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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.

Funded by the European Union under grant agreement No 101095435. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.