Note: The transcript of this meeting is posted on the NCVHS Web site, http://ncvhs.roseliassociates.com/lastmntr.htm

Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

February 13-14, 2007

Hubert H. Humphrey Building
Washington, D.C.

Meeting Minutes


The National Committee on Vital and Health Statistics was convened on February 13-14, 2007 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.
  • Leslie Pickering Francis, J.D., Ph.D.
  • Larry A. 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.

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

Others

  • Debbie Jackson, NCHS
  • Sheila Dwyer, Amer. Optometric Assn.
  • James Ferguson, Kaiser Permanente
  • Valerie Banner, Part B News
  • Miryam Granthon, OMH
  • Frank Kyle, American Dental Assn.
  • Walter Suarez, Insti. for HIPAA/HIT Education
  • Helen Olkaba, Amer. College of Radiology
  • Allison Viola, AHIMA

EXECUTIVE SUMMARY

ACTIONS

  1. The Committee passed a motion to approve a letter on the National Provider Identifier, as revised, with minor wordsmithing permitted, for final approval by the Executive Subcommittee.
  2. The Committee passed a motion, with Mr. Blair abstaining, to approve the existing content of the HIPAA annual report, with further work on it to be done and final approval by the Executive Subcommittee.

The National Committee held a two-day meeting, the first for four new members (named below). Besides hearing status reports on Data Council activities and budgetary matters, HIPAA implementation, and the work of the Office of Civil Rights (OCR) and the Office of the National Coordinator, the Committee approved two documents (see above), was briefed on initiatives by the Subcommittee on Populations, and engaged in several extended discussions of policy issues related to Committee projects.

UPDATE FROM THE DEPARTMENT

  • Data Council—James Scanlon, ASPE

  • HIPAA Implementation—Karen Trudel, CMS

  • Privacy Rule Compliance—Susan McAndrew, OCR

Mr. Scanlon reported on the President’s FY2008 budget and the Data Council’s efforts to support the Secretary’s 10 priorities. Discussion with the Committee focused on the impact of the declining funding for surveys and statistical systems.

Ms. Trudel reported on a landmark official guidance document on applying the HIPAA security rule, which particularly stresses the need to be deliberate about the remote use of electronic PHI. Committee members commended CMS for issuing the guidance.

Ms. McAndrew reported on the multiple activities of OCR. Members commented on OCR’s work to harmonize the privacy rule and the common rule, address the privacy issues related to genetic information, and expand public outreach.

OFFICE OF THE NATIONAL COORDINATOR UPDATE—John Loonsk, M.D.

Dr. Loonsk focused on ONC’s recent work on interoperability specifications, AHIC’s next-step use cases, and the status of the NHIN. The new use cases are in the areas of medication management, consumer access to clinical information, and quality. There will be an effort with all the use case activities in this round to coordinate among the different working groups. In addition, he described ONC’s third public forum on the NHIN, which focused on business models for making services self-sustaining and software prototypes. Dr. Loonsk stressed that NHIN is part of a broader cycle, which is being approached in an iterative fashion. ONC is advancing “a network of networks” to connect providers and consumers and to interconnect state, regional and non-geographic health information exchanges. This involves multiple interfaces that need to be differentiated. One focus of next steps for the NHIN concerns how to facilitate these different kinds of interconnections. The next incremental step is trial implementations, applying the work from the previous year. The discussion period covered a broad range of topics.

SUBCOMMITTEE ON STANDARDS AND SECURITY LETTER

Mr. Reynolds presented a draft letter on the National Provider Identifier (NPI), which was discussed, slightly revised and approved. The Subcommittee plans May and October hearings at which it will monitor progress on the NPI.

SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY — Mr. Rothstein

Following on its three recent hearings on coverage issues, the Subcommittee plans to draft letters and recommendations on two issues: 1) the use of health information in schools and the gaps and overlaps between HIPAA and Family Educational Rights and Privacy Act (FERPA); and 2) the issue of expanding HIPAA coverage to non-covered health care providers, such as employer health clinics and blood banks. The letters will be presented for approval at the June NCVHS meeting.

Dr. Green stimulated discussion by posing this large question: whether the Committee operates on the basis of a model of how health care is being delivered, is going to be delivered, and toward which we should be working.

