FDA issues draft document on mobile app regulations

July 19, 2011 | Eric Wicklund, Contributing Editor

SILVER SPRING, MD – 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The FDA has released a 30-page draft guidance designed to outline how mobile medical apps should be regulated as medical devices, targeting an issue that has long plagued physicians looking to adopt apps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.

“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:

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;
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.

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.

Eric Wicklund

Editor of mHIMSS.org

Follow Eric on Twitter @eriwick

Reader Comments (1)Login to Post a Comment

Jesse_EngAmer says: Dangerous Regulation

July 19, 2011 | 1:38PM GMT

I don’t remember the first amendment being repealed do you?

Within the draft exists an affront on the constitutional protection of the Internet granted by the Supreme Court in 1997, a contradiction, a rather worrisome clause that sets a dangerous precedent and removal of funding from more pressing matters.

1)Many apps are extensions of mobile sites and Websites. Like the unenforced 1989 medical software bill, the FDA is looking to enforce the 1996 bill outlining regulation of online medical information
2)Some apps to be regulated use algorithms to compute specific patient treatment, when electronic textbooks available on mobile platforms with the same algorithms will not be regulated.
3)One clause states “when the intended use of a mobile app is for the diagnosis of disease or other conditions” the app will be regulated. Many doctors consult medical apps. Internet and social media have often led to a diagnosis a doctor could not come up with.
4)The FDA cannot afford to carry out the 2011 Food Safety and Modernization Act (FSMA). The FDA stated that “Half of all medical devices used in this country are imported” and that “it would take 9 years just to inspect every high-priority pharmaceutical facility alone” ignoring those of lower priority. The money spent regulating mobile apps could be put to much better use ensuring the safety of a much higher percentage of medical devices.