UMC

This proposal seeks to build on the mobile application (app) functionality delivered through the original WEB-RADR project to expand access to the platform and the reach of the information contained within it. It will achieve this by making the functionality available through application programming interfaces (APIs), meaning that third party organisations will be able to embed WEB-RADR platform functionality into their own systems, applications and websites. An important component to this will be a terminology/classification mapping activity involving the three core healthcare terminology owners; MedDRA MSSO, SNOMED International and WHO. The mapping will facilitate communication between regulatory and healthcare databases by establishing mapping protocols and delivering an initial mapping between a subset of key pharmacovigilance terms. The project has established use cases and adopters for the proposed functionality through the networks established through the original WEB-RADR delivery, and has a diverse range of partners keen to utilise different aspects of the proposed solutions including regulatory authorities, health charities and system providers.

Europe is generating huge amounts of patient-level information contained in Electronic Health Record (EHR) systems and other types of health databases. These include structured data in the form of diagnoses, medications, laboratory test results, etc., and unstructured data in clinical narratives. The Electronic Health Data in a European Network (EHDEN) Consortium leverages these vast volumes of data to improve future clinical practice and individual patient outcomes by increasing our understanding of disease and treatment pathways. EHDEN will galvanize transparent and reproducible analytics that will generate valid real-world evidence to improve patient care, and enable medical outcomes-based research at an unprecedented scale. The EHDEN Consortium provides the infrastructure and eco-system supporting disease-specific projects in the IMI Big Data for Better Outcomes (BD4BO) programme. The core of EHDEN is the use of a common data model (OMOP-CDM), standardised outcome assessment (ICHOM), and transparent open-source analytics (OHDSI). The objective of the EHDEN consortium is to provide all the necessary services that enable a distributed European data network to perform fast, scalable and highly reproducible research, while respecting privacy regulations, local data provenance and governance. This will include services and tools to perform data standardization, analytical pipelines, tools to share study results, and tools for stakeholder engagement and training. The EHDEN Consortium combines active participation of stakeholder representatives with proven experience in: a) integrating different data types, methods and technologies to utilize diverse clinical datasets; b) platform development to make methods and datasets Findable, Accessible, Interoperable and Reusable (FAIR); and c) engaging a wide variety of stakeholders, including health technology assessment agencies, regulators and patients.