Key takeaways:

• FDA’s Commitment to Regulate Digital Health Technologies: The U.S. Food and Drug Administration (FDA) is establishing a Digital Health Advisory Committee to address the complexities of emerging digital health technologies (DHTs), such as AI/ML and augmented reality.

• Role of the Digital Health Advisory Committee: The committee will provide expert advice to the commissioner of the FDA on issues related to DHTs and FDA policies and regulations. It aims to enhance the FDA’s understanding of the benefits, risks and clinical outcomes associated with digital health technologies while identifying potential risks, barriers or unintended consequences resulting from FDA policies or regulations.

• Collaboration with Existing Initiatives: The relationship between the Digital Health Advisory Committee and the FDA’s Network of Digital Health Experts remains to be clarified. The network serves as a source of expert professionals in digital health, covering a wide range of topics. How these two entities will coordinate activities, leverage expertise and prevent overlaps or gaps in addressing digital health topics is a subject of interest.

The FDA has announced the formation of the Digital Health Advisory Committee, a group dedicated to navigating the complexities of emerging DHTs like AI/ML, augmented reality and more. This development evidences the FDA’s sourcing of expert knowledge from diverse disciplines to inform and support safe and effective regulation of digital health technologies. The Digital Health Advisory Committee will advise the commissioner of the FDA on issues related to DHTs and FDA policies and regulations regarding these technologies. It will provide relevant expertise and perspective to improve the FDA’s understanding of the benefits, risks and clinical outcomes associated with use of DHTs, as well as work to identify risks, barriers or unintended consequences that could result from proposed or established FDA policies or regulations related to DHTs. Set to be formed by 2024, the committee aims to align technological advancements with regulatory frameworks, promoting innovation while safeguarding public health.

The FDA utilizes public advisory committees to gain independent expert advice across various scientific and policy areas, and it values inclusivity and diversity in its advisory bodies. All qualified individuals are encouraged to nominate qualified candidates from all backgrounds to ensure a comprehensive array of perspectives.

The formation of the Digital Health Advisory Committee comes on the heels of the FDA’s establishing the Digital Health Center of Excellence (DHCoE), representing a continued commitment to harnessing and regulating evolving digital health technologies. The DHCoE plays a pivotal role in supporting digital health stakeholders, ensuring that technological advancements are translated into tools that materially benefit consumers. Similarly, the DHCoE launches initiatives and provides expert scientific, technological and policy advice across the FDA. Furthermore, it connects stakeholders, fosters collaboration, facilitates strategic partnerships and advances regulatory policy. The DHCoE shares knowledge and innovations in regulatory approaches, aiming to provide transparent, predictable product review processes; develop digital health guidance; and formulate efficient regulatory approaches that align with FDA standards. This framework offers a solid foundation and valuable insights for the establishment of the Digital Health Advisory Committee.

It remains unclear how the Digital Health Advisory Committee will collaborate with the FDA’s existing Network of Digital Health Experts. This network of expert professionals, developed to enhance the FDA’s DHCoE, offers insight on diverse digital health topics. With a scope encompassing AI, digital therapeutics, cybersecurity, and more, the network provides timely insights and advice across a wide gamut of digital health and cybersecurity matters. The network’s experts engage in discussions related to pre- and post-market issues, clinical care, field advancements, and other pertinent subjects, with their COIs and CVs accessible for internal review to ensure transparency and impartiality. How the Digital Health Advisory Committee will synchronize its activities with those of the network, particularly in coordinating expert advice, utilizing the available pool of expertise, and preventing any potential overlaps or gaps in addressing the multifaceted digital health topics, remains to be seen.

Nominations for representatives to serve on the Digital Health Advisory Committee are now open. The new committee will comprise nine core voting members, including the chair, all of whom will be selected by the commissioner of the FDA or another authority in the field of digital health. The FDA is calling for participation and nominations, specifically encouraging experts from a wide variety of disciplines and diverse backgrounds. Interested individuals or those looking to nominate representatives to this committee can submit nominations electronically through the FDA Advisory Committee Membership Nomination Portal.

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