EMA preparing big data Q&A guidance

Regulatory NewsRegulatory News | 11 May 2020 |  By 

The European Medicines Agency (EMA) says it is preparing a question and answer guidance on the application of EU data protection rules to the secondary use of health data in medicines development, evaluation and supervision.
EMA explains that secondary use of data describes “the use of data for a different purpose than the one for which it was originally collected,” and applies to various real-world data sources such as electronic health records, health insurance claims data and registry data.
The planned guidance comes after EMA and the Heads of Medicines Agencies’ (HMA) joint Big Data Task Force released its 10 priority recommendations for the use of big data in medicines regulation earlier this year, one of which is to develop a secure and ethical governance framework for managing and analyzing personal data. (RELATED: EMA, HMA set 10 priorities for big data, Regulatory Focus 20 January 2020).
“The aim is to help medicines developers, data providers and research bodies comply with EU data protection rules, and to help patients and consumers understand their rights and the existing safeguards to protect personal data,” EMA says.
EMA says it will begin gathering input from patients, consumers, drugmakers and other health care stakeholders in the coming months that will be used to develop a draft guidance for consultation in late 2020. EMA says it aims to finalize the guidance in the first half of 2021.


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