The European Commission has launched the European Health Data Space (EHDS), as part of its work on the European Health Union. The EHDS aims to empower people to control and utilise their health data in their home country or in other Member States. In addition, will create a consistent framework for the use of health data for research, innovation, policy-making and regulatory activities, while ensuring compliance with the EU's data protection standards. From the patient and healthcare perspective, the EHDS will:
• Ensure that patients will have access to their data in electronic form, which will be able to be shared with other health professionals in and across Member States
• Require Member States to ensure that patient summaries, ePrescriptions, images and image reports, laboratory results, discharge reports are issued and accepted in a common European format
• Mandate interoperability and security as requirements, with manufacturers of electronic health record systems needing to certify compliance
• Require Member States to appoint digital health authorities.
In relation to the use of health data for research, innovation and policymaking:
• The EHDS creates a legal framework for the use of health data for research, innovation, public health, policy-making and regulatory purposes
• Access to such data by researchers, companies or institutions will require a permit from a health data access body, to be set up in all Member States. Health data access bodies will be connected to the new decentralised EU-infrastructure for secondary use, which will be established up to support cross-border projects.
The proposal put forward by the European Commission will now be discussed by the Council and the European Parliament. Further details on the EHDS can be found at:
https://ec.europa.eu/commission/presscorner/detail/en/ip_22_2711