FDA is Becoming Something Very Different

Liz Bloss

In September, the US Food and Drug Administration (FDA) announced that it had established the Digital Health Center of Excellence (DHCoE), a new entity devoted to advancing “the development and adoption of digital health technologies, including mobile devices, software-as-medical-device, and various other innovative products.”  

In its announcement, the FDA stated further that through the Center it would “modernize digital health policies and regulatory approaches that help improve access to safe and effective digital health technologies.” 

FDA Commissioner Steve Hahn noted that the Center is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.” Hahn went on to say that the Center will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff.” 

Bakul Patel, an FDA veteran who previously served as Director of the Division of Digital Health, was named Director of the new Center. On October 19, he moderated the first listening session on the new DHCoE. A second session was held November 12. Both aimed to give digital health device manufacturers, developers, health care providers, researchers, and other stakeholders an opportunity to learn about the DHCoE and provide feedback to the FDA. 

As stated at the outset of the listening sessions, the intention of the DHCoE is to 

  • Drive synergy for digital health efforts 
  • Align strategy with implementation 
  • Prepare the FDA for the digital health future 
  • Protect patients and maintain the FDA standards of safety and effectiveness 

Wondering what exactly “digital health” is according to the FDA? The Agency has previously provided a definitionIt says, in part, that  . . .  

The broad scope of digital health includes categories such as mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine. 

Such broad scope in uncharted territory is likely to inspire a great deal of debate and, ultimately, regulation in the years to come. Stakeholders will want to pay close attention. 

If you would like to contact or engage with the new DHCoE, you are welcome to send an email to digitalhealth@fda.hhs.gov.

Note, too, that the DHCoE is hiring. Software engineers, health scientists, and clinicians are specifically invited to apply. 

Finally, remember that it’s always a good idea to stay close to your FDA friends—or to professionals like us at the Bracken Group who are in touch with the Agency on a daily basis and understand its workings. There is no substitute for expertise in regulatory affairs, particularly as the treatments and therapeutics of the future develop and come under the FDA's scrutiny and regulation.


Imaging Core eBook

Subscribe to receive more content