The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.
FDA announced on Oct. 11, 2023 that it has established the Digital Health Advisory Committee to advise the agency on the scientific and technical issues surrounding digital health technologies (DHTs) such as artificial intelligence (AI), machine learning (ML), augmented reality, virtual reality, digital therapeutics, wearables, and remote patient monitoring. The committee, which expects to be fully operational in 2024, will provide expertise and perspective on FDA’s understanding of the benefits and challenges of DHTs.
The development of the committee is in response to the rapidly evolving DHT space that covers a range of technologies. These technologies also include decentralized trials, patient-generated health data, and cybersecurity, according to FDA.
“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, director of FDA’s Center for Devices and Radiological Health, in a press release. “Digital health technologies are critical for achieving this transformation in care delivery. As digital health technologies advance, [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.”
“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 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.”
There will be nine core voting members on the committee including the committee chair. FDA is requesting that those interested in serving on the committee submit nominations electronically to the FDA Advisory Committee Membership Nomination Portal or by mail.