Letter to Secretary Thompson
on Impact of Medical Privacy Rule on Research
November 20, 2001
The Honorable Tommy G. Thompson
Secretary of Health and Human Services
Room 615F
Hubert H. Humphrey Building
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, and medical specialty and scientific
societies. We write to voice our serious concerns regarding
the Department's final rule, "Standards for Privacy of
Individually Identifiable Health Information." Unless
substantially amended, this Rule will create significant obstacles
to the conduct of biomedical, epidemiologic, health services,
and other health-related research. We recognize and strongly
support safeguards for patient privacy and confidentiality
that are profoundly important to research participants. We
do not believe that the final federal privacy rule, "Standards
for Privacy of Individually Identifiable Health Information,"
successfully balances the call for enhanced privacy protections
with the need for medical progress.
We 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 have been sent 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 our
community that the rule must be amended to avoid the harm
that will result when covered entities and research companies
in private industry begin their implementation efforts.
Federal research regulations, known as the "Common Rule,"
grant Institutional Review Boards (IRBs) the flexibility to
determine, on a case-by-case basis, the physical, procedural
and technical safeguards that are necessary to protect participants'
privacy and confidentiality. A 1997 report by the National
Committee on Vital and Health Statistics underscores that
the IRBs' privacy safeguards work. The final medical privacy
rule needlessly intrudes upon this longstanding and proven
system of IRB oversight, burdening biomedical and behavioral
research with onerous procedural requirements, ambiguous regulatory
standards, and intimidating liability concerns.
-
The rule is causing hospitals, health plans and providers
to question whether disclosing data for research purposes
carries too great a compliance cost and liability risk
to justify their continued sharing of deidentified or
identifiable data with unaffiliated researchers, even
if the research is approved by an IRB under the Common
Rule. The locking down of these data bases would paralyze
vital public health research.
-
The rule's standard for de-identification of medical
information will render the data useless for much epidemiological,
health services and other population-based research. Paradoxically,
researchers whose needs could have been met with more
reasonably de-identified information will be obliged to
seek identifiable information instead.
-
The rule's requirement that uses and disclosures of protected
health information for research be limited to the "minimum
necessary" imposes an unworkable standard upon research.
Even researchers themselves cannot always determine prospectively
what minimum amount of information will be necessary to
conduct the research safely and effectively.
-
The rule will make it much more difficult, costly, and
time-consuming to conduct multi-center clinical trials
of new devices, drugs or biologics. Given the significant
liability exposure imposed by the rule, covered entities
will be reluctant to rely on waivers granted by external
(e.g. central) IRBs or privacy boards necessitating duplicative
reviews of authorizations or waiver requests by each trial
site.
-
The rule fails to recognize the critical connection between
a vital public health system and the rich repository of
medical information that resides in the records of healthcare
providers and in voluntary registries whose existence
is neither mandated by law nor directed by the FDA. In
this regard, the rule will undercut efforts to strengthen
our public health system.
As leaders in our nation's medical schools, teaching and
community hospitals and scientific societies, we commend the
Department's commitment to protecting the privacy of personal
health information. We believe that the Department's final
rule, "Standards for Privacy of Individually Identifiable
Health Information" needs to be modified in order to
assure the United States of a strong public health and biomedical
research infrastructure, while protecting the privacy of personal
health information and strengthening safeguards of confidentiality
for patient information. We urge the Secretary to re-open
the Rule Making period to address the serious problems in
the rule, as we share the goal of ensuring the protection
of privacy in research. We are eager to assist the Department
in its efforts to accomplish this objective.
Sincerely,
Academy of Clinical Laboratory Physicians and Scientists
Advocate Health Care
Albert Einstein College of Medicine
Ambulatory Pediatric Association
American Academy of Neurology
American Academy of Orthopedic Surgeons
American Academy of Physical Medicine and Rehabilitation
American Association for the Surgery of Trauma
American Association for Vascular Surgery
American Association of Anatomists
American Association of Plastic Surgeons
American Board of Physical Medicine and Rehabilitation
American College of Epidemiology*
American College of Neuropsychopharmacology
American College of Obstetricians and Gynecologists
American College of Physicians - American Society of Internal
Medicine
American Geriatrics Society
American Hospital Association
American Pediatric Society
American Physiological Society
American Society for Biochemistry and Molecular Biology
American Society for Bone and Mineral Research
American Society for Clinical Nutrition
American Society for Clinical Pharmacology and Therapeutics
American Society for Investigative Pathology
American Society for Reproductive Medicine
American Society for Rickettsiology
American Society of Hematology
American Society of Human Genetics
A O North America
Associated Medical Schools of New York
Association for Medical School Pharmacology
Association for Molecular Pathology
Association for Surgical Education
Association of Academic Health Centers
Association of Academic Physiatrists
Association of American Medical Colleges
