7th Global Gastroenterology and Artificial Intelligence Summit (Live) | September 2025-09 2025 7Th Global Ai Summit And Workshop Part 10

Video Transcription

Video Summary

In session three, Jeremy Walsh, FDA's Chief AI Officer, discussed the rapid integration of AI within the agency, highlighting the deployment of the ELSA AI tool now used by about 70% of FDA staff. He emphasized efforts to modernize regulatory processes in gastroenterology, including transitioning from traditional document-heavy reviews to more AI-driven, real-time data analysis. Walsh noted the FDA’s goal to accelerate both pre-market and post-market activities, with faster adverse event reporting and surveillance systems transforming from months-long studies to near real-time monitoring. He stressed the balance between innovation and safety, addressing challenges in AI-driven clinical decision support and prescribing tools. Regulatory sandboxes were mentioned as potential environments for live data streaming to speed approvals. Walsh acknowledged the FDA’s traditionally cautious approach, explaining current initiatives to upskill staff and streamline workflows to keep pace with industry advancements, thus fostering innovation while ensuring public health protection.

Keywords

FDA AI integration

ELSA AI tool

regulatory modernization

real-time data analysis

AI-driven clinical decision support