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Evidencio and Syntho join forces to advance responsible AI in healthcare

2025-09-12

Evidencio and Syntho are proud to share an update on their joint R&D project, which is supported by the Dutch MIT R&D AI program from RvO. The project is aimed at transforming the development and deployment of artificial intelligence (AI) in healthcare. Together, the two companies are building a pipeline forAI algorithms as a medical device. This controlled environment enables the safe, standardized and compliant development, validation, certification (CE), and integration of AI and machine learning algorithms in clinical practice.

Healthcare holds enormous potential for AI, yet progress is often hindered by two main barriers: limited access to high quality data and complex compliance requirements under European regulations, such as the Medical Device Regulation (MDR) and AI Act. The joint R&D project directly addresses these challenges by combining synthetic data generation - a Privacy Enhancing Technology that unlocks realistic and high-quality medical datasets while fully preserving patient privacy - with a standardized development pipeline that guides AI algorithms through every stage, from concept to clinical validation, CE certification, and integration into clinical workflows.

So far, the consortium already delivered important building blocks of the pipeline. These include conditional generative models for creating high quality synthetic medical data, an automated data pipeline for preprocessing and imputing missing values, and a validation module to compare multiple AI algorithms head-to-head using standardized data. In addition, the pipeline has successfully been integrated with the Epic electronic health record (EHR) system, paving the way for CE-certified AI algorithms to be implemented in thousands of hospitals worldwide.

By combining Evidencio’s expertise in clinical decision support and medical algorithm certification with Syntho’s leading synthetic data technology, the project is creating a scalable ecosystem that enables healthcare providers, researchers and developers to collaborate on reliable, privacy-preserving and CE certified AI solutions. This initiative contributes directly to the mission of the Dutch AI Coalition (NL AIC) and supports the broader European ambition to establish trust, transparency and innovation in the application of AI in healthcare.

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