HIPAA 8TH ANNUAL REPORT

Ms. Bernstein presented the current draft of the 8th annual report to Congress on HIPAA implementation. Over the two days of this meeting, the Committee twice discussed the purpose, content and disposition of this report. Many members expressed a desire to analyze HIPAA’s overall impact and value; ultimately, the group agreed that while worthwhile, this should be done through a separate NCVHS process and document.

DATA LINKAGE ISSUES—Dr. Steuerle

The Subcommittee on Populations recently held a meeting on data linkages, attended by representatives of AHRQ, ASPE, CMS, NCHS and other agencies as well as the health research community, Census, IRS, Social Security and the VA. There was a sense of great potential, provided people can figure out how to work together and combine and use multiple data sets. Part of the hearing’s purpose was to figure out how to break through barriers. The Subcommittee is considering seven recommendations as well as what kind of document it should produce on this topic and whether it needs further hearings. Mr. Scanlon said such a study of linkage issues would be very helpful to the Department. In its discussion of this topic, members expressed strong interest in moving it forward, possibly in conjunction with the NCHS Board of Scientific Counselors in the context of work on health statistics for the 21st century.

SUBCOMMITTEE ON STANDARDS AND SECURITY LETTER

Mr. Blair and Mr. Reynolds presented a draft letter about accelerating the process of standards evaluation and modification. The Subcommittee is asking for input from the Committee on the draft letter, a revised version of which will be presented for approval at the June meeting. Again, the group engaged in a wide-ranging discussion, with a major theme being the importance of getting the entire industry involved in the standards process.

2005-2006 NCVHS BIENNIAL REPORT; SUBCOMMITTEE AND WORKGROUP UPDATES

(See brief sections at the end of the summary below.)


 DETAILED SUMMARY

—DAY ONE—

CALL TO ORDER, WELCOME, INTRODUCTIONS

Dr. Cohn began by welcoming and introducing the Committee’s four new members:

  • Garland Land, MPH, Executive Director of the National Association for Public Health Statistics and Information Systems
  • Leslie Pickering Francis, J.D., Ph.D., Chair and Professor of Philosophy Department and Professor of Law, University of Utah
  • Larry A. Green, M.D., Professor of Family Medicine, University of Colorado and Senior Scholar in residence, Robert Graham Center for Studies in Family Medicine and Primary Care (Washington, DC)
  • J. Marc Overhage, M.D., Ph.D., President and CEO, Indiana Health Information Exchange; Professor of Medicine, Indiana University; and Director, Regenstrief Institute

Following introductions around the room, Dr. Cohn noted that the snowy weather might have an effect on the meeting agenda and participation. He then reflected on the rapid pace of Committee, departmental and Congressional activities since the November NCVHS meeting, showing the growing importance of health information technology in the federal government’s eyes. Among other things, there were opportunities to brief the Secretary on the Committee’s work and to define a set of well-received functional requirements for the NHIN. The NCVHS report on privacy and the NHIN is being used as a resource by the wider health care community.

UPDATE FROM THE DEPARTMENT

Data Council—James Scanlon, ASPE

Mr. Scanlon reported that although the several HIT bills introduced in the 109th Congress did not lead to any action, there are indications of continued interest in the 110th Congress although no bills have been introduced to date. Interest in privacy is expected to continue on the Hill, as well. Mr. Rothschild recently testified on his own behalf before a Senate hearing on a GAO report on privacy and the NHIN.

On the budget, the President’s FY2008 budget, sent to Congress on February 5, continues to support HIT investments at past levels. It increases funding for ONC, with one aim being to transform AHIC (now a federal advisory committee) into a public/private partnership named Partnership for Health and Health Care Improvement. There is also funding for health data standards, assessment and mapping. Another initiative, under the rubric of the Secretary’s “personalized health care” priority, would support pioneering work into using HIT to link clinical care and research with genomic data.  The President’s FY08 budget funds most of the major HHS statistical systems and public health data systems at the previous year’s level, with the addition of funding for a new NCHS home and hospice survey.

