Bradley Merrill Thompson Quoted in “FDA Establishes Digital Health Center of Excellence”

The FDA announced today the launch of the Digital Health Center of Excellence, a central resource intended to help the agency as well as external stakeholders promote digital health technologies.

Housed within the Center for Devices and Radiological Health (CDRH), the Digital Health Center of Excellence (DHCE) will focus on a range of technologies “mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products,” the agency said. It will be headed by Bakul Patel, who until now has served as director of the CDRH’s Division of Digital Health. …

What’s The Impact?

The FDA has a broad range of goals for the DHCE. The center is intended to help the agency reimagine digital health oversight, advance best practices within the industry, provide technological advice when needed and generally serve as the quarterback for digital health-focused initiatives within the agency.

But the FDA also admitted that its newest center is still very much a work in progress, noting that “there are many aspects of the [DHCE] that are still under development.” On that front, the agency said that the DHCE will be building a network of digital health experts and organizing opportunities for stakeholders to share their digital health concerns, experiences and priorities through ongoing forums known as Collaborative Communities. From there, the center aims to launch strategic digital health initiatives and strategic partnerships that can inform its work and fuel regulatory science research for digital health technologies.

Of note, the DHCE has also put out a call for software engineers, artificial intelligence and machine learning engineers, security researchers, designers and product managers to join its ranks.

News of the DHCE’s launch comes at a time when both consumers and the healthcare industry are increasingly opening up to digital health technologies. …

Bradley Merrill Thompson, who counsels on medical device and FDA regulatory issues at Epstein Becker & Green, told MobiHealthNews that he was cautiously optimistic about the new center. The organizational change could bring more money and personnel attention to digital health issues at the agency, as well as general organizational effectiveness, but noted that it’s difficult to tell just how committed the agency really is from an announcement and a website.

“I fear that a lot of this is an attempt to sell the Precertification Program and that it is politically motivated since FDA has to get Congress to give them new authority,” he said in an email. “I continue to have my concerns that they are putting the cart before the horse, developing a Precertification Program before they are authorized to do so and frankly before Congress has had a chance to establish the high level design features for the program.”