Smartphone apps moving into regulatory gray area

This is the kind of statement that might scare the daylights out of your average healthcare software developer: "Medical applications are technically medical devices and therefore subject to federal regulation." It's followed by the kind of statement that might concern a skeptical public: "There currently are no clear federal measures in place, however, to guarantee their quality and accuracy."

Both lines come from no less a publication than Scientific American, which this week takes up the touchy subject of FDA regulation of smartphone apps. It's been a plausible possibility since February, when Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, testified before an FDA committee on health technology.

"With the rapid integration of apps into routine healthcare, however, time seems be of the essence. And as many physicians already use apps to check and update patient status, concern about logging crucial data incorrectly is not unfounded," Scientific American reports. "Adverse events resulting from medical apps and other health information technology errors have already been reported to the FDA."

Adam Wilcox, a medical informatics professor at Columbia University, believes the FDA has no business regulating reference apps, which essentially are electronic versions of textbooks. He likewise is against regulation of apps that serve as EMR portals because neither the interface nor the EMR itself is subject to FDA approval.

Image viewers--a subset of medical apps Scientific American does not address--could present more of a gray area, however, especially if they are used for diagnostic purposes. And Wilcox acknowledges that the FDA may have jurisdiction over apps that track vital signs or help physicians interpret EKG results.

"For the FDA the challenge will be to keep patients safe without impeding innovation," the story says.

To learn more:
- read this Scientific American story

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