The Data Council is looking at how the Department’s data and statistical systems can support the Secretary’s top 10 priorities, and at how the Department can improve access to and the utility of its data, statistical and analytical products. At a February meeting it will look at the Department’s research data centers (located at AHRQ, CMS and NCHS). Other projects include 1) a review of the potential for using EHR data for health survey and statistical purposes and 2) a review of the quality, comparability and utility of the income and asset data in the major surveys.

In response to a question, Mr. Scanlon explained that funds earmarked for a specific purpose such as mapping are supplementary funding; in addition, entities such as the National Library of Medicine usually allocate some of their own funding to such projects. Ms. Greenberg noted that the FY2008 request is consistent with a November letter from NCVHS encouraging continued funding for standards work.

Dr. (Bill) Scanlon pointed out that continued funding at current levels represents a “half-full glass” because current levels are too low, and are effectively lowered by inflation. Sacrifices have already been made in what is collected, when even more information is needed in order to manage the health care system better.

Mr. Scanlon reminded the group that the Department is operating on a continuing resolution for the current fiscal year, at 2006 levels, and this status is likely to continue for the rest of the year. He added that it is necessary to rethink some of the surveys because increased funding is not likely.

Dr. Steuerle noted the relevance of the Subcommittee on Populations’ current investigation of data linkages and asked Mr. Scanlon to help the Subcommittee think about how to integrate such efforts in a broad budgetary context. Mr. Scanlon said making better analytic use of surveys is always welcome. They then discussed a recent Presidential initiative on tax exclusion and the weak data on which it is based.

Mr. Land described the impending crisis in the vital statistics system due to inadequate funding, and the difficult choices that it necessitates. Dr. Sondik will be asked for periodic status reports.

Dr. Cohn suggested that the Subcommittee on Populations may want to hold hearings and/or draft a letter on these issues.

HIPAA Implementation—Karen Trudel, CMS

On December 28, CMS published a landmark official guidance document on applying the HIPAA security rule. Dramatic changes in technology and recent security incidents had drawn attention to the need to clarify security concepts with respect to remote access scenarios, in particular to stress the need to be deliberate about the remote use of electronic PHI (EPHI).   The guidance talks about access, storage and transmission of EPHI. The next step is to obtain industry input, for which CMS has provided a feedback mechanism. After that, the intention is to develop a proposed rule with at least the content of the security guidance. The May Subcommittee on Standards and Security hearing will include discussions about security.

Mr. Reynolds was the first of several Committee members and others to commend Ms. Trudel and CMS for issuing the guidance, which he said is very user-friendly and will advance the dialog at the business level. Mr. Houston agreed, and suggested that the document should apply to more than just the remote use of EPHI. He cited the merits of encrypting hard drives on desktop devices.

Mr. Blair expressed concern about disconnects to date between the CMS security guidance process and the Privacy and Security Solutions contract, and he stressed the importance of getting information from the contractor, RTI, soon.

Dr. Steuerle cautioned against preventing useful health care activities through too-stringent regulations or guidance. He urged CMS to be explicit about the existence of this form of risk as well as the risk of harm due to privacy violations.

Privacy Rule Compliance—Susan McAndrew, OCR

OCR had received just over 25,000 complaints by the end of January, roughly one quarter of which remain open. OCR is developing more data on the cases it is closing, a third of which involved investigated cases. The volume of cases in which corrective action is taken (usually through voluntary compliance) continues to increase. A Web page is being developed devoted to compliance activities. OCR also remains actively involved with ONC and AHIC on HIT projects, and it participates in the Consumer Empowerment Workgroup. OCR has been asked to map the privacy rule to PHR scenarios. She also predicted that AHIC’s Confidentiality, Privacy and Security Workgroup would become very active. OCR is also working with the Department’s research communities to harmonize HIPAA’s and the FDA’s rules with the Common Rule.  Other areas of activity for OCR include the intersection of privacy and genetic information and disaster and emergency preparedness.

Mr. Rothstein said he was anxious to see progress in harmonization of the privacy rule and the common rule. On protecting genetic information, he stressed the importance of doing this “in the right way,” without separating out and stigmatizing genetic information. He urged the Department to avoid this kind of “genetic exceptionalism.” Ms. McAndrew assured him that this is the Department’s intention. Mr. Houston asserted that the time is ripe to try and establish the appropriate framework for addressing people’s reasonable concerns about genetic privacy. He applauded the Department for taking the initiative in this area.

