Between Compliance and Innovation: A Socio-Legal Analysis of Health Data Regulators in France under the European Framework[Entre conformité et innovation : analyse socio-juridique des régulateurs des données de santé en France dans le cadre européen]

This article examines how health data governance in France is evolving under the combined influence of European regulations (GDPR, EHDS, AI Act, NIS 2, CRA) and the digital transformation of healthcare. Based on 28 semi-structured interviews with professionals from four categories, producers, disseminators, users, and decisionmakers, it analyzes how actors interpret and implement regulatory obligations, negotiate tensions between innovation and protection, and construct trust in datadriven health systems. A mixed socio-legal approach combines qualitative discourse analysis with quantitative indicators to map rationalities and frictions along the data access chain. Results reveal a strong consensus on the inclusion of social determinants within the definition of health data (91.7%), broad confidence in artificial intelligence when embedded in secure and traceable environments (66.7%), and major silences concerning cybersecurity (79.2% without explicit position). The study identifies a structural gap between law on the books and law in practice: producers and researchers view regulation as a constraint or procedural burden, while decision-makers regard it as a legitimacy tool ensuring accountability. These differentiated rationalitiespragmatic, procedural, scientific, and normative -shape the daily life of compliance and the possibilities of innovation. The paper argues that European instruments collectively aim to reconcile openness and trust through "useful but safeguarded" data sharing, while emerging technologies (synthetic data, generative models) challenge existing notions of privacy and representativeness. It concludes by outlining pathways toward an integrated, learning governance of health data that combines legal clarity, cybersecurity transparency, distributed responsibility for AI, and participatory oversight linking technical innovation with democratic health justice.