Interim Data Council Report to the Vice President: Status Report: Health Data Standards


Summary of Data Standards Efforts and Statement of Principles

Vice President Gore, in his March 8, 1995 Memorandum to Secretary Shalala, asked the Department of Health and Human Services (HHS) to lead an interagency effort with the long- term goal of promoting evolution toward more shared health data standards. HHS is now implementing that charge through three related efforts:

  1. Interdepartmental Coordination of Federal Data Standards Efforts: improving the coherence of health information systems and policy within the federal government, by (a) consolidating staff efforts (in particular, linking separate Departmental efforts with the Federal EDI Standards Management Committee through a consolidated interagency working group), and (b) creating a focal point for senior-level coordination, through meetings and regular communications. See Section I, below.
  2. Promoting Coordination of Federal, Private Sector, and State Information Systems: using a federal advisory committee to serve as a national forum of expert stakeholders to address data standards and privacy issues, and to explore ways to improve the compatibility of private sector, state, and federal health information systems. See Section II , below.
  3. Expert Forums on the Medicare Transaction System: convening focus groups to bring new voices to bear on crucial aspects of the relationship of the Medicare Transaction System to the rapidly evolving health information infrastructure. See Section III, below.

These efforts are based on the following principles:

  • Public and private sector health data should be of value to multiple users. Improvements in the collection and use of health data must be accompanied by assurances of privacy and security appropriate to an electronic environment.
  • Data standards are voluntary. All interested parties -- private sector, states, consumers, federal agencies -- should collaborate in the evolution toward more uniform, shared data standards.
  • The federal government should play three roles in this voluntary process:
    • create a national forum facilitating the collaboration of interested parties;
    • participate fully with private standards development organizations and other interested groups in the effort to develop more uniform health data standards; and,
    • to the greatest extent possible given its business needs, choose data standards for its own health information systems that are compatible with state and private sector business needs and standards.

(For a more detailed discussion of the principles guiding our activities, and their relationship to related principles articulated pursuant to the Vice President's NII activities, see TAB A).

SECTION I: Interdepartmental Coordination of Federal Health Data Standards

The Vice President's charge stems in part from the absence of coordination of health data standards activities across federal Departments. Each Department is pursuing its own activities, and links between those activities are often missing. To determine how best to move toward greater coordination of federal policy in this area, we undertook an aggressive outreach program, including inter-Departmental staff-level meetings and correspondence from Secretary Shalala to the heads of the other Cabinet agencies listed in the Vice President's memo. (TAB B includes a detailed description of our outreach efforts, the input we received, and the other models for interagency efforts that we reviewed.)

This outreach effort identified several key barriers to making interagency work effective:

  • Lack of a high level mandate for collaboration, and resulting difficulty translating recommendations into implementation.
  • Multiple, fragmented efforts addressing pieces of the health data standards puzzle.
  • Gaps between participants in these efforts and the official policy makers in their agencies.
  • Difficulty in reaching consensus when confronted with real or perceived conflicts in agency objectives.

The HHS effort is aimed at eliminating those barriers. The HHS Data Council will provide an organizational locus for Senior level communication and coordination, and for consolidation of staff activities on health data standards. Attached at TAB C is a chart, showing roughly how these efforts will relate to one another.

A. The HHS Data Council

The organization locus for HHS leadership of this effort is the HHS Data Council. The Data Council consists of all HHS Assistant Secretaries and Agency Administrators who have a direct reporting relationship to the Secretary, a privacy advocate appointed by the Secretary, plus the Secretary's Senior Advisor on Health Statistics. It is co-chaired by the Assistant Secretary for Planning and Evaluation and a rotating Operating Division head; the current OpDiv co-chair is the Administrator of the Health Care Financing Administration. (For a more detailed discussion of the HHS Data Council, see Tab D, which includes Secretary Shalala's Memorandum creating and charging the Data Council.)

B. Senior-Level Interagency Activities

As noted above, our outreach efforts indicate a need for a high-level mandate for collaboration on data standards issues from the participating agencies. While the Vice President's charge to HHS provides the beginnings of such a mandate, active participation by senior officials in each agency is needed to make that mandate real. The HHS Data Council will use two mechanisms to bring senior officials from other agencies closer together in data standards activities: the HHS Data Council will hold inter-departmental meetings when there are important action items, and will provide regularly scheduled written communication.

