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

European Pharmaceutical Law Review (EPLR), Lexxion Publisher, Forthcoming 2021

18 Pages Posted: 18 May 2021

See all articles by Anastasiya Kiseleva

Anastasiya Kiseleva

Vrije Universiteit Brussel (VUB)

Paul De Hert

Free University of Brussels (VUB)- LSTS; Tilburg University - Tilburg Institute for Law, Technology, and Society (TILT)

Date Written: April 26, 2021

Abstract

Creation of the European health data space is one of the core actions promoted by the European Commission in the EU Data Strategy. This task is challenging due to technical, organizational, economic and other 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 or may influence its development. 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 provides the analysis and comparison of these areas to submit the systemized view on causes and consequences of the identified issues and to suggest the vision of the further legislative process related to the European health data space.

Keywords: European Health Data Space, EU Data Strategy, AI Regulation, personal data, non personal data, rules on healthcare provision in the EU, health policy, data policy, AI policy, Data Act, Data Governance Act

JEL Classification: K32 , I1

Suggested Citation

Kiseleva, Anastasiya and De Hert, Paul, Creating a European Health Data Space. Obstacles in Four Key Legal Areas (April 26, 2021). European Pharmaceutical Law Review (EPLR), Lexxion Publisher, Forthcoming 2021, Available at SSRN: https://ssrn.com/abstract=3846781 or http://dx.doi.org/10.2139/ssrn.3846781

Anastasiya Kiseleva (Contact Author)

Vrije Universiteit Brussel (VUB) ( email )

Brussels
Belgium

Paul De Hert

Free University of Brussels (VUB)- LSTS ( email )

Pleinlaan 2
Brussels, Brabant 1050
Belgium

Tilburg University - Tilburg Institute for Law, Technology, and Society (TILT) ( email )

P.O.Box 90153
Prof. Cobbenhagenlaan 221
Tilburg, 5037
Netherlands

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