Open Access

Hammam Abu Attieh, Anna Haber, Felix Nikolaus Wirth, Benedikt Buchner, Fabian Prasser

• Open Science involves the sharing of knowledge and data as well as the exchange of research results. This is particularly important in the biomedical field, as it can foster validation studies in response to the replication crisis and improve resource utilisation. Since medical data is particularly privacy sensitive, its processing is subject to strong data protection requirements. Agencies, institutions, and projects in the European Union are still struggling with the establishment of widely accepted mechanisms supporting the sharing of data for Open Science practices. The goal of this paper is to provide an overview of different methods that have been used for this purpose and to discuss their technical properties and legal challenges. Our assessment is based on well-known conceptualizations, such as the Five Safes Framework. The result shows that different approaches provide different trade-offs between the functionalities and the degree of data protection provided, and that thereOpen Science involves the sharing of knowledge and data as well as the exchange of research results. This is particularly important in the biomedical field, as it can foster validation studies in response to the replication crisis and improve resource utilisation. Since medical data is particularly privacy sensitive, its processing is subject to strong data protection requirements. Agencies, institutions, and projects in the European Union are still struggling with the establishment of widely accepted mechanisms supporting the sharing of data for Open Science practices. The goal of this paper is to provide an overview of different methods that have been used for this purpose and to discuss their technical properties and legal challenges. Our assessment is based on well-known conceptualizations, such as the Five Safes Framework. The result shows that different approaches provide different trade-offs between the functionalities and the degree of data protection provided, and that there are open legal issues. Current legislative initiatives in the EU, including regulations for the European Health Data Space and the Data Governance Act, have the potential to address some of the resulting uncertainties.…