and Localio with certificates and letters of appreciation for their service.
The Committee approved a letter to the Secretary with comments on the disability and functioning domains of the Consolidated Health Informatics (CHI) Initiative, to be further wordsmithed and formatted as needed.
The Committee passed a motion approving a letter on the National Drug Code, subject to wordsmithing, with the final version to be reviewed by the Executive Subcommittee.
The Committee (excluding Ms. McCall, who recused herself) passed a motion approving the general content of a letter on uses of Medicare Part D data, authorizing the Executive Subcommittee to wordsmith it. The final version will be circulated to the Populations Subcommittee for comment before being acted on by the Executive Subcommittee in mid-December.
The Committee passed a motion approving a letter on the National Provider Identifier.

ANNOUNCEMENTS

This is the final meeting for Dr. Huff, Dr. Localio and Mr. Hungate. The terms of Dr. Steinwachs and Mr. Houston have been extended for another four years. The new members are Garland Land, Dr. Leslie Pickering Francis, Dr. Larry Green, and Dr. Marc Overhage.

UPDATE FROM THE DEPARTMENT

Data Council: Jim Scanlon, ASPE
HIPAA Data Standards Implementation— Karen Trudel, CMS
Privacy Rule Compliance—Sue McAndrews, OCR

Mr. Scanlon gave an update on 2007 appropriations, commented on the likelihood of HIT legislation in the 110th Congress, and described three new Data Council projects:

a review of the potential uses of EHR data for health survey and statistical purposes; an evaluation of collection, quality, utility and use of income and asset data; and a study of how to improve the utility of HHS data and statistical systems and products for the health and human services policy community. The Data Council is working on the 2008 budget and reviewing agency activities with respect to the Secretary’s 10 priorities.

Ms. Trudel gave an update on HIPAA complaints and described the work on claims attachments comments, the NPI, e-prescribing, and Medicare data-sharing for PHRs. CMS expects that everyone will have NPIs by the deadline, and it is encouraging people not to wait too late. (Concerns about this matter arose again with respect to an NCVHS letter on the subject.) All five e-prescribing pilot sites have been visited and an evaluation is under way. CMS expects to propose standards in an NPRM in April, when its report is due to Congress. The PHR data-sharing demonstration projects that end in December will lead to more robust activity in this area.

Ms. McAndrew gave the status of privacy rule complaints and described OCR’s work on compliance, disaster planning and identity theft, as well as its work with the research community on barriers to research. She will give more details about complaints at a Subcommittee on Privacy and Confidentiality hearing.

REPORT FROM THE OFFICE OF THE NATIONAL COORDINATOR—Dr. Kolodner

Dr. Kolodner, the Acting National HIT Coordinator, noted that the first set of interoperability standards were delivered for three use cases in October, and CCHIT has certified 35 ambulatory EHRs. ONC is looking at a new set of use cases and working on ways to keep use cases from being in separate stovepipes. He described ONC’s activities related to the states (on which Ms. Daniel also briefed the Committee; see below).

In the discussion period, Mr. Rothstein and Mr. Houston expressed concern about the apparent lack of any mechanism or plan for AHIC to address the NHIN privacy and confidentiality issues raised by NCVHS in its June 2006 report. Dr. Kolodner said he was aware of the need to pay attention to that report.

SUBCOMMITTEE ON STANDARDS AND SECURITY LETTERS

The Subcommittee presented for review draft letters on the NPI, CHI functioning and disability domains and the National Drug Code. Each was read aloud, discussed, revised, and approved as revised. See Actions 4, 5 and 7, above.

A substantive issue arose related to concerns about whether compliance regarding the NPI is attainable by the May 23 deadline; whether the contemplated actions are sufficient to achieve compliance; when is the right time to assess and address this issue; and how the NCVHS letter should address these concerns. Another letter is planned for February, following on a January hearing.

There was discussion of the possible need for a style guide, to help standardize NCVHS letters.

TOWARDS A NATIONAL FRAMEWORK FOR THE SECONDARY USE OF HEALTH DATA —Charles Safran, MD, Past-Chair, American Medical Informatics Association (AMIA)

The use of secondary data is widespread.
Secondary use has significant value to society.
Patient privacy issues dominate the public trust.
Technological capabilities to merge, link, re-use and exchange data are outpacing the establishment of policies, procedures and processes.
There is a need for additional attention and leadership at the national and state levels.

The report proposes a framework with six components: transparency, stewardship, consensus, awareness, comprehensiveness, and national leadership. These values are expressed through five recommendations. AMIA’s Board intends to convene a second, larger meeting in 2007 to formulate a roadmap.

In the discussion period, Mr. Rothstein recommended a broader definition of secondary data and use, to encompass “anything beyond treatment, payment or health care operations.” He cited the June 2006 NCVHS letter that addresses this issue and urged AMIA to look at the NCVHS recommendations. He hailed the fact that AMIA’s focus on secondary issues focuses attention on the gaps in protection. Dr. Safran said AMIA would work with NCVHS on its next iteration.

With respect to anonymization, Ms. McCall encouraged AMIA to look outside the health care field to the work of the “intelligence” industry. She also commented on the importance of helping the public understand the value of secondary data uses. Dr. Steuerle stressed the importance, in discussion and education about this issue, of not elevating the right to privacy or anonymity as the highest value in terms of public good, when other values are at stake as well.

8th REPORT TO CONGRESS ON HIPAA IMPLEMENTATION

The present draft of this report covers May 2005 through November 2006 and also reflects on the ten years during which HIPAA has been in effect. Members expressed varied views on the appropriate scope of the report. Work will continue on this report, which will be presented for approval in February.

POPULATIONS SUBCOMMITTEE LETTER

The Committee reviewed a draft letter, responding to and basically supporting an NPRM on the use of Medicare Part D data and citing the potential benefits that go beyond those to Medicare. (See Action 6.)

