REALM: Real-world-data enabled assessment for health regulatory decision-making
Medical Device Software is advancing quickly, but the current evaluation processes are outdated, making it difficult to get approval and implement these innovations. The REALM project is creating a collaborative platform to evaluate and certify Medical Device Software in the European Union. This platform brings together regulatory bodies, developers, and healthcare professionals to address the current needs of the Medical Device Software industry. REALM provides comprehensive testing, benchmarking data, and standardisation by collaborating across multiple cloud infrastructures. It integrates real-world and synthetic health data to ensure AI-driven medical solutions are safer and more effective.
REALM Vision
REALM strives to drive forward innovative solutions that enhance patient outcomes and empower healthcare practitioners to provide the best possible care. The REALM consortium envisions a future where patients benefit from cutting-edge medical software, developed and evaluated with a focus on safety, efficacy, and usability, thanks to the joint efforts of diverse stakeholders.
REALM Mission
REALM aims to develop a collaborative framework where regulatory authorities, software developers, healthcare professionals and policymakers can jointly create and evaluate innovative Medical Device Software, directly benefiting patients and healthcare practitioners.
The REALM project will provide a comprehensive testing infrastructure, benchmarking data, and standardisation for evaluating and certifying Medical Device Software in the healthcare industry. Currently, a framework for the certification and post-market monitoring of autonomous, self-learning, and potentially complex Medical Device Software is lacking.
This gap, combined with the differences in performance between artificial testing environments and real-world settings, necessitates extending existing regulatory guidelines. REALM will provide the data and technology needed for system-wide testing and certification of Medical Device Software across the EU.
The project aims to develop a federated cloud-based data resources catalogue, linking unstructured health data, clinical images, and real-world data, expanded by synthetic data generation and digital twins. This multimodal information will be organised into appropriate formats and standardised data structures.
Funded by the European Union under grant agreement No 101095435
VITO's role in REALM
VITO plays a crucial role in REALM by leveraging its expertise in data standardisation and regulatory methodologies to build a robust ecosystem for Medical Device Software evaluation. Our experts are actively developing the standardised REALM Data Catalogue using the OMOP CDM, integrating Electronic Health Records (EHR), clinical images, genomics data, and real-world data from hospitals, research centers, and healthcare stakeholders ensuring seamless, standardised, and anonymised data integration into the REALM infrastructure.
Beyond data standardisation, VITO is leading the development of the Regulatory Toolbox, shaping the methodologies necessary for evaluating and certifying autonomous, self-learning medical software. We are also at the forefront of platform integration, real-world testing, and continuous monitoring, ensuring that medical AI applications can be assessed under real-life conditions.
Additionally, VITO is actively involved in demonstrator concept planning and requirement gathering, playing a key role in defining pilot use cases. Our PGx (pharmacogenomics) application, as partially developed in DigiTwins4PH, serves as a concrete use case within REALM, demonstrating the REALM capabilities to evaluate (in-vitro) Medical Device Software.
As co-lead in establishing the REALM Academy, VITO is proud to contribute to this innovative online educational resource. The Academy provides comprehensive training for regulatory bodies and health technology assessment agencies in the field of Medical Device Software on the REALM architecture and integration.
Through these efforts, VITO contributes to design a safe, transparent, and effective regulatory framework for AI healthcare innovations.
Project partners
Discover all project partners on the project website.
