On 3 May 2022, the European Commission launched the European Health Data Space (EHDS).

The EHDS aims to make it possible for individuals to have access to their personal electronic health data in easily readable, consolidated, accessible and interoperable form (e.g. via patient portals), obtain an electronic copy of key health data and enable sharing this data between healthcare practitioners throughout the EU. Individuals will be able to rectify their electronic health data or restrict access by healthcare providers and professionals to some or all data, unless the data are necessary to protect their vital interests. Allen & Overy previously published an article on the European Health Data Spaces.

Member States will be required to ensure that patient data, electronic prescriptions, e-dispensations, image reports and laboratory results are provided in a common European format. Manufacturers of electronic health record systems that are placed on the market and put into service in the EU will be required to register their systems, ensure those meet the conformity requirements and standards of the EHDS, including regarding interoperability and security, and certify and mark conformity of their systems.

In addition, the EHDS will provide a legal framework for the use of health data for research, innovation, policy-making and regulatory activities. So-called “data holders” (any public and private entities carrying out research in the health sector) will need to make certain electronic health data and related metadata available for secondary use by data users. The EHDS establishes detailed obligations for such secondary use, including data anonymization and pseudonymisation, security, purpose limitation, and an obligation to make public any results or outputs of their processing.

The public consultation is open until 30 June 2022.

Read the EHDS press release here and the public consultation here.