From Law in the Books to Law in Action, Regulatory Rationalities in Health Data Governance A Socio-Legal Analysis of Health Data Regulators in France under the European Framework

De la loi sur le papier à la loi en action: les rationalités réglementaires dans la gouvernance des données de santé Une analyse socio-juridique des autorités de régulation 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 being reshaped by European regulation (GDPR, EHDS, AI Act, NIS2, CRA) and the digital transformation of healthcare. Drawing on 28 semi-structured interviews with four categories of actors, producers, disseminators, users, and decision-makers, it explores how regulatory obligations are interpreted and enacted in practice. Using a mixed socio-legal methodology combining qualitative analysis and quantitative indicators, the study maps tensions across the data access chain. Findings show broad support for including social determinants within the scope of health data (91.7%), conditional confidence in artificial intelligence when embedded in secure environments (66.7%), and significant silence regarding cybersecurity responsibilities (79.2%). The analysis reveals a persistent gap between law on the books and law in action: producers and researchers often experience regulation as constraint, whereas decision-makers frame it as a source of legitimacy and accountability. These divergent pragmatic, procedural, scientific, and normative rationalities shape both compliance practices and innovation pathways. The article argues that European health data governance increasingly seeks to reconcile openness with trust through safeguarded data sharing, while new technologies challenge existing notions of privacy, responsibility, and representativeness. It concludes by calling for a more integrated and adaptive model of governance combining legal clarity, transparent cybersecurity, distributed AI accountability, and participatory policy maker.

Keywords: Health data governance; regulation as process; distributed; co-production; cybersecurity and compliance; socio-legal analysis (search for similar items in EconPapers)
Date: 2026-07-06
Note: View the original document on HAL open archive server: https://hal.science/hal-05361837v2
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 ().