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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Can medical entities such as referring physicians, pathology departments, and surgeons release patient biopsy information to mammography facilities for purposes of their MQSA medical outcomes audit without obtaining patient authorization?

Policy Guidance Help System logoSection 164.512(b) of the HIPAA regulations allows a covered entity (e.g., referring physician, pathology department, surgeon) to release patient biopsy information to a mammography facility for purposes of the MQSA medical outcomes audit without patient authorization because the disclosure: (1) is to a person subject to FDA jurisdiction; (2) concerns an FDA-regulated product or activity for which the mammography facility has responsibility; and (3) relates to the quality, safety, or effectiveness of the product or activity.

Back to HIPAA and Release of Information for MQSA Purposes