Advice from the FDA on Medical Device Data Sharing

Among the many forms of data flow that might occur from a medical device is direct to the patient. This received some notoriety when a patient wanted to access the output directly from their own implanted device. They had to do battle with the device manufacturer who claimed among other things that the FDA would not allow them to make the data available. It turns out that the “FDA won’t let us” is a well known, if not necessarily correct, excuse in a different arena, that of medical device service and repair. The FDA has added some clarification in this area with a recent Draft Guidance Document (DGD) entitled “Dissemination of Patient-Specific Information from Devices by Device Manufacturers”. The DGD is not limited to implants but includes any device with which a patient is treated or diagnosed and which presumably retains such information. Remember that a Guidance Document is a non-binding communication from the FDA about its current thinking on a subject. That makes a Draft Guidance Document what FDA thinks it is thinking, subject to a comment period and a possible reworking, dropping of, or forgetting about the Draft which might remain in draft form for years. The DGD speaks to the “appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers to patients”. Since it is device manufacturers that are being addressed, the as...
Source: Medical Connectivity Consulting - Category: Information Technology Authors: Tags: Standards & Regulatory Source Type: blogs