FDA To Take 'Hands-Off' Approach To Apple Watch, Smartwatches, Apps

When the Apple Watch launches in a few short weeks, one obstacle that won’t be in its way is the U.S. Food and Drug Administration. The regulatory body plans to take a mostly “hands-off” approach to the smartwatches and other similar devices, according to Bloomberg.

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

It’s a stance that the agency has mostly maintained as technology firms and app developers continue to create devices and apps aimed at encouraging their users to stay fit. Earlier this year, the FDA issued draft regulations for how it plans to regulate smartwatches and other devices with health-tracking features. Generally, it doesn’t plan to regulate products that are aimed at general wellness and do not make references or claims to treat specific diseases or conditions.

The agency has also taken a similar position toward ResearchKit, Apple’s collection of software tools aimed at promoting research studies performed through the iPhone.

“The FDA supports using innovative tools during clinical studies that may make data collection easier and more efficient,” Andrea Fischer, FDA media affairs representative, said. “Mobile platforms and other tools could potentially contribute to efficient data collection, which could mean getting medical products to patients faster.”

But while the agency remains mostly hands off, other regulatory bodies have stepped in from time to time to shut down companies that overstep their bounds. Last month, the Federal Trade Commission cracked down on companies marketing their apps as “Melanoma Detectors,” issuing fines and barring them from making claims that their apps could detect melanoma by just taking a picture.