Turning synthetic data from a promising technology into a trusted tool for health policymaking requires more than technical innovation, it requires clear, actionable guidance on governance, regulation and public trust. This is the focus of SYNTHIA's policy engagement work. 

SYNTHIA supports policymakers by translating technical advances in synthetic data into policy-relevant guidance and evidence. This includes analysing the policy opportunities and limitations of synthetic data use, aligning with EU frameworks such as the GDPR, the AI Act, the European Health Data Space and Health-in-All-Policies approaches, and developing governance and assurance concepts to support responsible uptake. SYNTHIA also produces policy briefs and recommendations to inform decision-making at both national and European level. 

Public trust in synthetic data cannot be assumed simply because data is artificially generated, it is earned through robust validation, clear accountability, and meaningful transparency. SYNTHIA therefore approaches synthetic data as a governed public capability, not a technical shortcut, applying safeguards proportionate to the risk and stakes of use and embedding ethical, legal and societal considerations throughout the data lifecycle. 

"Synthetic data offers real promise for personalised medicine, but promise is not the same as trust. Policymakers need to know how it fits within existing rules, where the genuine risks lie, and what good governance looks like in practice, not in theory. That is exactly the gap SYNTHIA's policy work is designed to help close." 

— Denis Horgan, European Alliance for Personalised Medicine (EAPM) 

“Realizing the potential of synthetic data in personalized medicine requires both scientific rigor and public trust. Europe needs clear, consistent, and risk-based governance that enables researchers to collaborate across borders while demonstrating data quality and robust privacy safeguards. Public–private partnerships such as SYNTHIA can help translate these principles into practical approaches that support innovation for patients.” 

— Matthias Müllenborn, Novo Nordisk 

 "We need policy that advocates for trust in synthetic data from its origins, with adaptive governance that is proportionate to risk. Avoiding unnecessary barriers for low-risk uses, while ensuring oversight where synthetic data could influence important healthcare decisions can empower acceleration into use." 

— Serena Elizabeth Marshall, DNV 

Turning synthetic data innovation into policy and practice 

The SYNTHIA Policy Engagement Materials translate advances in synthetic data into practical, policy-relevant insights to support responsible use in health research and policymaking. Through a series of papers and recommendations, SYNTHIA explores the opportunities and limitations of synthetic data, its relationship with evolving EU legislation, and the governance, assurance and transparency needed to build public trust. As the first outputs of this work, SYNTHIA has published two complementary papers addressing the policy and public trust considerations surrounding synthetic data in health. 

The Strategic Framework Paper

Sets out why practical governance pathways for synthetic data are needed now. It examines how the EU regulatory landscape, from the GDPR and Data Governance Act to the AI Act, European Health Data Space and proposed European Biotech Act, is converging around a shared ambition without yet offering a single, coherent playbook.

Our paper maps where this tension becomes operational at Member State level and identifies SYNTHIA’s strategic priorities for closing the gap between regulatory principles and everyday practice.

 

The Trust Paper

Explores the conditions under which synthetic data can earn public trust in healthcare. It examines the organisational, technical, regulatory, ethical and societal factors that influence trust and proposes practical commitments and policy recommendations to support responsible adoption.

The central message of our paper is that trust depends not only on legal compliance or technical performance, but also on clear accountability, meaningful transparency, appropriate safeguards and opportunities for public engagement.

 

What's next for SYNTHIA's Policy Series

Together, these papers establish the foundation for the broader SYNTHIA Policy Engagement Materials Series. Future papers will address risk-based governance models, health data access pathways, synthetic control arms and differences in readiness and implementation across EU Member States. 

SYNTHIA engages with policymakers and public authorities at national and European level. We welcome dialogue on how synthetic data can support health policy priorities while maintaining high standards of ethics, transparency, and accountability. Explore more on our dedicated Policymakers page >