European Artificial Intelligence Act (AI Act)
The European Artificial Intelligence Act (AI Act) is a landmark regulation that aims to create a trustworthy, responsible, and ethical framework for the development and deployment of artificial intelligence (AI) within the European Union. Published in the Official Journal of the European Union in July 2024, the Act officially entered into force on 1 August 2024.
The AI Act represents the first comprehensive set of rules that tackles AI regulation, placing a strong emphasis on safety, transparency, and ethical development. The regulation seeks to substantially change the oversight of AI systems. It focuses on making AI technologies safe, transparent, traceable, and non-discriminatory. The framework introduces a uniform definition of AI systems, which is adaptable to future developments, and it categorises AI systems into four risk levels, each subject to specific obligations:
The implementation phase of the AI Act features a structured timeline with several critical dates and objectives, providing a roadmap for how AI regulation will evolve in the coming years. More specifically, it supports the gradual implementation and adaptation of the rules through guidelines, codes of conduct, standards and evaluations, while seeking to strike a balance between fostering innovation and safeguarding fundamental rights and safety.
Originally the AI Act set full application for August 2027, with the first major obligations for prohibited AI practices and AI literacy applying from February 2025 and high-risk system obligations from August 2026. Following the adoption of the Digital Omnibus on AI (see more information about the Digital Omnibus here) in 2026, the high-risk deadlines have been deferred to 2 December 2027 for stand-alone high-risk AI systems under Annex III and to 2 August 2028 for high-risk AI systems embedded in physical products under Annex I. Transparency obligations under Article 50 (e.g. disclosure of AI-generated content) remain unaffected and apply from August 2026, as originally scheduled.
As the AI Act addresses key concerns raised by the medical community regarding the risks associated with the use of AI in healthcare, including potential patient harm, misuse, and lack of transparency of medical AI tools, and has significant implications for the medical technology sector, the ESR has taken a proactive stance in advocating for the responsible and effective application of AI in healthcare. Under the lead of the ESR eHealth & Informatics Subcommittee, a specialised AI Act Working Group was formed in April 2024 to provide expert input and to ensure that the implementation of the AI Act reflects the interests and needs of radiologists’ medical realities.
The work of the AI Act Working Group resulted in an ESR statement outlining key policy considerations and recommendations for the effective implementation of the AI Act in radiology. It addresses key aspects of AI governance, including AI literacy, high-risk AI classification, data governance, transparency, human oversight and post-market monitoring. By providing practical recommendations, the statement aims to support the safe, effective and responsible integration of AI into radiology across Europe. Find more details on the ESR recommendations in the graphic below.
Furthermore, the ESR contributed to two European Commission surveys supporting the development of guidelines on the classification of high-risk AI systems under the AI Act. The guidelines aim to help providers, deployers and market surveillance authorities assess whether an AI system falls within the high-risk category, including through practical examples across different use cases. The ESR’s feedback focused on ensuring that the guidelines include relevant healthcare and radiology examples, helping to clarify how the classification rules apply to AI systems used in these areas.
The ESR AI Working Group continues to closely monitor the AI Act legislation process, aiming to ensure that the legislation effectively addresses the evolving challenges and opportunities in the realm of AI in healthcare, committed to advocating for the ethical and secure use of AI technologies, with a focus on enhancing safety, improving healthcare definitions, and streamlining legislations.
ESR statements and contributions to the European Commission public consultations:
- Joint Statement: ESR co-signs joint healthcare statement on the EU Artificial Intelligence Act
- ESR Statement and Recommendations on the AI Act implementation
- ESR feedback on the Draft Implementing Regulation Establishing a Scientific Panel of Independent Experts
- ESR response to the consultation on AI Act prohibitions and AI system definition
- ESR response to the Digital Omnibus on AI Consultation