FDA Answers Device Industry Complaints On Patient Information Sharing Policy

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...