European Health Union: a European area of ​​health data for people and for science

The European Commission is today launching 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 health care is delivered to citizens across Europe. It will empower citizens to control and use their health data, both in their home country and in other Member States. It will promote a true single market for digital health products and services, and it will provide a coherent, reliable and efficient framework for the use of health data for research, innovation, policy-making and regulation. , while ensuring full compliance with high EU data protection standards.

The Vice-President of the European Commission, Mr. Margaritis Schinassaid in this regard: I am proud to announce the first common European data space in a specific domain. The European health data space will be a “fresh start” for the EU’s digital health policy, making health data work for people and for science. Today we are laying the foundations for safe and reliable access to health data, in full respect of EU 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 putting in place today. Our vision becomes reality. The European Health Data Space is a fundamental game-changer when it comes to the digital transformation of healthcare in the EU. It puts citizens at the centre, giving them the power to fully control their data in order to benefit from better healthcare across the Union. This data, which will be accessible under strong security and privacy safeguards, will also be a gold mine for scientists, researchers, innovators and policy makers working on the next life-saving treatment. The Union is taking a historic step towards the digitization of healthcare within it. »

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

  • Thanks to the EHDS, citizens will have a immediate, free and simplified access to their health data in electronic form. They can easily share those data with other healthcare professionals within and across Member States to improve the delivery of healthcare. 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 for other people and obtain information on how their data is used and to what purposes.
  • Member States will have to ensure that patient records, electronic prescriptions, medical imaging images and reports, laboratory results and hospital discharge letters are issued and accepted in a common European format.
  • Interoperability and security will become mandatory. Manufacturers of electronic medical record systems will need to certify compliance with these standards.
  • In order to guarantee the protection of citizens’ rights, all Member States must designate digital health authorities. These authorities will have to participate in a cross-border digital infrastructure (MyHealth@EU) that 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 the 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 to develop life-saving treatments, vaccines or medical devices and ensure better access to healthcare and more resilient healthcare systems.
  • To access this data, researchers, companies or institutions will have to ask for permission with the body responsible for access to health data, which will have to be set up in each Member State. Access will only be granted if the requested data is used for special purposes, in closed and secure environments and without the identity of the persons being revealed. It will also be strictly prohibited to use the data for decisions harmful to citizens, for example to design harmful products or services or to increase the amount of an insurance premium.
  • Organizations responsible for access to health data will be connected to the new decentralized infrastructure of the Union for secondary data use (HealthData@EU), which will be set up to support cross-border projects.

context

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

The EHDS is an extension of the General Data Protection Regulation (GDPR), the proposal for an act on data governanceof the proposed data regulation and some NIS directive. It complements these initiatives and provides rules that are better suited to the health sector. A open public consultation on the EHDS took place between May 3 and July 26, 2021 and made it possible to collect a wide range of opinions which contributed to the design of this legal framework.

The EHDS will make use of the ongoing and future deployment in the EU of public digital goods such as artificial intelligence, high performance computing, cloud and intelligent middleware. Furthermore, it will be supported by the frameworks for AI, electronic identity and cybersecurity.

Next steps

The proposal presented by the European Commission will now be examined by the Council and the European Parliament.

To know more

Communication entitled “A European health data space: harnessing the potential of health data for citizens, patients and innovation

Proposal for a regulation on the European health data area

Questions and answers

Information sheet

February 19, 2020 Data Strategy

Web page

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European Health Union: a European area of ​​health data for people and for science


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