Reps. Thomas, Johnson Support
Modifications to Medical Privacy Rule
March 1, 2002 - Representatives Bill Thomas (R-Calif.)
and Nancy Johnson (R-Conn.), chairs of the full House Ways
and Means Committee and the Health Subcommittee, respectively,
wrote a letter (PDF, 5
pages, 819KB) Feb. 26 to Department of Health and Human
Services Secretary Tommy Thompson and Office of Management
and Budget Director Mitch Daniels calling on the Administration
to address four research-related issues before any final medical
privacy rule is published. The letter states "Improved
biomedical, epidemiological and outcomes research is critical
to provide high quality medical care in the Medicare program
and for private sector entities…. The current medical
records confidentiality rule runs counter to these shared
goals by inhibiting the flow of information necessary to conduct
biomedical research."
In the letter, Reps. Thomas and Johnson recommend changing
the requirements related to "de-identified" information,
suggesting that the definition be modified to require "direct
identifiers such as name and health plan number be removed,
but that indirect identifiers" remain in place. The letter
also notes that the additional burdens on Institutional Review
Boards (IRBs) are duplicative and unnecessary. Reps. Thomas
and Johnson call for the rule to "establish a 'regulatory
authorization' structure to allow covered entities to use
patient information for several defined purposes" and
to "eliminate the requirement for IRBs to evaluate the
potential risk of loss of privacy to the individual versus
the potential benefit of the research to the individual."
The letter also recommends that the use and disclosure of
existing archived medical records be grandfathered for research
purposes, and that all reporting to public health registries
be allowed without patient consent.
Similar concerns were raised last month by Sens. Judd Gregg
(R-N.H.) and Bill Frist (R-Tenn.) of the Senate Committee
on Health, Education, Labor, and Pensions [see
Washington Highlights, Feb. 22]. AAMC President
Jordan J. Cohen, M.D., expressed the concerns of the Association
in a Feb. 11 letter
to OMB.
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