Healthcare AI 2025

FRANCE Law and Practice Contributed by: Liliana Eskenazi, Julie Ernewein and Pauline Lecrenais, Fréget Glaser et Associés

2.2 Key Laws and Regulations Key Legal Frameworks Governing Healthcare AI in France AI use in the healthcare sector is governed by the following. • Regulation 2024/1689 of 13 June 2024 on Artificial Intelligence (the AI Act). This entered into force on 1 August 2024 with a phased implementation schedule. • Regulation 2017/745 of 5 April 2017 on Medical Devices (MDR). • Regulation 2017/746 of 5 April 2017 on In Vitro Diagnostic Medical Devices (IVDR). • Regulation 2025/327 of 11 February 2025 on the European Health Data Space (EHDS). This entered into force on 26 March 2025, marking the begin - ning of the “transition period” (phased implementa - tion schedule). • Directive 2024/2853 of 23 October 2024 on Liabil - ity for Defective Products. This must be transposed into French law by no later than 9 December 2026. • Article L. 4001-3 of the French Public Health Code, a provision stemming from the August 2021 Bio - ethics Law. • Regulation 2016/679 of 27 April 2016 (GDPR) and the French Data Protection Act of 6 July 1978. Alignment of EU Regulations and Existing Healthcare Laws In the field of AI and healthcare, European regulations such as the AI Act and the MDR provide a comprehen - sive framework for AI-driven medical technologies. The MDR sets specific requirements for the safety, performance and conformity assessment of medical devices, including those incorporating AI. The AI Act introduces additional obligations that focus on the specific risks posed by AI systems, particularly high-risk applications in healthcare. At national level, the provisions of the French Public Health Code (Article L.4001-3) also govern the use of AI in healthcare. These national rules are generally aligned with the ethical requirements set out in the AI Act.

• Health Data Hub – this platform is already opera - tional and supports 168 projects, 54% of which are led by hospitals and 28% involve industry partners; 40% of these projects use AI methods, such as the DEEP.PISTE project, which aims to optimise organ - ised breast cancer screening through advanced AI models. 2. Legal Framework for Healthcare AI 2.1 Regulatory Definition and Classification of Healthcare AI Healthcare AI systems are classified based on intend - ed use, risk level, and patient-health impact: • diagnostic AI tools – typically classified as medical devices, often high-risk if they affect critical clinical decisions, subject to MDR regulations requiring conformity assessment and CE marking before market entry; • therapeutic AI systems – AI applications influencing treatment or delivering therapy (eg, drug dosage calculators, robotic surgery aids) are also medical devices and regulated accordingly; and • administrative or operational AI tools – support healthcare operations without direct clinical impact (eg, appointment management), are generally not medical devices but must comply with data protec - tion and cybersecurity laws. The AI Act also introduces risk-based categories, identifying high-risk AI systems, including medical AI, with stricter transparency, robustness, and oversight requirements. According to the Medical Device Coordination Group (MDCG)’s guidance published in June 2025, the clas - sification of an AI system as high-risk under the AI Act does not automatically result in a higher risk class for the corresponding medical device or in vitro diagnos - tic under the MDR or IVDR. Rather, it is the device’s classification under the MDR/IVDR that determines whether the AI system is considered high-risk under the AI Act.

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