ORIGINAL RESEARCH article
Front. Digit. Health
Sec. Health Informatics
Volume 7 - 2025 | doi: 10.3389/fdgth.2025.1685774
This article is part of the Research TopicThe Design of Collaborative Frameworks for Sustainable Health Indicators in Europe: Using Diabetes and Its Complications as a Scalable Model Across Disease DomainsView all articles
Data Protection, Interoperability and Governance Assessment (DIGA) Tool: results from a proof-of-concept survey
Provisionally accepted
Concetta Tania DI IORIO1
ELETTRA RONCHI2
Ivan Pristas3
Tamara Buble3
Nicholas Nicholson4*
Fabrizio Carinci5- 1Serectrix Snc, Pescara, Italy
- 2Sciences Po, Paris, France
- 3Hrvatski zavod za javno zdravstvo, Zagreb, Croatia
- 4Joint Research Centre (Italy), Ispra, Italy
- 5UniCamillus International Medical University, Rome, Italy
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Background The Collaborative Health Information European Framework (CHIEF) supports consistent monitoring of quality of care and outcomes, through 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 navigating the increasingly complex and rapidly evolving legal conditions for health data governance. Methods We designed and applied a modular questionnaire to enable Data Protection, Interoperability and Governance Assessment (DIGA). The tool combines quantitative and qualitative analysis to measure the level of institutional compliance with EU data protection laws, governance standards and the EHDS Regulation. The instrument has been designed to enhance its usability and flexible implementation, allowing users to focus on sections that are considered most relevant for their operational purposes. A test survey was run to test its applicability. Results The study demonstrated the tool's effectiveness in capturing real-world practices and help data controllers and data holders in identifying both strengths and critical gaps. Survey results showed that users have already established solid foundations for data protection. Participating centres showed a moderate-to-high capacity to enable the secondary use of health data for both research and public health purposes, reflecting an encouraging level of preparedness for the EHDS Regulation. The user feedback collected alongside the survey confirmed the tool's relevance and usability. Conclusions We developed an ad-hoc tool to monitor and improve data protection, interoperability and governance, which may represent a strategic resource for disease registries and health information systems. The DIGA tool can support institutional self-assessment, fostering regulatory readiness and generating meaningful insights for the implementation of national and EU-level policies. Further studies are needed to assess the reliability of the tool under different 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.
Keywords: Data protection1, Data governance2, interoperability3, European Health DataSpace4, Preparedness5, Disease registries6, EU health information systems
Received: 02 Sep 2025; Accepted: 30 Sep 2025.
Copyright: © 2025 DI IORIO, RONCHI, Pristas, Buble, Nicholson and Carinci. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Nicholas Nicholson, nicholas.nicholson@ec.europa.eu
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