Healthcare AI 2025

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

For instance: • the ANAP, in its February 2025 guide on “deploying trustworthy AI in healthcare”, emphasises that AI systems must be understandable by developers, healthcare professionals and patients to ensure trust and safe use; and • the HAS is developing a “framework of trust” for the use of MDAI; therefore, in addition to its 2023 guide for choosing digital medical devices for professional use, the HAS is preparing further tools – including a forthcoming guide aimed at support - ing healthcare institutions and professionals in the responsible deployment and use of AI in care delivery. 8.3 Therapeutic and Treatment Planning See responses above regarding the legal framework, human oversight, clinical decision support and diag - nostic applications. 8.4 Remote Monitoring and Telemedicine Supervision of Telemedicine by the French Public Health Code Beyond compliance with the EU regulations, telemedi - cine, including remote monitoring, is governed by the French Public Health Code (Article L. 6316-1 and R. 6316-1 et seq.). A key requirement is that the health - care professional and the patients are clearly identi - fied. Furthermore, patient consent must be obtained, and the healthcare professional has a duty to inform (Article L. 1111-1 et seq.). The HAS has published a “Professional code of best practices” to help guide the practice of telemedicine in France. AI-Specific Requirements for Teleconsultation Reimbursement Telemedicine companies now also have ad hoc legal status and must obtain accreditation from the Minis - try of Health to bill the national health insurance for teleconsultations performed by employed physicians. To obtain such accreditation, companies are required, among other things, to certify that their information system complies with the standards established by the ANS. The accreditation framework includes sev - eral AI-related requirements, such as ensuring that

patients are informed of the use of AI systems, under - stand the system, and give their consent. 8.5 Drug Discovery and Development Compliance With European and National Regulations Drug discovery and development must comply with both European and French regulations, including pro - cedures involving the ANSM when applicable. Increasing Focus on AI in Drug Development by Health Agencies/Authorities Health authorities are placing growing emphasis on the integration of AI in drug development processes. For instance, at EU level, the European Medicines Agency (EMA) published a reflection paper in Septem - ber 2024 on “The use of AI in the medicinal product lifecycle”. This paper notably highlights that, within the context of clinical trials, AI use must comply with Good Clinical Practice (GCP) guidelines. When AI use involves high regulatory impact or patient risk and has not been previously qualified by the EMA for that specific purpose, detailed documentation – including model architecture, development logs, validation and testing results, training data, etc – may also be con - sidered part of the clinical trial data and required for comprehensive assessment. Furthermore, in May 2025, the EMA and Heads of Medicines Agencies (HMA) released a 2025-2028 work plan focused on “Data and AI in medicines regu - lation”. At national level, the ANSM recognises both the oppor - tunities AI presents for accelerating drug development and the challenges it introduces, such as ensuring data confidentiality, addressing potential algorithmic biases, and adapting to complex and diverse biologi - cal models. 9. Future Trends and Regulatory Developments in Healthcare AI 9.1 Pending Legislation and Regulation Several key EU regulations and directives are set to shape the legal landscape in the coming years, includ - ing the following.

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