The National Committee on Vital and Health Statistics was convened on Tuesday and Wednesday, June 20-21, at the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:
a) The Executive Subcommittee will consider this question at its strategic planning discussion in August.
b) Dr. Sondik will revise the proposal to reflect this meeting's discussion, for further consideration by the Committee.
c) NCHS briefings will be included in future NCVHS agendas.
d) The Subcommittee on Populations will review its charge and work plan for possible ways to increase its involvement with the Center and support its needs.
3. The use of incompatible measures in different agencies' surveys, e.g., functional status measures for vision impairment and deafness in the NHIS and MEPS, will be referred to the Data Strategy Committee.
4. The Report on Uniform Data Standards for Patient Medical Record Information, as modified by two amendments and editorial changes, was approved by unanimous vote (Mr. Blair recusing himself). A follow-up motion was unanimously passed permitting the Chairman to make technical and conforming changes to the report.
This meeting took place over two days. The Committee recessed the afternoon of June 20 to hold the NCVHS Fiftieth Anniversary Symposium at the National Academy of Sciences. A summary of that meeting will be published separately.
On day one of this meeting, Mr. Blair and Margret Amatayakul presented the draft report on PMRI standards. The report was developed over a two-year process by the Workgroup on Computer-Based Patient Records. They invited Committee members' comments, and proposed revisions were discussed. The Workgroup then revised the report based on this discussion, and the revised version was reviewed by the Committee on day two. Following discussion and two amendments, the Committee unanimously approved a final version, which will be forwarded to the Secretary. Mr. Blair recused himself from the vote.
This report, the result of a study requested by the National Library of Medicine, was released by the NRC Computer Science and Telecommunications Board in February 2000. It has four purposes: 1) defining the technical capabilities of the Internet; 2) envisioning applications; 3) discussing implementation strategies; and 4) assessing the extent of unique health sector requirements.
Dr. Shortliffe focused his remarks on the technical and policy issues addressed by the report. He stressed the appropriateness of using the Internet for health applications. The NRC study concluded that health care does not place unique requirements on the Internet. Nevertheless, health care has a strong vested interest in what direction it takes, what is emphasized, and the speed at which things occur. Today's Internet fails to meet the needs of many health care applications; and for its part, research within the health field has failed to advance the technology needed for these applications. The study asserts that the potential of the Internet for health care uses will not be fulfilled unless the policy issues it identifies are resolved.
Dr. Lumpkin asked the Subcommittees on Standards and Security and on Privacy to review the NRC report for its implications for their work plans.
Mr. Scanlon reported that the Data Council has established a standing Data Strategy Committee, replacing the Survey Integration Work Group. It is charged with integrating the recommendations of HHS content-oriented data groups into an overall data strategy. The goals include assuring that HHS has the data it needs, improving analytic capacity, and maximizing efficiency. Three priority areas have been identified. The Strategy Committee is also involved in budget planning. HHS has identified information as a priority area in the budget development process.
Committee members encouraged efforts to reconcile disparate estimates of the number of uninsured people in the country, and efforts to engage other parts of the administration outside HHS.
Mr. Fanning reported that the Data Council has established a standing Privacy Committee, and he related several other privacy-related news items.
Dr. Braithwaite reported that the Department is on track to issue the first HIPAA standard transaction rule at the end of June. It is hoped that all pending standards will be out by the end of 2000, but no specific target dates have been set. Mr. Nachimson reported that the standards development organizations have created a Strategic National Implementation Process, or SNIP, to manage standards implementation. HCFA and the Department are part of the SNIP steering committee.
In response to concern about a lack of coordination of Department activities related to summary health measures, the Department formed an interagency working group that Dr. Sondik described as a significant step forward. Its purpose is to stimulate research, data collection and application of measures; to coordinate administration activities; and to stay abreast of work in this area.
Committee members encouraged the use of non-survey-based as well as survey measures, and expressed interest in the scalability of the measures. Dr. Lumpkin suggested that the Committee have an ongoing relationship with this Working Group.
The Committee and Dr. Sondik discussed a June 2000 proposal for the establishment of a Board of Scientific Counselors (BSC) for NCHS. In general, Committee members agreed with Dr. Sondik that NCVHS can no longer meet all the Center's advisory needs. However, they expressed concern 1) that NCVHS retain its high-level, policy oriented role vis a vis NCHS, and 2) that the roles and responsibilities of the two bodies be clearly delineated. Dr. Sondik stressed that in addition to wanting ongoing advice on the quality of the Center's work, his aim is to enhance the NCVHS role and strengthen its relationship with the Center.
