The challenges of National Health Data Ecosystems in feeding the European Health Data Space: The Italian example

Ylenia Murgia¹Roberta Gazzarata^2,3,4Mario Ciampi⁵Mario Sicuranza⁵Franco Cirillo⁶Christian Carmine Esposito⁶Norbert Maggi¹GABRIELLA BALESTRA^7,8Lucia Sacchi^8,9Mauro Giacomini^1,8*

• ¹University of Genoa, Genoa, Italy
• ²Healthropy, Savona, Italy
• ³HL7 Europe, Brussels, Belgium
• ⁴HL7 Italy, Rome, Italy
• ⁵Institute for High Performance Computing and Networking, National Research Council of Italy (ICAR-CNR), Naples, Italy
• ⁶Department of Computer Science, University of Salerno, Fisciano, Italy
• ⁷PoliToBIOMedLab, Department of Electronics and Telecommunications, Politecnico di Torino, Turin, Italy
• ⁸Italian Scientific Society of Biomedical Informatics (SIBIM), Pavia, Italy
• ⁹Department of Industrial and Information Engineering, University of Pavia, Pavia, Italy

The European Health Data Space (EHDS) is an European Union (EU) initiative, aimed at helping facilitate the secure and standardized sharing of health data to improve continuity of care, research and innovation. However, the successful implementation of such an ecosystem requires the active participation and cooperation of EU Member States (MS), each of which needs to adapt its local health data infrastructure to meet the requirements at the European level. The specific characteristics of the various European countries, such as size, number of citizens, and internal organisation greatly influence the ease with which a country can integrate its health data structure into this supra-national system. States with higher levels of local autonomy are experiencing significant challenges in this process. For instance, the Italian National Healthcare System (NHS) is highly decentralized, with significant variability among regions and localities. This fragmentation raises problems for health data sharing and the integration of the Italian health ecosystem into the broader EHDS framework. This paper explores Italy's organizational and regulatory challenges, the technical barriers to interoperability, and the implications of data sharing in a decentralized environment. Moreover, by examining key Italian projects, such as Digital Health Solutions in Community Medicine (DHEAL-COM), and the tools developed by Standards Developing Organizations (SDOs) and affiliated bodies, such as Health Level 7 (HL7) Europe and Italy, the paper identifies successful initiatives and proposes strategies to overcome existing obstacles, also including security and privacy aspects of healthcare data.