On May 3, 2022, the European Commission launched the European Health Data Area (EHDS).
The EHDS aims to enable individuals to have access to their electronic personal health data in an easily readable, consolidated, accessible and interoperable form (for example via patient portals), to obtain an electronic copy of key health data and to enable the sharing of this data between healthcare practitioners across the EU. Individuals will be able to rectify their electronic health data or restrict the access of healthcare providers and healthcare professionals to all or part of the data, unless this data is necessary to protect their vital interests. Allen & Overy previously published an article on European Health Data Spaces.
Member States will be required to ensure that patient data, e-prescriptions, e-dispensations, imaging 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 they meet EHDS compliance requirements and standards , including with regard to interoperability and security, and to certify and mark the conformity of their systems.
In addition, the EHDS will provide a legal framework for the use of health data for research, innovation, policy development and regulatory activities. So-called “data holders” (any public and private entity conducting research in the health sector) will be required to make certain electronic health data and associated metadata available for secondary use by data users. The EHDS establishes detailed obligations for such secondary use, including the anonymization and pseudonymization of data, security, purpose limitation and the obligation to make public any results or outputs of their processing.
The public consultation is open until June 30, 2022.
Read the EHDS press release here and the public consultation here.