Ensuring Safe and Trustworthy AI
Explore the EU AI Act from a healthcare perspective
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The 2024 EU AI Act (AI Act) is the world’s first comprehensive legislation regulating the development, deployment, and responsible use of artificial intelligence (AI) systems. Under the AI Act, entities that develop and use AI in a high-risk context have new responsibilities for the safety and performance of their systems, regardless of the sector they operate in.
This paper explores the AI Act from a healthcare perspective, with a focus on the responsibilities of both the developers of AI systems and the health institutions that utilize AI. It covers key definitions, describes the interplay of the AI Act with established product safety law, and explains relevant regulatory topics including the conformity assessment pathway, risk classification and harmonized standards.
The paper gives extra focus to novel aspects of the AI Act, such as the new role of deployer, regulatory sandboxes, transparency obligations, human oversight requirements, and the protection of fundamental rights. Finally, this white paper includes a basic six-step plan to begin work towards AI Act compliance.