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New final guidance...

FDA Answers Device Industry Complaints On Patient Information Sharing Policy

November 08, 2017
FDA has significantly reworked portions of its guidelines relating to medical device manufacturers' sharing of patient-specific information with individual patients upon their request. A newly issued final guidance revises the agency's interpretation of the Health Insurance Portability and Accountability Act (HIPAA) requirements -- which industry stakeholders previously said was incorrect -- by stating that health care providers, not manufacturers, are responsible for providing context to patients about the information they receive, and assures manufacturers that patient-specific information will generally not...

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