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Health Research and the HIPAA Privacy Rule
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To the Editor: The study of the influence of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule on health research by Dr Ness1 and the accompanying Editorial by Drs Fost and Levine2 critiqued the institutional review board (IRB) process and the influence of the HIPAA requirements. The study conclusion that the HIPAA regulations make epidemiological research more burdensome with little benefit to privacy protections may be more reflective of ineffective alignment of HIPAA implementation with the IRB process by institutions rather than the regulations themselves.
Except for an assertion that the research plan should make adequate provision to preserve privacy and confidentiality, the IRB regulations contain none of the comprehensive standards found in the privacy and security rules.3 Harmonization of the 2 sets of regulations to facilitate research and still preserve privacy and confidentiality is essential. The regulations appear flexible enough for institutions to do this. Asking for . . . [Full Text of this Article]
Samuel J. Tilden, MD, JD, LLM
stilden@uab.edu Office of Research Compliance University of Alabama at Birmingham
RELATED ARTICLE
Influence of the HIPAA Privacy Rule on Health Research
Roberta B. Ness and for the Joint Policy Committee, Societies of Epidemiology
JAMA. 2007;298(18):2164-2170.
ABSTRACT
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Health Research and the HIPAA Privacy Rule
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Health Research and the HIPAA Privacy Rule—Reply
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