The Committee supported moving toward the existence of two well-differentiated advisory bodies for NCHS. They agreed to undertake four tasks, enumerated under "Actions."
Mr. Wack is a consultant to HCFA on implementation of digital signatures. He briefly described technical aspects of developing and using this technology, stressing the many challenges involved and the centrality of issues of trust. He described the testing he is conducting for HCFA and the Social Security Administration, using the U.S. Postal Service as the "trust hierarchy."
Mr. Blair explained that the digital signature has several inseparable functions: it authenticates the message sender's identity, seals the message to show that it has been unaltered in transmission, shows that the receiver has received the message and thus cannot repudiate it, and allows the receiver to add a signature and send it on.
Dr. Lumpkin said this would be the first of a series of presentations designed to familiarize the Committee with the technical areas in which they are required by HIPAA to offer recommendations. He also suggested, in view of the inherent privacy issues, that the Subcommittee on Privacy participate in the forthcoming hearings sponsored by the Standards and Security Subcommittee.
The meeting concluded with brief status reports.
Dr. Lumpkin called the meeting to order, remarking on the momentousness of the day, with three major reports to review and the afternoon dedicated to the 50th Anniversary Symposium. (A report on the Symposium will be published separately.) All present were asked to introduce themselves.
Dr. Lumpkin thanked Dr. Cohn, Mr. Blair, and the Work Group on Computer-based Patient Records for their work on this report. Dr. Cohn, Chair of the Subcommittee on Standards and Security, acknowledged Mr. Blair for his leadership in this effort, the Work Group members and staff for their work, and Margaret Amatayakul for her support in developing the report.
Mr. Blair, Chair of the Work Group, also thanked Ms. Amatayakul. By way of background, he explained that HIPAA requires NCVHS to make recommendations and legislative proposals on patient medical record information (PMRI). The Committee began work on this two years ago, took testimony from more than 90 individuals and groups, and started working on the report (generating eight drafts to date) in December 1999.
Ms. Amatayakul said the approved report, revised based on the forthcoming discussion, would be submitted to the Secretary. She invited comments, proceeding section by section through the document and finally focusing on the recommendations. Action is scheduled for day two of this meeting. The final approved version, reflecting all approved edits, will be available on the NCVHS Website, along with the transcript of this discussion.
The issues raised and discussed, most of which led to new language, included the following:
The Committee agreed not to specify the groups that should be more involved in the standards process, lest someone be left out, but rather to make a general statement about inclusion of the underrepresented.
The foregoing comments were referred to the Workgroup, which will revise the document accordingly, for action the following day.
This report, the result of a study requested by the National Library of Medicine, was released by the National Research Council (NRC) Computer Science and Telecommunications Board in February 2000. It has four parts or purposes:
Five terms are key: bandwidth, latency, availability, security, and ubiquity. Dr. Shortliffe briefly defined each one and discussed them in terms of applications to medical and healthcare uses of the Internet. The report looks at each of these concepts with respect to clinical care, consumer health, health care financing, public health, health education, and biomedical research.
Noting that the Committee has already thought a great deal about the potential impact of the Internet on health care, Dr. Shortliffe focused his remarks on technical and policy issues. Today's Internet, he said, fails to meet the needs of many health care applications in terms of quality of service, security, reliability, and ubiquity of high-speed access. Whether current research will address the Internet's utility for health care remains a question. However, it is clear that it is appropriate to emphasize the Internet, as private networks are too expensive and inflexible, among other limitations.
The NRC study concluded that health care does not place unique requirements on the Internet. Nevertheless, health care has a strong vested interest in what direction it takes, what is emphasized, and the speed at which things occur. For example, under certain conditions, quality of service and tight latency are critical for health care uses; issues of scalability are significant; and health care has high requirements for security, as well as for ubiquitous access.
At present, the health care communities are not making an adequate contribution to research. Even if the networking research community is thinking about the same problems, they are not thinking about them in a medical context; looking at the healthcare implications remains for the healthcare community. Solutions generated in that context would also have broader applicability.
The NRC report identifies the following policy issues: protection of information, access to the information infrastructure, intellectual property protection, regulation of electronic health services, federal support for research, and building a workforce with both health care and networking expertise. It states that "without deliberate and sustained action, the fundamental conflicts represented in these policy areas will keep the Internet from fulfilling its promise to health care." Dr. Shortliffe noted that in sum, what is required is a fundamental cultural change.
