FDA Creates Advisory Committee to Ensure Safe Development of AI and Digital Health Technologies
The United States Food and Drug Administration (FDA) has announced the establishment of a new advisory committee to oversee the safe and effective development of artificial intelligence (AI) and other digital health technologies. The FDA’s Digital Health Advisory Committee will focus on exploring the scientific and technical aspects of digital health technologies, including AI, machine learning, augmented and virtual reality, remote patient-monitoring software, digital therapeutics, and wearables. The committee will also address issues such as decentralized clinical trials, patient-generated health data, and cybersecurity.
The FDA intends for the advisory committee to provide expertise and insights to enhance its understanding of the benefits, risks, and clinical outcomes associated with the use of digital health technologies. The committee’s goal will be to foster the safe and effective development of these technologies while encouraging innovation.
It is expected that the advisory committee will be fully operational by 2024. The committee will consist of technical and scientific experts from diverse backgrounds to ensure that digital health technologies are created to meet the needs of diverse populations.
Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, stressed the agency’s commitment to advancing health equity. He emphasized the importance of digital health technologies in expanding access to healthcare for all individuals, regardless of their location or background.
To support the committee’s work, the FDA will release new guidance documents on AI and machine learning products before the committee’s first meeting next year. The committee will consist of nine core voting members, including a chairperson, with the possibility of additional temporary members depending on the specific meeting topic. The FDA is currently accepting applications for both voting and non-voting positions on the committee.
Tory Tazbaz, the director of the FDA’s Digital Health Center of Excellence, highlighted the need to keep pace with rapidly evolving technology. Tazbaz acknowledged that many of these technologies are novel and often undergo rapid changes. Therefore, it is crucial for the FDA to gather as much knowledge as possible to effectively regulate these tools and maintain standards of safety and effectiveness while promoting innovation and protecting public health.
In summary, the FDA’s creation of the Digital Health Advisory Committee underscores the agency’s commitment to ensuring the safe development of AI and digital health technologies. The committee, composed of experts from diverse disciplines, will play a vital role in providing guidance and insights to enhance the FDA’s understanding of these technologies and their impact on patient health. By establishing this committee, the FDA aims to strike a balance between regulating and encouraging innovation in the rapidly evolving field of digital health.
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