The Current State of Medical Device AI Regulation with Eric Henry

This video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI – https://online.yale.edu/medical-software-ai-program. Our guest is Eric Henry. Mr. Henry is the Senior Quality Systems & Compliance Advisor at the Law Firm King & Spalding and works from his home in the Cleveland area. He joined King & Spalding in 2018 after 30 years managing global technical and regulatory compliance organizations in various industries and in medical devices in particular over the last 22 years. Eric currently provides advisory and consulting services to corporate management, boards, and staff regarding regulatory compliance, enforcement, and policy matters for regulated life sciences companies. Mr. Henry is a member of the AFDO/RAPS Healthcare Products Collaborative AI Strategic Committee and co-chairs their Good Machine Learning Practices Working Team. He also advises the Coalition for Health AI in their Predictive AI and Assurance Lab Certification Work Groups.

00:10 Introduction. Who is Eric Henry?
06:28 The FDA and AI.
14:45 The state of affairs outside the United States. China and the EU.
19:44 The general state of upheaval in Medical Devices/AI in the EU.
23:44 The current discussion on medical AI at the FDA. Potential issues with a new administration.
29:33 AI Tools development inside Health Systems. Challenges, fears and opportunities
38:34 Concluding Thoughts

Additional Readings:
European Union. Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence [Internet]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202401689

U.S. Food and Drug Administration, Health Canada, Medicine & Helathcare products Regulatory Agency. Good Machine Learning Practice for Medical Device Development. 2021 Oct. Available from: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles

U.S. Food and Drug Administration, Health Canada, Medicine & Helathcare products Regulatory Agency. Transparency for machine learning-enabled medical devices: Guiding principles. 2024 Jun. Available from: https://www.fda.gov/medical-devices/software-medical-device-samd/transparency-machine-learning-enabled-medical-devices-guiding-principles

U.S. Food and Drug Administration, Health Canada, Medicine & Helathcare products Regulatory Agency. Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles 2023. Available from: https://www.fda.gov/medical-devices/software-medical-device-samd/predetermined-change-control-plans-machine-learning-enabled-medical-devices-guiding-principles

Readings from Mr. Henry’s own work:
AI/ML in Medical Devices: US & EU Regulatory Perspectives (https://array.aami.org/content/news/ai-ml-medical-devices-us-eu-regulatory-perspectives )

Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition (Chapter 3: Global Regulations and Standards) (https://us.artechhouse.com/Medical-Device-Cybersecurity-for-Engineers-and-Manufacturers-Second-Edition-P2416.aspx )

“Bias in Artificial Intelligence In Healthcare Deliverables” (https://healthcareproducts.org/ai/aighi/aio/whitepaper-bias-in-ai-healthcare/ )

Software Under the Regulatory Microscope: The Current and Future State of Enforcement for Regulated Computer Systems (https://www.americanpharmaceuticalreview.com/Featured-Articles/574553-Software-Under-the-Regulatory-Microscope-The-Current-and-Future-State-of-Enforcement-for-Regulated-Computer/ )

You can find a full list of Mr. Henry’s publications, conference presentations, and media interviews on his LinkedIn profile: https://www.linkedin.com/in/eric-henry-519bb48/