Arquitectura técnica distribuida y gobernanza del dato en entornos sanitarios conforme al marco regulatorio Europeo emergente

Abstract

The new digital transformation of the European healthcare sector is structured around the emerging concept of Healthcare 5.0. This evolution is driven by new enabling technologies, including artificial intelligence, advanced biomedical sensing, and distributed processing. In Europe, it must also comply with new technical and regulatory requirements applicable to medical devices and clinical software, as established in the European Artificial Intelligence Regulation (AI Act), the General Data Protection Regulation (GDPR), the Data Governance Act (DGA), the Data Act, and the Cyber Resilience Act, among others. This paper proposes a distributed functional architecture as an alternative to the traditional hierarchical model based on the ISA-95 standard, whose vertical structure proves insufficient for managing data flows generated in dynamic, patient-centred healthcare environments. Instead, it introduces an architecture for Healthcare 5.0 grounded in ethical data governance, self-sovereign identity, semantic interoperability, and technical traceability through open standards, all aligned with the evolving European regulatory landscape. Finally, the future implications of this framework in the field of healthcare engineering are discussed.