FDA seeking to regulate mobile medical apps

The federal agency is looking for public input on a proposal that would allow it to regulate certain types of medical apps designed for smartphones and other mobile devices.

The Food and Drug Administration is looking for input on a new proposal that would let it regulate certain medical apps that run on mobile devices.

Noting that today's crop of mobile medical apps can perform a variety of tasks, from counting calories to helping people monitor their weight to letting doctors view patient scans, the agency wants to ensure that such apps are safe.

"The use of mobile medical apps on smartphones and tablets is revolutionizing health care delivery," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a 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."

As such, the FDA's draft proposal would cover only specific types of mobile medical apps. One type would be an app used as an accessory to a medical device that's already regulated by the agency, for example, an app that lets a doctor make a specific diagnosis by viewing an image from a picture archiving and communication system (PACS) on a mobile device.

The other type would include apps that turn a smartphone or other mobile device into a regulated medical device through the use of certain attachments or sensors, for example, an app that converts a phone into an ECG (electrocardiogram) machine to measure heart rhythms.

Through its proposal, the FDA says it's actually looking to encourage the development of new apps. Anyone who wants to learn more about the proposal can find more information at the agency's Draft Guidance page.

About the author

Journalist, software trainer, and Web developer Lance Whitney writes columns and reviews for CNET, Computer Shopper, Microsoft TechNet, and other technology sites. His first book, "Windows 8 Five Minutes at a Time," was published by Wiley & Sons in November 2012.

 

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