The European Health Data Space (EHDS) is laying the groundwork to address these challenges. The industry is increasingly focused on real-world evidence, faster and more cost-effective clinical research, and sovereign AI solutions. But none of these ambitions can become reality without a solid data foundation that makes healthcare data accessible, interoperable, and reusable across borders.

While some EHDS requirements are still being finalized, healthcare organizations don’t need to wait to start preparing. Instead of trying to anticipate every regulatory detail, they can already focus on improving data quality, interoperability, and governance. Taking these steps now will make it easier to meet future requirements and avoid unnecessary costs and delays.

The EHDS timeline is taking shape

EHDS is no longer a distant framework. Regulation (EU) 2025/327 entered into force in March 2025 and applies generally from 26 March 2027. In September 2026, the European Commission published the first implementing regulations that turn the framework into concrete requirements: how national infrastructures connect through MyHealth@EU (Implementing Regulation (EU) 2026/2083), how identities are trusted across borders (2026/2099), and how health datasets must be described for secondary use (2026/2098). The first cross-border exchange obligations, covering patient summaries and ePrescriptions, apply from 26 March 2029.

What EHDS means in practice

EHDS aims to address two major challenges in European healthcare: making health data available for better patient care (primary use) and enabling its reuse for research, innovation, and policy development (secondary use).

Primary use: better care across borders

Primary use is about making health data available when and where care happens. In practical terms, that means a patient should be able to receive care in another EU country and have essential records available to clinicians there. EHDS will introduce these capabilities in stages.

From 26 March 2029: patient summaries, ePrescriptions, and eDispensations
From 26 March 2031: medical images and imaging reports, laboratory and other diagnostic results, and discharge reports

Imagine a patient living in Belgium, working in France, and traveling to Spain. If they need urgent treatment or medication, their core medical data should be accessible through a standardized cross-border framework.

For healthcare providers, EHDS is about more than meeting regulatory requirements. It means better access to patient information, smoother coordination between healthcare professionals, and more informed clinical decisions.

Secondary use: unlocking data for research and innovation

Secondary use focuses on making health data available for approved purposes such as:

medical research
drug development
population health analysis
AI model training
public health policy and planning

Under EHDS, health data access bodies in each country will play a central role in organizing access to datasets. Over time, this will create a more structured, searchable, and standardized ecosystem for accessing health data for research and innovation.

For healthcare providers, this means their data environment will need to support not only care delivery, but also discoverability, cataloging, governance, and secure data sharing for approved secondary uses.

Why act now while the details are still evolving?

This is the question many healthcare organizations are asking: if not everything is finalized, why move now?

The biggest challenge in preparing for EHDS is not understanding the regulation, but making the necessary changes to underlying systems, data structures, and operational model.

Many healthcare organizations still operate with fragmented, semi-structured, or siloed data. Records may live across multiple systems, formats, and departments. In some cases, organizations do not have a complete picture of what data they hold, where it resides, or how easily it can be exchanged. That is not something you fix in a quarter.

Becoming ready for EHDS may require:

assessing current EHR and clinical data architecture
identifying interoperability gaps
mapping legacy data models to FHIR-based formats
introducing standardized terminologies and coding
building import/export pipelines
establishing metadata and data cataloging practices
defining governance for consent, access, and secure processing

These are complex, cross-functional initiatives that affect technology, operations, compliance, and clinical workflows. Based on the current roadmap, the first EHDS rollout is expected around 2029, beginning with categories such as patient summaries and ePrescriptions, with additional data categories following later. For organizations working with fragmented legacy systems and poorly structured data, even a two-year window between final standards and initial obligations may not be enough.

Even if the timeline shifts, the direction is unlikely to change. Interoperability and standardized health data exchange are already being advanced through national initiatives across Europe. EHDS is not emerging in isolation; it is accelerating a broader shift that healthcare organizations will need to address either way.

Why EHDS matters beyond regulation

Many healthcare leaders still see EHDS primarily as another regulatory requirement. And compliance does matter: health data access bodies can impose fines of up to EUR 10 million or 2% of worldwide annual turnover, whichever is higher, on data holders that fail to meet their secondary-use obligations.

