European Commission Launches European Health Data Space
On 3 May 2022, the European Commission (the Commission) launched the European Health Data Space (EHDS), the European Union’s first sector-specific set of rules pursuant to its 2020 European data strategy. The EHDS, as expressed in the proposed Regulation on the European Health Data Space (COM(2022) 197 final) and in an associated Commission Communication (COM(2022) 196 final), has two principal components:
- primary use of electronic health data, i.e., rules to improve access to and control by natural persons over their personal electronic health data in healthcare; and
- secondary use of electronic health data, i.e., rules to broaden the use of health data for the benefit of society at large in areas as diverse as research, innovation, policy-making, patient safety, personalised medicine, statistics and regulatory activities.
Under the primary use of electronic health data individuals will have easy and free of charge access to their own health data for purposes of data management and sharing the data with healthcare professionals (HCP) in and across Member States in the language of the HCP. Files such as ePrescriptions, images, and laboratory results will be created and accepted in a common European format and will be stored and transferred in a safe environment. The rights of the individuals will be guaranteed by a new digital health authority in each Member State and each such authority will participate in [email protected], a central platform for digital health that will support and facilitate the exchange of electronic health data between Member State contact points for digital health.
The secondary use of electronic health data will boost the access to and utilisation of health data for research and other purposes of benefit to society. Access will be subject to a permit to be delivered by a newly created health data access body which will ensure that the data is used only for defined purposes in a close and secure environment. The identity of individuals will not be revealed, and specific types of data usage will be prohibited. Examples include taking decisions to exclude individuals or groups of natural persons from insurance coverage and engaging in advertising activities that target HCPs, health organisations or individuals. The health data access bodies will be connected to [email protected], a new European facility that creates a link between national contact points and the central platform specifically for the secondary use of electronic health data.
The principal documents that embody the EHDS are attached and include the proposed Regulation, the Commission Communication, a Commission press release and a set of questions and answers.