FDA Establishes New Digital Health Unit

The Food and Drug Administration (FDA) is making a new commitment to digital health. As Health Data Management and others first reported, the agency has established a new digital health unit, to be located within its existing Center for Devices and Radiological Health (CDRH). Said Dr. Bakul Patel, who serves as the CDRH associate director, “Because it’s such an emerging area, having a centralized unit in the Center Director’s Office is important for coordination on digital health topics and having consistency in applying policies.”

On the new unit’s agenda: topics like wireless medical devices, mobile apps, telemedicine, software as a medical device, and interoperability, among others. The overall focus will be on bringing “regulatory clarity” to the relatively new and continually evolving industry. In particular, the FDA is seeking to emphasize industry outreach, noting on its Web site that it will work toward “fostering collaborations and enhancing outreach to digital health customers.” The digital health unit will be funded beginning in the next fiscal year, with that money coming from medical device users fees. Rather than relying on existing staffers from other departments, the FDA is seeking to hire a new team of scientists to work on digital health.

Industry reactions to the new unit have largely been positive, though some FDA experts are concerned about the agency’s ability to recruit and retain scientists for it, given comparatively higher salaries in the private sector. As attorney Bradley Merrill Thompson told Health Data Management, “Right now salaries for people in those domains are sky-high, and that means many folks are very nervous about how FDA will succeed in recruiting the talent it needs.” However, he and others expressed optimism about the new digital health unit.

In other recent FDA news, the Senate on Wednesday confirmed a new commissioner, voting largely along party lines. Dr. Scott Gottlieb, who worked at the FDA during the George W. Bush administration and more recently at the right-leaning American Enterprise Institute, will take the helm of the agency. He had faced criticism from some senators for what they viewed as too-close ties to the medical device industry; industry leaders, for their part, praised Gottlieb’s confirmation.

Click here for the article from Health Data Management on the new FDA digital health unit.

Click here to view the FDA digital health unit Web site.


Leave a Reply