EU AI Act Compliance in Healthcare Systems

Healthcare organizations face regulatory exposure as the EU AI Act introduces strict requirements for high-risk AI systems. This article outlines how to classify healthcare AI use cases, align them with risk tiers, and implement governance controls across data, models, and deployment pipelines. It also details operational requirements such as transparency, human oversight, and post-market monitoring. Leaders should view compliance as an architectural concern, requiring integration into system design rather than a standalone legal exercise.