FDA's Bakul Patel: Agency taking 'hands-off approach' to wellness devices

The U.S. Food and Drug Administration stands at a crossroads when it comes to regulation and the influx of wearable health tools. So far, the FDA intends to do too little instead of too much.

"We are taking a very light touch, an almost hands-off approach," Bakul Patel, the FDA's associate director for digital health, tells 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."

The agency in January published draft guidance documents that propose to regulate medical device accessories based on risks they present when used as intended with their parent devices, and not to regulate products intended only for general wellness, FierceHealthIT previously reported.

Even though the FDA is being judicious in how it deals with wellness devices, companies such as Apple and Google need to screen their apps to ensure the developers don't falsify the product's benefits, Patel says in the article, adding that Apple and Google have both spent time at FDA headquarters discussing their health initiatives.

That relationship will grow in importance as the two tech giants continue to try to make a mark in healthcare. Apple recently announced its new ResearchKit platform, while Google reportedly is mulling a substantial investment in fitness tracker Jawbone.

Patel adds that his job forces him to work on the relationship between Silicon Valley and the FDA, as some in the healthcare industry feel the FDA impedes innovation.

There is a perception that the agency will interfere with the creation of new tools. That's something businesses worry about, even if their product will pass muster, Bob Kocher, a venture capitalist at Venrock, tells Bloomberg.

Patel says that, to tackle those worries, the FDA wants to add a staff member to improve relationships with startups and tech companies.

He adds that, as more wellness and health tools enter the market, the agency will have more critical responsibilities when it comes to oversight. "The FDA has a role to play for providing patients and consumers a level of confidence that they can use it."

The agency also has its sights on medical devices--and, most prominently, the security of such tools.

In October, the FDA published a final guidance document on medical device security. The document outlines measures it believes device manufacturers must take to ensure the safety and security of their tools in the face of growing cyberthreats. The agency calls on device makers to account for cybersecurity risks during design and creation, and to submit documentation on any risks identified and controls developed to lessen such risks, FierceHealthIT previously reported.

To learn more:
- here's the Bloomberg article