Inter-Departmental Meetings. Actions items triggering meetings will not be limited to disputes, but should include discussion of important staff recommendations, "testimony" type events, etc. These meetings can also authorize ad hoc and standing interdepartmental working groups as may be needed to address particular issues. Any agency can call for such a meeting.<1>

Regular Written Communications. At the same time, we recognize the need for on-going communications (i.e., regardless of whether "action items" are pending). While the interagency staff work will provide an important vehicle for this communication, our outreach efforts indicate that senior-level communication is also important. The Data Council will send regular newsletters, informing other agencies of events, progress, and issues. These newsletters will be "interactive" in that contact persons for each issue will be identified, and comments/suggestions will be solicited. Any Department or working group can contribute to the newsletter. Since the meetings will focus on action items, they may not provide opportunities for communication on matters that do not appear on the agenda; the newsletter is intended to fill that gap.

C. Staff-level Interagency Efforts

While Vice President Gore has asked HHS to lead the interagency effort on health data standards issues, there is also an ongoing effort to coordinate electronic data interchange (EDI) generally across federal Departments. The Federal EDI Standards Management Coordinating Committee (FESMCC) is an interagency body charged with a subset of data standards issues -- development and maintenance of implementation conventions (IC) for EDI applications used by federal agencies. While the FESMCC has work groups devoted to EDI for particular industries (i.e., procurement, finance), at present there is no health work group.

The most effective way to organize the inter-Departmental staff work on data standards under the Vice President's directive is to tie the FESMCC and HHS efforts together, by establishing a unified inter-Departmental health work group on data standards. The work group will have a dual mandate:

  • This work group will report to the FESMCC on health EDI implementation convention issues, pursuant to the FESMCC charter.
  • The group's charge will be expanded beyond EDI, to include data standards issues more broadly and coordination with private sector efforts; it will report to the HHS Data Council on these matters.

As last fall's process of revising the Federal Information Processing Standards publication 161 illustrates, a FESMCC health work group to address health EDI issues is urgently needed. It would be unwise for HHS to create a separate staff effort on the broader array of health data standards issues, because EDI issues are not separable from data standards issues (while not all data standards issues are encompassed by the term "EDI," all EDI issues are part of data standards work). The purpose of this effort is improved policy coherence and coordination; consolidation of staff effort will greatly promote this goal. In addition, the HHS Data Council can provide a link to the private sector that the EDI might not otherwise easily have, through its advisory committee (see below).

With the broadened mandate, this group can coordinate federal staff representation at standards development organization meetings (ANSI HISB, X.12, NCPDP, ASTM, etc.) and meetings of related groups (such as WEDI, MRI, CPRI, G7). The fact that the FESMCC, under NIST regulations, includes a regulatory mandate (evaluation of ANSI standards and registration of government-wide implementation conventions for EDI) is an important advantage in encouraging agencies to appoint appropriate people and focus on its activities. Any issues stemming from joint oversight of the FESMCC/HHS unified inter-Departmental health work group can be addressed in the context of the senior level interagency meetings described above.

D. Status and Next Steps

  1. Attached (at TAB E) is a letter from the cochairs of the HHS Data Council to Arati Prabhaker, Director of the National Institute of Standards and Technology, explaining why this approach is appropriate and initiating the process of establishing this work group. This letter was provided to NIST staff last fall, to solicit their support and comments. Initial discussions were positive, but were also put "on hold" pending resolution of NIST funding levels.
  2. Identify appropriate contacts in other Departments to participate in senior-level inter- Departmental meetings, to participate in the new FESMCC/HHS staff work group, and to receive and participate in preparing the newsletter.
  3. Send first newsletter, identifying participants and initial issues.

SECTION II. Promoting Coordination of Federal, Private Sector, and State Health Information Systems

The lack of shared standards for health data increases paperwork burdens and reduces the analytic potential of health data. There is little ability to share, make multiple uses of, or link data. Many electronic data systems cannot communicate with one another, either within the private sector or between public and private data holders. There is a developing consensus that everyone -- consumers, industry, policy makers -- would be better served by more uniform, voluntary, and shared standards for collection and transmission of health information.

A. The National Committee on Vital and Health Statistics

Pursuant to the Vice President's charge, HHS will provide a national forum for the collaboration of interested parties, in the form of a federal advisory committee, with the long-term goal of increasing the interoperability of diverse health information systems.