In response to a question about federal leadership, Dr. Shortliffe observed that the U.S. does not have "a national healthcare policy vision as it relates to IT," unlike other countries such as the U.K. In the U.S., most decision-making is done agency by agency. This calls for strategic planning and recognition of the role of IT in the big picture.
In conclusion, Dr. Lumpkin thanked Dr. Shortliffe for meeting with the Committee and he asked the Subcommittees on Standards and Security and on Privacy to review the NRC report for its implications for their work plans.
The Committee then recessed until the following day, in the interim, meeting at the National Academy of Sciences for the 50th Anniversary Symposium.
Mr. Scanlon focused on recent HHS activities related to data strategy. This effort follows on its recent stock-taking on statistics and population-based data initiatives, and on the survey integration process. The goal is to place such initiatives in the context of a broad approach to data strategy that looks at needs, gaps, and capabilities.
The Data Council has established a standing Data Strategy Committee, replacing the Survey Integration Work Group. It is charged with integrating the recommendations of HHS content-oriented data groups into an overall data strategy. The goals of the strategy include:
The priority areas the Strategy Committee is asked to look at are:
In each area, the group is asked to synthesize a picture of the data needs, assess HHS capabilities for data collection, analysis and dissemination in light of data needs, and identify optimal approaches to an HHS data strategy. On the basis of this review, the Strategy Committee will develop proposals for a multi-year HHS strategy, for submission to the Data Council.
The Committee has been formed with representatives from all HHS agencies, and is meeting every week. It is currently working on its general charge and also advising on priorities for the FY2002 budget. HHS has identified information as an area of special consideration in the budget development process.
In response to a question from Dr. Newacheck, Mr. Scanlon described how the Strategy Committee will deal with the disparate estimates of the number of uninsured people in the U.S. The Department has pulled together a 3-page primer describing the various estimates, how and why they differ, and their strengths and weaknesses. Dr. Newacheck suggested trying to reconcile them to the extent possible, as uniformity would be useful.
Regarding the scope of this effort, Mr. Scanlon said it is focused on HHS activities but with an eye to national issues, e.g., Healthy People and NCVHS recommendations. To implement the strategies that emerge, HHS intends to enlist partners outside the Department. Later in the process, there will be an effort to engage other Department such as the Census Bureau.
Mr. Fanning noted that the Secretary said in her remarks at the NCVHS Symposium that the Department would release its Privacy Regulations "at the end of summer." Other news items:
Mr. Scanlon also related various privacy-related news from Canada and Europe.
The Department is on track to issue the first HIPAA standard transaction rule at the end of June. The same issue of the Federal Register will contain an announcement of the designation of the Standards maintenance organizations that have committed to a process of maintaining the standards. It remains to be seen how industry will react.
Mr. Stanley Nachimson of HCFA reported that several months ago, WEDI expressed interest in sponsoring a national implementation effort with a coordinated approach involving all plans, providers, vendors, and clearinghouses. HCFA endorsed this industrywide approach to implementing HIPAA standards. These discussions led to the Strategic National Implementation Process, or SNIP. HCFA and the Department are part of its steering committee, which held its first meeting in mid-June with 180 attendees. Three groups were created -- on education and awareness (which is developing a website); timing, testing, and coordination; and security. The Department is enthusiastic about this industry initiative to manage national implementation.
Regarding the next set of standards, no date is set for their release; it is hoped that all pending standards will be out by the end of 2000. The next NPRMs expected are plan identifier and claims attachments. The enforcement NPRM will not be out until 2001, at the earliest.
Dr. Cohn congratulated HHS on getting the regs out. In response to a question, Mr. Nachimson said the SNIP would continue the work on security begun elsewhere, including that done last year at Johns Hopkins. Asked about the progress of work on digital signature, he said the Department will defer a decision in that area until the Department of Commerce determines that there is an agreed-upon industry standard.
Dr. Cohn noted that the Subcommittee on Standards would be briefed on all of these activities at its July 13-14 hearing.
Dr. Braithwaite described plans for that hearing.
This report follows on the panel discussion on summary measures that took place at the February 2000 NCVHS meeting. That discussion illustrated the variety of work going on in the Department. Concern about a lack of coordination of Department activities in this area led the Department to form an interagency working group to 1) stimulate data collection in this area, 2) foster research and application of measures, 3) coordinate activities in and among DHHS agencies, and 4) keep abreast of work in this area. Both CDC and HCFA were represented at the first meeting of the working group, which plans to meet three times a year with working groups meeting additionally.
