FDA Launches Advisory Committee for Digital Health Technologies

In a press release on October 11, 2023, the United States Food and Drug Administration announced that it created a new Digital Health Advisory Committee. According to the release, the committee will evaluate multiple tenants of digital health technologies, including scientific and technical issues.

The advisory board, which is expected to be up and running in 2024, will be responsible for weighing the benefits, risks, and clinical relevance of digital health technologies, such as artificial intelligence (AI), machine learning (ML), virtual reality (VR), augmented reality (AR), digital therapeutics, wearable devices, remote patient monitoring technologies, and digital health software.

“As one of our strategic priorities, our goal is to advance health equity in part through expanding access by bringing prevention, wellness, and healthcare to all people where they live  at home, at work, in big cities and rural communities,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the release. “Digital health technologies are critical for achieving this transformation in care delivery. As digital health technologies advance, the FDA must capitalize on knowledge from inside and outside of the agency to help ensure we appropriately apply our regulatory authority in a way that protects patient health while continuing to support innovation.” 

As digital technology continues to invade healthcare through medical device technology, data analytics, and decentralized clinical trials, clinicians, researchers, and regulatory bodies have been tasked with determining the benefits and risks of these products.

So far, stakeholder and other regulatory advisory committees have used their discretion when evaluating the clinical utility and appropriate applications of digital health technologies. However, having a dedicated team to address these issues can provide more explicit guidance and standardized protocols.

“Technology moves at an incredible pace, and we’re excited to have a committee of experts throughout the field who can help ensure our regulation of these exciting tools maintains an appropriate pace while working within parameters of safety and effectiveness standards,” said Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, in the release. “Many of these technologies are novel and tend to rapidly change; it’s our duty to seek as much knowledge on them as possible as we determine and implement appropriate regulation to encourage innovation while protecting public health.” 

According to the announcement, the FDA plans to have nine voting members on this advisory committee, including the chair, and variable numbers of temporary members depending on the issue discussed at each meeting.