The United States Food and Drug Administration will hold the first Digital Health Advisory Committee meeting November 20th and 21st 2024 in Gaithersburg, Maryland.
This inaugural committee meeting will centre around total product lifecycle considerations for generative AI-enabled medical devices. The committee will also discuss how generative AI can be integrated into medical devices safely, how to assess their performance and what regulation should be put place to ensure that these devices are safe, effective and useful.
Generation AI
AI is becoming increasingly valuable in assisting medical professionals. Radiologists and ophthalmologists have been testing image recognition capabilities to identify cancers and retinopathy for some years already.
Advances in generative AI have been hailed by some as the first step in a healthcare revolution. While the optimists among us might hope that AI will take the pressure off doctors by streamlining routine tasks, others are concerned. Troubling observations about the reliability of generative AI lead somd to question how private companies will incorporate it into devices.
Currently, generative AI tools like ChatGTP don’t perform well in operations that involve numbers and are prone to hallucinations. That is, when the algorithm can’t find what it expects to find in order to complete the task, it will make something up.
Speaking Up
The meeting will be open to the public. Attendees will have the opportunity to contribute during the open section of the hearing. The deadline for oral presentations during the public comment sessions is October the 25th 2024.
Oral presentations from the public will be heard November 20, 2024, 1 p.m. until 2 p.m. and November 21, 2024, between 9:15 a.m. and 10:45 a.m. at the Holiday Inn Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD 20879.
The meetings will also be accessible via webcast for those who wish to watch but can’t attend in person.
- Digital Health Advisory Committee (DHAC) Day 1 | 20 NOV 2024
- Digital Health Advisory Committee (DHAC) Day 2 | 21 NOV 2024
References
Digital Health Advisory Committee Meeting – Nov. 20-21, 2024. U.S. Food and Drug Administration. Accessed September 30, 2024. https://content.govdelivery.com/accounts/USFDA/bulletins/3b59bb9
Topol EJ. The revolution in high-throughput proteomics and AI. Science. 2024;385(6716):eads5749. doi:10.1126/science.ads5749
Virtual You: How Building Your Digital Twin Will Revolutionize Medicine and Change Your Life. Science. 2024;385(6716):1425-1425. doi:10.1126/science.ads7922
Gow G. Revealing The Dark Side: The Top 6 Problems With ChatGPT And Generative AI In 2024. Forbes. Accessed September 30, 2024. https://www.forbes.com/sites/glenngow/2024/01/28/revealing-the-dark-side-the-top-6-problems-with-chatgpt-and-generative-ai-in-2024/
