European Health Data Space
The creation of a European Data Space is one of the priorities of the Commission 2019-2025, including the health sector. A common European Health Data Space will promote better exchange and access to different types of health data (electronic health records, genomics data, data from patient registries etc.), not only to support healthcare delivery (so-called primary use of data) but also for health research and health policy making purposes (so-called secondary use of data).
The entire data system will be built on transparent foundations that fully protect citizens’ data and reinforce the portability of their health data, as stated in article 20 of the General Data Protection Regulation (GDPR).
The Commission, in collaboration with the Member States, is engaged in the preparatory work and development of the European Health Data Space. Member States will be supported by a new “Joint Action for the European Health Data Space” set up to help the Members States and the Commission facilitate the sharing of health data for public health, treatment, research and innovation in Europe.
The European Health Data Space will be built on 3 main pillars:
- a strong system of data governance and rules for data exchange
- data quality
- strong infrastructure and interoperability
Governance of the European Health Data Space
Preparatory work was conducted in 2020, through a series of workshops and a study (annex) to provide a framework for the primary and secondary use of health data in the Member States, particularly through
- a mapping of how the GDPR is implemented in the health sector in the different countries, including an overview of the legal and technical modalities applicable to health data sharing for primary and for secondary uses in the EU countries
- an overview of the existing governance structures for secondary use of health data in the EU countries
- recommendations for possible actions, legislative and non-legislative, at EU level to facilitate health data sharing across the EU for primary and for secondary uses
Data quality and interoperability
To fully exploit the potential of exchanging health data, it is essential to ensure health data quality and that the various sources of health data (e.g. electronic health records, different registries, various IT or digital tools) are able to “talk” to each other. This requires technical and semantic interoperability between the different infrastructures and IT systems.
It is also important to ensure that the health data are findable, accessible, interoperable and reusable (FAIR). The Commission is supporting mapping and “FAIR-ification” of existing health data registries and other data sources to establish common data sets for exchanges for health research and policy making purposes.
Infrastructure and technology
The infrastructure at European level will follow the overarching strategy of the European Data Space launched by the publication of the European strategy for data on 19 February 2020, while at the same time providing in-depth analysis of health sector specificities. It will build on and potentially scale up existing initiatives such as the eHealth Digital Service Infrastructure, the European Reference Networks and the Genomics project.