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Slide Presentations
National Institutes of Health
Slide Presentation on the Privacy Rule and Research
Slide 37:
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Slide 37 |
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Access to Research Records
- Individuals have the right to inspect and obtain a copy of their PHI maintained by covered entities in a "designated record set."
- For research records, patients may have right to access records if:
- The records involve medical records (e.g., some clinical trials) or they are used to "make decisions about individuals." AND
- The researcher is a covered entity or a business associate of a covered entity.
- EXCEPT: While a trial is ongoing, covered researchers may
deny access if the individual agrees in advance (e.g., in an
Authorization) and has been informed that access resumes
upon completion of research.
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