European Health Data Space

European Health Data Space

In order to unleash the full potential of health data, the European Commission is presenting a regulation to set up the European Health Data Space. This proposal supports individuals to take control of their own health data, supports the use of health data for better healthcare delivery, better research, innovation and policy making and enables the EU to make full use of the potential offered by a safe and secure exchange, use and reuse of health data.  

The European Health Data Space is a health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework that aims at

  • empowering individuals through increased digital access to and control of their electronic personal health data, nationally and cross-borders, as well as support to their free movement, fostering a genuine single market for electronic health record systems, relevant medical devices and high risk artificial intelligence (AI) systems (primary use of dataSearch for available translations of the preceding linkEN•••)
  • providing a consistent, trustworthy and efficient set-up for the use of health data for research, innovation, policy-making and regulatory activities (secondary use of data)

As such, the European Health Data Space is a key pillar of the strong European Health UnionSearch for available translations of the preceding linkEN••• and it is the first common EU data space in a specific area to emerge from the European strategy for dataSearch for available translations of the preceding linkEN•••.

Trust is a fundamental enabler for the success of the European Health Data Space. The European Health Data Space will provide a trustworthy setting for secure access to and processing of a wide range of health data. It builds on

As horizontal frameworks, they provide rules that also apply to the health sector. However, more specific rules are developed in the European Health Data Space Regulation, taken into account the sensitivity of health data.

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Source: European Health Data Space

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