FDA Rules Aimed at Riskiest Health Apps

Apps allowing physicians to diagnose a disease or use a smartphone to detect abnormal heart rhythms are among the mobile tools that will face scrutiny under a new FDA draft guidance issued July 19, 2011.

Some fear regulation will stunt the thriving mobile health market; however, FDA officials say the list of apps that will be subject to oversight is short. The rules’ narrow focus also means pharmacists who recommend mobile apps to patients or use them on the job are unlikely to lose access to their favorites anytime soon.

“Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health. These include any app that is used “as an accessory to an FDA-regulated medical device,” or to “transform a mobile platform into a regulated medical device.”

Most health apps pharmacists rely on—for example, drug databases offered by Lexicomp and Epocrates— don’t fall within these categories. In the draft guidance, FDA said it will not regulate mobile apps that are electronic “copies” of textbooks, teaching aids, or reference materials. Tools designed for consumers, such as weight loss or medication management apps, will also be exempt.

FDA expects 500 million smartphone users to be using a health application by 2015. With these growing numbers, said FDA policy adviser Bakul Patel, MS, MBA, “consumers and health care professionals should have a balanced awareness of the benefits and risks.”