FDA: Medical Device Orgs Must Offer Patient Access to Health Data

FDA has issued final guidance to authorized medical device manufacturers, clarifying that it is acceptable for those manufacturers to open patient access to health data for those patients who request access.

The guidance states that medical device manufacturers are not prohibited from sharing this information with patients and providers upon request. The guidance does not amend any current law, including HIPAA, nor does it override any existing FDA governance. The guide simply serves as a clarification for medical device manufacturers.

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