The National Committee on Vital and Health Statistics was convened by conference call at 1:00 p.m. on September 25. The meeting was open to the public. Present:
ACTION ITEM: By a vote of 6 to 3, with two recusals, the Committee approved an amended version of a letter from NCVHS to the Secretary concerning aspects of the privacy rule related to consent and minimum necessary. A subordinate motion, which also passed, removed a statement on independent assessment from the section on minimum necessary.
This meeting was conducted by telephone because of the events of September 11, 2001. Dr. Lumpkin called the meeting to order at 1 p.m., and roll was taken.
Mr. Rothstein presented a letter to the Secretary, drafted by the Subcommittee on Privacy and Confidentiality. It deals with topics that were the focus of hearings conducted in August 2001 by the Subcommittee and the HHS Office of Civil Rights (OCR). The purpose of the hearing was to explore practical issues in implementing the final privacy rule, including unintended consequences of the rule, possible inconsistencies, and areas needing further clarification. Panelists were asked to provide specific suggestions for possible modifications of the rule. More than 30 people, including healthcare providers, payers, researchers, members of professional organizations, other users of healthcare information, and members of the public, testified on four key issues identified by the Office of Civil Rights, OCR, and the NCVHS:
The present letter addresses the first two topics; the last two will be addressed in a subsequent letter. Mr. Rothstein expressed appreciation to Gail Horlick for her staffing role in preparing the letter, which was distributed to all Committee members in advance of this meeting. He noted that OCR participants attended the hearings, received copies of all the written comments, including those on issues beyond the scope of the hearings, and will have the opportunity to address additional issues and concerns not covered in the NCVHS letter.
Mr. Rothstein read the draft letter in its entirety, pausing at appropriate intervals for comments and discussion. Members offered suggestions on both structure and content of the letter. The approved revisions are contained in the final version of the letter (posted on the NCVHS Website). The group authorized the Executive Subcommittee to make stylistic and grammatical changes in the final version, as needed.
Mr. Rothstein said that in the future, the Subcommittee on Privacy and Confidentiality will take another look at aspects of the rule on revocation of consent¾specifically, whether an IRB in approving a research protocol would make a distinction between revoked consent and non-consent¾on which it has no recommendation at this time.
The subject of minimum necessary and its treatment in the letter generated considerable discussion among Committee members. Following discussion, a vote was taken on a motion to remove a passage referring to independent assessment from the section on minimum necessary in the draft letter (first item number, second paragraph). The motion passed by a vote of 6 to 3, with Mr. Blair abstaining and Dr. Cohn recusing himself.
A motion approving the entire letter, as amended, was then passed, with no opposing votes and Dr. Cohn and Dr. Harding recusing themselves. (Dr. Cohn had stated that because his employer, Kaiser Permanente, has publicly expressed itself on these aspects of the privacy rule, he would recuse himself from the voting. Dr. Harding recused himself because he is President of the American Psychiatric Association, which also has made public statements on the rule.)
The Committee agreed that the approved, amended letter would be e-mailed to the Committee to make certain that it correctly represents the Committee’s intentions. If no concerns are expressed within two days, it will be sent to the Secretary. If concerns are expressed, the Executive Subcommittee will have a conference call to try to resolve them.
In view of the time and an impending Executive Subcommittee conference call meeting, the Committee agreed to move its remaining agenda item, subcommittee and workgroup reports, to the executive subcommittee agenda.
Dr. Lumpkin then adjourned the meeting.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
John R. Lumpkin, M.D. 2-7-02
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Chair Date