The U.S. Food and Drug Administration 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.
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.
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.