Development and validation of a radiology digital competency profile aligned with the European health data space: A sequential framework-development study integrating evidence synthesis, regulatory mapping, and expert validation

Abstract

The European Health Data Space (EHDS) introduces new interoperability, governance, and data use requirements that will directly affect radiology practice across Europe. However, existing digital competence frameworks for healthcare professionals do not adequately address EHDS-specific requirements within the context of medical imaging. This thesis aimed to develop and validate an EHDS-aligned, radiology-specific competency profile and associated learning outcomes, translating regulatory and interoperability expectations into operational educational targets. A three-phase sequential design was applied. Phase 1 consisted of a structured scoping review to identify existing digital competence frameworks relevant to radiology. Phase 2 systematically extracted imaging-relevant operational requirements from the current EHDS Regulation, identifying radiology specific capability gaps. These findings informed the development of a draft radiology-specific competency profile overlay (RCPO) comprising 14 initial learning outcomes (LOs). Phase 3 involved expert validation with 11 European subject-matter experts (SMEs) using Likert scale appraisal (clarity, relevance, feasibility) combined with qualitative comments. Refinement was guided by a predefined combined quantitative–qualitative decision rule integrating median/ Interquartile range (IQR) thresholds with qualitative issue-pattern predominance to trigger structured review. Following expert informed refinement, the final RCPO version retained eight core LOs, with removed items largely reflecting highly technical interoperability tasks more suited to informatics or technical roles than routine clinical radiologist practice. The resulting overlay is methodologically transparent, radiologist calibrated and aligned with EHDS implementation. By translating regulatory requirements into structured learning outcomes, this work provides a reproducible framework for integrating digital interoperability preparedness into radiology education and continuing professional development across Europe.