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

Céline Gauthier-Maxence () and Carine Milcent ()
Additional contact information
Céline Gauthier-Maxence: PSE - Paris School of Economics - UP1 - Université Paris 1 Panthéon-Sorbonne - ENS-PSL - École normale supérieure - Paris - PSL - Université Paris Sciences et Lettres - EHESS - École des hautes études en sciences sociales - CNRS - Centre National de la Recherche Scientifique - INRAE - Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement - ENPC - École nationale des ponts et chaussées - IP Paris - Institut Polytechnique de Paris
Carine Milcent: PSE - Paris School of Economics - UP1 - Université Paris 1 Panthéon-Sorbonne - ENS-PSL - École normale supérieure - Paris - PSL - Université Paris Sciences et Lettres - EHESS - École des hautes études en sciences sociales - CNRS - Centre National de la Recherche Scientifique - INRAE - Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement - ENPC - École nationale des ponts et chaussées - IP Paris - Institut Polytechnique de Paris

Working Papers from HAL

Abstract: 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.

Keywords: Health data governance; law in action vs; socio-legal analysis; cybersecurity and compliance; artificial intelligence in healthcare; General Data Protection Regulation (GDPR); Health data governance European Health Data Space (EHDS) General Data Protection Regulation (GDPR) artificial intelligence in healthcare cybersecurity and compliance socio-legal analysis law in action vs; Cybersecurity; AI in healthcare; General Data Protection; European Health Data Space (EHDS); Health data governance European Health Data Space (EHDS) General Data Protection (search for similar items in EconPapers)
Date: 2025-11-26
Note: View the original document on HAL open archive server: https://hal.science/hal-05361837v1
References: Add references at CitEc
Citations:

There are no downloads for this item, see the EconPapers FAQ for hints about obtaining it.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:hal:wpaper:hal-05361837

Access Statistics for this paper

More papers in Working Papers from HAL
Bibliographic data for series maintained by CCSD ().