Asked about the status of OCR’s plans for outreach and public education, Ms. McAndrew said the Office has developed some activities and materials that are posted on the Web. Responsibility for this area has recently been assigned to Linda Sanchez, and they will share a new outreach plan for 2007 once it has been vetted.

OFFICE OF THE NATIONAL COORDINATOR UPDATE—John Loonsk, M.D.

Dr. Loonsk focused on ONC’s recent work on interoperability specifications, AHIC’s next-step use cases, and the status of the NHIN. On the first, the Secretary has stated his intention to recognize three Health Information Technology Standards Panel interoperability specifications in December 2007. This is the first step in putting them on a course for implementation in federal and private systems.

AHIC has identified its next-step use cases (i.e., priority areas) for the national agenda, in each case together with their related priorities and enabling technologies. The first group of use cases included consumer empowerment, medication history and registration data, labs and EHRs, and biosurveillance. In mid-cycle, a use case on emergency responder EHRs was introduced; it will be continued in the next phase, focusing on the ability to exchange a summary patient record and address issues about provider authentication, authorization and credentialing in emergency situations.

The new use cases are in the areas of medication management, consumer access to clinical information, and quality. The work on medication management will complement other activities on e-prescribing and standards. On consumer access, Dr. Loonsk noted that the community puts a high premium on the consumer’s role in moving the HIT infrastructure forward. The quality use case is viewed as an extension of the one on biosurveillance.

There will be an effort with all of the use case activities in this round to coordinate among the different working groups. He noted the rapid pace of activity around identifying priorities and ONC/AHIC’s desire to embody as many priorities as possible in actual projects. In addition, ONC has identified the enabling technologies associated with consumer empowerment and the synergies between these technologies and the next steps for the NHIN.

ONC recently held a well-attended third public forum on the NHIN. It focused on business models for making services self-sustaining and software prototypes. He pointed out that the four consortia had demonstrated applications connecting to network architectures and “not the network themselves.” The emphasis is supposed to be on the architecture issues, but the software provides excitement because it is more tangible. Dr. Loonsk stressed that NHIN is part of a broader cycle, which is being approached in an iterative fashion. ONC is advancing “a network of networks” to connect providers and consumers and to interconnect state, regional and non-geographic health information exchanges. This involves multiple interfaces that need to be differentiated.

One focus of next steps for the NHIN is how to facilitate these different kinds of interconnections. For example, ONC has been talking about the possible need for service providers to support health information exchange. This exists alongside business, trust, governance, and other needs. The prototype architecture presentations in the third forum “put a face on these efforts” that was compelling, and several important issues and potential approaches emerged through the discussions and models.

The next incremental step, he said, is trial implementations, applying the work from the previous year. This will involve such elements as the security model considerations from HITSP, the NCVHS recommendations on privacy and confidentiality and NHIN functional requirements, and the public input from the three NHIN fora. The past use cases will also figure in the next round. In general, it will step back from technology after last year’s “deep dive” into it, in order to focus on interfaces, needs for standardization and systems, and so forth. Some will directly engage state and regional HIE, with awards made in June and July.

In the discussion period, members talked with Dr. Loonsk about the following topics:

  • Any plans by ONC to ratchet up efforts on privacy “before it falls hopelessly behind technology developments”;
  • What AHIC group(s) will work on medication management;
  • Any movement toward criteria for patient identity reconciliation;
  • The interest in sustainability at the third forum;
  • The need for attention to questions about control of PHI;
  • How to build momentum with the emerging business cases for HIE and encourage innovation and flexibility;
  • How the Committee can help make the pieces tie together better, to enable greater progress;
  • How to improve the interoperability of data elements, name standards and use-case information exchanges; and
  • The logic behind the conclusion that the nation needs a national health information network.

On the last question, Dr. Loonsk pointed out the importance of ensuring compatibility and interoperability among the diverse local, regional and system-based networking initiatives that are taking place. He stressed that the NHIN is not about a common shared server or physical network run by a single entity.