  • This forum will facilitate and accelerate the development of voluntary consensus across the public and private sectors around key data standards and privacy issues.
  • The forum will inform decision making about data policy for HHS, the private sector, and states; participants will bring their expertise, perspectives, and concerns to the forum, and will bring back to their respective fields the collective recommendations and rationale of the Committee.
  • The advisory committee will help keep the federal government abreast of the data needs and issues of the rapidly changing health care market.

The Department has an existing and productive federal advisory committee, the National Committee on Vital and Health Statistics (NCVHS), addressing issues closely related to those described by the Vice President. As of March, 1996, a majority of seats on the NCVHS are open. Thus, this is an excellent time for a shift in focus for the NCVHS, and a refocused NCVHS will be an excellent vehicle for this endeavor.

B. Status and Next Steps

We have revised the charter of the NCVHS, and are well into the process of revising its membership and work plan.

  1. New Charter. A new charter has been approved by the HHS Data Council and signed by Secretary Shalala. It incorporate new activities pursuant to the Vice President's charge. The new charter is included in the Federal Register notice, attached at Tab F.
  2. Membership. It is our intent to find "expert stakeholders," persons who are knowledgeable and who are opinion leaders in their field, to fill the vacancies. As a whole, the NCVHS must represent a balance of health information stakeholders. There will not be seats designated for particular organizations; rather, the membership as a whole, over time, will be drawn from respected voices in key constituencies. To ensure maximum public input and openness, HHS is seeking nominations through a Federal Register notice, published February 6, 1996 (attached at Tab F).

    We are also conducting outreach to key constituencies interested in health data standards and privacy (i.e., the Secretary will not be bound by responses to the Federal Register notice). We have solicited suggestions for new members from many interested groups, including WEDI, the Koop Leadership Council, and others.

  1. New Work plan. We are now in the process of develop a revised work plan for the new NCVHS. Our transition work also includes working with the NCVHS to set priorities among on- going NCVHS work and find new sponsors for some of that work.

SECTION III. The MTS Expert Forums

The Vice President asked HHS to obtain input from the federal advisory committee regarding "How can HHS ensure that the Medicare Transaction System is fully compatible with the multiple health uses of the NII?" However, the Medicare Transaction System (MTS) is on a tight schedule, with key design documents scheduled to be finalized over the next few months. Thus, it is not feasible to expect the advisory committee to provide advice in that time frame.

To obtain equivalent input on the MTS prior to finalization of its design documents, the HHS Data Council has asked HCFA, working with other HHS personnel, to hold "Expert Forums" on particular topics related to MTS and its interface with the NII. The Forums will be "focus group" type sessions.

HCFA has already undertaken extensive outreach efforts in designing the MTS. The purpose of the Expert Forums will be to bring new voices to bear, and to ask new questions.

A. Expert Forum on Managed Care, Status and Next Steps: Planning for an Expert Forum on Managed Care is well underway. The agenda has been approved by the Data Council (prior to submission to the Data Council it was circulated to the HIAWG and others outside HHS for input). This Agenda is attached at Tab G. We are currently in the process of identifying appropriate participants, and will schedule the Forum based on their availability.

B. Expert Forum on Privacy, Status and Next Steps: The Data Council and HCFA have identified privacy as another issue on which an Expert Forum would be useful. HCFA is expecting an interim report on this and related issues from its contractor; an agenda for the Forum will be developed based on the contents of this report.

Budget Implications

We anticipate that the activities described in this status report will require significant commitment of FTE resources. However, given the current budget climate, these activities will be accomplished within existing budget ceilings. Just as HHS will be providing FTE support for these activities with existing resources, we will be asking the other participating Departments to do the same.

<1> We considered whether to establish a regular meeting schedule for senior officials, or to call meetings only to address actions items. On balance we decided that it is important to avoid "make work" meetings that can result from a regular meeting schedule. If there is not a meaningful agenda at every meeting, the attendees will lose the sense of significance that regularly scheduled meetings might otherwise promote. In this case, members will begin to send substitutes, and the group will no longer include the persons needed to provide the high-level mandate. We are aware that this approach diminishes the opportunities for unstructured exchange of information between Departments. To facilitate communication about matters that would not otherwise appear on a "action item" type agenda, we decided to include regular written communication as part of our activities. This approach may, of course, be revisited as experience warrants.