FDA announces dedicated center for digital health regulation

  • The FDA is creating a Digital Health Center of Excellence.
  • But some experts aren’t sure if the FDA will be able to follow through on its launch because of political hoops it must jump through first.
  • Insider Intelligence publishes hundreds of insights, charts, and forecasts on the Digital Health industry with the Digital Health Briefing. For a limited time, you can try the Briefing for a full week for just $1!

The FDA is creating a Digital Health Center of Excellence (DHCE)—which will establish a dedicated regulatory framework for digital health developers and assist in getting products to market faster.

4 in 5 us physicians have conducted virtual patient consultations as of July 2020

FDA is creating a Digital Health Center of Excellence.

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Headed by Bakul Patel—who’s been working within FDA’s digital health divisions—the agency is on the hunt for software engineers, experts in health AI, and healthcare security researchers to establish a regulatory blueprint for a range of technologies, including wearables and mobile health devices. 

The DHCE announcement is the latest event showcasing that the FDA is knuckling down on digital health development. 

  • The center builds off of the FDA’s digital health precertification program, which it’s been honing since 2017. The FDA debuted the program to streamline the regulatory process of bringing digital health products to market—and it’s been expanding its purview of the types of health tech it reviews. This program has already laid the groundwork for major digital health milestones, including the FDA’s approval of the Apple Watch’s heart-tracking features. 
  • This also adds to the list of digital health-friendly pushes the FDA has made amid the pandemic. Consumers and healthcare providers have been forced to come around on virtual care tech—hauling up adoption rates of digital health tools. The FDA reacted by rushing to facilitate the development and usage of new technologies: Most notably, it eliminated some requirements developers of mental health tech solutions had to check off before selling their products in April, and it expanded the use of remote monitoring devices in June.

However, the FDA said the DHCE is a work in progress—and it’s unclear what the timeline for an official launch looks like. The FDA noted that “there are many aspects of [the DHCE] that are still under development.” It isn’t clear how long it will take to bring the necessary talent on board—so, despite the fact that the pandemic is highlighting the need for a more transparent regulatory process for digital health, the DHCE may not be able to iron it out any time soon. 

And some experts aren’t sure if the FDA will be able to follow through on its launch because of political hoops it must jump through first. 

Bradley Merrill Thompson, who specializes in medical devices and FDA regulatory issues at law firm Epstein Becker & Green, told MobiHealthNews he has “concerns that [the FDA is] 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.” Thus, the announcement of the DHCE doesn’t necessarily foretell an imminent launch since it’ll have to get the OK from lawmakers. 

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