Challenges and Opportunities in the Evolution of the Italian Electronic Health Record and the Health Data Ecosystem

Health data interoperability is a critical enabler of digital transformation in healthcare, yet its implementation remains fraught with technological, semantic, and organisational challenges. This paper examines how the recent developments of the Italian Electronic Health Record (Fascicolo Sanitario Elettronico, FSE) and the Connected Health Data Ecosystem (EDS) within the broader European Health Data Space (EHDS) framework can overcome long-lasting fragmentation of health data management and improve health care coordination, data-driven medical research, and patient-centred services.The article analyses the existing Italian EHR architecture, identifying the regulatory, organisational, and technological barriers that have hindered effective interoperability to date and identifies the core requirements for its improving towards a new FSE 2.0 which can support public policy objectives while enhancing health data accessibility and enabling secondary use for research.