Descrizione del progetto
Quadro collaborativo per la valutazione e la regolamentazione delle tecnologie sanitarie digitali
In medicina e nell’assistenza sanitaria, è in costante crescita l’impiego di software per il funzionamento delle apparecchiature mediche, le cartelle cliniche elettroniche, le applicazioni di monitoraggio sanitario, nonché nella pratica medica e assistenziale a distanza. Il progetto REALM, finanziato dall’UE, propone di realizzare una piattaforma per la valutazione e la certificazione consolidate e uniformi di questi software sanitari. La piattaforma integrerà linee guida normative e direttive globali insieme alle metodologie per implementare in modo efficace i dati provenienti dal mondo reale. Fungerà inoltre da supporto nella valutazione del software medico/sanitario, garantendo il rispetto dei necessari standard di qualità. In tre paesi europei saranno condotti cinque progetti software nati nell’ambito dell’ecosistema di REALM e il consorzio si avvarrà delle tecnologie di intelligenza artificiale per contribuire alla valutazione tecnologica e al processo decisionale normativo.
Obiettivo
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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HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinatore
6200 MD Maastricht
Paesi Bassi