European Health Data Room: here we go!

On Tuesday 3 May, the European Commission published the draft regulation on European Health Data Space (or EHDS for European Health Data Space), which aims to regulate the use of health data in the EU. Whether it is continuity of care or research and innovation activities, this framework is intended to be reliable, efficient, interoperable and secure in accordance with EU data protection rules.

A new start for the EU’s digital health policy

Margaritis Schinas, Vice-President of the European Commission, believes that “the European Health Data Zone will be a ‘new start’ for the EU’s digital health policy, which will make health data work for citizens and for science”. He adds that the draft regulation lays “the foundation for secure and reliable access to health data while fully respecting the fundamental values ​​of the EU”.

On a continuous basis, the Commissioner for Health and Food Safety, Stella Kyriakides, maintains that “the Union is taking a historic step towards the digitalisation of healthcare within it” and that “the European data space is a fundamental game-changer when it comes to digital Transforming 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. These 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. “

For the continuity of patient care: the primary use of health data

EHDS promises citizens easier access to their health data, instantly, free of charge and simplified in electronic form. Every citizen will be able to share their data with health professionals in their own country, but also across borders. He will be able to add data, correct them or even restrict their access to other people.

To make this possible:

  • Electronic medical records and health documents (medical summaries, electronic prescriptions and dispensations, reports on biology and imaging procedures, etc.) must be standardized, issued by the Member States in a common exchange format.
  • Interoperability and security will be improved and mandatory; system certification mechanisms will be introduced.
  • All Member States will have to join the MaSanté @ EU (MyHealth @ EU) program, a European infrastructure and service for sharing health data for primary health care. MaSanté @ UE is already stationed in some countries, including France, where the Sesali.fr service, supported by the Digital Health Agency (ANS), provides healthcare professionals with access to medical summaries of European citizens.
  • Each Member State must designate a digital health authority, which must be responsible for guaranteeing the protection of citizens’ rights.

For science, innovation and public policy making: the secondary use of health data

EDHS aims to establish a common European legal framework for the use of health data to promote research, innovation, public policies or even personalized medicine.

  • EHDS will create the decentralized European infrastructure HealthData @ EU for the secondary use of health data, which all Member States must integrate. This will connect the health data access organizations to be set up by the Member States.
  • Organizations with access to health data
    • will be responsible for issuing access to health data to researchers, companies and other institutions,
    • shall guarantee the transparency of their activities and publish information on requests for data access.
  • Permission to access data will only be granted if applicants have clearly indicated how the data will be used and for what purposes.
  • Applicants who will be entitled to access the data must publish the results of their work and report any significant discovery concerning the health of individuals.
  • The data may only be used in closed environments and in accordance with (cyber) security norms and standards.

The next steps

The draft regulation published by the EC is now to be considered by the Council of the European Union, of which France holds the post of rotating presidency until the end of June, then by the European Parliament.

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