SUBCOMMITTEE AND WORKGROUP REPORTS; CROSSCUTTING ISSUES

The Subcommittee on Populations is working on data-linkage and surge capacity, and considering how to revisit the Vision for 21st Century Health Statistics. It is also identifying topics on which it can work with the NCHS Board of Scientific Counselors.

The Quality Workgroup is considering how it can best contribute to this dynamic arena, looking at enhancements to administrative data and ways to help consumers make better use of performance data as possible focuses. Committee members had several suggestions for possible contributions.

The Subcommittee on Standards and Security will hold a hearing on the NPI on January 24-25.

The Subcommittee on Privacy and Confidentiality is hosting a hearing following this meeting on implications of HIPAA for the financial industry and on approaches to conducting research on the HIPAA privacy rule and its impact. Its next hearing is scheduled for January 23.

The NHII Workgroup will hold a conference call soon to consider its workplan.

HEALTH INFORMATION SECURITY AND PRIVACY COLLABORATION (HISPC) —Jodi Daniel, ONC

Through contracts with ONC and AHRQ, 34 states and territories are looking at their privacy and security policies, practices and underlying state laws to identify variations and determine where practices, policies and laws might interfere with electronic health information exchange and to propose solutions. The project involves both state-level work and regional and national meetings to encourage sharing and mutual learning and problem-solving. Final implementation plans are due in March, and a national meeting is scheduled for March 5-6. A series of 10 regional meetings was held recently, with participation from 43 states and territories. The desire to start crossing state lines was evident.

The AHIC Confidentiality, Privacy and Security (CPS) Workgroup was formed at the recommendation of the other AHIC workgroups to feed in to the work on breakthroughs. NCVHS has a liaison on the Workgroup. The first issue it took on is patient identity-proofing, with recommendations expected at the January AHIC meeting.

These three groups are working on related issues at different levels—state, interstate, and national—and can refer topics to each other.

In the discussion period, Mr. Rothstein reiterated that he had seen no indication that the privacy and confidentiality issues raised in the June 2006 NCVHS letter are being discussed or considered by any of the groups mentioned in Ms. Daniel’s briefing. He added, “I have no confidence that they are going to be taken up in a timely manner where they can be integrated into the NHIN.” Ms. Daniel said CPS Workgroup members have seen the NCVHS letter and are “thinking about” the issues it raises.

Dr. Warren commented on the need for cross-fertilization and sharing among the various privacy and security efforts, and for the states to know about the NCVHS recommendations as a resource. She encouraged ONC to be a touch-point that keeps the projects informed of each other’s work, and to direct RTI to disseminate the NCVHS letter to all 34 states.

Carol Bickford of the American Nurses Association asked for a repository (or clearinghouse) at a dedicated location on the ONC Website for those working on inter-related issues. Ms. Daniel said ONC plans to work on its Website and will take this suggestion seriously.

INTERNATIONAL CLASSIFICATIONS AND RELATED ACTIVITIES —Ms. Greenberg and Dr. Steindel

An international network of 10 Collaborating Centers, established by language and geography, maintains the ICD and ICF. Major updates are made in ICD-10 every three years, and minor ones annually. WHO is trying to expand use of the classifications in developing countries and those with less infrastructure, and more Centers are under development. The North American Collaborating Center is housed at NCHS. There are five WHO-FIC committees, whose work Ms. Greenberg described, and four Reference Groups that advise on technical matters in specific classifications.

She reviewed the process for revising ICD-10. No firm timeline has been established, but the process is focusing initially on mental health, oncology, external causes of injury and rare diseases. She stressed that “ICD-10-CM [not ICD-9-CM] is the pathway to ICD-11.”

Dr. Steindel continued the briefing with a high-level overview of the following international standards organizations: Health Level 7, SNOMED, WHO International Terminology Network, and ISO TC215 (Health Informatics). He focused most of his brief remarks on SNOMED. A new SNOMED SDO was formed in October, 2006; the headquarters will be in Denmark, and the intellectual property is expected to transfer to the new SDO at the end of 2006. However, no impact is anticipated on the current US distribution license. A “massive terminology cleanup” is expected. The link to WHO will be coordinated through the WHO-FIC Terminology Reference Group, on which he serves.

Dr. Cohn and Ms. Greenberg said these topics would be revisited at a future meeting.

DETAILED SUMMARY

—DAY ONE—

CALL TO ORDER, WELCOME, INTRODUCTIONS, REVIEW OF AGENDA

Dr. Cohn called the meeting to order and asked all present to introduce themselves. He then noted that this is the last meeting for Dr. Huff, Dr. Localio and Mr. Hungate, who will be honored later in the meeting and at a dinner. Dr. Steinwachs’ and Mr. Houston’s terms have been extended for another four years. The new members are Garland Land, Dr. Leslie Pickering Francis, Dr. Larry Green, and Dr. Marc Overhage.

He thanked the members, staff and consultants of the ad hoc Workgroup on the NHIN, which prepared comments on the first ONC forum on NHIN functional requirements. Its work, which the full Committee approved in late October, has been delivered to the Secretary and ONC and posted on the Internet. Dr. Cohn officially dissolved the ad hoc Workgroup.

He then reflected on the Committee’s accomplishments in 2006 and the dynamic policy environment in which it is working.

UPDATE FROM THE DEPARTMENT

Data Council: Jim Scanlon, ASPE

Starting with data policy issues, Mr. Scanlon said there appears to be a lot of interest in health information technology (HIT) in the newly elected 110^th Congress, and several bills are expected, some of them giving NCVHS new responsibilities. HHS still has a continuing resolution for the current fiscal year (2007); he detailed relevant provisions of the President’s budget request for 2007. The Data Council is working on the FY2008 budget, approaching it in the light of the Secretary’s top 10 priorities. It is also reviewing agency activities with respect to these priorities.