SUBCOMMITTEE ON STANDARDS AND SECURITY LETTER

Mr. Reynolds presented a draft letter on the National Provider Identifier (NPI). Mr. Reynolds explained to new members that the Department had set a single implementation for everyone for the NPI, with no staging. At a recent hearing, the Subcommittee heard testimony from a cross-section of the industry that the May 23 deadline is not doable for everyone. While the Subcommittee recognizes that the required implementation date should retain its meaning, it is proposing “contingencies” to modify what is expected by May 23.

He then read aloud the draft letter to the Secretary, pausing periodically to accept substantive comments from the Committee. (Wordsmithing was handled separately.) A few modifications were made to the letter. There was extensive discussion about how, in this advice to the Department, to strike the right tone that recognizes the statutory requirement while also responding to the testimony heard from industry. The Subcommittee plans May and October hearings at which it will monitor progress on the NPI.

The Committee passed a motion to approve the letter, as revised, with minor wordsmithing permitted, for final approval by the Executive Subcommittee.

SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY — Mr. Rothstein

The Subcommittee on Privacy and Confidentiality plans to present two letters at the June full Committee meeting. He noted the recommendation in the Committee’s June 22 letter to the Secretary (#R-12) that HHS should ensure that the privacy and confidentiality rules apply to all those handling personal health information in any form and in any setting. After holding three hearings on coverage issues in September, November and January, the Subcommittee has decided to draft letters and recommendations on two issues: 1) the use of health information in schools and the gaps and overlaps between HIPAA and Family Educational Rights and Privacy Act (FERPA); and 2) the issue of expanding HIPAA coverage to non-covered health care providers, such as employer health clinics and blood banks.

Mr. Land noted that the impact of the privacy rule on new-born hearing programs is another issue.  The general issue, Mr. Rothstein said, is that there are problems of both gaps and overlaps between HIPAA and FERPA. Mr. Houston added that people want to know what they need to comply with.

Dr. Green posed a large question: whether the Committee operates on the basis of a model of how health care is being delivered, is going to be delivered, and toward which we should be working. He wondered how the Committee could proceed without agreement on such a model. Dr. Cohn cited Information for Health as one NCVHS vision statement; it focuses on health information, the domain of the Committee’s mandate.  Mr. Rothstein added that the Committee tries to come up with broad recommendations that are deemed appropriate under any health care delivery system, based on agreement within the Committee on broad principles.

Dr. Green posited that every member makes assumptions about how health information will be used, by whom and for what purposes, and within what structure and functions in the health care delivery system. Without a model, it is challenging to help plan for the information needs of a delivery system in the midst of transformative change.

Dr. Cohn noted that the Committee’s charge is broader than just health care, extending to personal health management and public health.

It was necessary to cut this discussion short because the federal government ordered its employees to depart due to impending inclement weather.

HIPAA 8TH ANNUAL REPORT

Ms. Bernstein presented the current draft 8th annual report to Congress on HIPAA implementation, explaining that the drafting is still in progress. She commented on its current gaps and what was needed from the Committee. She read aloud portions of the Executive Summary, and asked for comments and inputs from members before she completes the draft. The group then discussed the options for disposition of the report, agreeing to discuss this further on day two of the meeting or, if it is cancelled because of bad weather, to hold a conference call for this purpose.

Dr. Overhage speculated that Congress members would be most interested in whether Congress’s aims in creating HIPAA were being achieved, and he suggested that the existing structure of the annual HIPAA report does not lend itself to the level of synthesis necessary to address that question. This comment stimulated considerable discussion. Ms. Greenberg pointed to a related letter on lessons learned that has already been sent and is excerpted in the draft report.

Dr. Cohn observed that there had been interest, given that this is the tenth anniversary of HIPAA, in doing “something a little more thoughtful,” an idea consistent with Dr. Overhage’s comments. However, it would take time to create such an analysis. The group discussed whether to develop a separate ten-year overview or address this topic in the present document, with support for both alternatives. Ms. Greenberg pointed out that the Committee also will be developing a bi-annual report that goes to the Secretary and can also go to Congress; this is another opportunity to reflect on HIPAA in the context of the full scope of NCVHS activities.

After a brief discussion of logistics, the meeting recessed to reconvene the following day.

—DAY TWO—

Following introductions and a review of the agenda, Dr. Cohn announced that there would be an Executive Subcommittee meeting in May, to talk about strategy issues and revisit the conclusions of last June’s full-Committee retreat.

