The European health data space: Key features and opportunities for access and research

Scientist looking down through a microscope and reviewing data on a chart.

In a previous blog post, we briefly outlined the plans of the European Union (EU) to facilitate access to high-quality data for scientific research. Three main EU initiatives aim at enabling such access. The first initiative focusses on the establishment of a network of common European data spaces that will intermediate pooling and shared use of data among EU-based organisations in various sectors (e.g. health, energy, agriculture, finance). As part of this initiative, systems for cross-border sharing and use of health data for primary and secondary use have already been set up in most EU member states. The second initiative involves the creation of data laboratories for sharing and processing of data for training of artificial intelligence (AI) models and applications in the EU. The third initiative aims to bring into existence an EU-wide European Health Data Space intended to support the primary and secondary use of health data across a range of public services and social initiatives, such as health delivery, scientific research, policymaking and regulatory activities.  The subsequent use of data initially collected and processed for other purposes is considered as secondary. In this blog post, we break down for you the key features, research opportunities and access and use requirements of the European Health Data Space.

Key features

In its essence, the European Health Data Space:

  • Is an overall governance framework established through EU legislation, upcoming regulatory guidance, technical and governance standards, integrated information technology architecture and secure processing infrastructures;

  • Aims to ensure:

    • Greater integration and interoperability of the national systems of electronic health records across the 27 EU members states, 

    • Better access by health professions to electronic health records, 

    • Shared access to and secondary use of the ensuing pool of health data by a range of data users, including research organisations and private companies (see below);

  • Builds upon and integrates the health data spaces already set up (see above);

  • Streamlines the EU privacy requirements (e.g. under the EU General Data Protection Regulation) with regards to health data thus charting clearer pathways for data processing for health delivery and biomedical research;

  • Applies EU-wide, which should harmonise the health data sharing rules across all 27 EU member states at least to some extent (while some local variations still possible);

  • Becomes operational in stages, with access to data for most primary and secondary uses available from March 2029. 

Research opportunities

The European Health Data Space provides:

  • Access to and opportunities to use for scientific research large datasets including  anonymised or pseudonymised electronic health data, such as electronic health records, population health data, information on social determinants of health, human genetic, epigenomic and genomic data, healthcare-related administrative data, personal electronic health data automatically generated through medical devices, data from wellness applications, health data from biobanks and associated databases. For a full list of categories of data to be available for secondary use, including research, check here.

  • For the purposes of health- or healthcare-related scientific research that contributes to public health, high quality and safety of healthcare, or the development of drugs, medical devices or healthcare technologies, in the EU. The training, testing and evaluation of algorithms, including in medical devices, in vitro diagnostic medical devices, AI systems and digital health applications, are considered to constitute such socially beneficial R&D activities. 

  • For public and private commercial and non-profit entities to be granted access to the health data in line with the access requirements outlined below. Those who may apply for such access include individual researchers, as well as various types of organisations, such as research institutes, small and medium-sized enterprises, large corporations (including pharmaceutical and medical devices manufacturers). Individual researchers and entities based outside the EU would arguably be entitled to apply for access as long as their research contributes to socially beneficial R&D activities in the EU, as per above.

     However, three important caveats hold here:

  • Personal health data – e.g. from patients’ electronic health records or individual users’ wearable devices – will make its way into datasets only as long as the individuals from whom the data originates have not opted out of such secondary use. 

  • Proprietary electronic health data – e.g. from clinical trials or medical devices – will be included in datasets to the extent that sponsors’ or manufacturers’ intellectual property or regulatory data exclusivity rights do not bar against this.

  • The datasets may not be used for decision-making or activities detrimental to individuals or social groups, such as for the development of harmful products, marketing or advertising, increase of insurance premiums, or determining access to employment, banking or pension services, or automation of decision-making.

Key access and use requirements 

Eligible entities may access and use for scientific research datasets available through the European Health Data Space:

  • Only after receiving a bespoke data use permit, request or approval, and

  • Within the remits of this permit / request / approval, for example, while the research is in line with the original purposes for which the data was collected.

     Furthermore, such eligible data users must:

  • Not use the data in the detrimental ways described above;

  • Not attempt to or re-identify individuals from whom the data was collected;

  • Not provide access to the datasets to unauthorised third parties, e.g. investigators not motioned in the respective data permit, request or approval; 

  • Ensure “a high degree of data protection, security, confidentiality and ethical use” of the datasets. Our next blog posts will discuss the privacy and data protection protocols and safeguards for meeting this high compliance bar;

  • Make public the results or output of the scientific research while anonymising the data contained therein.

While the data in the European Health Data Space will be available for secondary use as of March 2029, prospective users must start planning the protocols and safeguards for privacy-preserving and ethical use already now in order to be able to meet the high compliance standards set out above. 

Do you want to learn more about how to set up your privacy and data protection protocols with regards to biomedical research with health data? Join us for our upcoming webinar Innovating with Health Data: Regulatory Opportunities and Key Requirements in the UK and the EU!  Email Kate Collocott at kate@datadrivenlegal.com or register here



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