FDA's Collaborative Approach to Promoting Responsible AI in Medical Products

Author: The Alliance for Artificial Intelligence in Healthcare

With Contributions from:

Hin Au, JD, Associate, Wilson Sonsini Goodrich & Rosati

Esther W.B. Bleicher, JD, MPH, General Counsel and Chief Compliance Officer, Hello Heart, Board, AAIH

Meredith Brown-Tuttle, RAC, FRAPS, Chief Regulatory Strategist, Regulatorium

Elaine Hamm, PhD, Executive Director, AAIH

Paul Howard, PhD, Senior Director, Public Policy, Amicus Therapeutics

Rafael Rosengarten, PhD, Chief Executive Officer, Genialis, Board, AAIH

Eva F. Yin, PhD, MPH, JD, Partner, Wilson Sonsini Goodrich & Rosati

Chandrasekhar Sharma, MBA, Senior Vice President, Course5i

Alex Yue, MBA Senior Director, Quality, Hello Heart

James Zanewicz, JD, LLM, Chief Strategy Officer Tulane School of Medicine, Treasurer AAIH

Executive Summary

The Alliance for Artificial Intelligence in Healthcare commends the recent joint publication by the FDA's Centers for Biologics Evaluation and Research (CBER), Drug Evaluation and Research (CDER), Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP). This article outlined four key recommended areas of focus:

1.     Fostering collaboration to safeguard public health

2.     Advancing regulatory approaches that support innovation

3.     Promoting standards, guidelines, best practices, and tools

4.     Supporting research related to evaluating and monitoring AI performance

This article underscores the transformative potential of AI in healthcare but also highlights the crucial steps needed to ensure we safely harness this potential. This is one of the key missions of the Alliance for AI in Healthcare.

Conclusion

AAIH will work with regulatory and legal experts to publish more in-depth articles on various topics in the AI space, including topics on AI in drug manufacturing and development, AI in medical devices, intellectual property considerations, and data privacy considerations.  Stay tuned for more!