Real-world-data Enabled Assessment for heaLth regulatory decision-Making

现实世界数据支持的健康监管决策评估

• 批准号: 10061921
• 金额: $ 24.89万
• 依托单位: UNIVERSITY OF OXFORD
• 依托单位国家: 英国
• 项目类别: EU-Funded
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10061921
• 关键词: Real; world; data; Enabled; Assessment

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).

REALM 项目的总体目标是为监管机构、应用程序开发人员、医疗保健专业人员和政策官员创建一个协作框架，共同创建和评估医疗和医疗保健用途的软件。我们建议创建一个包容性平台，形成一个透明的生态系统，用于医疗保健软件的评估和认证，开发人员和监管（以及卫生技术评估）机构都可以访问一组标准化的技术堆栈和数据。这将通过首先绘制和分析欧盟、国家机构和世界各地有关医疗保健实践软件的法规、立法工作和指南来实现。这些将指导建立包容、公平和多利益相关者生态系统的路线图。将与达尔文合作开发集成架构的支架，基于标准化数据模型和优化的数据驱动方法，以便在医疗保健监管实践中有效使用真实世界数据（RWD）。该架构将由四个部分组成：两个技术基础设施、一个生活实验室和一个上市后监控模块。 i) 将建立基于云的联合数据资源目录，以汇集当前可用的RWD数据和合成数据，以满足平台的数据需求。 ii) 将建立监管工具箱，汇集标准化工具来培训、测试、评估和监控医疗/保健软件。 iii) 用于试点医疗/保健软件技术评估的生活实验室环境，将人机交互考虑为系统的一部分。 iv) 与 RWD 进行上市后监督，以确保实践中认证软件的质量标准。最后，基于提议的架构，五个真正的医疗设备软件 (MDSW) 项目将在 3 个国家（荷兰、比利时和希腊）实施。