Public Health Service

National Committee on Vital and Health Statistics

Subcommittee on Privacy and Confidentiality

Conference Call

November 23, 1999

- Draft Summary -

The Subcommittee on Privacy and Confidentiality of the National Committee on Vital and Health Statistics was convened via telephone conference call on November 23, 1999. The meeting was open to the public. Present:

Subcommittee members

• Kathleen Frawley, J.D., Chair
• Jeffrey Blair
• Simon Cohn, M.D.
• Kathleen Fyffe
• Robert Gellman, J.D.
• Richard Harding, M.D.
• Mark Rothstein, J.D.
• M. Elizabeth Ward, M.N.
• Kepa Zubeldia, M.D.

Staff and liaisons

• James Scanlon, ASPE, Executive Staff Director
• Marjorie Greenberg, NCHS, Executive Secretary
• Gail Horlick, CDC

Others

• Dixie Snider, CDC
• Mike Tate, American Dental Association
• Dave Schultz, National Wholesale Druggists' Association
• Roberta Dean, National Wholesale Druggists' Association
• Suzie Burke-Bebee, NCHS
• Deborah Tress, CDC
• T.J. __________, Joint Health Care Information Technology Alliance
• Linda Sanchez, ASPE
• Kendall ____________

Kathleen Frawley chaired the conference call meeting. She acknowledged that an extension of the public comment period has been formally requested. A decision has not been made, but the February deadline for the final rule is likely to be a factor.

The timeline for the NCVHS comments: By December 8, this Subcommittee will get draft comments to the full Committee, which will discuss them by conference call later in December. The final comments will be approved by Dr. Lumpkin and submitted to the Department by the January 3 deadline.

The group noted the general points that should be included in the comments. Some were made at the November 3 NCVHS meeting:

• This statute does not obviate the need for antidiscrimination measures.
• There is also a need for federal privacy legislation that applies directly to holders of information.
• Congratulations to the Department for its good work.

The Subcommittee agreed to make these points in the comments:

• Rather than applying only to EDI records, the regulations should apply to all medical records. (Linda Sanchez said the Department's General Counsel believes the Department has the authority to cover non-electronic records held by covered entities.)
• Having uniform regulations that apply to all medical records is a way of simplifying the burdens of the regulations. Otherwise, they will be a logistical nightmare. This implies extending the scope beyond the three covered areas to employers and other contexts where information needs protection.
• The section on law enforcement access (subsection 164.510f) needs to be tightened up. The group discussed this issue at length, agreeing on the desirability (as standard procedure, to which there might be exceptions) of requiring a warrant, disclosure in the record that it was reviewed by law enforcement, and notification to the Department. For exigent circumstances, prior approval would not be required but post- disclosure notice would be. Also, the protections should apply to inmates in correctional facilities and detainees in detention facilities.
• Regarding the proposed shift from informed consent to statutory consent: the group agreed to record that members have differing views on this issue. Dr. Harding and Mr. Rothstein agreed that the proposed change undercuts traditional codes of medical ethics which require individual consent for review of individual records. Mr. Gellman and Dr. Cohn supported the thrust of the NPRM, noting that many state laws now permit disclosure for treatment or payment without consent, without discernable ill effect. It was noted that physicians still have the option of setting a higher standard for informed consent with their patients. The group discussed the issue of physician access without consent to the records of a patient's family members, to obtain genetic information.
• Regarding preemption of state laws: the group found the provisions in this area difficult to interpret. They agreed to recommend that the governors of states with less stringent rules be allowed to ask for a waiver only following a period of notice and public comment in that state.
• The term "family violence" should be substituted for references to child abuse and spouse abuse.
• On minimum necessary disclosure (section 506): a second standard should be added regarding the minimum identifiable form. The goal of the regulation should be disclosure of the minimum identifiable information. When the minimum necessary information is disclosed, it should be in minimally identifiable form. An additional comment will be made that this principle raises the question of how to reduce the potential for identifiability.

Other points discussed:

• Despite concerns about employer access to employees' medical records, members agreed that the proposed rules are not the correct vehicle for improving the current state of the law regarding discrimination and other abuses of medical information by employers.
• A concern was raised about the possibility that the restrictions will undercut the willingness of covered entities to provide data to researchers. In response, it was pointed out that covered entities are going to have to develop a facility for dealing with audit trails because they still must disclose records for public health and other purposes. This involves a one-time cost, whatever the purpose of the disclosure. Once a procedure is established, any form of authorized and justifiable disclosure should not be difficult. Further, it was noted that if there is a negative impact on disclosure for research, it is likely to be temporary, if only because the regulations do not provide for meaningful enforcement.
• Members had differing views on whether individuals should be allowed to opt out of having their records used for research. Those favoring such an opt-out provision suggested that an exception might be made if a researcher could convince an IRB that the research process would be distorted if a given category of people opted out.

Ms. Frawley adjourned the meeting, wishing everyone a Happy Thanksgiving. She will promptly circulate a draft of the letter to Subcommittee members, with a request for comments.

I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.

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Chair Date