Healthcare AI 2025

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

Ethical considerations also play a growing role. Digi - tal ethics in healthcare, both at French and Europe - an level, seeks to promote principles such as trust, transparency, and fairness in AI use. Transparency and explainability obligations are central to protect - ing patients’ rights and ensuring responsible use of AI in care. Notably, the French Digital Health Delegation and the Digital Health Agency have contributed to this effort through the publication of ethical implementation guidelines: • the 2022 “Ethics by Design Guide” outlines five core principles (non-maleficence, justice, autono - my, transparency, sustainability) and applies them across five AI development stages; • a new 2025 “Implementation Guide for Ethical AI Systems in Healthcare” has also been submitted for public consultation to provide more practical, phase-specific ethical benchmarks for developers and providers. In parallel, a regulatory framework on interoperability and security applies to digital medical devices that process personal data. Since February 2023, such devices must comply with the “Interoperability and Security Framework for Digital Medical Devices”, with certification issued by the Digital Health Agency (ANS) as a condition for reimbursement by the French National Health Insurance. Lastly, on the matter of liability, the EU has not yet adopted a dedicated regime for AI-related damages. While a specific AI Liability Directive was initially envis - aged, it was ultimately excluded from the Commis - sion’s 2025 work programme. In its place, the new Product Liability Directive (PLD), entering into force in December 2026, is expected to fill this gap. It intro - duces no-fault liability for software, including AI sys - tems, treating developers and providers as manufac - turers. The directive also lowers the burden of proof for claimants in compensation claims. In France, liabil - ity is currently governed by traditional frameworks: product liability (soon to be aligned with the PLD) and medical liability. In this context, AI is regarded as a decision-support tool, and healthcare profession -

als retain full responsibility for clinical decisions, in accordance with Article L. 1142-1 of the French Public Health Code. Ensuring proper use of health data Another critical issue concerns proper access to and use of health data, particularly for training and testing AI-based medical devices. Access to such data is highly regulated. Healthcare stakeholders may gain access to health data for research purposes – such as innovation activities or algorithm training – through the dedicated framework for the secondary use of health data, but only under specific conditions. At EU level, the EHDS Regulation establishes a harmo - nised framework for the access, use, and exchange of electronic health data across Member States. Its goals are to empower individuals with access to and control over their personal health data (primary use), and to enable the secure and reliable reuse of health data for research, innovation, policymaking, and regulatory purposes (secondary use). It introduces HealthData@EU, a central online platform that connects health datasets from across Europe. Under this framework, stakeholders may apply to the relevant health data access body (not yet designated) for permission to use health data for secondary pur - poses (as health data applicants). At the same time, they may be required to share health data (as health data holders). At national level, France has already established the Health Data Hub as a centralised platform that facili - tates access to data from the National Health Data System (SNDS). This enables the secondary use of health data for purposes such as the development and testing of AI algorithms. However, access to this data for secondary use may require prior authorisation from the French Data Protection Authority (the CNIL). Once access is granted, several other compliance considerations must be addressed.

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