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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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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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If you’re unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with: |
an organizational IRB, privacy officer or official, depending on the case |
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