AAMC Letter to OMB on Medical-Privacy
Rule
February 11, 2002
The Honorable Mitchell E. Daniels, Jr.
Director, Office of Management and Budget
Executive Office of the President
Washington, DC 20503
By facsimile: 202-395-3888
Dear Mr. Daniels:
I am writing on behalf of the Association of American Medical
Colleges to call your attention to the medical research community's
request for new rulemaking on research provisions of the Standards
for Privacy of Individually Identifiable Health Information.
Our concerns for the Privacy Rule have been repeatedly expressed
to the Department of Health and Human Services, including
recently in the enclosed letter
to Secretary Thompson endorsed by 190 research universities,
medical schools, teaching and community hospitals, and medical
specialty and scientific societies.
The AAMC and other organizations endorsing that letter strongly
support safeguards for patients' privacy and the confidentiality
of medical information. Protections for patients and participants
in research are currently afforded in part by the Common Rule
and Institutional Review Board (IRB) oversight. The provisions
for research within the privacy regulations mandated by the
Health Insurance Portability and Accountability Act do not,
we contend, provide sufficient further protection of the privacy
interests of patients and research participants beyond IRB
oversight to justify the substantial impairment of vital medical
and public health research that the Rule will necessarily
cause. We note that the National Committee on Vital and Health
Statistics, in its 1997 report to then-Secretary Shalala,
explicitly stated that it had been unable to identify significant
threats to patient privacy and confidentiality arising from
medical and health research.
The Rule's research provisions will create a climate of
defensiveness and fear of litigation that will only impede
health care innovation in a manner that will far exceed their
arguable benefit. In some respects, the privacy rule is redundant
with existing privacy protections, such as those required
by IRBs noted above. In other respects, the rule's provisions
are unacceptably ambiguous (e.g., the "minimum necessary"
standard for disclosure), dangerously excessive (e.g., standards
for de-identification of medical information applied to research),
or unworkably complex (e.g., criteria for waiver).
The Rule introduces substantial criminal and civil penalties
for noncompliance. The AAMC is deeply concerned that the effect
of the rule's complexity, ambiguity, lack of normative standards,
and liabilities will be to discourage covered entities from
sharing patient information that is essential to a broad array
of population-based medical and public health research, even
in instances where the privacy rule might be reasonably interpreted
to sanction the release of such data. We believe that the
adverse effects on health research of similarly over-zealous
privacy regulations are already observable in Minnesota and
Great Britain. Problems of regulatory burden, redundancy,
ambiguity, workability, and particularly cost-benefit assessment
are all matters of concern for regulatory policy that fall
within the OMB's expertise and purview.
We are further concerned that implementation of the Rule
will impede critical research on current national priorities,
including efforts to reduce medical errors and improve patient
safety and, especially, public health research to improve
disease surveillance for timely response to emergent biological
threats or terrorism. The Rule does allow for reporting of
health information without consent if such reporting is mandated
by statute or other governmental action, but public health
research has most always depended on access to information
much broader than that mandated by law.
One hundred and ninety research organizations and institutions
asked the Department of Health and Human Services to reopen
the research provisions to further rulemaking and public comment.
The Secretary's reply of January 17, 2002, (also enclosed)
has reassured us of the Administration's commitment to achieving
balanced, workable, and effective health privacy protections.
We particularly urge that the research provisions of the
Rule be opened for further rulemaking and public comment under
the Administrative Procedures Act and we ask for the assistance
of the Office of Management and Budget and the White House
to ensure this opportunity for modifying the Medical-Privacy
Rule.
Sincerely,
Jordan J. Cohen, M.D.
Enclosures
cc: John D. Graham, Ph.D., Administrator, Office of Information
and Regulatory Affairs, OMB
James C. Capretta, Associate Director, Human Resources Programs,
OMB
John Marburger, Ph.D., Director, Office of Science and Technology
Policy
Ann Phelps, Special Assistant to the President for Domestic
Policy (Health)
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