Data protection, interoperability and governance assessment tool: results from a proof-of-concept survey

Background The Collaborative Health Information European Framework (CHIEF) supports consistent monitoring of quality of care and outcomes, through the definition of a cohesive information infrastructure aligned with legal and ethical standards, to ensure preparedness to the European Health Data Space (EHDS). We aimed to define, develop and apply a practical solution to help data controllers and data holders of disease registries and health information systems navigate the increasingly complex and rapidly evolving legal conditions for the governance of health data. Methods We designed a tool for data protection, interoperability and governance assessment (DIGA) as a modular, self-assessment questionnaire with an integrated scoring system. The tool enables the application of a mixed-methods approach, combining quantitative and qualitative analytics to assess the level of institutional compliance with EU data protection laws, governance standards, and the EHDS Regulation. The tool has been designed to enhance usability and flexible implementation, allowing institutions to focus on sections that are considered most relevant for their operational purposes. A proof-of-concept survey was run to test and validate the capability of the tool in the field. Results The pilot study demonstrated the ability of the tool to capture real-world practices and help data controllers and data holders identify both strengths and critical gaps. The results of the survey showed that participating centres have already established solid foundations in several key areas of data protection. Participating centres showed a moderate-to-high ability to support the secondary use of health data for both research and public health purposes, reflecting an encouraging level of preparedness to the EHDS Regulation. The user feedback collected alongside the pilot study confirmed the relevance and usability of the tool. Conclusions We developed an ad-hoc tool to monitor and improve DIGA, as a strategic resource for disease registries and health information systems. The application on field showed that the DIGA tool can support institutional self-assessment, to foster regulatory readiness and generate meaningful insights on how to guide implementation of national and EU-level policies. Further studies are needed to assess the reliability of the tool under broader conditions and refine it accordingly for large-scale implementation. Validation across multiple networks and disease domains within CHIEF will allow strengthening its role in preparation of the EHDS.

DI IORIO Concetta Tania;  RONCHI Elettra;  PRISTAS Ivan;  BUBLE Tamara;  NICHOLSON Nicholas;  CARINCI Fabrizio; 

2025-11-12

FRONTIERS MEDIA S.A.

JRC143316

2673-253X (online),   

https://www.frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2025.1685774,    https://publications.jrc.ec.europa.eu/repository/handle/JRC143316,   

10.3389/fdgth.2025.1685774 (online),