FDA issues draft document on mobile app regulations

By Eric Wicklund
10:34 AM

The U.S. Food and Drug Administration is wading into the complex world of mobile medical applications.

The FDA has released a 30-page draft guidance designed to outline how mobile medical apps should be regulated as medical devices, targeting an issue that has long plagued physicians looking to adopt apps and vendors wondering how far they can go without incurring the regulations.

Comments on the draft regulations will be accepted by the FDA until October 19.

[See also: mHealth apps forecast to increase threefold by 2012.]

“The use of mobile medical apps on smartphones and tablets is revolutionizing healthcare delivery," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, in a press release. "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."

Under the draft guidelines, of the thousands of medical apps now available, only a small portion would face review. They would fall into two categories:

  1. Apps that serve as an accessory already regulated by the FDA, such as one that allows a professional to diagnose a condition from an X-ray or other image viewed on his or her smartphone;
  2. Apps which turn a mobile platform into a medical device, such as one that would allow a smartphone to receive ECG data and allow a physician to observe heart rhythm – and perhaps even diagnose a heart attack.

In some cases, FDA officials said, the guidelines would compel software developers to prove that their apps work as well as non-mobile devices.

Examples of mobile medical apps that would not fall under FDA review include electronic versions of medical reference manuals; devices that log, store, transmit and evaluate medical data but aren’t intended for making clinical diagnoses (wellness-based apps would fall under this category); devices that automate general office operations; mobile electronic health records or personal health records; and devices that offer assistance but aren’t marketed for a specific medial issue.

According to Research2Guidance 2010, 500 million smartphone users worldwide will be using a healthcare application by 2015. Recent estimates have pegged the number of mobile medical apps now on the market to more than 4,000.

[See also: Mobile health monitoring market on the rise.]

The issue of regulating mobile apps has come up frequently at healthcare conferences. At the 3rd mHealth Networking Conference, organized by the Boston-based mHealth Initiative this past March in Chicago, a panel session debated the difference between an app that simply collects and transmits information with one that provides clinical guidance.

Robert Jarrin, senior director of government affairs for the San Diego-based telecommunications giant Qualcomm, said at the time that the FDA and other agencies with a hand in governing medical devices are working with 30-year-old regulations that don’t mesh well with the ever-changing mobile healthcare market. He noted that in testimony on Capitol Hill last year, an electronic health record could conceivably be designated a medical device – thus opening the door to a host of devices, services and software solutions that may or may not be skirting the law.

Madeline Pantalone, vice president or strategy and business development for GreatCall, wondered at that time whether more guidelines would curb innovation.

“A lot of innovation comes out of small companies these days,” she said. “They can’t afford to be tied up in regulatory guidelines.”

Of today’s FDA announcement, Bakul Patel, a policy advisor for the FDA’s device center, was quoted in news reports as saying the agency has to keep safety in mind.

The FDA has to “strike that fine balance between promoting innovation and assuring safety and effectiveness,” he said.

The FDA is seeking public input on this approach. Once posted, comments can be submitted for 90 days, online or in writing, to the FDA’s Division of Dockets Management (HFA-305 at 5630 Fishers Lane, Room 1061, Rockville, MD 20852).

The FDA’s draft document can be found here.