HIPAA’s protections for health information used for research purposes… May be used at the institution’s discretion instead of the Common Rule and FDA protections. Supplement those of the Common Rule and FDA. Replace those of the Common Rule and FDA for human subjects protection. Only apply to research conducted inside covered entities.

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Explanation:

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.

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.

HIPAA includes in its definition of "research," activities related to ...

development of generalizable knowledge.

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.

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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