Tuesday, April 17, 2012

FDA Tangles With Wireless Medical-App Makers

From the article: "An onslaught of mobile health technology has forced an arranged marriage between smartphone app makers and the Food and Drug Administration — because someone had to regulate them. There’s just one problem: Many of the tech wizards aren’t used to FDA supervision. And now, both sides are struggling to figure out how to live with each other.

Last year, the FDA suggested some ground rules: If you make an app that claims to diagnose or treat a medical condition, then you need to show that it’s safe and effective before you sell it, just as other medical-device makers do.

That seemed reasonable enough to the traditional medical-device industry, which is well-versed in the ways of the FDA. But the requirements — data on effectiveness, possibly clinical trials — have gobsmacked some software developers who are used to working in the fast-paced, relatively unregulated wilds of the Internet." Read more