The U.S. Food and Drug Administration has announced the creation of a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software.
The Digital Health Advisory Committee will advise the FDA on issues related to DHTs, providing relevant expertise and perspective to help improve the agency’s understanding of the benefits, risks, and clinical outcomes associated with use of DHTs. The committee should be fully operational in 2024.
To support the development of safe and effective digital health technologies while also encouraging innovation, the FDA will solicit views from the committee, which will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds. This will help ensure digital health medical devices are designed and targeted to meet the needs of diverse populations.
“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, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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.”
Digital health is a rapidly evolving, cross-cutting space that spans a wide range of technologies. In addition to the technologies mentioned above, it also includes issues such as decentralized trials, patient-generated health data and cybersecurity.
“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. “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.”
The committee will consist of a core of nine voting members including the chair. The number of temporary members selected for a particular meeting will depend on the meeting topic.
Those interested in serving or nominating a representative to serve as a voting or non-voting member of the FDA's Digital Health Advisory Committee, may either submit nominations electronically by accessing the FDA Advisory Committee Membership Nomination Portal or by mail.