rec_45

Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance) · European Union

(45) Rapid access to and exchanges of health data, including real world data, i.e. health data generated outside of clinical studies, are essential to ensuring the effective management of public health emergencies and major events. This Regulation should allow the Agency to use and facilitate such exchanges and to be part of the establishment and operation of the European Health Data Space interoperable infrastructure, taking advantage of all the potential of supercomputing, artificial intelligence and big data science to develop predicting models and take better and more timely and effective decisions, without compromising privacy rights.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.