WP7 ensures that the synthetic data generated in SYNTHIA is reliable, high-quality, privacy-preserving, and clinically useful. It develops and applies tools to evaluate SD across multiple dimensions—from statistical fidelity and privacy to clinical utility and regulatory alignment. 

WP7 brings together AI, clinical, and legal experts to assess how SD compares to real data, performs in predictive models, and supports healthcare applications. It also explores how SD may trigger obligations under EU regulations like the AI Act, MDR, or IVDR. 

The work package will deliver two key outputs: a Synthetic Validation Framework (SVF) integrated into the SD platform, and a European Synthetic Data Assurance Framework (SDAF) to harmonise evaluation standards across the EU. 

WP Leadership