From: mobi health news
In June, the FDA offered up a draft guidance document designed to help medical device makers better understand how the agency thinks about a patient’s right to access their own data from a device. The guidance clarified that medical device makers can make a patient’s data available to them without additional clearance, though it cautioned them to do so thoughtfully to keep the data private and secure.
Now, as the Regulatory Affairs Professionals Society noted on Monday, a number of industry groups have already responded with comments to the draft guidance. Neither industry nor patient groups seem entirely happy with the level of clarity in the guidance.
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