FDA's Gottlieb Hints at a Huge Overhaul of Health Tech Regulations

The recently confirmed FDA commissioner plans to make good on his promise of getting out of Silicon Valley's way.


When Apple CEO Tim Cook was asked in 2015 if the forthcoming Apple Watch would feature cutting edge health technology, the answer was a very clear no. Making the Apple Watch more than just a really pricey fitness tracker would require approval from the Food and Drug Administration, and that, in turn, would "hold [Apple] back from innovating."

In a blog post published this week, recently approved FDA Commissioner Scott Gottlieb acknowledged that "ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures."

To that end, writes Gottlieb,

FDA will provide guidance to clarify our position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not. In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements. Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA's compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher risk priorities.

We don't yet know what the FDA's new guidelines will look like, but the tech industry is likely to get more clarity. Gottlieb wants the new guidelines to be transparent enough that developers can "apply them on their own, without having to seek out, on a case-by-case basis, FDA's position on every individual technological change or iterative software development."

The timing for these reforms couldn't be better. Apple has been hiring medical tech engineers since early last year, and it is allegedly working on a blood glucose monitor for diabetes patients that doesn't require piercing the skin. Verily, meanwhile, is working with Dexcom, which manufactures a continuous glucose monitor that does pierce the skin, to make the device even less obtrusive. (All of Verily's projects look great, actually—and all, I suspect, will require some interaction with the FDA.)

At the cheaper end of the market, we may just get better fitness and health apps for mobile devices. This software generally doesn't require FDA approval, but even device makers aren't sure when they should talk to the agency. In 2015, when he was still at the American Enterprise Institute, Gottlieb told NPR that bringing these apps under the FDA's purview would "create so much uncertainty for product developers that it's going to discourage a lot of investment and it's going to discourage a lot of programmers from getting into this space."

"Hopefully this is a signal that the FDA is waking up to the realities of the Information Age and are willing to let consumers take advantage of the many life-enriching—and potentially even life-saving—technologies that could be at their disposal if not for excessive bureaucratic red tape," says Adam Thierer, a senior fellow at the Mercatus Center's Technology Policy Program.

As soon as this fall, writes Gottlieb, the "FDA will pilot an entirely new approach toward regulating this technology."