FRANCE Law and Practice Contributed by: Liliana Eskenazi, Julie Ernewein and Pauline Lecrenais, Fréget Glaser et Associés
• The AI Act, which entered into force on 1 August 2024, and will be implemented progressively. The application to high-risk AI systems is scheduled for 2 August 2026 and 2 August 2027. • The EHDS, which entered into force on 26 March 2025, which will also be implemented progres - sively. In particular, Chapter IV on secondary use will become applicable four years after entry into force for most data categories, six years after entry for certain sensitive categories, and ten years after entry for the participation of third countries in the HealthData@EU. • The Directive of 23 October 2024 on liability for defective products, which modernises the EU’s product liability framework to better account for emerging technologies, including AI-driven sys - tems. Member States are required to transpose this directive into national law by December 2026. 9.2 Regulatory Sandboxes and Innovation Programmes At EU level, the AI Act requires each Member State to establish an AI regulatory sandbox by 2 August 2026. These sandboxes are designed to support the development, testing and validation of innovative AI systems in a controlled environment while ensuring compliance with applicable legal and ethical require - ments. At national level, the CNIL has already implemented this approach by creating a regulatory sandbox to help innovative actors incorporate GDPR compliance from the early stages of development. For example, in 2023, the CNIL offered guidance to several health- related projects. 9.3 International Harmonisation France plays a leading role in the development of AI and in promoting the harmonisation of regulatory frameworks at both European and international levels. For instance, the country hosted and co-chaired the AI Action Summit in February 2025, which gathered representatives from over 100 countries and resulted in the announcement of 100 concrete actions and commitments. One full day of the summit focused specifically on AI in healthcare. In addition, France is a member of the WHO Europe’s Strategic Partners’
Initiative for Data and Digital Health (SPI-DDH), which aims to promote safe and responsible digital health innovation. However, AI developers may encounter cross-border regulatory challenges, including the transfer of sen - sitive health data, particularly to non-EU countries. These transfers are subject to strict requirements under the GDPR and other applicable EU/national regulations, which may create operational and legal hurdles. 9.4 Emerging Legal Challenges The French government underscores the need to anticipate technological advancements and emerg - ing applications of AI, while ensuring their relevance, safety and ethical integrity. AI must be developed to support both patients and healthcare professionals. Several national initiatives have been launched to meet these objectives. These include a pilot programme to evaluate the medico-economic impact of AI-assisted electrocardiogram interpretation, an observatory for monitoring AI usage in healthcare, and ongoing efforts to develop evaluation frameworks for digital medical devices incorporating AI. These initiatives aim to fos - ter responsible and effective integration of AI into the healthcare system. Healthcare AI providers must adopt a comprehensive compliance strategy, ensuring their solutions meet (notably) regulatory requirements under the GDPR, the AI Act and the MDR/IDVR. This involves implementing transparency and explainability measures, conduct - ing regular internal audits, and establishing robust post-deployment monitoring and risk-management procedures. Healthcare institutions and professionals, for their part, are expected to use AI tools in a transparent, ethical and accountable manner. This includes inform - ing patients when AI is involved in their care and exer - cising professional judgment rather than relying solely 10. Practical Considerations in Healthcare AI 10.1 Compliance Strategies
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