Letter to HHS Secretary Thompson
on HIPAA Privacy Regulations and Research
August 14, 2001
The Honorable Tommy G. Thompson
Secretary of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Dear Mr. Secretary:
The undersigned individuals and organizations represent America's
leading research universities, medical schools, teaching and
community hospitals, scientific societies, and health care
analysts, as well as the pharmaceutical research, medical
device, and biotechnology firms that produce new medical products
and therapies. We write to voice our shared concern that the
Department's final rule, "Standards for Privacy of Individually
Identifiable Health Information," unless substantially
amended, will harm patients and scientific innovation by creating
significant obstacles to the conduct of biomedical, epidemiologic,
health services, and other research.
The academic and industry research communities believe that
the rule's restrictions on the use and disclosure of protected
health information for research purposes and limits on the
retention of research data will seriously impair our ability
to conduct clinical trials, clinico-pathological studies of
the natural history and therapeutic responsiveness of disease,
epidemiologic and health outcome studies, and genetic research.
The Department's recently issued (7/06/01) guidance, intended
to provide technical assistance with implementation of the
privacy regulation, does not address this or the majority
of the other concerns that research organizations have raised
about the rule's impact.
Our concerns, along with a range of proposed modifications
to address the rule's impediments to research, were detailed
in the many letters that we severally submitted to the Department
during the comment periods on the proposed and final rules,
and in subsequent communications. With this letter we hope
to alert the Department to the growing consensus within the
research community that the rule must be amended as quickly
as possible, to avoid the inevitable harm that will result
when covered entities and research companies in private industry
begin their implementation efforts.
As researchers and representatives of research organizations,
we recognize that safeguards for privacy and confidentiality
are profoundly important to research participants. We commend
the Department's commitment to protecting health information
privacy, and we share the goal of ensuring the protection
of privacy in research. We believe nonetheless that the privacy
rule can be - and must be - amended to better serve the public
interest in sustaining the research enterprise. We are eager
to assist the Department in its efforts to accomplish this
objective.
Sincerely,
AdvaMed, Advanced Medical Technology Association
American Medical Group Association
Association of Academic Health Centers
Association of American Medical Colleges
Association of American Universities
BIO, Biotechnology Industry Organization
California Healthcare Institute
Council on Governmental Relations
Federation of American Societies for Experimental Biology
Healthcare Leadership Council
Lasker /Funding First
Pharmaceutical Research and Manufacturers of America
Society for Epidemiologic Research
Task Force on Informed Consent Issues in Psychiatric Genetics
(US) of the International Society of Psychiatric Genetics
cc: The Hon. Mitchell E. Daniels, Director, Office of Management
and Budget Members of the 107th Congress
Replies to the endorsing organizations may be addressed care
of David Korn, MD and Roger Meyer, MD, Association of American
Medical Colleges, 2450 N St. NW, Washington, DC, 20037.
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