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What are the requirements for research use of PHI?

The Privacy Rule applies to the following types of research activities when they involve PHI:

  • Research using or creating PHI about living individuals
    • Retrospective medical chart reviews
    • Existing biological samples
  • Activities preparatory to research
  • Research on decedents
  • Recruitment
  • Research using a limited data set
  • Collection of PHI of secondary subjects

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