EMA lays down its recommendations for making use of big data

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have assessed Big Data databases to improve public health, and have identified ten key recommendations to unlock its potential.

The EMA describes big data as:

“extremely large, rapidly accumulating datasets captured across multiple settings and devices, for example through wearable devices, electronic health records, clinical trials or spontaneous adverse reaction reports”

The sheer quantity of data available opens myriad routes for elucidation and use of hitherto unknown factors underpinning aspects of health. Guido Rasi, Executive Director of EMA, said:

“I look forward to working with the European Commission and national competent authorities to see how these concrete proposals can be implemented to better harness the potential of Big Data. This will help to further strengthen the robustness and quality of the evidence upon which we take decisions on medicines”

Find the EMA press release here, including the Priority Recommendations of the HMA-EMA joint Big Data Task Force document containing more detail on the recommendation titles given below.

Priority Recommendations of the HMA-EMA joint Big Data Task Force

  1. Deliver a sustainable platform (DARWIN) 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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Published on 21. January 2020 in News, News EU, Press Release