The FDA has created a Digital Health Advisory Committee to help it 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, software, decentralized trials, patient-generated health data, and cybersecurity.
The committee, which should be fully operational next year, 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.
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 members with technical and scientific expertise from diverse disciplines and backgrounds.
“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,” says 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.”
Anyone 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 submit nominations electronically by accessing the FDA Advisory Committee Membership Nomination Portal or by mail.