On June 10, 2016, FDA-CDRH issued a draft guidance document, UCM505756, Dissemination of Patient-Specific Information from Devices by Device Manufacturers.
You may the comments to the docket at https://www.regulations.gov. The Docket Number is FDA-2016-D-1264.
In the introduction, the draft guidance, FDA points out that patients increasingly seek to play a role in their own healthcare. The draft guidance document is intended to clarify that manufacturers may share patient-specific information recorded, stored, processed, retrieved, and/or derived from a medical device with the patient who is either treated or diagnosed with that specific device.