Three new projects are under way. The first is a review with NCHS and other statistical programs of the potential uses of EHR data for health survey and statistical purposes. They will look both at the potential role and the potential roadmap, involving NCVHS members in the process. There will be a background paper and a workshop. The second is an evaluation of the way income and asset data are collected in 10 of the major federal surveys and how the data compare to benchmarks and other distributions of data, as well as the quality and utility of the data and what improvements are needed. Third, ASPE is looking at how to improve the utility of HHS data and statistical systems and products for the health and human services policy community. The focus is on survey results. NCVHS members will be involved in this activity, as well.

In the discussion period, Dr. Bill Scanlon asked about delays in IT legislation, and Mr. Scanlon explained that the two bills with the most “legs” were delayed by 1) differing views about adopting ICD-10 and introducing 5010 and 2) the complexities of streamlining the process for updating HIPAA, which needed more time to work out than was available. He predicted that momentum toward an HIT bill would pick up in January.

HIPAA Data Standards Implementation— Karen Trudel, CMS

Since October 2003, CMS has received 521 complaints related to transactions and code sets, 96 of which remain open. None of the open complaints concern payments. There have been 162 security complaints, which are more difficult to investigate, and 94 remain open. CMS is gearing up to handle complaints on the employer identifier, which goes into effect May 23. It is retooling its system to handle complaints related to the NPI.

CMS also is assessing the comments received on the NPRM on claims attachments, and looking at using HL-7, X-12 and LOINC in one standard transaction.

1.46 million NPIs have been assigned, which is estimated to be about 63 percent of the total needed by next May. CMS expects that everyone will have them by the deadline at the rate assignment is going. It is encouraging people not to wait too late. The task of using them and testing them in HIPAA transactions is complex. CMS is doing a lot of environmental scanning.

Regarding e-prescribing, CMS has visited all five pilot sites, which are generating a lot of valuable information. The evaluation contractor is now at work. The report to Congress is due in April, and CMS expects to be able to propose some standards in an NPRM in April. It is also developing a roadmap for moving forward on e-prescribing, addressing among other topics how to work with partners on research and implementation. The impact of e-prescribing on physician and pharmacist work-flow is being studied.

Turning to PHRs, Ms. Trudel said CMS, in response to a request for information about Medicare’s role in PHRs, was encouraged to enable the sharing of Medicare data. It developed a proof of concept project taking Medicare claims data and seeing how it can be used in existing PHR products, and there are demonstrations. The project ends in mid-December. The results will feed into increasingly robust activities in this area. CMS is also working with ONC to look into the usability of PHR products for Medicare beneficiaries. She added that beneficiaries can already access some of their personal data on the beneficiary portal, mymedicare.gov.

In response to a question, Ms. Trudel said CMS has not yet published the data dissemination document explaining what data it will share from the NPI file, so the master databases are not yet publicly available. She affirmed that CMS is looking into the possibility of testing other standards at the five pilot sites if funding can be secured.

Asked about efforts to examine the accuracy of claims data versus clinical diagnosis in Medicare claims, she said CMS is interested in moving forward on this, in consultation with AHIC.

Privacy Rule Compliance—Sue McAndrews, OCR

OCR has received 23,270 complaints since April 2003 and has closed 76 percent of them. Ms. McAndrews said she would present a more detailed look at the data on the cases at the forthcoming Subcommittee on Privacy and Confidentiality hearing. A third to 40 percent of the closed cases warranted an investigation.

There has been a lot of effort around compliance, with recent media stories on inappropriate pharmacy dumping creating public attention. OCR is coordinating with ONC and AHIC workgroups on various HIT initiatives. It is also working with disaster planners to plan responses to disasters, and has posted a tool on its Website for responders and planners on accessing information. It is finishing its work with the White House task force on identity theft, with recommendations expected in February 2007. OCR also has been working with the research community on several fronts including harmonizing the privacy rule with other rules and developing guidance on the boundaries between research, quality improvement and other studies.

In the discussion period, Mr. Blair pointed out that the privacy law was designed to give the public greater confidence in the protection of its electronic health information, and he urged analysis of whether that has happened. Mr. Houston hailed the effort to collaborate with the research community and the recognition of problems in this area. Dr. Tang noted the public concern about the lack of prosecutions for violations. Ms. McAndrews explained that the large majority of complaints are technical in nature, and that the lack of monetary penalties is not a measure of the “vigor” with which OCR is approaching enforcement. It follows up cases even when DOJ decides not to pursue them.

REPORT FROM THE OFFICE OF THE NATIONAL COORDINATOR—Dr. Kolodner

Dr. Cohn welcomed Dr. Rob Kolodner, the Acting Coordinator, and commended his strong background in the field through his work with the VA. Dr. Kolodner thanked the Committee for its recommendations on the initial functional requirements for the NHIN and said he looks forward to a long and productive collaboration with NCVHS. He also expressed appreciation for members’ participation in AHIC meetings and workgroups.

He noted that the first set of interoperability standards were delivered for three use cases in October, representing a step beyond talk about standardization. Another “turn of the crank” was CCHIT’s certification of 35 ambulatory EHRs, with others on the way. A baseline has been defined: ten percent of physicians are using EHRs with these four specific functions—computerized prescribing, computerized test ordering, electronic receipt of test results, and electronic physician notes. Another milestone is the AHIMA “how-to” workbook for state health information exchange activities. ONC will provide ongoing support so they can address barriers and do some analysis. To begin the collaborative process to address cross-state issues, ONC has issued a contract with the National Governors Association for a state alliance for e-health. Several state learning forums will take place throughout 2007. A number of meetings are coming up, including NHIN prototype architecture demonstrations on January 23 and the first state alliance meeting on January 26.

