Slide Presentations

National Institutes of Health
Slide Presentation on the Privacy Rule and Research

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Slide 35:

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Public Health Disclosures to a Public Health Authority Disclosure without Authorization permitted to a public health authority and certain other entities for public health activities. EXAMPLE: Adverse event reporting to a person subject to the jurisdiction of FDA (e.g., clinical trials drug sponsor), FDA or NIH (where authorized to receive such reports). A covered entity may disclose PHI related to an adverse event to NIH if required to do so by NIH regulations. Even if not required to do so, the researcher may disclose adverse events to NIH as a public health authority, as noted above. Also see guidance on public health at http://www.cdc.gov/privacyrule/