A special conference call meeting of the National Committee on Vital and Health Statistics was convened at 11 a.m. on Monday, December 20. The meeting was open to the public. Present:
This meeting was convened to review draft comments on the privacy rules proposed by the Department of Health and Human Services. The comments were drafted by the Subcommittee on Privacy and Confidentiality. Ms. Greenberg noted that the draft summary of the Subcommittee's November 23 conference call was posted on the NCVHS Web site to provide background for this discussion.
Following roll-call, the group reviewed and exchanged views on each component of the comments, in the categories outlined below. They then agreed on a process for modifying the redrafted comments based on this discussion, and agreed to reconvene the Committee by telephone in late January for a final decision on the comments. (The process is outlined at the end of this summary.)
The participants sought a level of specificity that would allow them to address the full scope of the rules and, wherever possible, reach agreement. The Committee's comments will also elucidate areas of significant disagreement among members, for the Department's benefit. In addition, individual members were encouraged to submit individual comments in areas of particular concern and expertise. Several points raised in the November preliminary discussion of the proposed rules were reiterated, e.g., that the scope defined by HIPAA is too narrow, that privacy legislation is still needed, and that there is a danger that those who control medical information will refuse to share it, to the detriment of research.
The redrafted comments may state that while the proposed rule is limited in that it does not cover all records or all entities, some members feel there are other ways in which it is excessive.
This topic precipitated a long discussion of HHS authority, authority under HIPAA, and the relationship between the two. The group agreed to comment that all records should be covered by the regulation, not just electronic ones, along with all holders of identifiable medical information. Also, the Department should use all available authority to try to achieve uniform regulations across medical records, types of records, and types of entities.
Some members expressed concern that the proposed rules will interfere with good clinical care. The issues raised included how much access physicians should have to the records of non-patients, and what should be recommended concerning patient permissions/consents. Dr. McDonald agreed to seek clarification of the NPRM's intent regarding treatment consents.
Dr. Lumpkin outlined the following three scenarios, and members stated which one they favored (total number in parentheses):
A-- The physician may look at medical records of patients and non-patients without consent (2).
B-- The physician may look only at records of patients without patient consent (4).
C-- The physician may look at nothing without patient consent (1).
They agreed that the comments on this area should more fully explain the Committee's concerns.
Dr. McDonald expounded on the need for trust and the importance of not hampering patient care. He agreed to write a paragraph on the need to balance two values, the protection of privacy and good medical practice.
The group agreed to change the header of this section to "Statutory versus informed consent for treatments, payment, and health operations."
Dr. McDonald will draft language stating the Committee's view that the "minimum necessary" provision should not apply to public health requests, nor should they interfere with or duplicate IRB operations. Not all members agreed with his view that patient care should be exempt from the provision. After a lengthy discussion, they agreed that distinctions are needed among treatment, payment, and operations. Members had differing views as to which, if any, of these should be exempt from the "minimum necessary" requirements. A plurality (3 members) favored exempting only patient care.
This topic will be addressed in the January discussion. Essentially, the group supported the draft comments in this area.
Discussion focused on the medical information of incarcerated individuals. They agreed to comment that the information about this vulnerable population should be protected to the extent possible without jeopardizing the safety of the facilities or other inmates.
There was then a long discussion about the provision allowing patient access to medical records, particularly concerning providers' vulnerability to lawsuits. Thirty-three states allow patients to acquire their records, and this has not led to excessive suits or other problems. The impact on physician note-taking behavior was discussed. Ms. Frawley will supply Dr. McDonald information on an AHIMA document on this subject.
Dr. McDonald raised questions about "what limited what" in the proposed rules. He was encouraged to discuss this with Mr. Fanning and to create tables to help clarify the rules for other members.
Members and staff agreed to the following process for redrafting and discussing the comments:
Dr. Lumpkin adjourned the conference call at 1 p.m.
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