On October 11, the FDA announced the formation of a new Digital Health Advisory Committee to assist the FDA in exploring the complex, scientific and technical issues related to digital health technologies (DHTs). The committee's function is to advise the FDA on issues related to DHTs, help the agency understand the benefits, risks, and clinical outcomes associated with use of DHTs. The FDA notice explained that:
"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, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "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."
The FDA's stated goal is to tap experts in the field of DHTs to help the FDA establish regulations at an appropriate pace consistent with its safety and effectiveness standards. The Press Release is found here. Additional details are provided in the Federal Register notice (here) which identifies as topics for consideration include but are not limited to:
- Transparency and bias management considerations, including promoting health equity in DHTs
- Augmented reality and virtual reality technical and clinical questions
- Transparency and labeling considerations for "opaque box" algorithms
- Digital therapeutics
- AI/ML
- Input on regulation of AI/ML-enabled devices
- Real-world data and real-world evidence
- Patient-generated health data
- Postmarket monitoring considerations for a total product lifecycle approach to DHTs
- Interoperability
- Personalized medicine/genetics
- Wearables, remote patient monitoring, and internet of things
- Postmarket monitoring of DHTs
- Technologies to enable decentralized clinical trials
- Cybersecurity best practices in software development for cloud-based software
Comments are due December 11, 2023.
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