The U.S. Food and Drug Administration plans to monitor some of the thousands of mobile health applications that have sprung up for smart phones, PDAs and tablet computers. The apps need to do what they promise if there's any chance a failure could endanger patient health, the agency said Tuesday.
That's when the FDA issued 30 pages of guidelines for its proposed oversight. The agency says its goal is to "balance patient safety with innovation."
The FDA already regulates medical devices, so it may opt to cover mobile medical apps under that category, rather than issue a new regulation for them. Consumers can learn about what is covered and what's planned through the FDA's mobile health-related apps page.
Those it plans to oversee are the ones "used as an accessory to an FDA-regulated medical device," such as an app that lets a doctor view an ultrasound on a smartphone. That falls under the category of devices that can "impact" how an already-regulated device — in this case, an ultrasound — performs, the agency said in a news release. It will also oversee the apps that "transform a mobile platform into a regulated medical device." Its example is the app that turns a smartphone into an electrocardiography (ECG) machine to look at heart rhythms and possible disorders.
By 2015, the FDA predicts a half-billion smartphone users worldwide will use one health care app or another.
"The use of mobile medical apps on smartphones and tablets is revolutionizing health care delivery," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a prepared statement. "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."
A release by the FDA notes the wide range of health-related apps available, from the National Institutes of Health's LactMed app that provides information for nursing mothers to a Radiation Emergency Medical Management app to help care providers deal with radiation injuries, to simpler programs that track calories burned. They've already "cleared a handful of mobile medical apps used by health care professionals, such as a smartphone-based ultrasound and an application for iPhones and iPads that allows doctors to view medical images and X-rays."
The rules won't apply to "apps that track exercise regimens or help patients quit smoking, for example," according to a Los Angeles Times story, which also noted that in a Twitter chat "the federal agency also clarified that the ultimate responsibility for an app's safety and effectiveness falls to the manufacturer."
Apps that give advice won't be overseen by the federal watchdog, either.
The proposed regulations were included in the Federal Register Wednesday.
The public can respond to the proposal during a 90-day comment period by going to the government regulations comment site, which calls itself "Your voice in federal decision-making."
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