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The 2021-2023 HMA-EMA joint Big Data Steering Group (BDSG) workplan was adopted on 18 June 2021. This document introduces each topic and outlines key deliverables. The plan was prepared based on the BDSG mandate, the continuation of the activities launched in 2020-21 and the need to address new topics. The document is structured in line with the key recommendations of the Big Data Task Force (see Annex I).

Information security and ethical data governance are at the core of the work of the BDSG. Implementation of the actions in the Big Data Steering Group workplan 2021-23 will need to be flexible given uncertainties on the resources that will need to be prioritised towards the regulatory response to the COVID-19 pandemic.

PRIORITY RECOMMENDATIONS OF THE HMA-EMA JOINT BIG DATA TASK FORCE

1. Deliver a sustainable platform to access and analyse healthcare data from across the EU
2. Establish an EU framework for data quality and representativeness
3. Enable data discoverability
4. Develop EU network skills in big data
5. Strengthen EU network processes for big data submissions
6. Build EU Network capability to analyse big data
7. Modernise the delivery of expert advice
8. Ensure data are managed and analysed within a secure and ethical governance framework
9. Collaborate with international initiatives on big data
10. Create an EU big data ‘stakeholder implementation forum’

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