Between liberalisation and protection: the European Health Data Space and the regulation of health data in the post-Covid era

The European Health Data Space (EHDS) constitutes one of the most ambitious regulatory initiatives under the European Union's digital strategy. It aims to standardise the utilisation of health data among Member States by enhancing accessibility, interoperability, and secondary application for research and innovation. Nonetheless, the EHDS poses significant enquiries regarding the equilibrium between data liberalisation and the safeguarding of basic rights. This thesis examines how the EHDS reconfigures the interplay between accessibility and protection within the context of European health data governance. While the General Data Protection Regulation (GDPR) traditionally conceived privacy as a defensive right limiting data circulation, the EHDS introduces a new paradigm that incorporates protection into the very design of access. Through secure processing environments, proportionality principles, and the creation of Health Data Access Bodies, protection becomes an internal condition of circulation rather than an external constraint. The thesis argues that the EHDS embodies a model of regulated liberalisation, where data mobility and innovation are legitimised through institutional safeguards. However, this model runs the risk of proceduralising rights, changing them into tools that facilitate rather than restrict data flows. The thesis concludes that the EHDS's legitimacy and success will be determined by whether citizens view protection as a genuine guarantee of liberty and fairness, rather than as a bureaucratic compliance measure. The European Union faces the task of maintaining a constructive tension between openness and protection. Meaningful opt-outs, participatory governance, equitable benefit-sharing, and balanced capability among Member States have been identified as critical requirements for ensuring that the EHDS enhances, rather than destroys, public trust in digital health governance.