a European space with human and science health data

The European Commission today launches the European Health Data Space (EHDS), a cornerstone in building a strong European health union. The EHDS will enable the Union to transform the way healthcare is provided to citizens across Europe. It will give citizens the power to control and use their health data, both in their country of origin and in other Member States. It will promote a genuine single market for digital healthcare products and services, and provide a coherent, reliable and effective framework for the use of healthcare data for research, innovation, policy-making and regulation, while ensuring full compliance with high EU data protection standards.

Vice-President of the European Commission, Mr Margaritis Schinassaid in this connection: I am proud to announce the first common European data space on a specific domain. The European Health Data Zone will be a “fresh start” for the EU’s digital health policy, which will make health data work for people and for science. Today, we lay the foundation for secure and reliable access to health data with full respect for the EU’s core values. »

Mrs. Stella KyriaksCommissioner for Health and Food Safety, continued in these terms:This is another pillar of the European Health Union that we are introducing today. Our vision becomes a reality. The European Health Data Zone is a fundamental game-changer when it comes to the digital transformation of healthcare in the EU. It puts citizens at the center and gives them the power to fully control their data in order to benefit from better healthcare across the Union. This data, which will be available under strong security and privacy guarantees, will also be a goldmine for scientists, researchers, innovators and policy makers working on the next life-saving treatment. The Union is taking a historic step towards the digitalisation of healthcare within it. »

Empowering citizens to control their own health data, within their country and across borders

  • Thanks to EHDS, citizens want one instant, free and simplified access to their health data in electronic form. They can easily do that share these data with other healthcare professionals in and across Member States to improve healthcare delivery. They will be able to exercise full control over their data and will be able to add information, correct erroneous data, restrict access to their data to other people and obtain information about how their data is used and for what purposes.
  • Member States shall ensure that patient records, electronic prescriptions, medical imaging images and reports, laboratory results and hospital discharge letters are issued and accepted in a pan-European format.
  • Interoperability and security becomes mandatory. Manufacturers of electronic record systems must certify compliance with these standards.
  • In order to guarantee the protection of citizens’ rights, all Member States must designate digital health authorities. These authorities must participate in a cross-border digital infrastructure (MyHealth @ EU), which will help patients share their data across borders.

Improving the use of health data for research, innovation and policy making

  • EHDS created a solid legal framework for its use health data for research, innovation, public health, policy and regulatory purposes. Under strict conditions, researchers, innovators, public institutions or companies will have access to large amounts of high-quality health data. These are essential for developing life-saving treatments, vaccines or medical devices and ensuring better access to health care and more robust health systems.
  • To access this data, researchers, companies or institutions will need it ask for permission with the body responsible for accessing health data to be set up in each Member State. Access is only granted if the desired data is used for special purposes, in closed and safe environments and without the identity of the persons being revealed. It will also be strictly forbidden to use the data for decisions that are harmful to citizens, for example to design harmful products or services or to increase the size of an insurance premium.
  • Organizations responsible for accessing health data will be connected to new decentralized infrastructure in the EU for secondary data use (HealthData @ EU), which will be set up to support cross-border projects.

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The COVID-19 pandemic has made the importance of digital services in healthcare very clear. The introduction of digital tools has accelerated significantly during this period. The complexity of existing rules, structures and processes in the Member States hinders access to and sharing of health data, in particular across borders. In addition, health systems are now increasingly the target of cyber attacks.

EHDS is an extension of the General Data Protection Regulation (GDPR), the proposed Data Management Act, the proposed Data Regulation and the NIS Directive. It complements these initiatives and provides rules that better suit the healthcare sector. An open public hearing on the EHDS took place between 3 May and 26 July 2021 and gathered a wide range of opinions which contributed to the shaping of this legal framework.

EHDS will make use of the current and future distribution of public digital goods in the EU, such as artificial intelligence, high-performance computing, cloud and intelligent middleware. Furthermore, it will be supported by the framework of artificial intelligence, electronic identity and cyber security.

Next step

The European Commission’s proposal will now be considered by the Council and the European Parliament.

To know more

Communication entitled “A European Health Data Room: exploiting the potential of health data for citizens, patients and innovation

Proposal for a regulation on the European Health Data Area

Questions and answers

Fact sheet

February 19, 2020 Data Strategy

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