Syntho announces progress on its joint R&D project with Evidencio, supported by the Dutch MIT R&D AI program from RvO. The initiative contributes to the development of artificial intelligence (AI) as a key digital technology for healthcare by creating a safe, standardized, compliant pipeline for AI algorithms as medical devices.
The healthcare industry generates vast amounts of valuable data, making it a fertile ground for AI-driven innovation. Yet, much of this potential remains untapped. Strict privacy regulations such as the Medical Device Regulation (MDR) and the EU AI Act create significant barriers, resulting in:
This joint project bridges these challenges by combining Syntho’s synthetic data generation with Evidencio’s standardized development and validation pipelines.
Syntho’s technology makes it possible to create high-quality, realistic medical datasets that fully preserve patient privacy. Whereas Evidencio’s expertise in clinical decision support and medical algorithm certification ensures that AI models can meet stringent regulatory requirements.
Together, we will develop a controlled environment that guides AI algorithms through the entire lifecycle, from training and validation with synthetic data to CE certification and eventual integration into clinical workflows.
The collaboration has already delivered important milestones, including generative models for synthetic health data, automated preprocessing pipelines and imputing missing values, and validation modules for comparing multiple AI models. Additionally, the pipeline has been successfully integrated with the Epic electronic health record (EHR) system, which further enables the pathway for CE-certified AI algorithms to be implemented at scale across hospitals worldwide.
“With this collaboration, we are proving that privacy-preserving synthetic data and standardized validation pipelines can accelerate safe AI adoption in healthcare,” said Simon Brouwer, COO and Co-Founder of Syntho. “It’s about enabling innovation without compromising patient trust.”
This joint project supports the mission of the Dutch AI Coalition (NL AIC) and the broader European ambition to build trust, transparency, and innovation in AI for healthcare.
Syntho is an Amsterdam-based company revolutionizing the tech industry with AI-generated synthetic data. As the leading provider of synthetic data software, Syntho’s mission is to empower businesses worldwide to generate and leverage high-quality Synthetic Data at scale.
By combining AI with synthetic data, Syntho empowers organizations to overcome data limitations and unlock new opportunities through our solutions.
Evidencio is a Netherlands-based healthtech company specializing in clinical decision support software as a medical device (SaMD). Their platform provides a standardized environment for developing, validating, and certifying predictive algorithms and AI tools. By combining medical expertise with regulatory know-how, Evidencio facilitates healthcare innovators to transform their algorithms into CE-certified, clinically trusted solutions that can be safely integrated into medical practice worldwide.
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