FDA forms advisory committee to ensure 'safe and effective' development of AI, other digital health technologies

The United States Food and Drug Administration announced Wednesday that it plans to form a new advisory committee to ensure the "safe and effective" development of artificial intelligence and other digital health technologies.

A press release from the agency revealed that the FDA's Digital Health Advisory Committee will help "explore the complex, scientific and technical issues related to digital health technologies," including AI and machine learning, augmented and virtual reality, remote patient-monitoring software, digital therapeutics, and wearables. Additionally, members will tackle issues including decentralizing clinical trial designs, patient-generated health data, and cybersecurity, the agency stated.

The committee will provide the FDA with relevant expertise and perspective to help improve the agency's understanding of the benefits, risks, and clinical outcomes associated with the use of DHTs. It will be tasked with establishing "safe and effective" development "while also encouraging innovation."

The FDA's news release noted that it aims to have the advisory committee fully operational in 2024. The committee's members will be technical and scientific experts "from diverse disciplines and backgrounds" to ensure DHTs are "designed and targeted to meet the needs of diverse populations."

Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, stated that the agency hopes to "advance health equity."

"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," Shuren said.

"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," he added.

According to Shuren, the agency plans to release new guidance documents regarding AI and machine learning products before the committee's first meeting next year.

The committee will have nine core voting members, including the chair. The FDA noted that the number of temporary members will depend on the meeting topic. The agency is currently welcoming applications for voting and non-voting members.

Tory Tazbaz, director of the FDA's Digital Health Center of Excellence, emphasized the importance of keeping up with rapidly evolving technology.

"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," Tazbaz stated. "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."

Like Blaze News? Bypass the censors, sign up for our newsletters, and get stories like this direct to your inbox. Sign up here!