In response to a question, Dr. Kolodner said ONC has started to identify and prioritize new use cases, and it is also working to make sure the use cases don’t end up in separate stovepipes. To another question, he said ONC has a contract to address data element harmonization to facilitate interoperability, with HITSP as the mechanism. The idea is that this will be a trusted, independent process, fostered and stimulated by government.

Mr. Rothstein asked whether, or how, the Committee’s June report on privacy and confidentiality in the NHIN will be implemented with respect to architecture development and other elements of the system. Dr. Kolodner said he was aware of the need to pay attention to that report. Mr. Houston said he has recommended that the CPS Workgroup consider the letter. Outstanding questions such as opt-in/opt-out need to be resolved. Dr. Warren asked about efforts to coordinate the various activities around privacy and security. Dr. Kolodner referred all these issues to Jodi Daniel of ONC, who reports later in the meeting.

Dr. Steindel praised a matrix being developed to coordinate AHIC work, and he encouraged its fleshing out as a mechanism for discussion and a useful tool.

Dr. Cohn introduced new member Garland Land, Executive Director of the National Association for Public Health Statistics and Information Systems and formerly a senior staff member of the Missouri Department of Health.

SUBCOMMITTEE ON STANDARDS AND SECURITY LETTERS

National Provider Identifier

Before discussion began on this letter, Mr. Houston raised a question about its purpose and whether it should be sent. Mr. Blair acknowledged that it has a different character than the typical NCVHS letter; he characterized it as a “positional letter,” its content partly determined by the fact that the Committee does not meet again until February. Dr. Cohn asked that discussion of this issue be deferred until later in the day, and he asked Dr. Buenning to read the letter aloud. It conveys the Committee’s observations on the industry’s progress toward meeting the compliance date and recommends actions to encourage compliance and early testing.

The group discussed ways to strengthen the recommendations and clarify the letter. It will be revised by the Subcommittee and the revised version will be presented on day two of this meeting.

CHI-Functioning and Disability

Dr. Buenning then read the second letter aloud, which conveys the Committee’s comments and recommendations on the functioning and disability domain of the Consolidated Health Informatics (CHI) Initiative. A few minor modifications were suggested to the letter.

Two general issues arose in the context of discussing this letter. First, Dr. Steuerle repeated a past query as to whether the Committee drafts its letters with full cognizance of the way its communications are handled in the Secretary’s office. For example, would the use of devices such as bold face and bullets help call attention to key content? Second, Dr. Carr suggested that the Committee adopt a standard format for its letters as well as guidelines and perhaps definitions for using terms such as “encourage” vs. “recommend” (an issue with this letter). Dr. Cohn said a style guide might be in order.

The Committee then passed a motion approving the CHI letter, as revised, to be further wordsmithed and formatted as needed.

National Drug Code (NDC)

Dr. Cohn noted that Randy Leavitt of FDA was present to address questions about this letter. Dr. Buenning then read it aloud. Several revisions were proposed and discussed. The Committee passed a motion approving the letter, subject to wordsmithing, with the final version to be reviewed by the Executive Subcommittee.

RECOGNITION OF RETIRING MEMBERS

Mr. Scanlon presented Mr. Hungate, Dr. Huff and Mr. Localio with certificates and letters of appreciation for their service. They also will be honored in a dinner following the meeting.

TOWARDS A NATIONAL FRAMEWORK FOR THE SECONDARY USE OF HEALTH DATA —Charles Safran, MD, Past-Chair, American Medical Informatics Association (AMIA)

AMIA has identified the secondary use of personal health information as a critical issue for the widespread adoption of HIT. It convened a blue ribbon panel of about 30 experts from industry, government and academia in a two-day meeting to develop a framework to help guide policy in this area. The panel issued a preliminary report, posted on the AMIA journal Website. It defined secondary use of health data as “the non-direct care use of personal health information including but not limited to analysis, research, quality/safety measurement, public health, payment, provider certification or accreditation, and marketing and other business including strictly commercial activities.” Its findings were as follows:

The use of secondary data is widespread. (Dr. Safran added that in some cases, neither physicians nor patients in a practice are aware of this action by administrators.)
Secondary use has significant value to society.
Patient privacy issues dominate the public trust.
Technological capabilities to merge, link, re-use and exchange data are outpacing the establishment of policies, procedures and processes. (Existing policies are out of date. The panel believes anonymization cannot be practically achieved at present and that this issue requires urgent attention.)
There is a need for additional attention and leadership at national and state levels.

Increase the transparency of data use and public awareness. Secondary use of health data must be conducted and managed solely through the use of open and transparent processes.
Focus ongoing discussions on data access, use, and control (i.e., stewardship; ownership is not a useful concept).
(two components:)
1. Continue discussions on privacy policy and security with regard to the secondary use of health data. (This element focuses on involving a wider range and variety of citizen, consumer, and patient stakeholders.)
2. Increase public awareness efforts on the benefits and challenges associated with the secondary use of health data. (Dr. Safran said a recurrent theme was that consumers are “particularly poorly informed about the use of their health information.”)
(two components:)
1. Create a taxonomy of the secondary uses of health data. (The idea is that such a classification would clarify the societal, public policy, legal, and technical issues involved.)
2. Address increasingly difficult current and evolving questions related to the secondary use of health data in a comprehensive manner (e.g., those concerning identity management and authentication).
Focus national and state attention on the secondary use of health data.

Dr. Safran added that the development of genomic data is part of the challenge and is “particularly concerning.” AMIA’s Board intends to convene a second, larger meeting in 2007 to formulate a roadmap.