However, EHDS also creates opportunities beyond compliance. Organizations that start preparing now can improve data interoperability, streamline operations, and make better use of healthcare data for research and innovation. These benefits are already relevant, even as some implementation details continue to evolve.

Interoperability improves care delivery

When systems can exchange data in a consistent format, providers gain faster access to relevant information. That can mean less time spent searching for records, fewer duplicate procedures, and better-informed clinical decisions. It also creates a better experience for patients, especially those who receive care across multiple providers or across borders.

Standardization supports digital transformation

One of the important effects of EHDS is the push toward common exchange standards such as FHIR. That matters because organizations cannot scale digital health with fragmented, proprietary data structures forever.

FHIR-based interoperability creates a foundation for:

more flexible application ecosystems
smoother system integrations
cloud-enabled healthcare services
digital front doors and patient-facing apps
AI-enabled workflows and analytics

For many providers, EHDS may become the catalyst that finally moves interoperability from “important someday” to “business-critical now.”

Research access can reduce cost and accelerate innovation

EHDS also matters beyond providers. For life sciences, medtech, digital health, and AI companies, more structured access to health datasets could reduce the cost and complexity of research and development.

Instead of building every dataset from scratch through expensive recruitment and collection efforts, organizations may be able to discover and request access to relevant data through emerging national and EU-level mechanisms. That does not eliminate complexity, but it creates a clearer pathway to innovation.

In other words, EHDS readiness is not just a regulatory exercise, it is a modernization strategy.

What healthcare organizations should do now

The right next step depends on your role in the healthcare ecosystem.

If you are a health data holder

This includes hospitals, clinics, laboratories, and organizations that own, manage, process, or control healthcare data.

Assess your current interoperability maturity Start with a realistic view of your current state: Is your EHR already FHIR-compatible? Can your systems import and export health data in standardized formats? Are you using consistent clinical coding and terminologies? Can you receive external health records as well as send them? If the answer is no, this is where your preparation begins.

Start with a realistic view of your current state:

Is your EHR already FHIR-compatible?
Can your systems import and export health data in standardized formats?
Are you using consistent clinical coding and terminologies?
Can you receive external health records as well as send them?

If the answer is no, this is where your preparation begins.

Build a FHIR roadmap For primary use under EHDS, FHIR-based exchange is expected to play a central role in interoperability and cross-border data exchange. That does not always mean replacing your entire platform immediately, but it does mean deciding how you will get there. For primary use, EHDS defines the European Electronic Health Record Exchange Format (EEHRxF). The European Commission is expected to adopt implementing acts setting out its technical specifications by 26 March 2027, and HL7 Europe has already published FHIR Implementation Guides aligned with this direction. That means organizations do not need to wait for every final detail before they begin planning and building against real specifications. Typical options include: upgrading to a FHIR-compliant EHR adding connectors and transformation layers modernizing your data architecture to support standardized exchange Format alone, however, is not enough. The MyHealth@EU implementing regulation also introduces semantic interoperability requirements, including the translation and mapping of coding systems. In practice, that means a system can be technically connected and still fall short of compliance if its terminology and coding are not aligned. For many organizations, terminology management, coding harmonization, and semantic mapping will need to become core elements of the FHIR roadmap. This can become a major transformation project, so it should be planned early.

For primary use under EHDS, FHIR-based exchange is expected to play a central role in interoperability and cross-border data exchange. That does not always mean replacing your entire platform immediately, but it does mean deciding how you will get there.

For primary use, EHDS defines the European Electronic Health Record Exchange Format (EEHRxF). The European Commission is expected to adopt implementing acts setting out its technical specifications by 26 March 2027, and HL7 Europe has already published FHIR Implementation Guides aligned with this direction. That means organizations do not need to wait for every final detail before they begin planning and building against real specifications.

Typical options include:

upgrading to a FHIR-compliant EHR
adding connectors and transformation layers
modernizing your data architecture to support standardized exchange

Format alone, however, is not enough. The MyHealth@EU implementing regulation also introduces semantic interoperability requirements, including the translation and mapping of coding systems. In practice, that means a system can be technically connected and still fall short of compliance if its terminology and coding are not aligned. For many organizations, terminology management, coding harmonization, and semantic mapping will need to become core elements of the FHIR roadmap.

This can become a major transformation project, so it should be planned early.

