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4. Does HIPAA apply to clinical research?


Yes.  HIPAA applies to clinical research that includes a treatment element or protocol, such as images or medications.  In addition to the information provided in Privacy Policies 30 (Research), 31 (Limited Data Sets, and 32 (De-Identified Data), investigators may refer to IRB policies and to the NIH’s “Clinical Research and the HIPAA Privacy Rule” fact sheet, located at https://privacyruleandresearch.nih.gov/clin_research.asp.

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