Digital health innovation plan announced by FDA

Sutherland Editorial

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has very real healthcare IT credentials. In 2013 he was nominated by then Senate minority leader Mitch McConnell to the government’s Health IT Policy Committee that subsequently made recommendations on a wide variety of IT issues in the health sector.

Now Gottlieb has announced, through the FDA’s senior leadership blog, that the department will create “a new Digital Health Innovation Plan that is focused on fostering innovation at the intersection of medicine and digital health technology.”

The blog posting acknowledges the huge potential that technology offers to both consumers and professionals in improving individuals’ awareness of their health and how that can be coordinated with every element of their care team.

It also notes the growing possibilities to improve clinical practice through the development of decision support software as well as better management of electronic health records.

The main thrust of the posting, which follows the recent announcement that the FDA will create a digital health unit within its Center for Devices and Radiological Health, is to assure developers of medical devices, smartphone apps, etc. that the FDA – while continuing to protect public safety – will do whatever it can to not stand in the way of new products reaching the market in a timely manner.

Under the 21st Century Cures Act passed by Congress last December, clinical administrative support software and mobile apps intended only for maintaining or encouraging a healthy lifestyle were removed from the FDA’s oversight. The new Digital Health Innovation Plan will clarify exactly what is or is not subject to FDA review.

While Gottlieb’s initiative is undoubtedly in part the product of a desire to cut through regulation and promote a market-based approach, it also recognizes the reality of today’s healthcare technology sector, one that is moving forward faster than government can keep up with!