Discussion

Responding to a question, Dr. Safran said the panel did not contain the expertise needed to explore the issue of anonymization, but that will be one of the issues addressed at the next meeting. He explained the thinking and research behind the working assumption that it is not possible. Meryl Blumrosen of AMIA explained that research indicates that it is possible to link de-identified data sets and identify patients. Dr. Safran said pharmas really want unidentifiable data, for liability reasons, and therefore want development of a technology that supports anonymization.

Mr. Rothstein recommended a broader definition of secondary data and use, to encompass “anything beyond treatment, payment or health care operations.” He cited the June 2006 NCVHS letter that addresses this issue and urged AMIA to look at the NCVHS recommendations—notably those regarding contextual access criteria, regulation of compelled disclosures to secondary users, and the extension of privacy and confidentiality protections beyond the scope of HIPAA. He hailed the fact that AMIA’s focus on secondary issues focuses attention on the gap in protection. Dr. Safran said AMIA would work with NCVHS on its next iteration.

Asked why AMIA took on this topic, Dr. Safran said it recognized it as both a need and potentially an initiative with broad-based community support. The amount of interest in this topic by panel members highlighted its urgency.

Ms. McCall observed that aggregation is a distinct discipline with its own technical process, standards and policy issues. Regarding anonymization, she encouraged AMIA to look outside the health care field to the work of the “intelligence” industry. She also commented on the importance of helping the public understand the value of secondary data uses for learning and discovery.

Dr. Tang talked about “the increasing prevalence of the misuse of data” as an impetus for the AMIA initiative. For example, many contracts “entitle” vendors to have access to identified data in practices’ databases and allow them to re-sell data deemed to be anonymous. These databases can include people’s genetic information. He reiterated that NCVHS stresses the importance of extending coverage to prohibit misuse by anyone who touches the data, rather than depending on anonymization, which is of questionable reliability.

Dr. Steindel commented that fully de-identified data may not be very useful. He described CDC’s “Bio-sense” biosurveillance program, which stores data in a pseudo-anonymized fashion to allow re-identification in the event of public health problems.

Dr. Steuerle stressed the importance, in discussion and education about this issue, of not elevating the right to privacy or anonymity as the highest value in terms of public good, when other values are at stake. He noted that there are parallel issues with Census data and elsewhere.

Mr. Blair suggested that “anonymization” and “de-identification” are not synonymous and should not be used interchangeably.

Ms. McCall and Ms. Trudell discussed the applications of the foregoing principles to CMS use of PHR data, and the need to specify and limit secondary uses.

8^th REPORT TO CONGRESS ON HIPAA IMPLEMENTATION

Mr. Scanlon commented on the history of this roughly annual report and the fact that over the years, its purview has expanded to include topics such as e-prescribing, terminology and data exchange standards, and now the NHIN, which “completes the picture.” (It was noted that patient identifiers might also be included.) The present draft report, which covers May 2005 through November 2006, also reflects on the ten years that HIPAA has been in effect.

Members expressed varied views on the appropriate scope of the present report, with some arguing that important new arenas such as e-prescribing and the NHIN should not, in the words of Mr. Blair, simply be “put under the banner of HIPAA.”

Ms. Greenberg explained that there also will be the usual bi-annual report, covering 2005-2006, which will discuss all the work of the National Committee. As usual, it will reference the HIPAA report, but it provides a vehicle for addressing broader topics.

Dr. Cohn stressed the importance in the HIPAA report of including the lessons learned and “the positive things going forward.” He is seeing the emergence of a positive ROI for HIPAA in industry. The group expanded on the topic of the changes brought about by HIPAA over the last decade, with Dr. Tang agreeing that there has been a tipping point. He noted the themes of today’s discussion that need future attention: the perpetual delay, the need for a streamlined way to update, and processes that can be improved upon to keep up with the technology, notably related to privacy and security.

Mr. Rothstein noted that the fundamental question for the Committee concerns what kind of report it wants to present. He asserted that the proposed approach, with a substantive assessment of lessons learned and ways to move forward, is broader than past reports and would take six months to produce, given the diverse views to be reconciled. He suggested going ahead with a traditional, descriptive report and considering developing a separate report on the wider topics, possibly through an ad hoc workgroup. Mr. Scanlon agreed, and added that new recommendations would require an evidence base and a developmental process. Ms. McCall proposed as the criterion for the type of report what would be most valuable to Congress. Noting that many will be new to Congress in 2007, she commented on the merits of not giving them “a Groundhog Day experience” and of educating them about the history and context of HIPAA.

Dr. Cohn asked the subcommittees to take a hard look at the descriptive information in the draft report and proposed creating a brief cover letter calling out the key messages. The documents will be presented for review and approval in February. The Executive Subcommittee will work with the Chairs in the meantime. There will be an effort to distinguish HIPAA content from content related to “the next wave.” The group agreed to this process.

POPULATIONS SUBCOMMITTEE LETTER

Mr. Localio presented a draft letter responding to and basically supporting an NPRM on the use of Medicare Part D data and citing the potential benefits that go beyond those to Medicare, consistent with positions NCVHS has taken in the past. Senators Grasle and Bacchus have introduced legislation along similar lines.

Ms. McCall recused herself from the vote on this matter because of a possible conflict of interest.

The Committee, excluding Ms. McCall, then passed a motion approving the general content of the letter and authorizing the Executive Subcommittee to wordsmith it. The final version will be circulated to the Populations Subcommittee for comment before being acted on by the Executive Subcommittee in mid-December.

The meeting then recessed into subcommittees and workgroups, to reconvene the following day.

— DAY TWO —

Following introductions, Dr. Cohn announced that he had appointed Dr. Carr the new Chair of the Quality Workgroup, replacing Mr. Hungate, who is retiring.

LETTER ON THE NPI—Mr. Reynolds

Mr. Reynolds brought forward a new version of the letter on the National Provider Identifier, revised based on the previous day’s discussion. He read the new version aloud. Members praised the revisions and proposed a few more.

