European Commission launches European Health Data Space
Browse this blog post
Related news and insights
Publications: 30 October 2023
Blog Post: 26 October 2023
Blog Post: 23 October 2023
Blog Post: 12 October 2023
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.