New Advisory Committee on Digital Health established by the FDA

The U.S. Food and Drug Administration (FDA) has established a groundbreaking initiative, the Digital Health Advisory Committee, to address the intricate and dynamic landscape of digital health technologies (DHTs), including artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software.

The Digital Health Advisory Committee's primary objective is to offer expert guidance to the FDA on various DHT-related matters, enriching the agency's comprehension of the advantages, potential risks, and clinical outcomes associated with DHT deployment. This strategic committee is set to become fully operational in 2024.

To foster the development of safe and effective digital health technologies while nurturing innovation, the FDA will actively seek input from the committee. The committee will comprise individuals with diverse technical and scientific backgrounds, ensuring a holistic approach to address the needs of a wide range of populations.

Jeff Shuren, M.D., J.D., the director of the FDA's Center for Devices and Radiological Health, highlighted the agency's commitment to advancing health equity by broadening access to healthcare. He stated, "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 the agency to help ensure we appropriately apply our regulatory authority to protect patient health while continuing to support innovation."

Digital health is a dynamic and multifaceted realm encompassing an array of technologies, including those mentioned above, decentralized trials, patient-generated health data, and cybersecurity considerations.

Troy Tazbaz, director of the FDA's Digital Health Center of Excellence, emphasized the importance of expertise in regulating rapidly evolving technologies, stating, "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."

Stay tuned for more updates and developments on this exciting path toward a healthier, more accessible future for all.