NCVHS members were supplied with a chart summarizing the activities of 13 HHS entities in the area of summary health measures. Dr. Sondik characterized this working group as a significant step forward for the Department, with particular implications for CDC and its influence on states and counties. There is no hurry to settle on a particular summary measure of health; rather, the intention is to explore multiple measures.
Dr. Friedman observed that survey data lack the ability to drill down to smaller geographic areas or groups, and he asked if any thought were being given to using non-survey- based summary health measures. Dr. Sondik said the Department is very interested in looking at leading health indicators not only at the national level but at state and smaller levels. Regarding summary measures, the Department (e.g., CDC and ODPHP) is no doubt open to non-survey based measures for the purposes noted. He promised to make sure this question gets onto a Working Group agenda.
Dr. Lumpkin said states would be very interested in the scalability of the Working Group's deliberations. In addition, he suggested a relationship between NCHS and the Working Group rather like what it had with the HIPAA workgroups. Dr. Sondik welcomed the suggestion and said he would relay it.
The Committee and Dr. Sondik discussed a June 2000 proposal for the establishment of a Board of Scientific Counselors (BSC) for NCHS. This proposal developed because NCVHS -- which in the past had a close advisory relationship to NCHS and played key roles in the development of early health surveys -- has been unable to sustain this relationship since the responsibilities imposed by HIPAA.
Dr. Sondik said that NCHS needs a formal source of continuing advice on all its activities, and also on overall policy issues, e.g., on resource allocation. He invited suggestions on how to integrate this with an ongoing role for NCVHS. Later in the meeting, he explained that he is looking for ongoing advice, of a peer review nature, on the quality of the Center's work, guidance on how to improve it, and identification of holes in its activities. He envisions the BSC as operating at a more "nuts and bolts level" than NCVHS, advising on specific programs, surveys, technical and scientific issues, and so on.
In general, Committee members agreed that NCVHS cannot meet all the Center's advisory needs. However, they expressed concern 1) that NCVHS retain its high-level, policy oriented role vis a vis NCHS, and 2) that the roles and responsibilities of the two bodies be clearly delineated. Other issues raised concerned the relationship between the two bodies, the need for a threshold mechanism governing the assignment of agenda items to the two bodies, BSC recruitment issues, HHS agency participation, and improving communication between NCHS and NCVHS. Following are specific comments and suggestions:
Asked his vision for the National Committee's role, Dr. Sondik stressed that his aim is to enhance the NCVHS role and strengthen its relationship with the Center. To this end, he proposed a detailed annual report from the Center, covering such topics as new NCHS activities and issues related to resources, training and staffing, with time allowed to receive the Committee's advice. Further, NCHS might brief the Committee at most or all meetings, as the Data Council does.
Asked for a sense of the Committee, members agreed that NCVHS cannot meet all the Center's advisory needs, and that the task is to define a mechanism that divides the roles and clearly delineates responsibilities of the two bodies. They also set for themselves the following tasks:
Mr. Nachimson introduced Jay Wack, a consultant to HCFA on implementation of digital signatures. His company has provided security consultant services to federal agencies including the U.S. Navy, the IRS, and the U.S. Post Office.
Mr. Wack began with comments about the foundation of information security, noting that trust is the fundamental issue and the first priority with digital signatures. He briefly discussed interoperability, scalability and adherence to standards as part of the foundation.
The public key infrastructure (PKI) is a critical piece. It is a hierarchical system involving a certificate authority. Digital signature is a component of PKI that provides authentication. It is "a cryptographic representation of a value and a way to assign to some electronic transmission some authentication or identity." Repudiation, another element, is "probably the stickiest wicket."
One impediment at present is that few infrastructures are large enough to support what is being attempted. The military has tried and failed. Mr. Wack believes that the only infrastructure that provides the trust hierarchy is the U.S. Postal Service, and he is involved in pilots with the USPS. Despite the many difficulties with developing and using this technology (a theme he emphasized in his remarks), he predicted that the U.S. will continue to pursue electronic communication because technology is driving it, there's money to be made and saved, and the Paperwork Reduction and Paperwork Elimination Act requires a 40 percent reduction in paper.
