16.05.2022
LAUNCH OF THE EUROPEAN HEALTH DATA SPACE
The European Commission has launched the European Health Data Space (EHDS), one of the central building blocks of a strong European Health Union. The EHDS will help the EU make a qualitative leap forward in the way people across Europe are provided with healthcare. It will enable people to control and use their health data in their own country or in other EU countries. The EHDS promotes a true single market for digital health services and products. In addition, it provides a coherent, reliable and efficient framework for the use of health data for research, innovation, policy-making and regulatory activities, while ensuring full compliance with high EU data protection standards.
EC Vice-President Margaritis Schinas said: I am proud to announce the first common EU data space in a specific area. The European Health Data Space will be a "new beginning" for EU digital health policy, and health data will be used for the benefit of citizens and science. Today, we are laying the foundations for secure and reliable access to health data in full compliance with the core values on which the EU is founded.
Commissioner for Health and Food Safety Stella Kiriakidou said: Today we are introducing another pillar of the European Health Union. Our vision is becoming a reality. The European Health Data Space is a key determinant of the digital transformation of healthcare in the EU. It puts citizens at the center of attention, enabling them to exercise full control over their data in order to receive better healthcare across the EU. This data, which will be accessed under strict guarantees of security and privacy, will also be a real treasure trove for scientists, researchers, innovators and policy makers working on future life-saving treatments. The EU is truly taking a historic step towards digital healthcare.
Enabling people to control their health data at home and abroad
Thanks to the EHDS, people will have immediate, free and easy access to their health data electronically. They can easily share this data with other health professionals in EU countries to improve the provision of health care. Citizens will have full control over their data, as they will be able to add information, correct incorrect data, restrict access to others and receive information on how their data is used and for what purposes.
EU countries will ensure that aggregate patient data, e-prescriptions, medical images and conclusions, laboratory results and medical records are published and adopted in a common European format.
Interoperability and security will become mandatory requirements. Manufacturers of electronic health record systems will need to certify compliance with these standards.
To ensure the protection of citizens' rights, all EU countries must set up digital health authorities. These authorities will be involved in a cross-border digital infrastructure (MyHealth@EU, My Health in the EU data infrastructure) to help patients share their data abroad.
Improving the use of health data for research, innovation and policy making
The EHDS creates a solid legal framework for the use of health data in the areas of research, innovation, public health, policy-making and regulatory activities. Under strict conditions, researchers, innovators, public institutions or industry will have access to large amounts of high-quality health data, which are crucial for the development of life-saving treatments, vaccines or medical devices and provide better access to healthcare and more sustainable health systems.
To access such data, researchers, companies or institutions will need permission from a health data access authority, which must be set up in each EU country. Access will be granted only if the requested data is used for specific purposes, in a closed and secure environment and without revealing the identity of the persons. In addition, it is strictly forbidden to use data for decisions that are detrimental to citizens, such as designing harmful products or services or increasing the insurance premium.
Health data access authorities will be linked to the new decentralized infrastructure at EU level for secondary use (HealthData@EU, EU Health Data Infrastructure), which will be set up to support cross-border projects.
Context
The COVID-19 pandemic has clearly demonstrated the importance of digital health services. The use of digital tools increased significantly during this period. However, the complexity of the rules, structures and processes in the Member States makes it difficult to access and share health data, especially abroad. In addition, health systems are currently the subject of intensified cyber attacks.
The EHDS builds on the ORD, the proposed Data Management Act, the draft Data Legislation and the Cyber Security Directive. It complements these initiatives and provides more individualized rules for the health sector. An open public consultation on the EHDS took place from 3 May to 26 July 2021, bringing together a wide range of views that contributed to the development of this legal framework.
The EHDS will use the current and upcoming deployment of digital public goods in the EU, such as artificial intelligence, high-performance computing technologies, cloud computing and smart middleware. In addition, the EHDS will be supported by frameworks on AI, e-identity and cybersecurity.
Next steps
The European Commission's proposal will be discussed by the Council and the European Parliament.
