One, No One, and One Hundred Thousand: the new concept of personal data in the European Health Data Space

The creation of a European data space for the health data sharing aims to facilitate for European citizens the access and portability of their own data (primary use) and enables, the public and private entities, the unlimited access to anonymized data for public interest (secondary use), including scientific research. The system is based on the total digitalisation of the health data, the creation of secure processing environment and, especially, the concept of data as a common good. Interoperability and adoption of quality standards allow the use of the crossborder healthcare, thanks to an easier and faster access to the foreign center of excellence, essential resource for many patients (especially rare disease patients), but still voluntarily and unequally guaranteed in the different EU countries. The Regulation (EU) 2025/327 on the European Health Data Space also sets out specific rules for the secondary use of health data, supporting sharing informations through large data sets. All this opens new perspectives for scientific research thanks to convergence, preservation and circulation of an unprecedented flow of data in health domain, and to possibility of cross-sectional correlations with epidemiological, environmental, socio-demographic, climatic factors, determinants of disease patterns. We propose a reflection on the role of the informed consent and on the concept of personal data, intended as alienable good as thanks to the legal provision favoring data altruism, and the re-use of health data of European citizens for scope of significant public interest.