"Medical applications are technically medical devices and therefore subject to federal regulation... There currently are no clear federal measures in place, however, to guarantee their quality and accuracy."

These lines, from the article "iRegulate: Should Medical Apps Face Government Oversight?" in Scientific American, got me thinking about the smartphone as 'medical device'. In February, Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, testified before an FDA committee on health technology. He said: "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... Adverse events resulting from medical apps and other health information technology errors have already been reported to the FDA."

Certainly as we see more 'expert decision support systems' built into smartphone devices, there use in the health care field will expand - and will draw increasing attention from regulators.

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