Recommendations for a national electronic health record in Spain: a Delphi study.

Abstract

Despite decades of health-care digitalisation efforts worldwide, health information systems remain highly fragmented, with multiple vendor-specific silos that communicate through incomplete solutions. This fragmentation prevents the creation of real-time, lifelong patient health records and becomes increasingly problematic as demand grows for person-centred care, data-driven clinical practice, and greater patient involvement in health-care decisions. To address these challenges and establish a foundation for a nationwide electronic health record (EHR), the Spanish Ministry of Health commissioned a steering committee to develop recommendations based on a comprehensive national consensus. The committee conducted a Delphi study comprising 45 items across four domains, which was distributed to 220 experts from June 23, 2023, to Sept 26, 2023. With a response rate of 69·1% (152/220), the study achieved consensus in a single round, with all items reaching the pre-established threshold of greater than or equal to 70% agreement (scores 7-9 on a 9-point Likert scale), and consensus ranging from 118 (77·6%) to 151 (99·3%) of 152 responses (44 items ≥80%). The resulting recommendations were externally validated by an international advisory board, which assessed their consistency and alignment with global best practices and standards. The final set included 20 recommendations across four domains: justification of need (2 items), functional characteristics (7 items), technical characteristics (6 items), and governance (5 items). These recommendations provide a roadmap for developing a robust, integrated national health information system centred on a standardised, longitudinal EHR. The proposed approach moves beyond generic calls for interoperability by embedding clinical knowledge into open, standardised EHR architectures through ontology-driven semantic integration, supported by federated governance and citizen-controlled data use. This roadmap equips Spain to implement a longitudinal, knowledge-driven national record while providing a scalable model for other countries transforming fragmented health information systems.