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Other literature type . 2025
License: CC BY
Data sources: ZENODO
ZENODO
Project milestone . 2025
License: CC BY
Data sources: Datacite
ZENODO
Project milestone . 2025
License: CC BY
Data sources: Datacite
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Documentation of the EHDS governance model and the proposed ELSI governance model and HealthData@EU methodology

Authors: Gonzalez-Garcia, Juan; Montolío, Alberto; Rabal, Javier; Nevala, Aapeli; Pankakoski, Maiju;

Documentation of the EHDS governance model and the proposed ELSI governance model and HealthData@EU methodology

Abstract

This document provides a comprehensive and technically clear overview of the European Health Data Space (EHDS) regulatory framework, its implications for cancer screening programmes, and a detailed proposal for an EHDS-compliant technical architecture using containerised analytics (Docker and ASPIRE). It also integrates an expanded Ethical, Legal, and Societal Implications (ELSI) governance model and structured recommendations for Member States. A summary of key findings: EHDS introduces a federated, secure, metadata-driven ecosystem for secondary use of health data. Survey results show large heterogeneity in current governance and technical processes, with major gaps regarding EHDS readiness. WP5’s ASPIRE container framework aligns naturally with EHDS requirements, enabling federated analytics in Secure Processing Environments (SPE). A lack of awareness of EHDS directly correlates with a lack of institutional preparedness. A clear ELSI governance framework is required to ensure ethical, transparent, and equitable secondary-use practices.

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
Green