Operationalising ethics in the EHDS: Tools, principles, and governance mechanisms.

Abstract

The European Health Data Space (EHDS) offers significant opportunities for the secondary use of health data to support research, innovation, and public health across Europe. However, it introduces complex ethical governance challenges. While the EHDS Regulation requires data access applications to address ethical considerations, it does not establish a uniform EU-level ethics review pathway, leaving oversight largely to national law and institutional competence. This variability risks fragmentation, procedural inconsistency, and barriers to cross-border data access. This article presents recommendations for operationalising ethical governance under the EHDS, informed by an EU-wide, multi-stakeholder workshop conducted under the TEHDAS2 Joint Action. Insights were analysed thematically in relation to the EHDS user journey and relevant governance frameworks, yielding recommendations across three interconnected areas: First, harmonisation with national flexibility calls for shared minimum ethical standards and a voluntary common ethics reference framework to support consistent assessments without constraining national autonomy. Standardised documentation and mutual recognition agreements can further reduce duplication while facilitating cross-border secondary use. Second, building public trust, security, and transparency require making ethical governance visible and intelligible through accessible summaries of approved data uses, clear communication on data security safeguards, and inclusive citizen engagement. Healthcare professionals are identified as key trusted intermediaries whose informed involvement can reinforce confidence in the system. Third, building capacity and expertise for ethical assessment emphasises the need for interdisciplinary skills spanning bioethics, artificial intelligence ethics, data protection, and health informatics within Health Data Access Bodies and ethics committees. EU-supported knowledge exchange, mentorship schemes, and shared digital platforms can help mitigate disparities across Member States. Together, these recommendations offer a practical roadmap for policymakers, Health Data Access Bodies, and stakeholders to establish ethical governance that is coherent, transparent, and oriented toward the collective public good as the EHDS becomes operational.