WP9 bridges the SYNTHIA project with regulatory bodies, health technology assessment (HTA) agencies, and payers to explore how synthetic data can be used in healthcare decision-making. It aims to understand current practices, build consensus on best practices, and identify opportunities and concerns related to SD use in regulatory and HTA settings. 

Through literature reviews, interviews, and stakeholder workshops, WP9 gathers insights from agencies like EMA, as well as global counterparts. It develops use cases demonstrating the application of SD in real-world decision-making contexts and examines implications under EU frameworks such as the MDR, IVDR, and AI Act. 

WP9 will ultimately deliver a White Paper with policy recommendations and practical guidance for integrating synthetic data into regulatory, HTA, and payer workflows. 

WP Leadership