Scientific research processing health data in the European Union: data protection regime vs. open data

Data processing is fundamental for medical and biomedical scientific research. Data access and open sharing foster innovation and knowledge in these fields. However, supporting data-intensive research raises several data protection issues. The legal framework is complex and the proposal recently issued by the European Commission on the European Health Data Space aims at introducing rules to open research data. This paper provides an overview of the relevant data protection laws in the European Union, focusing on the key elements for researchers. It also deals with the policies and legislation on Open Science and Open Data, and discusses the new acts within the Data Strategy that may be relevant for a scientific project to open medical research. Then, the tensions between the data protection regime and the open research data framework are analysed to find the viable solutions for data access and sharing.