Real-world-data Enabled Assessment for heaLth regulatory decision-Making
The REALM project aims to improve the development, testing and evaluation of medical device software through the use of real-world data (RWD), synthetic data and advanced digital technologies. The project develops a federated platform that enables healthcare organisations, researchers and technology providers to access and use high-quality medical data while ensuring privacy, security and compliance with relevant European regulations.
REALM combines artificial intelligence, data analytics and digital technologies to support the evaluation of medical software throughout its lifecycle. Its solutions include tools for generating realistic synthetic medical data, selecting relevant real-world datasets and monitoring software performance. By providing a secure and standardised environment for testing and validation, REALM aims to improve the reliability, safety and regulatory compliance of medical software and support the development of more effective digital healthcare solutions.
MetaMind Innovations (MINDS) serves as the Technical Coordinator of the REALM project, overseeing the integration of technical results and their implementation across the project’s applications. MINDS also leads WP3 – REALM Architecture & Regulatory Toolbox Methodology, coordinating the development of the platform’s technical architecture and supporting the integration of its different components.
As leader of Task 3.1, MINDS is responsible for designing the federated REALM architecture, defining system requirements, interfaces and integration mechanisms while addressing security, privacy and regulatory considerations. The company also leads Task 4.2 – Standard Data Quality Framework, focusing on the identification of user, technical, security and data protection requirements for the REALM ecosystem.
In addition, MINDS contributes to explainable AI and process monitoring under Task 3.3, helping make AI-based medical software evaluations more transparent and understandable. It also participates in Task 5.1, supporting the selection of relevant real-world medical data and the generation of synthetic datasets for software testing and evaluation. Through these activities, MINDS helps strengthen the reliability, interoperability and transparency of the REALM platform.
