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National Institutes of Health HIPAA Privacy Rule - Information for Researchers
This website is currently in the process of being updated. For guidance on the HIPAA Privacy Rule in research, please see: https://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html
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Slide Presentation on the Privacy Rule and Research


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Use or Disclosure of PHI Without Authorization

Covered entities do not always need to get Authorization for research-related activities.

  1. De-identify PHI.
  2. Limited Data Set with Data Use Agreement.
  3. IRB or Privacy Board waiver of Authorization requirement.
  4. Activity preparatory to research.
  5. Research is on decedents’ information.
  6. Research qualifies for the Transition Provisions.

Department of Health and Human Services National Institutes of Health USAGov The HIPAA Privacy Rule