One substantive issue arose, related to concerns about whether compliance is attainable by the May 23 deadline, whether the contemplated actions are sufficient to achieve compliance, when is the right time to assess and address this issue, and how the letter should address these concerns. Another letter is planned for February, following on a January hearing. In the meantime, the present letter was strengthened in regard to these concerns. The Committee passed a motion approving the letter, as revised.

SUBCOMMITTEE AND WORKGROUP REPORTS; CROSSCUTTING ISSUES

Subcommittee on Populations—Dr. Steinwachs

The Subcommittee held a workshop on data linkage on September 18-19; minutes are now being prepared, and the Subcommittee is considering possible actions. The themes include the role and limitations of data centers; the possibility of remote access; standardization of the rules for accessing and linking data; state issues; and standardization of data-sharing agreements. It will present a draft letter at the February meeting.

Mr. Scanlon noted the countervailing forces at work: pressure for more and better access, and heightened concern about privacy and security.

Dr. Steuerle said the Subcommittee wants to identify how it can move the agenda along. He noted the absence of a single decision-maker because of the multiplicity of agencies involved. Limited human and financial resources are another limiting factor.

Mr. Rothstein pointed out that different subpopulations have very different views about privacy and confidentiality; there is no monolithic “public opinion” on this matter. He offered to work with the Subcommittee on Populations to flesh out the issues regarding data usage. Mr. Localio added that some sub-populations have expressed strong desire for more information on their group’s health status, and they want to participate in decisions about the degree of identifiability of the information. Mr. Blair noted that income level is another significant variable.

Dr. Steinwachs said there is a lot of overlap around these issues with the agenda of the NCHS Board of Scientific Counselors, to whom he and Dr. Scanlon will report in January. This may lead to joint activities.

Returning to his report, he said the Subcommittee is also working on surge capacity, particularly on how to measure it and how to get the data. It is proposing a half-day hearing in mid-February.

Dr. Scanlon said while it has not received much public attention, a great deal of capacity has been eliminated. People’s views on this are widely divergent. The hearing will look first at the range of views and then at data issues.

In response to a question from Dr. Steindel, Dr. Scanlon said the issue of efficiency would be explored, as well. Re-engineering processes is part of what must be attended to.

Mr. Scanlon said analysis of this issue would be very helpful to the Department.

Mr. Rothstein said AHIC’s Biosurveillance working group is also working on this issue.

Finally, Dr. Steinwachs said the Subcommittee is talking about following up on the vision for health statistics in the 21^st century, which is now about five years old.

Quality Workgroup—Dr. Carr

Dr. Carr noted the rapid changes in the Workgroup’s agenda and in the environment around quality issues. In the year following the Workgroup’s last hearing, there has been an explosion of activity. The challenge for the Workgroup is figuring out where it fits in all this and how it can add value. Despite the interest in and shift toward electronic data, administrative data are still relevant, and the Workgroup is thinking about moving elements of the EHR to enhance administrative data. It is also looking at clinical and infrastructure questions. Another dimension is how to help consumers and the community at large understand performance information for informed decision making.

As stated in its February 2006 report, two key areas stand out for health information policy: 1) understanding what it would take to measure, assess and improve quality at a population health level and 2) understanding what it would mean to have a person-centric approach and how that links to population health.

Dr. Tang noted the plethora of quality measures and wondered if the Committee might contribute to harmonizing them in a clinical context. Dr. Carr agreed, noting that the goal is to have the myriad data elements “tell a story that is understandable and that resonates with progress and outcomes.”

Mr. Localio cited an editorial he wrote a dozen years ago, “A Report Card on Report Cards,” containing several technical issues about reporting that have not yet been answered. Some relate to the need for risk-adjustment.

Mr. Hungate stressed “the consumer empowerment piece of the HHS equation.” Patients have a problem sorting out the multiple sources of performance information and knowing what is authoritative and trustworthy. This is another standardization issue that needs to be addressed.

Dr. Tang commented on the different denominators and sub-populations for which performance data are collected (capitated patients, all patients in a practice, etc.) and the additional challenge of relating these units to population quality measures. Pulling together data on a population would be a big step forward. He also stressed the importance of deriving the information from clinical data.

Dr. Steinwachs noted that the growing significance of chronic disease and care increases the importance of cross-sectional and longitudinal data to get a handle on quality; this might be something to which the Quality Workgroup could contribute. Mr. Houston and Ms. McCall affirmed that this is a big issue for plans.

Dr. Steuerle suggested tracking the success of the recommendations of the many organizations in the quality field.

Subcommittee on Standards and Security—Mr. Reynolds

The Subcommittee will hold a hearing on January 24-25 to look at the NPI and have a presentation on streamlining standards. It is thinking through its future workplan for the next year or more, and will also be working on the HIPAA report.

Subcommittee on Privacy and Confidentiality—Mr. Rothstein

The Subcommittee is hosting a hearing November 29-30 focusing on implications of HIPAA for the financial industry, following on other hearings that have focused on employers, life insurers and schools. The hearing will also address related laws such as FERPA and approaches to conducting research on the HIPAA privacy rule and its impact. Its next hearing is scheduled for January 23.

Board of Scientific Counselors—Dr. Scanlon

Dr. Scanlon called the September joint meeting with the BSC a success in terms of identifying the synergy between the two groups. The Subcommittee on Populations is working to identify specific topics on which the two bodies can work together, in consultation with Dr. Elo and other BSC members. The vital statistics system is of particular interest. Dr. Cohn said he hoped that would open the door to revisiting the 21^st century health statistics vision.

NHII Workgroup and Executive Subcommittee—Dr. Cohn

The Workgroup will hold a conference call with Dr. Deering to discuss next steps. The NCVHS Executive Subcommittee will have a conference call on December 15 to discuss next steps and the February agenda and to finalize several letters.

