How the European Health Data Space is reshaping healthcare interoperability

If you work in healthcare IT in Europe, the European Health Data Space (EHDS) has likely been on your radar for some time. But EHDS is more than just another policy development to keep an eye on. It marks a structural shift in how health data will need to be shared, governed, and used across Europe.

For healthcare providers, vendors, and decision-makers, that matters now. Not only because EHDS introduces legal obligations and concrete timelines, but because it is accelerating a broader move toward a more connected European health data landscape.

In other words: interoperability is no longer just a national issue. It is becoming a European one.

Giving patients control over their own data

At its core, EHDS is about making health data more accessible and more useful, starting with the patient.

Today, that is still far from straightforward. Health data is often fragmented across organizations, systems, and national infrastructures. For patients, that can mean limited access to their own information and unnecessary barriers when receiving care in another EU country.

EHDS is intended to change that. It creates a legal framework that requires EU member states to support cross-border health data exchange. What has long been discussed as an ambition is now becoming a shared obligation.

The regulation also goes beyond direct patient care. EHDS introduces a framework for the secondary use of health data, enabling anonymized data to be used for research, innovation, public health, and policymaking.

That opens the door to broader benefits for healthcare systems across Europe, provided the right governance and infrastructure are in place.

What data does the EHDS cover? The priority categories explained

EHDS applies broadly to electronic health data. That includes data stored in EHR systems, data generated by medical devices, and data from digital applications that support clinical workflows.

For cross-border exchange, the regulation defines a set of priority categories that will be introduced in phases.

From March 2029:

• Patient summaries – diagnoses, allergies, medications, vaccinations, and care plans in the agreed European format (IPS)
• Electronic prescriptions and dispensations – patients can collect medication in another EU country, and that dispensing information flows back, to prevent duplicate prescribing

From March 2031:

• Medical imaging studies and related reports — scans, X-rays, MRI, and radiology reports
• Medical test results — laboratory results and other diagnostic reports
• Discharge reports — structured summaries when a patient leaves hospital

That phased approach may suggest that there is still plenty of time. In practice, however, the 2029 and 2031 deadlines are compliance dates, not start dates. The architectural, semantic, and governance choices that underpin EHDS-ready exchange cannot be made overnight.

Implementing FHIR-based infrastructure, aligning data models, and establishing cross-organizational governance typically takes years. Organizations that begin that work only when the deadlines are upon them will not meet them.

Where the Netherlands stands: progress, but also a new level of pressure

The Netherlands is not starting from zero. Far from it. Over the past years, Dutch healthcare has made meaningful progress in data exchange. Medication records, GP referrals, and acute care transfers are all examples of areas where interoperability is already improving in practice.

That is important, because EHDS readiness does not require organizations to start over. It requires them to build on what is already in motion and align it with a broader European direction.

That aligns with national ambitions already set out by VWS. In April 2023, the Dutch government published the Nationale Visie op het gezondheidsinformatiestelsel, outlining a long-term vision for a more coherent and future-proof health information system by 2035. Themes such as data availability, trust, and governance remain just as relevant under EHDS.

The difference is that the European context is now becoming much more concrete. National progress still matters, but it will increasingly need to connect to common European expectations around data formats, standards, patient access, and cross-border exchange.

For Dutch organizations, that creates both an opportunity and a pressure point. The opportunity is that a lot of relevant work is already underway. The pressure is that local or national interoperability alone will no longer be enough.

The real technical shift: toward a shared European baseline

One of the most important things EHDS does is push interoperability standards in a clearer and more consistent direction. FHIR is emerging as the common language for health data exchange. SNOMED CT and LOINC support shared clinical semantics.

The International Patient Summary provides the structure for cross-border patient records. Together, these standards are becoming more than best practice. They are forming the baseline for participation in a European health data ecosystem.

That does not mean national requirements disappear. Dutch healthcare, for example, includes data elements and workflows that go beyond what is covered in the IPS. GP contact moments, correspondence history, and national information models still matter. So the challenge is not to choose between local relevance and European alignment. It is to design for both.

That is where many organizations will need to shift their thinking. EHDS is not simply about sending a few documents across borders. It is about whether your architecture, terminology strategy, and data models are ready to operate in an environment where interoperability expectations are becoming more consistent across Europe.

What organizations should focus on now

Whether you are a healthcare provider, software vendor, or strategic decision-maker, the key question is not whether EHDS will affect you. It is how prepared you want to be when the requirements become operational. A few priorities stand out.

Keep national programs moving
Existing initiatives around medication data, GP exchange, acute care, and regional interoperability remain highly relevant. EHDS builds on this kind of progress. Pausing or deprioritising those efforts would be a mistake.

Assess the gap to European specifications
Now is the time to understand how your current data models and exchange patterns relate to IPS and emerging European specifications. Some parts may already align well. Others may require new mappings, terminology work, or profile changes.

Put FHIR on the core roadmap
If FHIR is not yet part of your strategic roadmap, it should be. EHDS is reinforcing a direction that the market was already moving towards: more structured, standards-based, API-driven exchange built on FHIR.

Start early on qualification and compliance planning
One of the most common mistakes organizations make is assuming they can wait until specifications are final before taking action. In reality, vendor qualification, implementation planning, and internal alignment often take longer than expected. Early preparation creates options. Late preparation usually creates pressure.

EHDS is bigger than compliance

This was also a theme in our presentation during DMEA: EHDS is not just a compliance exercise, but a practical interoperability challenge that depends on governance, mature standards, and strong alignment across the ecosystem. It is tempting to view EHDS mainly as a regulatory requirement. That would be too narrow.

What EHDS really represents is a shift from fragmented interoperability efforts toward a more shared European foundation for health data exchange. That has implications not only for compliance teams, but also for product strategy, architecture, governance, and long-term investment decisions.

Organizations that move early are likely to benefit in several ways: lower transition costs, more room to influence standards adoption, and a stronger position in a healthcare landscape that is becoming more connected across borders.

At Firely, we work with organizations across Europe that are navigating exactly these questions: how to align national realities with European standards, how to use FHIR effectively, and how to prepare for the regulatory and technical changes ahead.

If EHDS is becoming part of your roadmap discussion, this is the time to start turning that discussion into a concrete plan. Get in touch if you want to talk through what EHDS means for your roadmap.