“The use of mobile medical apps on smartphones and tablets is revolutionizing healthcare delivery,” Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a news release announcing the regulatory advisory. “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.”
The FDA's 29-page proposal does not establish legally enforceable responsibilities for app and device developers—though it signals a likely move in that direction. A 90-day public comment period on the recommendations is now open.
All of this suits Chuck Parker, executive director of the Continua Health Alliance trade group, just fine. Continua Health Alliance advocates for the adoption of common communication standards by medical devicemakers.
“I think it's a good thing,” Parker said of the FDA proposal. “Anything we can get from them has been a positive for us. We had been in a fog up to now. And it's open for comment, so it opens a dialogue.”
The FDA proposal differentiates between what it calls “mobile platforms,” which are defined as commercial off-the-shelf computing platforms, such as smartphones and tablets, and “mobile medical applications”—software programs tailored to run on a mobile platform.
According to the FDA's guidance, not all health-related programs running on an iPad, iPhone or BlackBerry qualify as mobile medical apps—that designation is reserved for apps that are “used as an accessory to a regulated medical device” or that “transform a mobile platform into a regulated medical device.” By definition, according to the FDA, when a mobile app's intended use is for diagnosing, preventing, treating or curing a disease or condition, the app is a device. The level of risk to a person's health associated with the use of the mobile medical app also will have a bearing on the level of federal regulation it receives, according to the FDA.
Dr. Joseph Smith, chief medical officer and chief science officer at the West Wireless Health Institute, a not-for-profit organization promoting the use of wireless home health technology to improve care and lower healthcare costs, echoed Parker's praise.
“I really like that the FDA has drawn a really clean line between the ubiquitous smartphone system and the healthcare apps that can reside on them,” Smith said.
Also, he said, it's helpful that the FDA has differentiated between those software applications that merely record and analyze self-reported wellness data, such as weight, diet or physical activities and those that aim to aid in diagnosis of disease or help clinicians make a better decision about a treatment plan, he said.
“It provides clarity,” he said. “When the regulatory space is uncertain, it kind of stymies innovation. I liken it to, if you're an Olympic slalom skier, there's no way you're going to jump off and head down the mountain if they're still putting the gates in position. You can't plan your course.”
Parker said a recent recommendation by a National Resource Council committee (see "Joint effort," July 25)—that the FDA adapt its adverse reporting system to receive complaints about home health devices—also would be worthwhile for application developers and devicemakers.
“We are dealing in this case with first generation of technology,” he said. “We need to know what the feedback is to improve these technologies, so this is sort of an innovative model to institute this type of feedback.”