“The European Health Data Space: Forecasting Technoscientific, Ethical and Social Challenges in Implementation” is the title of workshops scheduled in Berlin on May 29th dedicated to the theme of European Health Data Area Regulation and the ethical, legal and “technical” aspects it raises. The workshop is organized within the project NeuroCOV, international research project on the long-term neurological and psychiatric effects of COVID-19, coordinated by the German Center for Neurodegenerative Diseases (DZNE) in Bonn and involving ten different European institutions in seven countries and of which the State University of Milan, whose team is coordinated by Domenico Mavilioprofessor of technical sciences of laboratory medicine at the department of Medical biotechnology and translational medicine, represents one of the main partners.
The European Health Data Area Regulation (European Health Data Space, EHDS) has been proposed by the European Commission in May 2022. Subsequently, as part of the ordinary legislative procedure, the European Parliament reached an agreement with the Council (March 2024) and then voted in the plenary session (April 2024) on an amended text, a prelude to definitive approval and subsequent implementation of the Regulation.
As the first common data space in a specific sector to emerge from the “European Data Strategy”, the Regulation intends to pursue a profound technical-regulatory standardization, with two objectives in particular. In the first place, give people greater digital access to electronic personal health data and greater control of such data, at national and European level, as well as fostering the development of a single market for electronic health record systems, medical devices and artificial intelligence systems (primary use of data). Secondly, encourage extensive practices of data sharing aimed at reusing health data for research, innovation, policy making and regulatory activities (secondary use of data).
In light of the objectives indicated – the most significant of which is represented by a extensive liberalization in the sharing of health data for secondary uses by public, non-profit and private actors on the European continent –, the Regulation is destined to have a significant impact on healthcare systems, research networks and European societies as a whole.
Starting from these considerations, the seminar intends to bring together policymakers involved in the European legislative process, representatives of national regulatory bodies, researchers, social scientists and experts in the field of research ethics and new technologies, to promote a discussion aimed at analyzing the impact and anticipating the challenges posed by the implementation of the ‘EHDS.
The workshop will start with an overview of the legislative process and the “Trilogue” negotiations following the issuing of the proposed Regulation by the Commission in 2022, with the aim of highlighting the salient and most debated themes. The seminar will then focus on possible opportunities and challenges in aligning current research and healthcare practices with the EHDS standards and regulatory requirements introduced. Finally, possible ethical-normative approaches – from governance to consensus – aimed at an ethically sound implementation of the EHDS will be outlined and discussed.
