Project description
Collaborative framework for assessment and regulation of digital health technologies
Software in medicine and healthcare is increasingly being used for the operation of medical equipment, in electronic health records, in health tracking applications, as well as for remote medicine and healthcare practice. The EU-funded REALM project proposes to build a platform for the robust and uniform evaluation and certification of such healthcare software. The platform will integrate global regulatory guidelines and legislation alongside methodologies for effectively implementing real-world data. It will assist in the assessment of medical/healthcare software, ensuring that the necessary quality standards are met. Five software projects generated through the REALM ecosystem will be implemented in three European countries, and the consortium will use artificial intelligence technologies to support technology assessment and regulatory decision making.
Objective
The overall aim of the REALM project is to create a collaborative framework for regulatory authorities, application developers, healthcare professionals and policy officers to co-create and evaluate software for medical and healthcare use. We propose to create an inclusive platform leading to a transparent ecosystem for evaluation and certification of software in healthcare where both the developers and the regulatory (and Health Technology Assessment) bodies have access to a standardized set of technology stack and data.
This will be achieved by first mapping and analyzing regulations, legislative efforts and guidelines from EU, national bodies and around the world on software in healthcare practice. These will guide the roadmap towards building an inclusive, fair and multi-stakeholder ecosystem. The scaffold for an integrated architecture will be developed in collaboration with DARWIN, based on standardized data models and optimized data driven methodologies for the effective use of real-world data (RWD) in healthcare regulatory practice.
The architecture will consist of four components: two technological infrastructures, a living lab and a post-marketing surveillance module. i) a federated cloud-based data resources catalog will be established, to bring together currently available RWD data and synthetic data to facilitate the data needs of the platform. ii) Regulatory Toolbox will be established to bring together standardized tools to train, test, evaluate and monitor medical/healthcare software. iii) Living lab environment for piloting medical/healthcare software technology assessment taking into account human-software interactions as part of the system. iv) Post-marketing surveillance with RWD for ensuring quality standards of the certified software in practice. Finally, building on the proposed architecture, five real Medical Device Software (MDSW) projects are going to be implemented across 3 countries (Netherlands, Belgium and Greece).
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Funding Scheme
HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinator
6200 MD Maastricht
Netherlands