Between February and May 2026, the FDA underwent a forced migration of its Elsa AI system from Claude to Gemini, followed by the May 6 announcement consolidating 40+ data systems into the new HALO platform. These rapid, politically-driven changes create immediate risks for sponsors with pending or planned submissions.
In this webinar, regulatory and AI professionals Kimberly Chew and Michael Yang will explain:
- What happened during the forced AI migration and why it matters.
- How HALO’s consolidation amplifies data security and administrative record risks.
- New exposure vectors: cross-center access, custom grants, OCR metadata, and web search bias.
- Practical safeguards you must implement this week to protect trade secrets and regulatory outcomes.
Breaking Update: This webinar has been revised to address the May 6, 2026, HALO announcement and Elsa 4.0 launch. Whether you have active submissions under review or are planning future filings, this session will equip you with the knowledge and tools to navigate FDA’s rapidly evolving AI infrastructure.
Presenters
Kimberly I. Chew, Attorney
Michael S. Yang, Principal, AI Advisory Services, Husch Blackwell Consulting
Who Should Attend
This program is intended for in house counsel, regulatory and compliance professionals, and legal teams supporting life sciences companies with products under FDA review, including INDs, NDAs, BLAs, PMAs, and 510(k)s. It will also benefit executives and board members overseeing FDA stage programs; investors and diligence teams; regulatory affairs leaders; privacy and data governance professionals; intellectual property and trade secret counsel; clinical research and R&D leaders involved in FDA submissions; digital health, medtech, and biotech professionals; and attorneys, consultants, and government affairs professionals supporting clients on FDA, healthcare, and life sciences regulation.
Continuing Education Credit
This program is pending approval for California, Colorado, Illinois, Iowa, Kansas, Missouri, Minnesota, Nebraska, Pennsylvania, Tennessee, Texas, and Wisconsin continuing legal education credit.
Did you miss the webinar?
The webinar recording is available after the event date. Simply register using this on-demand link to access the recorded program.
Questions?
Contact Cilla Montgomery at 512.370.3457.