FDA to regulate mobile medical apps

Whether you want to measure your heart rate or count calories, there’s probably a smartphone “app” to help you do it.

In an attempt to regulate the rapidly expanding selection of mobile health-related applications, the Food and Drug Administration (FDA) recently issued final guidance for developers of medical apps.

Industry analysts estimate that there are already more than 17,000 medical apps available for mobile device users, and that as many as 1,000 new medical software products are being sold each month for smartphones.

“Mobile applications can be a great tool for people with chronic health diseases,” said Gloria Boland, a Certified Diabetes Educator and nurse at Advocate Condell Medical Center in Libertyville, Illinois. “Anything that’s going to make it easier for patients to stay on top of their condition is definitely beneficial,” said Boland.

The FDA said the vast majority of health-related apps don’t pose much of a danger to consumers if they malfunction and will not be federally regulated. Instead, the agency will focus on apps that present a greater risk to patients if they do not work as intended, such as those that:

• are intended to be used as an accessory to a regulated medical device; or
• transform a mobile platform into a regulated medical device.

“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Dr. Jeffery Shuren, director of the FDA’s Center for Devices and Radiological Health, in a news release. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”

The FDA will consider the apps case by case and subject them to the same regulatory standards that apply to other medical devices. To date, the agency has cleared approximately 100 mobile medical applications, with nearly 40 of those cleared in the past two years.