Descripción del proyecto
Marco colaborativo para la evaluación y regulación de las tecnologías sanitarias digitales
Los programas informáticos de medicina y sanidad se utilizan cada vez más para el funcionamiento de equipos médicos, en historias clínicas digitales, en aplicaciones de seguimiento sanitario, así como para la práctica de la medicina y la sanidad a distancia. En el proyecto REALM, financiado con fondos europeos, se propone crear una plataforma para la evaluación y la certificación sólidas y uniformes de este tipo de programas informáticos del sector sanitario. La plataforma integrará directrices normativas y legislación internacionales junto con metodologías para aplicar eficazmente datos del mundo real. Ayudará en la evaluación de los programas informáticos de medicina y sanidad, garantizando el cumplimiento de las normas de calidad necesarias. Se pondrán en marcha en tres países europeos cinco proyectos de programas informáticos generados a través del ecosistema REALM, y el consorcio utilizará tecnologías de inteligencia artificial para apoyar la evaluación de tecnologías y la toma de decisiones normativas.
Objetivo
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 ActionsCoordinador
6200 MD Maastricht
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