SYNTHIA: Promoting the Responsible Use of Synthetic Data in Healthcare

SYNTHIA is an ambitious collaborative project between public and private institutions aimed at advancing the use of synthetic data (SD) in healthcare. The project focuses on improving the methodological and technical aspects of synthetic data generation (SDG), including the development of new techniques for different data modalities such as genomics and imaging to enhance the generation of realistic multimodal and longitudinal datasets. A key aspect of the project is providing approaches for transparent benchmarking of alternative SDG methods, identifying and establishing evaluation metrics, and contributing to the standardization of an assessment framework for SD. These advancements are crucial to demonstrating the potential of SD to accelerate data-driven solutions that are of comparable quality to those derived from real patient data. Additionally, the legal and regulatory implications of SD use will be analyzed to develop a framework that ensures the secure and responsible use of SD in healthcare.The Department of Innovation and Digitalisation in Law works on addressing the ethical, legal, and societal issues of the project. Our department closely collaborates with the data protection officers and legal teams of the involved institutions. Our primary tasks include defining the legal bases for the processing of data, including real-world patient data and clinical trial data. We support the consortium by providing guidance documents and procedures to ensure data protection and ethics by design and by default. Additionally, we develop a Data Protection Impact Assessment (DPIA) framework for SYNTHIA and assist project partners in meeting regulatory compliance needs. Another focus is on analyzing emerging ethical, legal, and societal questions related to the use of synthetic data.

 

Experts of the Department working on this project: