Analysis And Modeling of the New Italian HIS model “Fascicolo Sanitario Elettronico 2.0 and EDS” towards further actionable solutions to enabling improved healthdata access and secondary data use for research purposes

This doctoral thesis investigates how Italy, within the European Union framework, can overcome the fragmentation and inefficiencies that have constrained the digital transformation of its National Health Service and limited the secondary use of health data for research. The analysis focuses on the Fascicolo Sanitario Elettronico (FSE), the Italian Electronic Health Record, and its evolution into FSE 2.0, which, in alignment with the European Health Data Space (EHDS), is intended to secure more reliable and equitable access to clinical data. The research systematically analyses and models the current FSE architecture, highlighting the regulatory, organisational, and technological barriers that have prevented effective interoperability. It combines workflow modelling with the analysis of the more recent legislative reforms and incorporates evidence from interviews with key stakeholders, including ministries, regional authorities and healthcare professionals. The findings identify four fundamental requirements for FSE 2.0: the delivery of a homogeneous national supply of digital health services; the standardisation of data content and coding to guarantee semantic interoperability; the development of a robust infrastructural model linking national and regional systems; and reinforced governance ensuring compliance with standards, validation of interoperable software, definition of performance indicators, and equitable service levels. The thesis concludes with an original proposal for a coordinated architectural model for FSE 2.0, aligned with the objectives and requirements of the most recent national legislation. Conducted within an industrial doctoral programme, the research moves beyond theory by providing an implementable technical solution that addresses policy objectives while enabling improved health data access including secondary use for research purposes.