When To Regulate mHealth Apps?

Diana Manos | Government Health IT | January 8, 2013

With events such as the Consumer Electronics Associations’ 2013 International CES conference this week in Las Vegas, featuring a dizzying 3,000 global app companies and a digital health summit, there is a lot of hype around what apps can do for healthcare. But as the apps flood forth, what about regulation, in a world where the sluggish wait for FDA approval is a dirge often heard? What do experts advise doctors to look for when they want to use an app?

Kerry McDermott, the former director of healthcare for the Federal Communications Commission (FCC), now senior director of health care technology policy for West Health Institute, a non-profit organization focused on lowering healthcare costs, says there is “a lot of consternation in the market.”

“[Vendors] can innovate faster than the regulatory environment can keep up with," she says. "The FDA is trying to set up guidance in the mobile app space. They are really trying to take a light-touch approach. There are so many apps that can do good; regulators want to let them flourish. Policy is a very blunt instrument. In today's world that doesn't cut it anymore. We need something to be more tailored."...