FDA Says It Should Regulate Medical Apps

Proposal would allow agency to regulate apps used for diagnosis or medical monitoring.
Image courtesy of the FDA
Image courtesy of the FDA

Imagine you’re suffering from heart disease, and you have a nifty little attachment that fits into your smartphone with an app that turns it into an electrocardiogram. You depend on the app to let you know when your heart is working normally, but it malfunctions, fails to alert you to a problem, and you wind up having a heart attack.

This is the sort of scenario the Food and Drug Administration is seeking to prevent with its proposal to regulate mobile medical apps that users increasingly depend on to advise them about their health. “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,” says a statement from the FDA. Only those apps that monitor health, either by combination with other devices or by providing doctors information they use for diagnosis would be included.

The FDA says it’s seeking comment, so we’ll start: Sounds like a pretty good idea to us.

Read more at CNET.

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