HEALTH INFORMATION SECURITY AND PRIVACY COLLABORATION (HISPC) —Jodi Daniel, ONC

A contract was awarded to RTI International in September 2005, co-managed and co-funded by ONC and AHRQ. The contractor has subcontracted with 34 states and territories to look at privacy and security policies, practices and underlying state laws to identify variations and determine where practices, policies and laws might interfere with electronic health information exchange. The states were asked to look at 18 different scenarios, and some states created more. Where there are challenges, the states have been asked to propose solutions. One goal of the project is to engage the states in health information exchange efforts. There are requirements to include people in government and public health plus a broad array of stakeholders to identify issues, solutions and implementation plans.

The project involves both state-level work and regional and national meetings to encourage sharing and mutual learning and problem-solving. The states’ interim assessments are now being reviewed by technical advisory panels. The summary of the interim assessments is due to HHS on December 30, 2006. Final implementation plans are due in March, and a national meeting will take place on March 5-6 (although some states are requesting more time, which may happen).

A series of 10 regional meetings was held recently, with participation from 43 states and territories. The key issues that arose were in three areas: practice, trust, and legal issues. Ms. Daniel described some of each. For example, patient consent or authorization variations are a common issue, as are challenges and variations in the way patients are identified; there are concerns about the competitive use of medical data; and there are concerns about varying interpretations of HIPAA, such as regarding minimum necessary. The patchwork of state laws also came up in every meeting. Interest was shown in achieving greater consistency among state laws. There also was confusion about other federal laws in relation to HIPAA.

Another common theme was the question of whether this effort is bringing the right stakeholders together. It was helpful, Ms. Daniel said, to identify who the right people are and to start building collaborative relationships. The desire to start crossing state lines was evident in the regional meetings, and there was a lot of exchange.

On inter-state collaboration, ONC recently signed a contract with the National Governors Association (NGA) Center for Best Practices to establish the State Alliance, a state-level health IT decision body to address interstate issues. The steering committee will meet quarterly and be composed of governors, legislators, attorneys general and state CIOs—all decision-makers, plus technical advisors. The meetings will be open to the public, starting on January 26. Three task forces—on privacy and security, medical practice issues, and the state role in health information exchange—will report to the Steering Committee. NGA has been asked to work closely with state-level organizations. The project has a one-year contract with an option to renew for another two years.

Finally, Ms. Daniel reported on the AHIC Confidentiality, Privacy and Security (CPS) Workgroup, which was formed at the recommendation of the other AHIC workgroups to feed in to the work on breakthroughs. NCVHS has a liaison on the Workgroup. The first issue it took on is patient identity-proofing, with recommendations expected at the January AHIC meeting; it is prioritizing future issues.

The three groups described above are working on related issues at different levels—state, interstate, and national—and can refer topics to each other.

Discussion

Mr. Rothstein explained that at Dr. Brailer’s request, the Committee undertook a comprehensive study of the privacy and confidentiality issues surrounding the NHIN and sent its recommendations to the Secretary in June 2006. The two categories of the recommendations were 1) foundational privacy issues for the NHIN, e.g., does an individual have any ability or right to deny permission for the electronic interchange of the record? and 2) issues that should be built into the NHIN architecture from the outset.

He said, “I have seen no indication that the issues are being discussed or considered by any of the groups” mentioned in Ms. Daniel’s briefing, “and I have no confidence that they are going to be taken up in a timely manner where they can be integrated into the NHIN.”

Ms. Daniel said CPS Workgroup members have seen the NCVHS letter and are “thinking about” the issues it raises. Regarding architecture issues, she said the projects underway now under contract are prototypes, with many policy issues yet to be addressed. Mr. Rothstein responded that the contractors are not talking about privacy issues, but only security issues.

Mr. Houston agreed with Mr. Rothstein’s statements and stressed that it is vital to delve into the issues the Committee identified. He wondered whether NCVHS should be asked to address some of the issues it raised.

In response to another question, Ms. Daniel said at least some state-level projects are looking at administrative rules and court opinions regarding state laws. Mr. Houston commented that many states are adopting their own identity-theft-related statutes and there may be resistance to an effort to align them. He noted the large problem of misinterpretation of HIPAA and suggested model forms and consents that can be widely used on an interstate basis because now, “dueling forms” are a problem.

Dr. Tang pointed out that some state differences are intentional, and he asked about mechanisms to align the states in the face of such barriers. Ms. Daniel agreed, and said some states assert that impeding electronic health information exchange is positive, not negative and is intended to protect patients. The influential National Governors Association tries to get all states involved in task forces, as a way to educate state policymakers. She added that some problems may only be addressable through federal legislation.

Carol Bickford of the American Nurses Association asked for a repository (clearinghouse) at a dedicated location on the Website for those working on related issues. For example, ANA is working on interstate licensure issues related to nursing. Now, the knowledge is “in pockets” when it should be centrally located and retrievable.

Ms. Daniel said ONC plans to work on its Website and will take this suggestion seriously.

INTERNATIONAL CLASSIFICATIONS AND RELATED ACTIVITIES —Ms. Greenberg

Ms. Greenberg said the WHO Collaborating Center for the Family of International Classifications for North America, which she heads, looks to NCVHS in an advisory capacity; and, in fact, a WHO recommendation was the impetus for the founding of the National Committee in 1949.

The WHO Family of International Classifications (WHO-FIC) is a suite for international use as meaningful information tools to capture the core health dimensions such as deaths, disease, disability and health as well as related health-system parameters such as health interventions. At the core are the International Classification of Diseases (ICD) and the International Classification of Functioning, Disability and Health (ICF). Under discussion is a third classification, for health interventions. In addition, there are derived classifications, such as the new Children and Youth version of the ICF, and related classifications, such as the International Classification on Primary Care, which build on or are related to the reference classifications and provide additional information. There is a protocol through which new members of the family can apply for related or derived status, conferring recognition and an approach to updating and compatibility. WHO is not responsible for most of the related classifications.

