FDA takes 'light touch' in Apple Watch regulation

The Food and Drug Administration will enforce minimal scrutiny on wearables such as the Apple Watch.

Bakul Patel, the FDA's policy advisor in the Office of the Center Director and the associate director for digital health, told Bloomberg Business that wearables and smartphone apps have not shown enough potential for danger to warrant close scrutiny from the FDA.

"We are taking a very light touch, an almost hands-off approach," Mr. Patel told Bloomberg Business. "If you have technology that's going to motivate a person to stay healthy, that's not something we want to be engaged in."

The FDA is reconsidering its oversight processes for the increasing market of wearable devices and smartphone apps in healthcare. The Federal Trade Commission has stepped in a few times this year, cracking down on smartphone apps that claimed to diagnose melanoma based on pictures, according to the report. Mr. Patel said companies like Apple and Google should take a larger role in scrutinizing apps and programs to ensure that the developers are not blowing the software's potential out of proportion.

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