EHDS and the history of the EHRxF

The digitisation of healthcare provides the opportunity to improve healthcare for individuals, make secondary use possible and provide efficiency in healthcare systems that increasingly have to deal with labour shortages. For the last decades, this potential has been limited due to bottlenecks in sharing and interpreting shared data between healthcare professionals in a local, national or cross-border context.

As part of the Digital Single Market Strategy, the European Health Data Space (EHDS) is an initiative of the European Union aimed to improve the accessibility, interoperability and sharing of health data across member states. By doing so, empowering citizens to make use of their own health data both for primary as well as secondary use.

By the EHDS, the EU aims to ensure that health data is harnessed to its fullest potential while maintaining the highest standards of data protection and privacy. Resulting in a more citizen-centred, efficient, and innovative healthcare system focusing on prevention, promotion of healthcare and curing/caring for disease.

Key EHDS moments (timeline)

• 2018 – Digital healthcare became a part of the Digital Single Market from the European Union;
• 2019 – The Council of Europe emphasised the importance of Digital Health;
• 2020 – The COVID pandemic worked as an accelerator for sharing data and interoperability;
• 2022 – The European Commission proposed the EHDS Regulation;
• 2024 – Provisional/political acceptance of the EHDS.

During the 13th eHealth Network (eHN) meeting held on 15 May 2018, a constructive discussion was initiated, with members of the eHN noting that an ‘European EHRxF’ should be developed. The first mention of the format in a document was on the eHAction’s deliverable ‘D8.2 – Policy document about technology report’.

Core Principles

The European EHRxF was introduced more widely in a recommendation of the European Commission on February 6, 2019. This document also included the core principles behind the format:

1. Citizen-centric by design;
2. Comprehensiveness and machine-readability;
3. Data protection and confidentiality;
4. Consent or other lawful basis;
5. Auditability;
6. Security;
7. Identification and authentication;
8. Continuity of service.

The objective of the European EHRxF is to achieve secure, interoperable, cross-border access to, and exchange of, electronic health data in the Union.