Healthcare AI 2025

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

thereby entailing a substantial reputational risk for the companies concerned.

Healthcare professionals may be personally liable for mishandling AI (eg, misinterpreting results) unless they can justify following or disregarding AI recommenda - tions. Patients must prove both breach of duty and causation for harm. Standards of Care With AI Doctors must provide attentive care consistent with current science (Article R4127-32 of the French Public Health Code). When using AI, they must be trained, avoid undue reliance if better methods exist, justify AI use or non-use, obtain informed consent, maintain autonomy and avoid automation bias. AI increases responsibility without lowering standards. Though not involving AI specifically, decisions ruled by French jurisdictions suggest how liability could be applied: • in 2020, the Paris Court of Appeal held a doc - tor liable for using a robotic technique instead of a standard one, causing unnecessary risk to the patient (Article L. 1142-1 CSP) (Paris Court of Appeal, 19 November 2020, 17/15960); and • in 2022, the Council of State clarified that telemedi - cine reforms do not exempt doctors from their duties; teleconsultations still require attentive care, informed consent, and respect for the care path - way (French Council of State, 14 October 2022, 461412). Determining Causation in Cases Involving AI Systems Proving causation is difficult due to what can be described at times as AI’s “black box” nature. The French courts allow some flexibility, but the burden remains on patients. If fault remains unproven, com - pensation may be sought via the National Office for Compensation of Medical Accidents (Oniam), subject to strict legal conditions and seriousness thresholds. 4.3 Risk Management Requirements Regulatory Risk Management Requirements Healthcare AI systems used for diagnosis, treatment, or clinical decision-making are classified as high-risk technologies under the EU AI Act. As such, AI systems are subject to stringent risk-management obligations across their entire lifecycle.

4. Liability and Risk in Healthcare AI 4.1 Liability Framework Liability Frameworks The AI Act does not define the legal regime for AI- related damages. The proposed AI Liability Directive, intended to address this, was removed from the Euro - pean Commission’s 2025 work programme. In the absence of a specific instrument, PLD should therefore cover AI liability questions following its entry into force in December 2026. It treats software as a product subject to no-fault liability, with developers and AI providers regarded as manufacturers. The PLD also introduces eased proof requirements for claim - ants. In France, liability for healthcare AI currently relies on existing frameworks – product liability (to be updated with the PLD) and traditional medical liability – without a dedicated AI-specific regime. Allocation of Responsibility • Developers and manufacturers can be held liable if harm results from a defective AI system. • Healthcare providers remain liable for improper use of AI tools, including misuse, over-reliance, lack of training, or failure to inform patients. • Other actors, such as distributors and importers, may be liable when the manufacturer is not estab - lished in the EU. • The AI Act outlines responsibilities across the entire AI value chain, especially for high-risk AI systems. 4.2 Patient Harm and Malpractice Application of Traditional Medical Liability Standards to AI Systems In France, traditional medical liability applies to clini - cians using AI, which is viewed as a support tool – not a decision-maker. Doctors retain clinical judgment and are liable for errors from misuse of AI under Article L1142-1 of the French Public Health Code.

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