An international network of Collaborating Centers, established by language and geography, maintains the ICD and ICF. Their mission is “to develop, disseminate, implement and update WHO Family of International Classifications to support national and international health information systems, statistics and evidence; to improve the international comparability of health data; and to assist in addressing the ‘information paradox'” (i.e., that the countries with the worst health outcomes have the least information to address those problems). The priorities for the network of centers are to implement, update and revise ICD (mortality and morbidity) and to implement and update ICF.

There are 10 fully designated centers, accommodating different languages (there are six official WHO languages) and regions. Another four to 10 centers are in various stages of designation, most in the southern hemisphere. WHO is trying to expand use of the classifications in developing countries and those with less infrastructure. The North American Center, which covers the U.S. and Canada, was formed in 1976 and is housed at NCHS.

Ms. Greenberg chairs WHO-FIC’s Education Committee, which is developing and piloting an international training and certification program for ICD-10 mortality and morbidity coders. It has also developed a core curriculum and best practices for certifiers of cause of death, and is working on web-based training tools. The other WHO committees are for Electronic Tools, Family Development, Implementation, and Update and Revision. Ms. Greenberg described some of the initiatives of these committees. She said the efforts are carried out, essentially, by “an international group of volunteers” with no direct resources other than staff support from WHO and varying amounts from other sources. She then described the update process for ICD and ICF. Major changes are made every three years, and minor ones annually.

Four Reference Groups augment the committee structure by providing forums for technical discussion. They are more specific to a classification—ICF or ICD. The first such group, on mortality, was established in 1999; three were added in 2006.

Establishing collaborating centers in Southeast Asia, Africa and the Eastern Mediterranean and making the case internationally for the importance of health information are some of the ways to challenge the information paradox. Another is to form national committees that can bring stakeholders together. Ms. Greenberg suggested that NCVHS consider creating a “tool kit” to assist other national committees.

Finally, she reviewed the process for revising ICD-10. No firm timeline has been established, but the process is focusing initially on mental health, oncology, external causes of injury and rare diseases. She stressed that “ICD-10-CM [not ICD-9-CM] is the pathway to ICD-11.”

—Dr. Steindel

Dr. Steindel continued the briefing with a high-level overview of the following international standards organizations: Health Level 7, SNOMED, WHO International Terminology Network, and ISO TC215 (Health Informatics). On HL-7, he noted that some 18 other countries are involved, and the international affiliates meet annually and they influence the HL-7 standard.

He focused most of his brief remarks on SNOMED. A new SNOMED SDO was formed in October, 2006; the headquarters will be in Denmark, and the intellectual property is expected to transfer to the new SDO at the end of 2006. However, no impact is anticipated on the current US distribution license. A “massive terminology cleanup” is expected. Many details have yet to be worked out and/or announced. WHO was involved in extensive negotiations on this change, and the link to WHO will be coordinated through the WHO-FIC Terminology Reference Group, on which he serves.

The WHO International Terminology Network was formed in October 2006, with no funding, and with the aim of sharing knowledge and collaborating towards creation of multi-lingual international tools and normative standards. It will add linkages to classifications and administrative features. There is an effort to have classification systems and terminologies communicate seamlessly. A key component is empirical QA and QC tests of system use. All the tools under development will be open source and synergistic.

The ISO international Health Informatics Group, which “covers the whole world” and is housed in ANSI, has several US representatives. NCVHS has talked about whether US contact should be formalized. With all the international health informatics activities, the U.S. is most involved with semantic content and the business requirements for EHR and data interchange.

There was no discussion of these presentations because of the lateness of the hour; Dr. Cohn said there would be opportunities to do so at the next meeting.

REFLECTIONS ON THE MEETING

As is its custom, the group ended the meeting by commenting on what worked, what didn’t, and what to do differently in the future:

Dr. Cohn noted that Departmental updates and discussions need more time on the agenda.
Mr. Reynolds said the Committee needs more time to discuss the overlap among the subjects on which its subgroups are working.
Mr. Houston noted the need to streamline the way letters are written and reviewed.
Dr. Carr suggested that members be given a lexicon of the arcane vocabulary used by the Committee, a glossary of acronyms, and a summary of the intended process for writing, reviewing, revising and approving letters. This should include standards for using such terms as “recommend” and “encourage.”
Dr. Tang reiterated an earlier suggestion for a standard structure and framework for letters.
Ms. McCall said it’s helpful to have a summary of what the authors are trying to accomplish with letters, before they are discussed. She also suggested that the Committee come up with a short list of NCVHS priorities and themes for the coming year, akin to the Secretary’s top 10 priorities.
Dr. Steuerle suggested that when new topics are introduced, members be told why the topic is relevant and the implications for the Committee’s use. He also noted that “some conversations repeat” and there may be ways to avoid them. An example is the “constant question” about better data on HIPAA complaints.
Ms. Greenberg observed that the Committee used to meet for two full days, and in addition more meeting time is now dedicated to subcommittee and workgroup sessions. This is something the Executive Subcommittee needs to look at.
Dr. Cohn noted that one of the functions of the Executive Subcommittee is to address cross-cutting issues. He asked members to think about how much full Committee time should be spent on this, versus delegating it to the Subcommittee. He also recalled the previous day’s idea of having an editor review documents before they come to the full Committee for review.
Mr. Reynolds urged people to be respectful of an authoring group’s understanding of the environment into which letters and recommendations are released when they consider recommending revisions.

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/ February 14, 2007

Simon Cohn
Chair Date