[Position paper on the processing of personal data in clinical and outcomes research.]

This position paper examines the strategic value of clinical and outcome research data for the National Health Service, with a specific focus on the dual mandate of Scientific Institutes for Research, Hospitalization and Healthcare (IRCCS) and the role of Local Health Authorities as custodians of extensive Real World Data repositories. Although the European regulatory framework - represented by the GDPR (Art. 89) and the upcoming European Health Data Space (EHDS) - alongside the Italian Privacy Code (Art. 110), provides solid legal bases for the secondary use of health data for scientific purposes, a significant gap persists between the potential of these informational assets and their effective exploitation. The document, resulting from a multidisciplinary collaboration involving researchers, legal experts, decision-makers, Data Protection Officers, Ethics Committees, and patient representatives, identifies current operational criticalities and proposes three priority strategic directions. First, it is imperative to systematize research governance to optimize resource allocation by integrating privacy by design principles and promoting interoperability standards and Federated Learning architectures. Second, the paper advocates transparency in management processes, urging institutions to move beyond the ineffective paradigm of security through obscurity in favor of verifiable architectures and clear traceability of data flows. Finally, the systematic development of the data stewardship function is recommended. Rather than acting as a bureaucratic control, the data steward should provide strategic mentorship and high-level consultation, bridging scientific research needs and regulatory compliance requirements. In conclusion, personal data protection must not be perceived as a barrier to biomedical progress, but as an enabling framework based on shared responsibility, safeguarding patients' rights while ensuring high standards of research excellence.