National Committee on Vital & Health Statistics

June 23, 1998

The Honorable Donna E. Shalala
Secretary of Health and Human Services
200 Independence Avenue S.W.
Washington, D.C. 20201

Dear Secretary Shalala:

Last year, the National Committee on Vital and Health Statistics (NCVHS) forwarded to you our recommendations on health information privacy. The recommendations complied with the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). I appreciate your leadership on health information privacy.

Privacy and confidentiality issues continue as a major subject of the Committee's deliberations and activities. In particular, the Committee continues to focus on specific topics in health information privacy where additional fact-finding and analysis is needed to support legislative and policy activities.

To that end, the NCVHS Subcommittee on Privacy and Confidentiality convened two full-day public meetings earlier this year to gather information, stimulate dialogue, and identify issues related to: 1) the concept of "identifiability" of health records in the context of rapidly evolving information practices and technology; and 2) confidentiality issues presented by the collection, maintenance, and disclosure of information by health and medical registries. Participants at each meeting included about a dozen experts from the health industry, federal and State government, interest and advocacy groups, academia and the public health community.

The public meetings resulted in the following conclusions, and we offer them for your consideration.

Identifiability of Health Information

Distinguishing between identifiable and non-identifiable information is at the heart of every current legislative proposal for health privacy, including the HHS recommendations.

The distinction between identifiable and non-identifiable data has become much harder to make. Whether something is non-identifiable depends in large measure on what other information is known or knowable. For example, it may be possible to identify a person from their health data given their zip code or date of birth.

The amount of personally identifiable information available from public and commercial sources has grown significantly in recent years. The growth has been fueled by cheaper computer power, the Internet, and the commercial sale of personal information.

Health and statistical agencies have always been and continue to be aware of the potential for identification of individuals from publicly released information, including public use data tapes. The explosion of individually identifiable data from other sources means that these agencies must constantly reexamine their policies and practices to guard against inadvertent identification.

The NCVHS believes it is important that:

• everyone who collects and uses health data must also pay attention to and continually evaluate the likelihood that data once believed to be non-identifiable may no longer retain that status. In particular, Institutional Review Boards should be alerted to this issue;
• from a legislative perspective, more specific substantive definition to distinguish between identifiable and non-identifiable data and procedural mechanisms are needed to protect individuals against identification; and
• mechanisms that may be appropriate include the use of contracts or other legal restrictions designed to expressly prevent those who receive data from manipulating it to identify individuals. The goal is to continue to support socially beneficial uses of health data without impinging on the privacy interests of individuals.

Confidentiality Considerations for Health Registries

Many health and medical registries exist. There is no common definition of a registry. They serve numerous purposes, exhibit considerable diversity, and operate under different agencies, both public and private, mandated and voluntary.

There are laws mandating registries at the federal and State levels. No comprehensive regulatory or policy structure can be found that addresses or defines the universe of registries.

The Committee strongly supports the work of registries for research, public health, and related purposes.

Any health privacy legislation will affect the flow of health records into and out of registries. None of the legislative proposals for privacy to date, including the HHS recommendations, expressly address registries.

The NCVHS believes it is important that:

• health data be provided only to registries that conduct research, public health, and related activities;
• legislation should not undermine the flow of health information into or out of such registries; and
• registries should be brought under any new legislative framework so that data subjects can be assured that information entering a registry will be fairly treated and so that record keepers can be assured that cooperating with registries is permissible.

Clearer rules for registries may contribute to more effective research and public health activities by permitting data from other countries to be shared with registries in the U.S.

Solutions to the issue of registries may include a statutory definition or administrative process for identifying appropriate registries.

We hope that these findings are helpful to the Department in its privacy deliberations. We are pleased to provide a national public forum for deliberation and advice on health information privacy issues. We offer our continuing advice and assistance in working with you and the Congress.

Sincerely,

Don E. Detmer, M.D.
Chair