The European Health Data Space

Details

Supervisors

Defraigne, Jean-Christophe

Faculty

Louvain School of Management

Degree label

Master de spécialisation en entreprises et politiques économiques européennes

Abstract

enThe European Health Data Space (EHDS), adopted in February 2025, represents a landmark step in the European Union's ambition to build a unified framework for the sharing and reuse of health data across Member States. By establishing harmonised standards for primary and secondary use of health data, the EHDS aims to improve patient care, accelerate medical research, and reinforce European digital sovereignty in the health sector. This thesis examines the conditions under which the EHDS can effectively fulfil its objectives, with a particular focus on the legal and geopolitical challenges it faces. The analysis covers three interconnected dimensions: the technical and institutional architecture of the regulation, the fragility of the transatlantic data transfer framework on which it partly relies, and the internal tensions within the European Union itself. The thesis argues that while the EHDS provides a solid legal foundation, its success is far from guaranteed. The instability of the Data Privacy Framework, the paralysis of the PCLOB under the second Trump administration, and the proposed redefinition of personal data under the Digital Omnibus package all represent structural vulnerabilities that could undermine the regulation before it is fully deployed. Ultimately, the EHDS can only succeed if the European Union remains coherent with the values and principles on which it was built ; choosing genuine digital sovereignty over short-term competitiveness, and ensuring that the legislative framework surrounding the regulation does not contradict its own foundations.