Brussels, 14 June 2022 (TDI): European Union (EU) ministers are meeting today in Brussels, and on agenda is European health data space and a review of the EU’s global health strategy.

Firstly, the European health data space (EHDS) is a proposal for a directive from May 2022.

It is for making it easier for patients to have access to their health data in electronic form. As well as to share this data with health professionals in the EU.

Following this, the Ministers are holding a policy debate on the mentioned topic.

Secondly, in terms of the EU’s global health strategy, the present EU global health strategy dates back to 2010.

Therefore, the Commission is proposing an update considering developments in recent years including the COVID-19 crisis. Thus, Ministers are holding a policy debate on the revision of the EU’s global health strategy.

In addition, the Presidency is informing delegates about the state of play of the draft cross-border threats to health regulation.

The Commission is also informing on the implementation of the regulations on medical devices and on health technology assessment. Together with the situation in Ukraine from a health as well as humanitarian point of view.

European Health Data Space

In order to release the full potential of health data, the European Commission presents a regulation to set up the European Health Data Space.

The proposal supports individuals having control over their own health data and also supports the utilization of health data.

Specifically, for better healthcare delivery, better research, innovation, and policy making. It enables the EU to make full utilization of the potential provided by a safe and secure exchange, use, and reuse of health data.

As a health-specific ecosystem, the European Health Data Space consists of rules, common standards, and practices.

Along with infrastructures and a governance framework that aims at empowering individuals.

That is, through increased digital access to and control of their electronic personal health data. At both the national level and EU-wide, and support their free movement.

Also, fostering a genuine single market for electronic health record systems, relevant medical devices, and high-risk AI systems.

Additionally, providing a consistent, trustworthy, and efficient set-up for the utilization of health data. Namely, for research, innovation, policy-making, and regulatory activities.

In line with this, the European Health Data Space is a key pillar of the European Health Union.

Thus, it is the first common EU data space in a specific area to come out of the European strategy for data.

As trust is vital in enabling the success of the European Health Data Space, the European Health Data Space will offer a trustworthy setting for secure access to and processing of a wide range of health data.

Furthermore, it builds upon the General Data Protection Regulation (GDPR), proposed Data Governance Act, draft Data Act, and Network and Information Systems Directive.

By taking into account the sensitivity of health data, more specific rules are also developed in the European Health Data Space Regulation.

Most importantly, the proposal for the European Health Data Regulation is accompanied by a Communication from the Commission. It is the outcome of a process that involved an impact assessment and an open public consultation.

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