FRANCE Trends and Developments Contributed by: Mathilde Merckx, Xavier Lebrasseur, Juliette Migeon and Diane Courtier, Alchimie Avocats
autonomy and that may exhibit adaptiveness after deployment (…).” This new regime, although not initially designat- ed to apply exclusively to a specific category of products, then opens the door to products liabil- ity claims related to damages caused by artificial intelligence in Europe and, correlatively due to upcoming transposition, in France. Unresolved Legal Questions While the upcoming reform represents a signifi- cant step forward in adapting current legislation to technological advancements and changes in practices, the abandonment of the AI Liability Directive means that each member state will continue to interpret and apply liability rules independently, including in relation to AI-related damages. In the healthcare sector, this is especially prob- lematic given the issues at stake and the mul- tiplicity of actors that may be involved, directly or indirectly, in a patient’s care: medical device manufacturers, software developers, healthcare institutions and professionals, etc. Determin- ing fault and apportioning liability among them – particularly where damage results from com- plete algorithmic behaviour – will then remain a legal challenge.
Key issues also seem to remain unresolved such as the question of the burden of proof in causa- tion claims involving autonomous systems, or the adequacy of existing insurance coverage for AI-related risks. Conclusion France, like many EU member states, finds itself at a critical juncture, where the fast digitalisation of healthcare requires not only political vision and support but also legal and ethical clarity. The country has largely improved in digital health innovation and infrastructure but remains vigilant in the face of the challenges of ethics, security, inclusion and governance challenges. The current strategy is part of a long-term vision to transform the healthcare system, enhance prevention and care, and reduce inequalities. It brings together a wide ecosystem of public and private actors within a framework of innovation serving the common good. The coming years will be decisive in consoli- dating achievements, building users’ trust, and establishing digital health as a structural pillar of the French healthcare system.
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