Organize and govern your data estate EHDS readiness depends on knowing your data. Many organizations need to first answer basic questions: What data do we have? Where is it stored? In what format? How complete and usable is it? Who owns and governs it? Without that visibility, compliance and interoperability will remain difficult.

EHDS readiness depends on knowing your data. Many organizations need to first answer basic questions:

What data do we have?
Where is it stored?
In what format?
How complete and usable is it?
Who owns and governs it?

Without that visibility, compliance and interoperability will remain difficult.

Prepare for cataloging and secondary use Secondary use is not just about having data. It is about describing it in a standardized way so others can discover it through formal channels, and since October 2026, that standard has a legal basis. Commission Implementing Regulation (EU) 2026/2098 defines the minimum metadata that health data holders must provide when describing datasets for secondary use, based on the HealthDCAT-AP metadata profile that applies from 26 March 2029. HealthDCAT-AP standardizes how a dataset is described, including its content, coverage, coding systems, legal basis, and access conditions, rather than the clinical data itself. Data holders must also review their dataset descriptions at least once a year, which makes cataloging an ongoing governance process rather than a one-time project. Publicly funded datasets face an additional requirement: a mandatory data quality and utility label covering documentation, technical quality, the maturity of data quality processes, population coverage, and data modifications. The gap between current practice and these requirements may be significant. A recent preprint study of Nordic national data catalogues found that none of the 2,811 health dataset descriptions it examined met all mandatory HealthDCAT-AP requirements. Organizations should begin exploring: dataset inventory and classification mapping existing dataset metadata to HealthDCAT-AP metadata standards and mapping for coverage, coding systems, legal basis, and access conditions measuring data quality against the Article 78 label dimensions cataloging workflows and governance for dataset descriptions an annual review and revalidation process for metadata and dataset records governance around anonymization, de-identification, and access controls export pipelines for approved data-sharing scenarios

Secondary use is not just about having data. It is about describing it in a standardized way so others can discover it through formal channels, and since October 2026, that standard has a legal basis.

Commission Implementing Regulation (EU) 2026/2098 defines the minimum metadata that health data holders must provide when describing datasets for secondary use, based on the HealthDCAT-AP metadata profile that applies from 26 March 2029. HealthDCAT-AP standardizes how a dataset is described, including its content, coverage, coding systems, legal basis, and access conditions, rather than the clinical data itself. Data holders must also review their dataset descriptions at least once a year, which makes cataloging an ongoing governance process rather than a one-time project.

Publicly funded datasets face an additional requirement: a mandatory data quality and utility label covering documentation, technical quality, the maturity of data quality processes, population coverage, and data modifications. The gap between current practice and these requirements may be significant. A recent preprint study of Nordic national data catalogues found that none of the 2,811 health dataset descriptions it examined met all mandatory HealthDCAT-AP requirements.

Organizations should begin exploring:

dataset inventory and classification
mapping existing dataset metadata to HealthDCAT-AP
metadata standards and mapping for coverage, coding systems, legal basis, and access conditions
measuring data quality against the Article 78 label dimensions
cataloging workflows and governance for dataset descriptions
an annual review and revalidation process for metadata and dataset records
governance around anonymization, de-identification, and access controls
export pipelines for approved data-sharing scenarios

If you are a health data consumer

This includes pharma, medtech, research organizations, digital health companies, and AI firms that may want to use EHDS-enabled datasets.

Understand how health data catalogs will work EHDS uses a two-level catalogue: national catalogues maintained by each country’s health data access body feed a central EU dataset catalogue on the HealthData@EU platform. Users will be able to search it by clinical keywords, data category, coding systems such as ICD-10, SNOMED CT or OMOP, population characteristics, quality label and update frequency. Because every description follows the same HealthDCAT-AP structure, companies can start designing their dataset discovery and feasibility processes around it today.

EHDS uses a two-level catalogue: national catalogues maintained by each country’s health data access body feed a central EU dataset catalogue on the HealthData@EU platform. Users will be able to search it by clinical keywords, data category, coding systems such as ICD-10, SNOMED CT or OMOP, population characteristics, quality label and update frequency. Because every description follows the same HealthDCAT-AP structure, companies can start designing their dataset discovery and feasibility processes around it today.

