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


REALM Vision
REALM strives to drive forward innovative solutions that improve patient outcomes and empower healthcare practitioners to deliver the best possible care. The REALM consortium envisions a future where patients can benefit from cutting-edge medical software that is developed and evaluated with a focus on safety, efficacy, and usability, thanks to the joint efforts of our diverse stakeholders.

REALM Mission
REALM aims to develop a collaborative framework through which regulatory authorities, software developers, healthcare professionals and policy offers can jointly create and evaluate innovative medical device software – for the direct benefit of patients and healthcare practitioners.


  • REALM will develop a decentralised, secure evaluation and certification framework for health innovations and medical algorithms, using blockchain technology and intelligent contracts, offering transparency, repeatability, and traceability while fully complying with General Date Protection Regulation.
  • REALM will create AI-powered regulatory tools to evaluate algorithms and models in terms of bias, privacy, accuracy, legal accountability, ethics, etc., which improves data-driven decision-making.
  • REALM will enable the creation of synthetic data and medical/healthcare digital twins for training and testing medical algorithms, even in scenarios with limited available samples, enabling decision-making on vast medical data.
  • REALM will promote trust and adoptability of the machine learning solutions through explainable AI approaches that address transparency, accountability, explainability concerns and potential biases induced by model predictions.