As wearables move further into the realm of bona fide health devices (see our site Health Tech Insider for lots more on the subject), developers and manufacturers will inevitably have to deal with the U.S. Food and Drug Administration. The FDA regulates health devices. Most current wearables don’t fall under its jurisdiction, but it’s entirely possible that more sophisticated devices will, at some point in the not-very-distant future.
The FDA is rightly concerned about the security of medical devices, and has just released its latest guidelines on the subject. This covers far more than wearables, and applies to the full universe of digital medical devices. The key recommendation is that data security be considered from the initial stages of product design, and not added on as a patch or after-thought. Particular concerns include malware, data corruption and unauthorized dissemination, and password leaks.
There’s a public workshop on the subject scheduled for October 21. Paying attention to security won’t automatically result in FDA approval for a medical device, but failing to do so will most likely make a difficult approval process that much harder.