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European Health Data Space · EU-wide · 21 Sep 2025 · Guidance

European Health Data Space (EHDS) Regulation: overview

Original title: What is the EHDS Regulation about

AI-generated summary

The European Health Data Space (EHDS) is a central component of the European Health Union, designed to improve healthcare delivery across EU countries by enabling people to control their health data and providing researchers, innovators, and industry secure access to high-quality health data under strict conditions. It aims to foster a single market for digital health services while building on rigorous data privacy, interoperability, and security requirements. The EHDS supports the EU's broader health goals of better protecting citizens, preventing pandemics, and improving health system resilience.

From European Health Data Space

What is the European Health Union

The European Commission has been building a strong European Health Union, in which all EU countries prepare and respond together to health crises, medical supplies are available, affordable and innovative, and countries work together to improve prevention, treatment and aftercare for diseases such as cancer.

The European Health Union helps

- better protecting the health of our citizens

- equipping the EU and its Member States to better prevent and address future pandemics

- improving the resilience of Europe’s health systems

Lessons from the coronavirus pandemic

The pandemic showed the importance of coordination among European countries to protect people’s health, both during a crisis and in normal times when we can tackle underlying health conditions, invest in strong health systems and train the healthcare workforce. The European Health Union improves EU-level protection, prevention, preparedness and response against human health hazards.

European Health Data Space

The European Health Data Space is one of the central building blocks of the European Health Union and a milestone in EU’s digital transformation. It aims to:

- improve healthcare delivery across the EU, by empowering people to control their health data in their home country or in other EU countries

- offer a consistent, secure, trustworthy and efficient framework for the use of health data. Under strict conditions, researchers, innovators, public institutions or industry will have access to large amounts of high-quality health data, crucial to developing life-saving treatments, vaccines or medical devices.

- foster a genuine single market for digital health services and products

The European Health Data Space builds on rigorous data privacy, interoperability and security requirements, including cybersecurity, which is key for the trust of citizens and the robustness of the project.

Global health security

To improve global health security and deliver better health for all in a changing world, the Commission adopted a new EU Global Health Strategy in November 2022.

The Strategy positions global health as an essential pillar of the EU’s external policy. It promotes sustainable, meaningful partnerships of equals drawing on the Global Gateway. As the external dimension of the European Health Union, the strategy is designed to guide EU action for ensuring better preparedness and response to health threats.

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This page was last reviewed on 6 November 2025

Excerpt from the official page. The original is authoritative.