Source: Lexology

Lexology discusses the growing integration of artificial intelligence into medical devices and the resulting legal challenges in the U.S. regulatory framework. The article highlights how the FDA is updating its oversight approach to better manage risks tied to machine learning algorithms embedded in diagnostic or therapeutic tools.

Legal concerns include product liability, informed consent, data protection, and post-market surveillance. The piece outlines the tension between encouraging innovation and ensuring patient safety, noting that regulation often lags behind technological progress.

Lawyers working in health tech are advised to monitor evolving legal requirements and advocate for standards that address the unique nature of adaptive AI technologies.