In response to a question, Mr. Wack stressed that encryption is a separate component and mathematical function from digital signatures. In helping the Committee understand this subject, he endorsed Mr. Blair's explanation: An electronic signature performs several inseparable functions: it authenticates the message sender's identity, seals the message to show that it has been unaltered in transmission, shows that the receiver has received the message and thus cannot repudiate it, and allows them to add a signature and send it on.
Dr. Lumpkin observed that this presentation is the first of a series of briefings to familiarize the Committee with this field, in preparation for future decisions. There will be a presentation in the future on the public key infrastructure. Dr. Cohn said the Standards and Security Subcommittee's October hearings will look further at the topic.
At Dr. Cohn's request, Mr. Wack described the testing he is conducting involving HCFA, the Social Security Administration, and the USPS.
Ms. Frawley asked his views of the health care impact of the legislation just signed by the President. Mr. Wack predicted that technology will drive policy in this area, as is generally the case.
With reference to various privacy issues raised in this discussion, Dr. Lumpkin suggested that the Subcommittee on Privacy participate in the forthcoming hearings sponsored by the Standards Subcommittee.
Dr. Zubeldia raised technical questions that were referred to the Standards and Security Subcommittee.
Dr. Lumpkin asked for notification by any members with a conflict related to the issue on which the Committee is about to vote. Mr. Blair recused himself from voting on the document because he is a member of the Executive Committee of ANSI-HISB. There were no other notifications.
Members were supplied with a revised version of the report, reflecting the previous day's discussion and recommendations. Dr. Lumpkin reviewed the substantive changes made, asking for comments as he proceeded through the document. A few minor editorial changes were made.
It was moved and seconded that this iteration of the report be approved.
As an amendment, it was moved and seconded that a number of revisions be made to a section newly entitled "The Need for Acceleration to Improve Interoperability." (The changes are specified in the transcript and reflected in the final document.) The motion passed, with seven in favor, five opposed.
Dr. McDonald questioned the passage calling for broader participation and representation in the development of PMRI standards. This stimulated discussion, leading to agreement that the key point concerns the lack of official U.S. government representation in international standards organizations.
It was moved and seconded to remove two references on page 34 (items 13 and 14). Following discussion, this motion was approved, with seven votes for, two against, and three abstentions.
The document, as modified by the two amendments and editorial changes, was then put to a vote and approved unanimously. A follow-up motion was unanimously passed permitting the Chairman to make technical and conforming changes to the report.
Dr. Lumpkin thanked and congratulated the Committee for the successful completion of "a labor of long and tireless effort." Mr. Blair was commended for his leadership.
The Subcommittee will hold hearings on July 13-14 on early tracking of implementation issues, local code issues, and related HIPAA matters.
The Subcommittee will follow up on the issues raised by Dr. Sondik, and will consider changing its charge to be more inclusive of his concerns.
Dr. Iezzoni expressed the Subcommittee's regret at the sudden death of Allan Meyers of Boston University, who testified before the Subcommittee in April about functional status measurement.
At the April hearings, the Subcommittee learned about the ICIDH, to be continued in hearings in July and on September 17-18. Advocacy groups and provider groups will testify about their views of the ICIDH.
Dr. Iezzoni asked Mr. Scanlon to get a response from the Data Council to the Subcommittee's reports on Medicaid managed care and on the insular areas, both of which were submitted several months ago. He said the Data Strategy Group is looking at both reports, and he will ask for a response.
The Workgroup will sponsor a panel at the September full Committee meeting on the national quality report effort, with a patient safety report follow-up.
The Workgroup plans four hearings in the summer and fall. It also will work on mapping existing data systems to a conceptual model, and will study privacy and confidentiality concerns related to health statistics. Dr. Friedman said he favors not binding the Committee to a fixed delivery date for the final report, and would prefer to take as much time as needed to produce a good final product. Dr. Lumpkin agreed.
This Workgroup will share hearings with the aforementioned Workgroup. Its goal is to complete the NHII report, revising the interim report as needed and adding a section on barriers along with recommendations.
At the request of the Subcommittee on Populations, the Subcommittee will review the revised draft of the ICIDH to discuss any privacy concerns. It will also look at the recent IOM report on privacy.
The Subcommittee will hold a strategic planning retreat on August 18. The discussions will be shared with the full Committee.
Dr. Lumpkin then adjourned the meeting, remarking on all that was accomplished and celebrated in these two days.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
/s/ John R. Lumpkin, M.D. 9/19/00
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Chair Date