The European Union is taking a decisive step forward with the AI Act, the first European legislation dedicated to artificial intelligence. In a sector such as e-health, where data and critical systems are at the heart of patient care, this European regulation redefines the rules, obligations, and possible uses of AI systems, in line with other foundational legislation, such as the Cyber Resilience Act. This legislation also reinforces the concept of controlled use that aligns with the expectations of the European digital market.
Objective: to establish a robust compliance framework that respects citizens’ rights, health, and safety, and to implement AI
governance. In this article, we detail the key points of the regulation, the risks, implementation, and the direct impacts on businesses, solution providers, and healthcare stakeholders in France and the European Union.