A2 Refereed review article in a scientific journal
Rethinking Trust in Synthetic Health Data: Lessons From 7 European Research Initiatives
Authors: Declerck, Jens; Kalra, Dipak; Airola, Antti; Amer, Ahmed Youssef Ali; Chatzichristos, Christos; del Mar Mañu Pereira, Maria; de Brito Robalo, Bruno M.; Ghini, Francesco; Gutierrez-Torre, Alberto; Hoogteijling, Sem; Hultsch, Susanne; Ramon, Jan; Reidel, Sara; Regazzoni, Francesco; Silva, Luís; Silveira, Inês; Sofia, Tsekeridou; Maes, Christophe
Publisher: JMIR Publications Inc.
Publication year: 2026
Journal: Journal of Medical Internet Research
Article number: e83369
Volume: 28
ISSN: 1439-4456
eISSN: 1438-8871
DOI: https://doi.org/10.2196/83369
Publication's open availability at the time of reporting: Open Access
Publication channel's open availability : Open Access publication channel
Web address : https://doi.org/10.2196/83369
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/523444888
Self-archived copy's licence: CC BY
Self-archived copy's version: Publisher`s PDF
Synthetic data generation (SDG) structured health data is increasingly promoted as a solution to longstanding barriers in health data access. It is offering the promise of privacy-preserving data reuse for research, innovation, and policy. Despite rapid technical advances, the adoption of synthetic health data in real-world settings remains limited. Shaped by challenges around data quality, representativeness, infrastructure readiness, trust, and legal uncertainty, this viewpoint draws on experiences from 7 European research initiatives within the HealthData4EU cluster to reflect on how SDG is being operationalized in practice. It synthesizes cross-project insights to highlight recurring methodological and governance tensions and to examine their implications for trust and responsible use. The analysis argues that trustworthy SDG cannot be achieved through technical optimization alone but requires alignment between evaluation practices, upstream data stewardship, regulatory clarity, and sustained stakeholder engagement. Addressing these conditions is essential for moving synthetic data from experimental pilots toward a credible and sustainable component of European health research ecosystems.
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Funding information in the publication:
This paper was funded by the Innovative Health Initiative through the SYNTHIA project. The study draws on insights from 7 research projects that form part of the HealthData4EU cluster. Projects within the cluster and their funding sources are as follows. SYNTHEMA, PHASE IV AI, SECURED, FLUTE, and AISym4MED are funded by the Horizon Europe program. PHEMS is funded by Horizon Europe and UK Research and Innovation. SYNTHIA is funded through the Innovative Health Initiative.
