FDA plans oversight of some mobile medical apps

A fast-growing number of software applications offers doctors the chance to view X-rays or monitor heart rates from iPads or smartphones, prompting U.S. health officials to propose government oversight for some of the more complex health apps.

A portion of the apps perform tasks that mimic the work of medical devices and could cause harm if they failed to perform as promised, Food and Drug Administration officials said. New FDA guidelines state that in some cases software developers would have to show their apps worked as well as non-mobile devices for the same use. The agency would have to provide clearance for those apps before they could be sold. FDA officials said they recognized the potential benefits from mobile medical apps and aimed to encourage future development. "At the same time, we need to make sure these things are also safe and effective," said Dr. Jeffrey Shuren, head of the agency's medical device center.