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HIPAA Overview - HIPAA Waiver Criteria, con't
HIPAA Waiver Criteria, cont
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Waiver
requires IRB/Privacy Board approval
and documentation of three (3) waiver criteria:
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2. |
The research could not practicably be conducted without waiver or alteration |
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3. |
The research could not practicably be conducted without access to and use of the PHI
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Note: HHS intends to issue future guidance for IRBs and Privacy Boards on applying waiver criteria
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