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Real-world-data enabled assessment
for health regulatory decision-making


VITO is a leading European independent research and technology organization in the areas of health, cleantech and sustainable development.

VITO is active in five domains: sustainable health, sustainable energy, sustainable materials, sustainable chemistry, and sustainable land use. VITO is committed to excellence, sustainability and social responsibility in its research activities. Within these domains, VITO conducts multidisciplinary research projects that address global challenges such as climate change, resource scarcity, urbanization and affordable precision healthcare.

As a leading research organisation with more than 900 experts from various disciplines, VITO operates several state-of-the-art facilities and laboratories with its headquarters in Mol, Belgium, and has offices across Belgium, in China, and the Middle East.

VITO HEALTH aims to develop innovative solutions for sustainable health challenges, precision health monitoring, environmental health risk assessment and policy advice and circular health system design. VITO HEALTH combines expertise in data science, artificial intelligence, remote sensing, biotechnology, and nanotechnology to create impact for businesses and policymakers.

Role within REALM

VITO acts as Project Co-Coordinator and Scientific Coordinator within the REALM project. Also, VITO is the lead of work package five on platform integration, real world testing and monitoring.

The main roles of VITO are:

  • The creation of a regulatory toolbox methodology for the evaluation of medical AI. This methodology will support high-quality model evaluations, enabling regulatory bodies to assess the novel medical AI products under optimal conditions.
  • VITO will research anonymous information sharing with European medical data pools for medical data such as Electronic Health Records (EHR), and genomics data.
  • VITO will research technological solutions for monitoring of the performance of medical AI products in the clinical practice. This is needed to be able to guarantee that the expected model performance is obtained in each hospital at all times.
  • VITO is also taking the lead to organize the concept planning of the REALM demonstrators and to determine the requirements for the demonstrators. Furthermore, VITO is responsible for the PGx2P demonstrator of the REALM project on pre-emptive pharmacogenetics. Here patients will receive personalized drug recommendations via medical professionals based on the specific genetic variants they possess for eliciting a better drug response.

Main contacts

Photo of Dr Gökhan Ertaylan
Dr Gökhan Ertaylan

Research Lead

Photo of Ing. Bart Elen
Ing. Bart Elen