By establishing new waiver criteria and authorization requirements, hasn't the HIPAA Privacy Rule, in effect, modified the Common Rule?


No. Where both the Privacy Rule and the Common Rule apply, both regulations must be followed. The Privacy Rule regulates only the content and conditions of the documentation that  covered entities must obtain before using or disclosing protected health information for research purposes.

See our  research section and frequently asked questions about the research provisions for more information about the Common Rule.

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