A European digital space for health will be created. What does this mean for patients? – The pulse of medicine

The European Commission has launched the European Health Data Area (EHDS), which should be one of the cornerstones of a strong European Health Union. The aim is to advance the way healthcare is delivered to citizens across Europe. What does the new EC initiative mean in practice?

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Thanks to the European Health Data Area, electronic information will be immediately and easily accessible to everyone.

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The European Health Data Area (EHDS) will allow patients to track them; and it will also be possible to use the data in their own country or in other Member States.

As the European Commission explains, the initiative supports a genuine single market for digital health services and products. It also provides a consistent, reliable and efficient framework for the use of health data for research, innovation, policy-making and regulatory activities, while fully respecting the high data protection standards of the EU.

A ‘fresh start’ for EU digital health policy

European Commission Vice-President Margaritis Schinas said the European health data space would be a “fresh start” for EU digital health policy, making this data usable for citizens and science . “Today we are laying the foundations for safe and reliable access to health data which is fully in line with the fundamental values ​​on which the EU is based,” he underlined.

Health and Food Safety Commissioner Stella Kyriakides said:

– Today we are introducing another pillar of the European Health Union. Our vision becomes reality. The European Health Data Space is a fundamental breakthrough in the digital transformation of healthcare in the EU. It puts citizens in the spotlight, giving them full control of their data for better healthcare across the EU. Backed by strong security and privacy measures, health data will also be a repository of knowledge for scientists, researchers, innovators and policy makers working on the next lifesaving treatments. The EU is taking a truly historic step towards digital healthcare in the EU.

Control of your own health data at home and abroad

Thanks to EHDS, everyone will have immediate and easy access to data in electronic form. It will be easy to share this data with other healthcare professionals within and between Member States in order to improve the delivery of healthcare. Citizens will have full control of their data and will be able to add information, correct inaccurate data, restrict other people’s access and obtain information on how and for what purpose their data is used.

Member States will have to ensure that patient summary health cards, electronic prescriptions, medical images and descriptions, laboratory test results and hospital discharge notes are issued and accepted in a common European format.

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Interoperability and security will become mandatory requirements. Manufacturers of electronic health record systems will need to certify compliance with these standards.

To protect the rights of citizens, all member states must designate digital health authorities. These authorities will participate in the cross-border digital infrastructure ([email protected]) supporting patients in cross-border data exchange.

Better use of health data in research, innovation and policy-making

The EHDS creates a solid legal framework for the use of health data for research, innovation, public health, policy-making and regulatory purposes. Under strict conditions, large amounts of high-quality health data will be available to scientists, innovators, public institutions or industrykey to developing life-saving treatments, vaccines or medical devices, and ensuring better access to healthcare and more resilient healthcare systems.

Health data access authorities will be linked to the new EU infrastructure

To access this data, scientists, companies or institutions will have to request authorization from the health data access authority which will be established in all Member States. Access will only be granted if the data requested is used for specific purposes, in a closed and secure environment and without revealing the identity of specific persons. It is also strictly forbidden to use the data to make decisions unfavorable to citizens, such as developing harmful products or services or increasing the insurance premium.

Health data access authorities will need to be linked to the EU’s new decentralized infrastructure for the re-use of health data ([email protected]), which will be useful for the implementation of cross-border projects.

The COVID-19 pandemic has clearly demonstrated the importance of digital health services. Meanwhile, the use of digital tools has increased dramatically. However, the complexity of legislation, structures and processes in Member States makes it difficult to access and share health data, especially across borders. In addition, healthcare systems are now an increasingly frequent target of cyberattacks.

EHDS will leverage the ongoing and future deployment of public digital services in the EU, such as artificial intelligence, high performance computing, cloud and intelligent middleware. In addition, the EHDS will support a framework on artificial intelligence, electronic identity and cybersecurity.

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

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