Assess whether your data environment can consume EHDS-aligned data Once access becomes available, can your teams actually use the data efficiently? Review: target schemas and data models normalization requirements integration pipelines infrastructure for secure analytics model training workflows in controlled environments This is especially important because access models for secondary use may vary. Some datasets may be exportable in aggregated form, while others may need to be analyzed only within secure processing environments.

Once access becomes available, can your teams actually use the data efficiently?

Review:

target schemas and data models
normalization requirements
integration pipelines
infrastructure for secure analytics
model training workflows in controlled environments

This is especially important because access models for secondary use may vary. Some datasets may be exportable in aggregated form, while others may need to be analyzed only within secure processing environments.

Monitor local implementation details Not every country is moving at the same pace. Health Data Access Bodies are still being established in many places, and consent rules, access models, and operational specifics may differ. Companies that start monitoring these local developments now will be better positioned to move quickly when access pathways mature.

Not every country is moving at the same pace. Health Data Access Bodies are still being established in many places, and consent rules, access models, and operational specifics may differ. Companies that start monitoring these local developments now will be better positioned to move quickly when access pathways mature.

If you are an EHR system manufacturer

This includes vendors that build EHR systems or other health IT software that may fall within the EHDS definition of an EHR system.

Determine whether your products fall within scope Start by identifying which of your products fall under the EHDS definition of an EHR system. This is the first step in understanding where direct obligations may apply.

Start by identifying which of your products fall under the EHDS definition of an EHR system. This is the first step in understanding where direct obligations may apply.

Assess import and export readiness against EEHRxF requirements EHDS places direct interoperability requirements on covered EHR systems. These systems must include an interoperability component that can import and export data in the European Electronic Health Record Exchange Format (EEHRxF). These requirements are phased in alongside the priority data categories in 2029 and 2031. Manufacturers should review: current import capabilities current export capabilities alignment with relevant HL7 Europe FHIR guides gaps in support for priority data categories

EHDS places direct interoperability requirements on covered EHR systems. These systems must include an interoperability component that can import and export data in the European Electronic Health Record Exchange Format (EEHRxF). These requirements are phased in alongside the priority data categories in 2029 and 2031.

Manufacturers should review:

current import capabilities
current export capabilities
alignment with relevant HL7 Europe FHIR guides
gaps in support for priority data categories
Plan logging and audit features Covered systems must also include a logging component that records who accessed health data. Manufacturers should assess what logging and audit features already exist and what may need to be added or updated. This should include: current access logging capabilities audit feature coverage gaps in recording access to health data

Covered systems must also include a logging component that records who accessed health data. Manufacturers should assess what logging and audit features already exist and what may need to be added or updated.

This should include:

current access logging capabilities
audit feature coverage
gaps in recording access to health data
Prepare for conformity requirements EHDS also introduces conformity requirements that apply before covered products can be placed on the EU market. Vendors should begin preparing early so they understand what changes may be needed across affected products.

EHDS also introduces conformity requirements that apply before covered products can be placed on the EU market. Vendors should begin preparing early so they understand what changes may be needed across affected products.

The biggest mistake: waiting for perfect clarity

A common market response today is to wait. The logic sounds reasonable: details are still developing, so why invest too early?

But in practice, waiting creates more risk than acting.

That is because the foundational work required for EHDS readiness is useful regardless of final implementation nuances. No healthcare organization will regret:

cleaning up fragmented clinical data
improving interoperability
adopting standard data models
strengthening governance
preparing for secure exchange and reuse

The exact reporting flow may evolve. Country-specific processes may vary. But the need for modern, interoperable, well-governed health data infrastructure is already here.

Conclusion

EHDS readiness isn’t just about compliance. It is about creating a more connected, interoperable, and innovation-ready healthcare ecosystem across Europe. The shift is coming, and healthcare organizations should prepare. Those who start now will have more time to assess, prioritize, modernize, and adapt. Those who wait may find themselves rushing through a high-stakes transformation under deadline pressure.

DataArt helps healthcare organizations assess EHDS readiness, map existing clinical data to EEHRxF-aligned FHIR profiles, and automate HealthDCAT-AP dataset descriptions from their existing data platform metadata, including the annual revalidation the regulation requires. Contact us to build an EHDS roadmap that aligns compliance requirements with your business priorities.