In 2025, the European Health Data Space Regulation (“EHDS Regulation”) was adopted marking a major development for life sciences organisations (particularly clinical trials sponsors) in optimising the use of electronic health data for secondary use purposes such as research, innovation and policy-making. The EU hopes that the secondary use provisions will drive developments in the form of new medicines and medical devices. Most of the secondary use provisions will become applicable in March 2029, giving organisations just over three years to prepare.
Regardless of whether a health data holder is the subject of a data permit or a health data request, it will be required to provide the HDAB with a description of the datasets it holds for inclusion in national and EU data catalogues.
As a result, all organisations within the scope of the EHDS Regulation will need to consider its implications and prepare for its application from March 2029.
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