Mobile Health: What Should Be Regulated And What Not?

With the mHealth industry anxiously awaiting the U.S. Food and Drug Administration's final draft of guidelines for mobile medical apps (expected by this fall), the talk at that particular panel discussion focused on what should be regulated and what shouldn't. Bakul Patel, a policy adviser for the FDA's Center for Devices and Radiological Health, pointed out that the market is flooded with apps – many of them harmless, but some of them potentially dangerous and in need of regulation. "It's not just about cool software or making something useful," he said in a video feed to the conference, held at the Collonade Hotel. "You have to understand the risks … and the intentions."

Taking up the reins for most of the session was Brad Merrill Thompson, general counsel for the mHealth Regulatory Coalition and counsel for the Continua Health Alliance. Thompson, who drafted a response from the coalition to the FDA's guidance document, issued about a year ago, said the FDA is only concerned with a small fraction of mobile medical apps that meet specific uses: They either assist in the development of clinical decisions for health issues, or as accessories that cause an app to be used as a medical device.Thompson said stakeholders want the FDA to clarify the issue of intended use, which focuses on the difference between wellness and health apps, and much of that discussion focuses on what the developer says the app will do. "It all comes down to how you promote the product," he said...