m-health

FDA’s Patel: Apple Watch is safe from scrutiny for now

Apple Watch

The U.S. Food and Drug Administration’s point man on consumer-Apple Watchfacing mHealth products says his agency is going to take it easy on regulating wearables like the Apple Watch.

That’s because the industry is focusing on health and fitness sensors, he said, and hasn’t gotten to the point where it’s collecting viable healthcare data.

In an interview with Bloomberg, Bakul Patel said the FDA doesn’t want to get in the way of innovation, especially at a time when the wearables market isn’t targeting healthcare functions that would warrant closer scrutiny.

“We are taking a very light touch, an almost hands-off approach,” the FDA’s associate director for digital health said in the interview. “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”

For now, the smartwatch and wearables market is focused on using sensors to gather health and fitness data – such as heart rate, calories consumed and steps taken – but isn’t using that data to formulate or reinforce a clinical decision. If and when these products start assuming the functions of a medical device, Patel said, the FDA would then step in.

“We are focusing only on the higher end of technology,” he said. “What are benefits to public health against the risks to public health? We always try to balance that.”

“We have to be confident in what we are getting,” Patel added in the interview. “The trajectory is there and all signals are headed that way, but by the same token the research and science should get us that confidence. It boils down to will it work or not.”

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