For The Apple Watch’s Health Apps, The FDA Will Take A Hands-Off Approach

The U.S. Food and Drug Administration is re-emphasizing that it will give plenty of regulatory leeway to health apps for the Apple Watch and other wearable devices, after the agency issued new guidelines last month, Bloomberg News reported.

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

Apple’s wearable device was originally intended to be primarily a health and fitness device, though problems with sensor reliability eventually encouraged the company to widen its scope to other areas, including contactless payments. But Apple and its rivals are still building sensors into their wearables to detect medical indications ranging from pulse rate, body temperature and blood pressure to hydration and glucose levels.

According to guidelines the FDA issued in February for how mobile apps will be regulated, the dividing line is whether the app — or the device itself — is acting like a medical testing device. Fitness tracking, counting steps or heartbeats, and other health monitoring won’t come under the microscope, while devices and software used for diagnosis, treatment and prevention will continue to get close examination.

One bright line: A product that’s marketed to help doctors make medical decisions will get the full FDA treatment, Patel said. For example, the FDA reviewed — and approved — a glucose-monitoring iPhone app for the first time in January. Another guiding consideration is whether a user could suffer harm if a product fails.

That standard still puts some potential uses of the Apple Watch under the FDA’s watchful eye. Apple CEO Tim Cook has suggested that, over the next few decades, the Watch and Apple’s HealthKit software development toolkit might help pinpoint certain diseases, including cancers.

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

And there’s always the bottom-line consideration for medically related claims, Patel added: “It boils down to will it work or not.”