FDA Commissioner Robert Califf discussed the challenges of regulating AI in digital health at the Consumer Electronics Show in Las Vegas. Califf emphasised that the FDA alone cannot regulate AI use and must rely on a committee of experts to evaluate AI algorithms. He likened the adoption of AI in digital health to the beginning of a tidal wave, highlighting the need for a community of entities to assess and certify algorithms to ensure they are beneficial and not harmful.
The FDA launched a new advisory committee in the fall to address issues in digital health, including the regulation of AI-enabled devices and increased transparency for algorithms.
Drawing on his experience heading medical strategy at Alphabet, Califf cautioned against the immediate adoption of digital technologies in healthcare, emphasising the importance of considering long-term health outcomes. He stressed that testing algorithms is not only about their current functionality but also about assessing health outcomes over time.
Califf expressed the FDA's responsibility to educate the public about AI in health tech and the need for societal accountability in the development and deployment of these technologies. Despite the challenges, Califf expressed excitement about innovations in home care devices, surgical robots, and time-saving automation for medical billing, highlighting the FDA's role in ensuring their reliable and trustworthy deployment.
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