EU AI Act: what could AI literacy mean for medical laboratories? – Opinion Paper on behalf of the Section Digital Competence and AI of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL)

Abstract The EU AI Act came into force on August 1, 2024, and since February 2, 2025, employees must be sufficiently trained in the use of AI systems (Article 4 of the EU AI Act). But what does “sufficient” AI literacy mean in the context of the EU AI Act? This article highlights the statements of the EU AI Act on AI literacy and aims to help in the development of training curricula. Medical laboratories offer numerous areas of application for AI, including improving the organization of laboratory processes and knowledge management. Even though there are no mandatory training requirements yet, basic data literacy is considered a prerequisite for AI Literacy. Three major topics are identified for AI literacy training: a general knowledge on the content of the EU AI Act, fundamentals of artificial intelligence, and context-specific training. This combination of fundamental data expertise and fundamental AI expertise will enable Article 4 of the EU AI Act to be fulfilled “to the best of ability” and lay the foundation for the transformation of medical laboratories.