Senators Gregg and Frist Back Modifications to Medical Privacy
Rule
February 22, 2002 - In a Feb. 7 letter
to Secretary of Health and Human Services Tommy Thompson,
Sens. Judd Gregg (R-N.H.) and Bill Frist (R-Tenn.) support
modifications to the new federal medical-privacy rule, specifically
addressing concerns for the rule's potentially deleterious
impact on medical research and innovation in health care.
The two senators, ranking Republicans on the full Senate Committee
on Health, Education, Labor, and Pensions and the Public Health
Subcommittee, respectively, quoted a letter endorsed by nearly
200 biomedical research institutions and medical and professional
societies, including the AAMC, that was sent to Secretary
Thompson on Nov. 20, 2001 [see
Washington Highlights, Nov. 30, 2001].
Sens. Gregg and Frist urge modification of the privacy rule's
criteria for the de-identification of medical records data,
which they note could render these records essentially unusable
for much public health research and may provide researchers,
contrary to federal intent, an incentive not to use de-identified
medical information in their studies. Similarly, the privacy
rule sets a potentially unworkable standard for Privacy Boards
to consider a waiver of the authorization form otherwise required
to use or disclose "Protected Health Information"
for research. The waiver criteria ask the boards to weigh
the expected benefits of research against the privacy risk
to individuals. "This requirement will result in confusion
rather than clarity, and impose additional unnecessary burdens
on research," the legislators said.
They also note that the rule may further impose "unnecessarily
stringent" requirements on research that is reviewed
by Institutional Review Boards (IRBs), which are already obligated
to oversee privacy protections for participants in human subjects
research. These new requirements include the addition of lengthy
explanations related to the privacy rule within informed consent
documents. The Senators suggest that the privacy rule afford
greater deference to IRB-reviewed research. The letter urges
the Department of Health and Human Services to take necessary
steps now to modify the cited provisions of the rule while
maintaining strong privacy protections for consumers and patients.
On Feb. 11, the AAMC
asked the Office of Management and Budget to examine the rule's
research provisions closely. "Problems [pertaining to
the medical privacy rule] of regulatory burden, redundancy,
ambiguity, workability . . . are all matters of concern for
regulatory policy that fall within the OMB's expertise and
purview," wrote AAMC President Jordan Cohen, M.D.
Information:
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