Decoding Digital Health: AI/ML Webinar Recap—U.S. FDA & European Perspectives

On this episode of Ropes & Gray’s podcast series, Decoding Digital Health, host Kellie Combs, a partner in the life sciences regulatory and compliance group and co-chair of the firm’s cross-practice digital health group, is joined by Greg Levine, chair of the firm's global life sciences regulatory and compliance practice, and Lincoln Tsang, head of the European life sciences practice. They unpack some key insights from a recent webinar on regulatory issues surrounding artificial intelligence (“AI”) and machine learning (“ML”) devices, hosted by Ropes & Gray and HLTH. The conversation covers the boundaries of AI and ML regulation as a medical device, the evolving regulatory frameworks in the U.S. and Europe, and upcoming guidance and developments in the field.