Hello everyone!
Sharing with you some of the materials from the first ever Digital Health Advisory Committee meeting held on Nov 20-21, 2024. The purpose of the meeting was to discuss the total product lifecycle (pre-market performance evaluation to post-market monitoring) of GenAI enabled devices. The meeting included participants from several areas including different sectors from the FDA, academia, and industry. The need to generate real world data on the use of these technologies was highlighted as a key focus area throughout the meeting.
All meeting materials (DHAC roster, youtube links, presentations, discussion questions) can be found here: LINK.
To this post, I'm attaching the executive summary.
Thank you all and happiest of holidays to you and your loved ones!
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John Diaz-Decaro
Vice Chair- ISPE Digital Epidemiology SIG
Sr. Director, Epidemiology Latent Viruses (EBV)
ModernaTX, Inc.
Cambridge, MA
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