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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 29:
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Option 4: Preparatory to Research Covered entity must obtain representation from the researcher that:

Covered entity must obtain representation from the researcher that:

  • The use or disclosure of PHI is sought solely to prepare a protocol or for a similar preparatory purpose.
  • PHI will not be removed from the covered entity. AND
  • PHI is necessary for research purposes.

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