backPlease join members of King & Spalding’s Washington, D.C., Frankfurt, and Brussels Government Matters teams who will provide an overview of worldwide standards and guidance on artificial intelligence/machine learning in medical devices.
Government regulation of AI and ML in medical devices is on the rise. This session will update attendees on the small library of current medical device AI/ML regulatory literature and the much more significant coming additions around the world. Attendees will hear about existing standards and guidance from the U.S., UK, EU, Canada, China, Singapore, South Korea and Saudi Arabia. Regulatory works in progress include draft guidance from the U.S. Food and Drug Administration (FDA), a proposed rule from the U.S. Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC), the proposed EU Artificial Intelligence Act, and efforts from a variety of standards bodies.