L’ambito di applicazione del Regolamento (UE) 2025/327 sullo Spazio Europeo dei Dati Sanitari

This article examines the objective and subjective scope of Regulation (EU) 2025/327 on the European Health Data Space through a systematic reading of the EHDS in relation to the GDPR and the EU legal framework on data governance. It argues that the Regulation’s field of application cannot be determined solely by reference to the nature of electronic health data, whether personal or non-personal, but requires a functional qualification of the processing operation, centred on the distinction between primary and secondary use. This functional criterion also allows the article to address borderline cases, including telemedicine, informal communication channels, sports, wearable devices and post-mortem health data, and to reconstruct the role of the main actors under the EHDS: the natural person, the healthcare professional, the healthcare provider, the health data holder and the health data user.