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

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.