Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Food and Drug Administration


Comment: A few comments expressed concerns about the use of protected health information for reporting activities to the Food and Drug Administration ("FDA"). Their concern focused on the ability to obtain or disclose protected health information for pre- and post-marketing adverse event reports, device tracking, and post-marketing safety and efficacy evaluation.

Response: We agree with this comment and have provided that covered entities may disclose protected health information to persons subject to the jurisdiction of the FDA, to comply with the requirements of, or at the direction of, the FDA with regard to reporting adverse events (or similar reports with respect to dietary supplements), the tracking of medical devices, other post-marketing surveillance, or other similar requirements described at § 164.512(b).