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Data protection, interoperability and governance assessment tool: results from a proof-of-concept survey
Concetta Tania Di Iorio1, Elettra Ronchi2, Ivan Pristas3
1Serectrix Srls, Pescara, Italy.
Frontiers in Digital Health
|November 12, 2025
Summary
A new tool, Data Protection, Interoperability and Governance Assessment (DIGA), helps health data controllers and holders navigate complex regulations. It assesses compliance and preparedness for the European Health Data Space (EHDS), showing promising results for data governance.
Area of Science:
- Health Informatics
- Data Governance
- Regulatory Compliance
Background:
- The Collaborative Health Information European Framework (CHIEF) aims to standardize quality of care monitoring and prepare for the European Health Data Space (EHDS).
- Navigating complex legal and ethical standards for health data governance is a significant challenge for data controllers and holders.
- There is a need for practical solutions to ensure compliance and facilitate the secondary use of health data.
Purpose of the Study:
- To define, develop, and apply a practical tool for assessing data protection, interoperability, and governance in health information systems.
- To aid data controllers and holders in understanding and adapting to evolving legal conditions for health data.
- To evaluate the tool's effectiveness in measuring institutional compliance and preparedness for the EHDS.
Main Methods:
- A modular questionnaire, Data Protection, Interoperability and Governance Assessment (DIGA), was designed and applied.
- The DIGA tool employs both quantitative and qualitative analysis to measure compliance with EU data protection laws, governance standards, and the EHDS Regulation.
- A test survey was conducted to assess the tool's applicability and usability.
Main Results:
- The DIGA tool effectively captured real-world practices and identified strengths and gaps in data governance.
- Survey participants demonstrated solid data protection foundations and a moderate-to-high capacity for secondary health data use.
- User feedback confirmed the tool's relevance and usability, indicating preparedness for the EHDS Regulation.
Conclusions:
- The DIGA tool is a strategic resource for disease registries and health information systems, supporting self-assessment and regulatory readiness.
- The tool provides insights for implementing national and EU-level health data policies.
- Further validation and refinement are necessary for large-scale implementation and to strengthen its role in EHDS preparation.
Keywords:
EU health information systemsEuropean Health Data Spacedata governancedata protectiondisease registriesinteroperabilitypreparednessMore Related Videos
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