In late April 2026, Dr. Petra Wilson, Managing Director of Health Connect Partners, joined Understanding Patient Data at our two-part EHDS Unpacked webinar series. In Part One, What Europe’s health data future means for the UK, she traced the evolution of the European Health Data Space (EHDS), exploring its legal foundations, and the policy and court decisions that shaped cross-border healthcare.
Treaties that give the EU the right to act on healthcare
At its core, the EHDS sits at an intersection between ambition and legal reality.
It is firmly rooted in EU law, drawing on three key provisions from the Treaty on the Functioning of the European Union (TFEU) that define both the scope of its actions and its limits. These foundations enable the EU to foster collaboration in areas like cross-border healthcare, data sharing, and the functioning of the internal market – but they also make clear that responsibility for healthcare, and the legislation that underpins its delivery, remains at national level.
As a result, implementation of the EHDS is inherently challenging, as EU Member States retain control of a number of aspects – for example, individual countries decide whether they offer opt‑out for primary health data use under the EHDS.
Court cases that caused change
Cross-border healthcare in Europe has two foundations, one dating back to 1958 when the rights to social security portability for cross- border workers were established in EU level Regulations; and the other through a series of court cases beginning in the late 1990s, when patients began challenging restrictions on seeking care abroad.
The rulings from cases like Kohll and Müller-Fauré gradually expanded patient rights beyond emergency care for tourists and care for regular cross-border workers, to recognising that healthcare is a service which patients are entitled to seek, within certain limits, in any Member State. The rights recognised by the European Court of Justice were formalised into the Cross-Border Healthcare Directive in 2011.
Limitations in cross-border healthcare delivery
While the Directive provides the legal backbone for accessing care abroad, it falls short on some aspects of healthcare delivery, in particular because, the system was designed around physical movement - assuming that care would involve travelling from one country to another. It did not anticipate the rapid growth of digital healthcare, where data and knowledge/expertise, rather than people, increasingly needs to move.
Data sharing within this framework has remained limited and fragmented. Even where protections exist – such as those under the General Data Protection Regulation (GDPR) – navigating the rules can be complex, and approaches can vary between countries.
These shortcomings exposed a system not fit for a digital, data-driven health ecosystem, creating the space for the EHDS to step in.
A shift in the use of health data
The EHDS addresses these gaps by introducing a major shift based on three pillars – giving patients greater control over their health data, creating a truly integrated internal market for digital health, and enabling more effective use of data for research and policy. Taken together, these ambitions aim to create a more connected and effective European health data ecosystem. However, delivering on this vision depends not only on technical, operational, semantic or legal alignment. It depends on whether people trust the system being built.
Enabling use while maintaining safeguards
The EHDS creates new opportunities to use a wide range of health data – including electronic health records, genomic information, and public health datasets – across borders. To manage this, each country will establish a Health Data Access Body, responsible for reviewing data access applications and data requests, and ensuring consistent application of the rules.
Access, however, is not unrestricted. Safeguards are central to the model: data must be accessed within secure environments, individuals should remain non-identifiable in most use cases, and people may retain important choices – such as a right to opt-out of secondary use of their health data.
The aim is to strike a careful balance between unlocking the benefits of data use and safeguarding individual rights. Ultimately, how fair this balance is perceived to be will play a crucial role in shaping how the EHDS is received.
What this journey highlights
The development of the EHDS reflects a broader pattern in European healthcare – change rarely follows a linear path. Rather than being the result of a single policy decision, it has emerged from a combination of legal frameworks, court rulings, technological advances, and evolving expectations about how health systems should function.
It reflects an attempt to move beyond a system designed for occasional physical mobility towards one that enables the secure, trusted flow of information across borders. Yet its success will ultimately depend not only on legal frameworks or technical infrastructure, but on whether it can earn and sustain the confidence and trust of Member States, stakeholders, and citizens alike.
Find out more about Understanding Patient Data's engagement with the European Health Data Space, and catch up on EHDS Unpacked Part One: What Europe’s health data future means for the UK.