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Creating a European Health Data Space: Obstacles in Four Key Legal Areas

Anastasiya Kiseleva, Paul de Hert


The creation of the European health data space is one of the core actions promoted by the European Commission in its EU Data Strategy. This task is challenging due to technical, organisational, economic issues that require different measures. This paper focuses on the issues in the legal field and identifies four key legal areas where the creation of a European health data space may face obstacles. These areas are: 1) rules on the provision of healthcare in the Member States; 2) protection of personal data in healthcare provision and medical research; 3) control and use of non-personal data and 4) the regulatory framework on AI. The article analyses and compares these areas and provides a systemised view on causes and consequences. The article concludes with an outlook further legislatives developments related to the European health data space.

Anastasiya Kiseleva is a PhD candidate under the EUTOPIA program at Vrije Universiteit Brussel (research groups Law, Science, Technology and Society (LSTS) and its subgroup Health and Ageing Law Lab (HALL)) and at CY Cergy Paris University (ETIS research lab). For correspondence: <> Paul De Hert is a Professor at Vrije Universiteit Brussel (VUB) and associate professor at Tilburg University. He is Director of the VUB Research Group on Fundamental Rights and Constitutionalism (FRC), Director of the Department of Interdisciplinary Studies of Law (Metajuridica) and the core member of the research group Law, Science, Technology and Society (LSTS). For correspondence: <>


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