Association of Anesthesiology Program Directors
Association of Departments of Family Medicine
Association of Family Practice Residency Directors
Association of Medical School Microbiology and Immunology
Chairs
Association of Medical School Pediatric Department Chairs
Association of Medical School Psychologists
Association of Pathology Chairs
Association of Professors for Human and Medical Genetics
Association of Professors of Dermatology
Association of Professors of Medicine
Association of Program Directors in Internal Medicine
Association of Subspecialty Professors
Association of Teachers of Preventive Medicine
Association of University Radiologists
Aultman Hospital
Ball Memorial Hospital
Baystate Medical Center
Boston University School of Medicine
Bridgeport Hospital
Brody School of Medicine at East Carolina University
Brown Medical School
Cardinal Health System
Carolinas Medical Center
Cedars-Sinai Medical Center
Charleston Area Medical Center Health Education and Research
Institute
Children's Hospital and Regional Medical Center, Seattle
Children's Hospital Medical Center, Cincinnati
Cleveland Clinic Foundation
Coalition for American Trauma Care
College of American Pathologists
Columbia University College of Physicians and Surgeons
Conference of Boston Teaching Hospitals
Cooper Health System
Creighton University
Duke University School of Medicine
Eastern Association for the Surgery of Trauma
Eastern Virginia Medical School
Federation of American Societies for Experimental Biology
Greenwich Hospital
Harlem Hospital Center
Henry Ford Health System
International Society for Pharmacoepidemiology
Jefferson Medical College
Johns Hopkins Hospital and Health System
Johns Hopkins Medicine
Johns Hopkins University
Keck School of Medicine of the University of Southern California
Lehigh Valley Hospital and Health Network
Long Beach Memorial Medical Center
Louisiana State University Health Sciences Center - New Orleans
Louisiana State University Health Sciences Center - Shreveport
Magee-Womens Hospital
Maine Medical Center
Medical College of Georgia
Medical College of Wisconsin
MedStar Health - Columbia, Maryland
Meharry Medical College
Meharry Medical Services Foundation
Memorial Health System
Memorial Sloan - Kettering Cancer Center
Michigan State University - Kalamazoo Center for Medical Studies
Michigan State University College of Human Medicine
Morehouse School of Medicine
New York University Medical Center
Northeastern Ohio Universities College of Medicine
Northwestern University Medical School
Ochsner Clinic Foundation
Ohio State University
Orthopaedic Trauma Association
Parkland Health & Hospital System
Pennsylvania State University College of Medicine
Research Institute, University Hospitals of Cleveland
Rockefeller University
Saint Louis University Health Sciences Center
Shands HealthCare
Sioux Valley Hospitals and Health System
Society for Academic Continuing Medical Education
Society for Education in Anesthesia
Society for Epidemiologic Research
Society for Investigative Dermatology
Society for Pediatric Research
Society for Vascular Surgery
Society of Academic Anesthesiology Chairs
Society of General Internal Medicine
Society of Teachers of Family Medicine
Society of University Otolaryngologists
Spectrum Health
Stanford University School of Medicine
Stony Brook University Health Sciences Center
The Sturge-Weber Foundation
Summa Health System Hospitals
SUNY Upstate Medical University - Syracuse
Texas A&M University
Thomas Jefferson University Hospital
Tufts University School of Medicine
Universidad Central del Caribe School of Medicine
UCSF Medical Center
University Hospitals Health System
University Hospitals of Cleveland
University of Alabama School of Medicine
University of Arkansas for Medicine Sciences
University of California, San Francisco, School of Medicine
University of Chicago
University of Cincinnati College of Medicine
University of Connecticut Health Center
University of Florida Health Science Center
University of Illinois at Chicago
University of Iowa College of Medicine
University of Iowa Hospitals and Clinics
University of Kansas Medical Center
University of Kansas School of Medicine
University of Kentucky College of Medicine
University of Louisville School of Medicine
University of Medicine and Dentistry of New Jersey - Robert
Johnson Medical School
University of Michigan
University of Minnesota Medical School - Twin Cities
University of Mississippi Medical Center
University of Nevada School of Medicine
University of North Carolina
University of North Dakota School of Medicine and Health Sciences
University of North Texas Science Center/Texas College of
Osteopathic Medicine
University of Oklahoma Health Sciences Center College of Medicine
University of Pennsylvania Health System
University of Pittsburgh
University of Puerto Rico, Medical Science Campus, School
of Medicine
University of Rochester Medical Center
University of South Dakota School of Medicine
University of South Florida, College of Medicine, Health Science
Center
University of Tennessee Health Science Center
University of Texas Health Center at Tyler
University of Texas Health Science Center at Houston
University of Texas Health Science Center at San Antonio
University of Texas M.D. Anderson Cancer Center
University of Texas Medical Branch at Galveston
University of Texas Medical Branch School of Medicine
University of Texas Medical School at Houston
University of Texas Southwestern Medical Center at Dallas
University of Texas System
University of Utah
University of Vermont College of Medicine
University of Virginia School of Medicine
University of Washington Medical Center
University of Washington School of Medicine
University of Wisconsin Hospital and Clinics
UPMC Health System
Vanderbilt University Medical Center
ViaHealth
Virginia Commonwealth University
Wake Forest University School of Medicine
Washington University School of Medicine in St. Louis
Weill Medical College of Cornell University
West Virginia University School of Medicine
Yale-New Haven Health System
Yale University
cc: Sally Canfield
Arthur J. Lawrence
Ann-Marie Lynch
John H. Marburger, III
Ann Phelps
William Raub
* Endorsed after Nov. 20, 2001
|