DATA LINKAGE ISSUES—Dr. Steuerle

The Subcommittee on Populations recently held a meeting on data linkages, attended by representatives of AHRQ, ASPE, CMS, NCHS and other agencies as well as the health research community, Census, IRS, Social Security and the VA. There was a sense of great potential, provided people can figure out how to work together and combine and use multiple data sets. Part of the hearing’s purpose was to figure out how to break through barriers.

As a result of its investigations, the Subcommittee is considering seven recommendations that have been compiled in a draft summary. The recommendations under consideration include continued research, Department-wide standards for linking data systems, and elevating linkages as a priority activity within the Department. As next steps, the Subcommittee is considering preparing a letter to the Secretary with refined recommendations, and exploring the topic further. Dr. Steuerle stressed the importance of giving researchers access to useful data. Ideas include a research center, making better use of Internet systems, and setting rules for tabulating sensitive data.

Dr. Steinwachs added that access and timeliness are the major issues. Dr. Vigilante noted the parallels between the hearing on linkages and the hearings on the data required for surge capacity (described below).

Mr. Scanlon said a study of linkage issues would be very helpful to the Department. He described the evolution of statistical and research systems and the need to look ahead to future needs and uses. The Committee also could be helpful in addressing the issue of balancing privacy and data access, as well as identifying gaps in data and ways to fill them.

Dr. Bill Scanlon pointed out the strong overlaps between NCVHS and the Board of Scientific Counselors in their interest in this subject, which is part of the broader topic of data for the 21st century.

Dr. Steuerle added that the Committee might investigate the structural issues involved, such as possible legal barriers and accountability and responsibility.

Dr. Francis pointed out that some state agencies have good data sets that might also be of interest.

Dr. Green commented on possible relevance of community-based participatory research, a methodology that can produce useful specificity in community-level public health information. Some community groups might be interested in data on their communities’ health. (For clarification, he added that he is not Lawrence W. Green, who has authored a lot of literature on this subject.)

Ms. McCall commented that many of these themes are consistent with developments in the business community. The relevant field is business intelligence, which focuses on stewardship and strategic uses of the masses of available data. Emerging approaches to taxonomies and ontologies offer ways to harmonize information at the meta-data level.

Dr. Cohn noted the importance of clarifying and focusing on the public policy uses and potential public benefits of these new capabilities. He reiterated that one of the Committee’s recommendations should concern the need for an HHS structure to help promote these possibilities.

The group suggested other actionable recommendations that might emerge. Mr. Scanlon also pointed out the connections of this topic to the endeavors around health statistics for the 21st century. He cautioned against focusing on structures, and urged a focus on functions and potential outcomes. Members suggested next steps, and Dr. Cohn expressed hope that the Subcommittee might be able to produce a draft document for consideration at the June meeting.

COMMITTEE ACTIONS

Subcommittee on Standards and Security Letter

Mr. Blair explained that this draft letter is about how to accelerate the process of standards evaluation and modification. The Subcommittee is asking for input from the Committee on the draft letter, a revised version of which will be presented for approval at the June meeting. To illustrate the problem, Mr. Reynolds noted that the NPRM for claims attachment standards was first drafted in 1998, and the final rule still has not been published. It is not unusual for the process to take five years or more. This letter plays off a facet of last year’s HIT bill (which did not go forward) that would have streamlined the process. The Subcommittee heard testimony that the SDOs and designated standards maintenance organizations would like to make their deliberations more visible and more open for comment, with NCVHS as the primary public forum for vetting modifications and the gateway to the approval process via NCVHS recommendations. The Subcommittee has heard from health care providers, payers, vendors and clearinghouses that they do not oppose this process. The letter under consideration recommends that the Secretary evaluate the proposed process and have it examined by legal staff.

Dr. Scanlon wondered about the root cause of the delays and whether the letter addresses it. In response, Ms. Greenberg noted that the draft letter proposes a different process, not just a faster version of the existing one. Mr. Scanlon commented on the multiple reasons for delays, starting with the content of the law itself; he added that “one person’s delay is another person’s public protection process.” Dr. Scanlon observed that the situation has changed since the law was written, calling for different solutions. Dr. Steindel outlined the steps in the standards development, approval and modification process.

