Role of big data for evaluation and supervision of medicines in the EU

BEUC, The European Consumer Organisation welcomes the core recommendations of the joint EMA-HMA taskforce on big data in health; nonetheless, we call on for a stronger focus on ethical and practical challenges related to the use of big data in health in the final set of recommendations. BEUC agrees with the EMA-HMA taskforce that interoperability, data sharing frameworks, data linkage and use of new analytical approaches and other recommended tools and actions are expected to contribute to a more meaningful use of biomedical big data and could lead to significant progress in medicine. While there are significant expectations of big data in health, it is of key importance to establish common standards and a strong regulatory framework to ensure the benefits of big data materialise in benefit for individual patients and the society as a whole. 

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