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European Health Data and Evidence Network

Periodic Reporting for period 3 - EHDEN (European Health Data and Evidence Network)

Reporting period: 2020-11-01 to 2021-10-31

Presently, Europe is generating unprecedented amounts of patient-level information contained in Electronic Health Record (EHR) systems and other types of health databases. This includes structured data in the form of diagnoses, medication, laboratory test results, etc., and unstructured data in clinical narratives, all of which likely contain invaluable insights into the natural history and burden of disease. It is our ambition to fully leverage these vast volumes of data to improve clinical practice and individual patient outcomes by increasing our understanding of disease and treatment pathways and effects. We will galvanize transparent and reproducible analytics that will generate valid real-world evidence (RWE) to improve patient care and enable medical outcomes-based research at an unprecedented scale. The European Health Data and Evidence Network (EHDEN, consortium is building the infrastructure and eco-system to make this ambition come true.
EHDEN’s has met all deliverables and outputs with little deviation from the DoA. The project’s activity has been focused in three main pillars. Key highlights in each have been:

• Open Calls:
o Processes and tools for the open calls have been developed and implemented and are being finetuned following each call.
o We now have 143 Data Partners across 27 countries ( from five open calls.
o Meanwhile, we also have 47 small and medium-sized enterprises (SMEs, selected, trained, and certified following three open calls.
o The Data Selection Prioritisation Committee (DSPC) and SME Certification Committee (SMECC) has served calls to date and will be refreshed as per the DoA in year four.

• Infrastructure:
o Establishment of the EHDEN architecture, with continued advancement of the EHDEN Database Catalogue, data source dashboards. Inclusion of Data Partners metadata in the Database Catalogue is being expanded. Development of feasibility and quality dashboards have progressed.
o EHDEN and OHDSI continue to collaborate (effectively symbiotic) with reference to open source tooling, skills and methods development. We made contributions to ETL and mapping tools, further developed Odysseus’s ARACHNE tool, integrated ELIXIR authentication (AAI) mechanisms, improved the data quality dashboards (published in 2021 link), and advanced multiple analytical pipelines.

• Research and Outcomes:
o Over the course of the project, three study-a-thons have been held by EHDEN and in collaboration with ODHSI and PIONEER. A manuscript on the study-a-thon methodology will be submitted for publication early in 2022. All project publications are available via the Zenodo platform.
o EHDEN created and led an Evidence Task Force that aims to finalise the training and onboarding of new data partners by completing a research study with them and generate evidence with the EHDEN community. The First Evidence-A-Thon (ETHON) was conducted in July 2021. Future e-thons are planned for years 4 and 5.
o Initial evaluation of the ICHOM standards for inclusion into the OMOP common data model (CDM) was completed in year two, and expansion beyond this to generate machine readable standards and audit data via the CDM is being explored.
o Multiple use cases have developed and executed to drive the agile development of the eco-system. This included studies in the domain of characterisation, population-effect estimation including assessment of heterogeneity of treatment effect, and patient-level prediction.
o Extensive methodological research has been performed in the domain of personalised medicine including advances in the patient-level prediction pipeline and the assessment of risk stratified estimation this has also resulted in multiple (pre-print) publications in 2021.

• Education and Community:
o The EHDEN Academy has been successfully supportive of the SME certification curriculum. Beyond this, the EHDEN Academy has grown to be a considerable educational and collaborative resource for EHDEN, OHDSI and the global community with regards to training and upskilling. As of the date of reporting there are ~1800 participant enrolees in more than 60 countries and fourteen courses about working with real world, observational data.
o EHDEN Communications Team have continued to establish the project as a key stakeholder in this domain, particularly as the European setting sees development of the European Commission’s European Health Data Space programme. The project has also deepened its network via communications tools, such as a monthly blog and a bi-monthly Voice of EHDEN podcast. Diverse channels have been utilised to highlight our activity, and in particular to promote our Data Partner and SME calls. EMA is also continuing to promote EHDEN’s Data Partner calls to its distribution lists, such the ENCEPP Database.
o Value propositions (VPs) have expanded across stakeholders, and we have been evaluating these with key stakeholders, in particular Data Partners, SMEs and Industry. Survey work has been conducted to support further insights to substantiate value proposition refinement, as well as the future trajectory of our service model development.
o The Scientific and Ethics Advisory Boards are ongoing, and we have continued to consult our SAB members as relevant, whilst working on the development of a governance framework for EHDEN with our EAB.
o EHDEN is actively collaborating within the TEHDAS Joint Action as part of the European Health Data Space initiative by the European Commission, as well as with the wider community of organisations in this space, with e.g. IMI PIONEER, IMI HARMONY, ELIXIR, European Patients Forum, i~HD, et al., positioning EHDEN within the proposed legislative changes (2022).
o The project has been very proactive in collaborating with the wider community with OHDSI, statutory bodies (Regulatory Authorities, Health Technology Assessment bodies, representative bodies, e.g. EFPIA, MedTech Europe, DIGITALEUROPE, et al.) and a myriad of other projects and programmes in IMI and Horizon Europe. Propagating the OMOP common data model by EHDEN has also been mirrored by wider organic adoption across countries, projects and programmes, inclusive of within IMI, further accelerating the harmonisation efforts in Europe.
o We have an ongoing collaboration with OHDSI to help strengthen both our communities. Additionally, OHDSI has helped us to promote the EHDEN academy via our leadership (Project Lead) of the OHDSI Education Working Group, working on the global education strategy.
Based on this three year’s activity and outputs, we are seeing completion of mapping to the CDM by the end of year three, and especially early in year four for many of our Data Partners, performed between them and certified SMEs, which will form the basis for the progenitor EHDEN network.
Year 3 has seen continued, remarkable progress of the project as it transitions into a start-up phase, preparing for longer term sustainability. We have seen unprecedented responses to our Open Calls, both for Data Partners and SMEs, while generating evidence at scale, and at speed, in response to therapeutic queries. We have already demonstrated that EHDEN is making a real difference in answering critical questions for clinicians, regulatory authorities, the wider research community and above all patients.
The 3 pillars in EHDEN
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