The European Data Protection Regulation establishes a common framework for the use and exchange of electronic health data across the EU. The system under discussion facilitates individuals’ access to and control over their electronic personal health data. Secondary utilisation of specific data is permitted for applications that fall under the umbrella of general interest, in addition to policy-making and research endeavours. Furthermore, it establishes an integrated health data environment, thereby facilitating a single market for digital health services and products. The establishment of a harmonised legal and technical framework for electronic technical documentation systems is also of consequence. The European Health Data Space is poised to unlock the vast potential inherent in data, a development that is set to redound to the benefit of patients, health professionals, researchers and innovators alike. This regulation appears to be another step towards realising the vision of Ursula von der Leyen, who, in her 2020 State of the EU address, called for Europe to create a European Health Union. The speech was followed by a Communication from the Commission to the European Parliament and the Council, the European Economic and Social Committee and the Committee of the Regions, entitled ‘Building a European Health Union: Strengthening EU resilience to cross-border health threats’. The advent of the Health Union project coincided with a resurgence of cases of the novel coronavirus in both the European Union and its Member States. This development precipitated the implementation of requisite measures to contain the pandemic.