Abstract
The creation of a European Data Space is one of the priorities of the Commission 2019-2025, including the health sector. A common European Health Data Space will promote better exchange and access to different types of health data (electronic health records, genomics data, data from patient registries, etc.), not only to support healthcare delivery (so-called primary use of data) but also for health research and health policy-making purposes (so-called secondary use of data). The COVID-19 pandemic has further underlined the importance of having timely access to health data within the Members States and across Europe. The EHDS would give a valuable contribution to research activities on new preventive strategies and effective treatments and medical devices, thus contributing to improving citizens' health and their quality of life. The European Health Data Space will require a common framework that should be based on three pillars: a strong system of data governance and rules for data exchange;data quality;strong infrastructure and interoperability A concerted effort is needed to overcome some of the difficulties that are arising and that relate to: different levels of health digitalization and infrastructure quality at national levels; fragmentation of data standards and limited interoperability between healthcare systems; limited access and operability due to legal (GDPR) issues.We believe there is an urgent need to discuss with relevant stakeholders about strategies to: Establish an appropriate legal and governance framework to cover the access to and exchange of health data for healthcare provision, research, policy-making and regulatory activities.Lower technical barriers hindering data use and re-use, in particular those related to infrastructure, interoperability, data quality and standards in the health field.Ensure access and control of patients and citizens over their own health data. The workshop's structure and content aim at accomplishing with the above by: 1) introducing the principles and potential of the European Health Data Space (EHDS) project, ii) providing contributions from stakeholders on the three pillars of the EHDS, stimulating the debate around current gaps in knowledge, as well as system and policy barriers to the design and implementation of the EHDS.Key messages The European Health Data Space (EHDS) will have a strategic importance for public health, supporting policy makers and researchers all across Europe.To fully develop the potential of the EHDS, some main challenges need to be addressed within the legal and technical frameworks.
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