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.

“Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings,” FDA Commissioner Dr. Stephen M. Hahn said in a statement.

“The [DHCE] will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public and FDA staff.”


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.

“The DHCE will play a critical role to play in gathering and analyzing data from the skyrocketing use of the range of digital tools being developed, including those in the wake of the COVID-19 pandemic. The FDA has the experience to analyze the effectiveness of digital health solutions and improve both outcomes and patient safety,” Morgan Reed, executive director of the Connected Health Initiative industry group, said in a statement responding to the agency’s news.

“The DHCE is also well positioned to bring together industry, government, and academia as part of larger collaborations to advance digital health. We look forward to the opportunity to work with DHCE to continue to advance the use of 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.”


Dr. Jeff Shuren, director of the FDA’s CDRH, characterized the DHCE as the latest chapter in a string of digital health moves from the agency.

“In the last several years, we have established partnerships internally and externally to coordinate digital health activities and to promote the consistency of regulatory policy while continuing to innovate in our regulatory approaches,” he said in a statement.

Among the best known of these efforts is likely the aforementioned Digital Health Software Precertification Program, which for the past few years has been developing a new regulatory framework that better reflects the software development and refinement process. (Although the program appears to have made some headway this year with the approval of the first digital product put through its paces, and although an update from the agency released this month suggests that there’s still more work to be done before the FDA is ready to lock in its “Working Model v1.0.”)

The agency also has also been working to propose, refine and finalize guidances on digital health-related regulatory areas such as multiple-function device products and clinical decision support software – the majority of which is now conveniently listed on a DHCE’s web page.

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