FDA will have hands off approach to wearables

Although wearables are beginning to catch on in mainstream society, there is still some concerns in private and public sectors about personal privacy. That’s fair enough since this is the first time in history that we’ve developed consumer grade technology that’s designed to track data about us and been happy about it! To make sure that the public is being treated fairly by manufacturers and developers though, the US’ Food and Drug Administration recently looked into the way wearables track data and whether there should be some regulation. The results of that study suggest that for now at least, the FDA should have a hands off approach.

The reason that the FDA doesn’t really want to get involved though, isn’t necessarily because it’s entirely happy with current products and legislation – though it is – but because wearables are unlikely to fall under its jurisdiction, as long as they don’t pretend to be medical devices. While wearables can advertise themselves as being good for general fitness, or help you to live a healthier lifestyle, they can’t claim to make sweeping changes to your life all by themselves. If they do, the FDA may need to step in and require manufacturer to prove any such claims.

“We are taking a very light touch, an almost hands-off approach,” said FDA associate director for digital health Bakul Patel in a chat with Bloomberg. “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”

Many current wearables are described as "health trackers," by retailers.

Many current wearables are described as “health trackers,” by retailers.

That’s not to say that the FDA will always steer clear of regulating wearables, but that we are at a pivotal moment where we decide who should be in charge of new, emerging technologies. Surely an organisation with a technological basis should govern something as forward thinking as wearables? But then a new group would add bureaucracy and extra costs, versus adding some expertise to the old one.

However even if the FDA does stay in charge of wearable and other technology that claims to affect health, other federal organisations may step in too. Previously the Federal Trade Comission has gone after certain smartphone application makers, which previously claimed to be able to diagnose some serious conditions simply by users uploading a photograph of their problem.

Who would you guys like to see in charge of managing wearable development at a federal level?