Dr. Overhage said he was more concerned about the usable, if not perfect, standards that are out there but are not being used—i.e., the gaps in implementation. Mr. Reynolds commented on the importance of getting business people from the covered organizations involved in the standards, rather than just the technical people, and the need to be sure the business people understand why standards will make a difference. He said it is time to talk with the SDOs about this issue. Ms. McCall agreed, and added that recommendations for how to change processes can only come from having used the standards.

Dr. Green asked about the influence of commercial interests on the implementation of a standard, and Mr. Reynolds said this is key, combined with the fact that different-size players have different interests. He also posed the question, “What does adoption mean?” Further, some of the things that have not yet been implemented would have the greatest business return in the end. The key question is how to get the entire industry to buy in; also, what does “buy-in” look like? Part of the Committee’s effort is to continue to make sure the right people come to the table to talk about the subject, so that the effect is improvements to health care, not just implementation of a standard.

Mr. Blair referenced a new document, “Coming to Terms,” which puts the issues discussed above in the broader context of interoperability.

By way of transition to the next topic, Dr. Cohn observed that the foregoing discussion illustrates the differing views about the impact of HIPAA. He added that every software implementation begins with implementation and moves on to optimization, and the latter is just beginning with HIPAA.

HIPAA Annual Report—Ms. Bernstein

Ms. Bernstein pointed out that this retrospective annual report is not the place to talk about anything new. Ms. Greenberg thanked her for taking on the project of pulling the report together, and she and others offered comments on the document.

Dr. Green raised a “meta-issue” — that in his experience HIPAA has not helped him at all as a citizen, patient, family caregiver or physician. He urged that the tone of the report not be too positive. Dr. Overhage expressed agreement and reiterated his earlier suggestion that the report address the big question of “how far we are along the pathway,” which is what will interest Congress.

While supporting these comments, Mr. Blair observed that on the positive side, HIPAA has taken an important first step in helping the health care delivery system move into the information age. He proposed using a “journey” metaphor in talking about the HIPAA process.

Mr. Rothstein added the problems with the privacy rule to the list of HIPAA shortcomings; however, he proposed that the Committee not try to address these large issues in the forthcoming annual report to Congress, but rather appoint a “HIPAA assessment working group” for that purpose. He advised confining the immediate task to developing a cleaner, tighter, more explicit and understandable report that avoids making sweeping judgments. Mr. Reynolds noted that the Committee is already on record with the Secretary regarding implementation and return on investment issues.

The group discussed various courses of action for completing the report and moving it through the Committee approval process. The Committee then passed a motion, with Mr. Blair abstaining, to approve the existing content of the HIPAA annual report, with further work on it to be done and final approval by the Executive Subcommittee.

2005-2006 NCVHS BIENNIAL REPORT

Ms. Greenberg explained that the Committee had a long tradition of doing an annual report on all NCVHS activities, recently converted to a biennial report. The next one due is for 2005-2006. Ms. Kanaan will take the lead and will interview Subcommittee chairs and Dr. Cohn for major content. She suggested that new members look at past reports as examples and invited everyone to send suggestions to her and Dr. Cohn regarding content or alternative structures. The plan is to review a draft at the June meeting and aim for final approval in September.

SUBCOMMITTEE AND WORKGROUP UPDATES

The NHII Workgroup will soon hold a conference call to continue its discussion of next steps.

The Executive Subcommittee will meet in May. Dr. Cohn has asked Mr. Blair, Mr. Rothstein, Dr. Carr and Mr. Reynolds to serve as a planning group to work with him on issues related to secondary uses of data.

The Quality Workgroup held a productive and well-attended conference call meeting prior to this day’s meeting to plan one or more hearings to identify how a blend of administrative and electronic clinical data are currently being used for quality assessment.

The Subcommittee on Privacy and Confidentiality is planning an April hearing on a topic to be determined and a series of conference calls to discuss the two letters in the pipeline (described above).

The Subcommittee on Standards and Security will be keeping an eye on NPI for the rest of the year, and has hearings scheduled in May and October. It will also look at the security issues discussed on day one of this meeting.

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/                                                              June 21, 2007

_____________________________________________________________________

Chair                                                                              Date