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# Draft Patient-Specific Info Dissemination Guidance
- URL: https://www.fdaweb.com/draft-patient-specific-info-dissemination-guidance/
- Published: 2016-06-09T12:00:00.000Z
- Updated: 2026-09-14T21:08:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135887

FDA has issued a draft guidance, *Dissemination of Patient-Specific Information from Devices by Device Manufacturers*, to “facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers to patients.” The [document](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM505756.pdf?ref=fdaweb.com) notes that patients increasingly are seeking to play an active role in their own healthcare. FDA wants manufacturers to understand that they may share information from a medical device with the patient who is either treated or diagnosed with that specific device.

“FDA believes that providing patients with access to accurate, useable information about their healthcare when they request it (including the medical products they use and patient-specific information these products generate) will empower patients to be more engaged with their healthcare providers in making sound medical decisions,” it says. The agency recommends that when manufacturers share patient-specific information, they consider the content of the information provided, the context in which patient information from medical devices should be understood, and the need for access to additional, follow-up information from the manufacturer of a healthcare provider. These considerations, it says, will help ensure that the information is useable by the patient and will help avoid disclosure of confusing or unclear information that could be misinterpreted.