1. What is the EHDS?
The EHDS is Regulation (EU) 2025/327 on the European Health Data Space. As a regulation it applies directly in every member state, Finland included.
It has two main aims. The first is primary use: patients can see their own health data electronically, and the data can reach the treating professional in another EU country. The second is secondary use: with a permit, health data can be used for purposes such as research and development.
2. Timeline
The obligations phase in. The first legal deadlines are in 2029, and the full data set by 2031.
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The Regulation enters into force
Regulation (EU) 2025/327 was published in the Official Journal and entered into force.
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Applies from
The general rules start to apply. The Commission adopts implementing acts, including on the exchange format.
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First legal deadlines
First priority categories: patient summary, ePrescription and eDispensation. Most secondary-use obligations also begin.
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Full data set
Second group: laboratory results, medical imaging with reports, and discharge reports.
Source: Regulation (EU) 2025/327, Article 105. Check the current text on EUR-Lex.
3. The obligations in plain language
The Regulation affects different parties in different ways. These are the main points for a healthcare provider.
PATIENTS
Patients get their data electronically
Patients have the right to see their health data electronically, free of charge and without delay. They can also restrict who sees it and see who has looked at it.
EXCHANGE
Data in a common format
The priority categories must be exchangeable in the European exchange format, which is set by implementing act.
SYSTEMS
Requirements for EHR systems
EHR systems must meet interoperability and logging requirements, and the manufacturer must show that they do.
SECONDARY USE
Data made available under a permit
Data holders must describe the data they hold and make it available against a data permit. The first obligations begin in 2029.
Warning: This guide is not legal advice. Check your organisation's obligations with a legal expert.
4. Self-check: 10 questions
Tick what you already have in place. Every empty box is a good topic for an EHDS review.
Let us go through the gaps together5. How Saumo helps
No system replacement
Saumo is a read-only data layer beside your current patient record system. It never writes to the original system.
Data in a common format
Saumo reads CDA R2 documents, FHIR R4 interfaces and spreadsheet exports, and maps them to FHIR R4. AI suggests the mapping and a person reviews it.
Controlled access
Repositories have access control, monitoring and an access log. Data processed in Finland.
6. FAQ
Does the EHDS apply to private providers?
Yes. It applies to healthcare providers that process electronic health data, private ones included.
Is it enough that our data is in Kanta?
Kanta is Finland's national service. It is worth checking which data is already there in structured form and which stays only in your own systems.
Can a vendor already promise full EHDS readiness?
Not yet. The European exchange format will be set by implementing act. Ask the vendor which standards and profiles the solution is aligned to.
What should we do first?
Map your data sources and their formats. Everything else depends on it, and it needs no system changes.