Wearables are quickly becoming popular, and a large draw of these new devices is health. Not only do they track the basics like heart rate and walking distance, but they now suggest ways to better yourself and create plans for you. You can even input caloric intake and a lot more. Health apps are getting smarter and smarter, and the FDA doesn’t want it to get out of hand.
I know what it sounds like, the FDA is butting into this and it’s more regulation that we don’t need. But thankfully, that doesn’t seem to be the case. This draft, which is not law and will be revised as feedback comes in, makes the distinction between general wellness devices and devices that have a risk to your health.
General wellness devices are what we’re all used to: the normal wearable that records info and shows it to you. Devices that provide suggestions on exercise and caloric intake are perfectly fine. The FDA draws the line at wearables that claim to treat diseases or provide medical functions, something that could be very dangerous and should rightfully be regulated.
So despite this being extra regulation, it’s probably for the best. We don’t want to see people being fooled into thinking they can solve serious ailments and not seek medical help when it’s needed. And thankfully, our regular wearables will be untouched.