FDA taking ‘hands-off approach’ to regulating Apple Watch

With the Apple Watch poised to launch Apple into the health care industry, the Food and Drug Administration is doing its best to stay out of the way, Bloomberg reports. Current FDA guidelines leave mobile applications geared toward wellness and fitness tracking mostly free from scrutiny, focusing more on technology used to diagnose, treat and prevent illnesses.

FDA taking ‘hands-off approach’ to regulating Apple Watch

The Federal Trade Commission has cracked down on apps making dubious claims about diagnosing illnesses, but Bakul Patel, the FDA’s associate director for digital health, said his agency is a long way from scrutinizing the Apple Watch and other wearables. “We are taking a very light touch, an almost hands-off approach,” Patel said.

“If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.” Patel said the level of future FDA regulation will depend on how devices are marketed and whether a product is being promoted to aid doctors in making medical decisions.

.
Share