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HIPAA’s protections for health information used for research purposes… |
supplement those of the Common Rule and FDA. |
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HIPAA protects a category of information known as protected health information (PHI). PHI includes: |
identifiable health information that is created or held by covered entities and their business associates. |
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When required, the information provided to the data subject in a HIPAA disclosure accounting … |
must be more detailed for disclosures that involve fewer than 50 subject records. |
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HIPAA includes in its definition of "research," activities related to … |
development of generalizable knowledge. |
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Under HIPAA, a "disclosure accounting" is required: |
for all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets. |
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A HIPAA authorization has which of the following characteristics: |
Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document. |
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Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally … |
is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization. |
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