Justice in the governance of personal health data spaces: stakeholder perspectives in Belgium.

backgroundContemporary health data governance in Europe operates within a persistent tension between the protection of individual rights and the collective benefits that can be achieved through data sharing. Recent legislative initiatives such as the Data Act, Data Governance Act and the European Health Data Space attempt to reconcile these values by promoting trustworthy data reuse while safeguarding individual rights. However, these frameworks often rely on models of citizens as passive data donors, without ensuring citizen empowerment or equitable benefit sharing. This study examines how institutional stakeholders in Flanders understand the ethical conditions under which a Personal Health Data Space could be governed legitimately for secondary health-data use. We use literature on distributive, procedural, and recognition justice to interpret these expectations and to identify design considerations for participatory health-data governance.

methodsThe study employed an embedded research design within the We Are project, a Personal Health Data Space system under development in Flanders (Belgium). Empirical data were collected through stakeholder interviews and complemented by a purposive conceptual literature review on justice in health data governance. Data were thematically analysed through the lens of the three justice dimensions.

resultsFindings indicate that stakeholders support data solidarity, entailing expectations of reciprocity, transparency, and accountability. Distributive justice was associated with fair benefit-sharing mechanisms and reinvestment of data-derived value into public goods. Procedural justice was understood as continuous citizen participation and oversight, rather than one-time consent. Recognition justice emerged as the need to value diverse forms of knowledge and to include marginalised or underrepresented groups through inclusive data stewardship.

conclusionsThe study concludes that both literature and stakeholder views support data solidarity as a more ethically robust foundation for health data governance than data altruism. Collective and participatory governance arrangements can operationalise solidarity by embedding fairness, inclusivity, and accountability in data reuse. These findings provide practical and conceptual guidance for the ethical design of Personal Health Data Space systems.

trial registrationThis study is not a clinical trial. It is a conceptual and empirical qualitative / ethical analysis study and therefore clinical trial registration is not applicable.