Regulation (EU) 2025/327, establishing the European Health Data Space, entered into force on 26 March 2025 and begins to apply on 26 March 2027. It is not a proposal or a consultation: it is law in force with a phased timetable.
As with almost everything in this area, the problem is not that the rule exists — it is that nobody knows who it applies to.
The four dates
| When | What |
|---|---|
| 26 Mar 2025 | Entry into force |
| 26 Mar 2027 | General application, including rules on secure processing environments and health data access applications |
| 26 Mar 2029 | Secondary use (Chapter III) and exchange of the first priority categories — patient summaries, ePrescriptions and eDispensations |
| 26 Mar 2031 | Mandatory sharing of medical imaging and reports, test results and discharge reports |
Note that the date everyone quotes, 2027, is the least demanding of the three. The obligations that most affect systems — secondary use and imaging sharing — are 2029 and 2031.
Two halves that always get confused
Primary use is about the person and their care: accessing your own record, carrying it between countries and providers, and systems being able to talk to each other.
Secondary use is about research, innovation, public policy and regulation: access to de-identified health data through dedicated bodies, with applications, permits and secure processing environments.
Confusing the two leads to the wrong conversations with suppliers. A system can be irrelevant to one half and central to the other.
What changes for electronic health record systems
This is the part that catches software: the regulation sets requirements for electronic health record systems, with mandatory interoperability and logging components, plus a conformity and declaration regime.
So the useful question is not "are you EHDS compliant?" — it is:
Is your system an electronic health record system within the meaning of the regulation? And if not, what health data does it process, and for whom?
A supplier answering "yes, we are fully EHDS compliant" about a regulation whose general application is in 2027 is telling you very little.
Where RVer sits in this
Being specific, because it is the only way this is useful:
- RVer is not an electronic health record system. It is not a clinical record, does not replace one, and does not aim to be one.
- It does not collect patient clinical data. What exists is the session log — what played, when, for how long, whether it was stopped — which is operational information about equipment use.
- It does not assess, classify or diagnose, so it generates no new clinical data.
- It does not integrate with the hospital IT system, and playback runs on the local network, with no cloud.
This has one pleasant practical consequence and one unpleasant one. The pleasant one is that the EHDS exposure surface is small. The unpleasant one is that it also means sessions do not enter the patient's clinical record — anyone wanting that integration has to build it, and it is not what this system does.
On GDPR, which continues to apply in parallel and was replaced by nothing, we have written what there is to know.
What to ask any supplier, now
Worth doing already, because answers take time to arrive:
- Is it an electronic health record system within the meaning of the regulation?
- What data does it process, and where does it sit? Inside the institution, on your server, on a third party's?
- Who is the controller, and who is the processor?
- If covered, what is the plan up to March 2027? A date and a name, not a statement of intent.
- What happens to the data if the relationship ends?
The last two tell you the most about the maturity of whoever is answering.
What we do not know
Plainly: this is not legal advice. We are a manufacturer, not a law firm. Parts of the regulation are still settling in practice for niche systems, implementing acts keep arriving, and the boundary between wellness software, medical device and record system is being drawn in real time. If your institution needs a formal position, it has to come from someone who can sign it.
In short
- In force since March 2025, general application March 2027, secondary use 2029, medical imaging 2031.
- Primary and secondary use are different conversations.
- The right question is whether the system is an electronic health record, not whether it "complies with EHDS".
- RVer is not one, and collects no clinical data — at the cost of sessions not entering the patient's record.