A European place of health information for humans and for science

The European Commission is launching the European Health Data Space (EHDS) today, the foundation for building a strong European Health Union. EHDS will enable the Union to change the way it provides healthcare to citizens across Europe. This will enable citizens to control and use their health data both in their own country and in other member states. It will promote a truly unified marketplace for digital health products and services and provide a coherent, reliable and efficient framework for the use of health data for research, innovation, policy-making and control. Data protection standards.

Margaritas, Vice-President of the European Commission ShinasIn this context, I am proud to announce the first common European data space in a specific domain The European Health Data Space will be a “new beginning” for the EU’s digital health policy, which works for health data people and science. Today we are laying the groundwork for secure and reliable access to health data in full compliance with EU core values.. A

Mrs. Stella KyrixThe Commissioner for Health and Food Safety continues on the condition that:This is another pillar of the European Health Union that we are establishing today. Our vision becomes reality. European health data space is a fundamental game-changer in the digital transformation of healthcare in the European Union. It puts citizens at the center, giving them full control over their data to benefit from improved healthcare across the union. This data, which will be accessible under strong security and privacy protections, will also be a gold mine for scientists, researchers, inventors and policy makers working on life-saving treatments. The union is taking a historic step towards digitalisation of its healthcare. A

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

  • Thanks to EHDS, citizens will have one Immediate, free and simplified access to their health data In electronic form. They could easily Share ঐ Information With other healthcare professionals in and across member states to improve the delivery of healthcare. They will be able to exercise complete control over their data, and will be able to add information, correct inaccurate information, restrict their data access to other people and get information about how and for what purpose their data is used.
  • Member states must ensure that patient records, electronic prescriptions, medical imaging images and reports, laboratory results and hospital discharge letters are issued and received. In a typical European format.
  • Interoperability and security Will become mandatory. Manufacturers of electronic medical record systems must certify compliance with these standards.
  • To ensure the protection of the rights of citizens, all member states must Nominate the Digital Health Authority. This authority needs to participate in a cross-border digital infrastructure (MyHealth @ EU) Which will help patients share their data across borders.

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

  • EHDS Has created a solid legal framework for use Health data for research, innovation, public health, policy and regulatory purposes. Under strict conditions, researchers, inventors, public institutions or companies will have access to huge amounts of high-quality health data. These are essential for the development of life-saving medicine, vaccines or medical devices, and for ensuring better access to healthcare and more resilient healthcare systems.
  • To access this information, researchers, companies or institutions need to Ask permission With the agency responsible for accessing health data, which must be set up in each member state. Access will only be granted if the requested data is used For special purposes, In a closed and secure environment And People are being published without identification. The use of data for making harmful decisions for citizens will also be strictly prohibited, for example designing harmful products or services or increasing the amount of insurance premiums.
  • Will be linked to the agencies responsible for accessing health data The new decentralized infrastructure of the union For secondary data usage (HealthData @ EU), Which will be set up to support cross-border projects

Context

The COVID-19 epidemic highlights the importance of digital services in healthcare. The adoption of digital equipment has accelerated considerably during this period. However, the complexity of effective rules, structures and processes in member states hinders access to and sharing of health data, especially across borders. Also, the healthcare system is now the target of increasing cyber attacks.

EHDS is an extension of the General Data Protection Regulation (GDPR), the proposed Data Governance Act, the proposed Data Regulation and the NIS guidelines. It complements these initiatives and provides more appropriate rules for the health sector An open public consultation on EHDS took place between May 3 and July 26, 2021, and gathered broad views to contribute to the design of this legal framework.

EHDS will use ongoing and future deployments of public digital products in the EU, such as artificial intelligence, high-performance computing, cloud and intelligent middleware. In addition, it will be supported by frameworks for AI, Electronic Identity and Cyber ​​Security.

The next step

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

To know more

Contact entitled “A European Health Data Space: Utilizing the Possibilities of Health Data for Citizens, Patients and Innovators”

Proposal for a Regulation in the European Health Information Area

Questions and answers

Information sheet

February 19, 2020 Data Strategy

Web page

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