· Yves Thorrez · Tutorials · 4 min read
What is the Difference between Trusted Data Holders and Health Data Intermediation Entities?
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EHDS labels in a nutshell
| Feature | Trusted health data holder | Health-data intermediation entity |
|---|---|---|
| Legal basis | Article 72 EHDS | Recital (59)–(60) + Art. 50 §3 (“duties fulfilled by intermediation entities”) |
| Who designates it? | Member-State authority, per individual data-holder | Member-State law may assign whole categories of data-holders to one intermediation entity |
| Scope of data | Own datasets only (one hospital, one registry, etc.) | May act for many heterogeneous data-holders (e.g. all public hospitals < 300 beds) |
| May assess access requests? | Yes. It reviews the application, then sends a recommendation to the HDAB; HDAB still grants/refuses the permit. citeturn7view0 | No. All requests are handled by the HDAB; the entity just prepares / transmits data. |
| Secure Processing Environment (SPE) | Must run an SPE that meets Art. 73 requirements. This is a pre-condition for designation. | Does not host an SPE. Access is delivered through the HDAB’s SPE (or, in a multi-country case, the Commission’s). |
| Simplified workflow | Yes – if the request involves only this holder, the HDAB can forward the file straight to it (no multi-holder consolidation). | No – standard Chapter IV timelines apply. |
| Segregation of functions | Same organisation both prepares data and hosts the SPE; still under HDAB permit. | Preparation and hosting are separated: the entity prepares and uploads, the HDAB hosts. |
| Can it also be the other? | A trusted holder cannot be an intermediation entity for others. | Intermediation entities may not be designated as trusted holders. |
Why an intermediation entity does not run an SPE
Recital 77 makes clear that SPEs are provided only by HDABs or trusted holders. The policy idea is segregation of powers:
- the body that grants permits (HDAB) or the single trusted holder that owns the data environment controls live access;
- any “proxy” that merely collects/cleans data for many hospitals should not also control the compute environment, to avoid conflicts of interest and consolidate security certification in one place.
Positioning your platform
Option A — support trusted-holder hospitals
Each hospital that onboards could pursue designation as a trusted health data holder.
Your platform would:
- Provide and operate an Art. 73-compliant SPE for each hospital.
- Offer the case-management workflow & catalogue that prove “necessary expertise”.
- Expose the hospital’s datasets under its own entry in the national catalogue.
- Receive forwarded applications from the HDAB, assess them, upload prepared data into the local SPE, and let users in.
Pros:
- Shorter turnaround for “single-holder” requests.
- Full control of security stack remains with the hospital (good for sensitive cohorts).
Cons:
- Each hospital must pass the designation audit individually; ongoing reviews apply.
- You cannot merge datasets from several holders inside one SPE.
Option B — act as a health-data intermediation entity
Your company (or a consortium) is appointed in national law to perform Chapter IV duties for a class of hospitals.
Your platform would:
- Harvest / harmonise data from member hospitals.
- Register the combined datasets in the EHDS catalogue on the hospitals’ behalf.
- Hand the prepared extracts to the HDAB, which then loads them into its own SPE for users.
Pros:
- Hospitals off-load the Chapter IV admin burden to you (big selling point).
- One designation covers many hospitals; easier onboarding.
- No need to certify an SPE—lower up-front cost.
Cons:
- No “simplified” permit pathway; HDAB timelines still apply.
- Users work in the HDAB’s environment, so advanced tools must be whitelisted there.
- Revenue comes from cost-recovery fees set by the HDAB, not from direct SPE services.
Option C — hybrid
Operate as an intermediation entity and sell your SPE as a managed service to hospitals that want trusted-holder status. Legally the SPE then belongs to those hospitals; you host it under a processor contract. This keeps you within the letter of Recital 244 (the intermediation entity itself is not the trusted holder).
Decision checklist
| Question | If answer is Yes → lean towards |
|---|---|
| Do target hospitals insist on keeping data inside their perimeter? | Trusted-holder model |
| Is there political appetite to delegate HDAB-level admin work to a central service? | Intermediation entity |
| Will you invest in ISO 27001/27701 + future EHDS SPE certification? | Trusted-holder / hybrid |
| Is fast, single-holder turnaround a competitive edge for your research users? | Trusted-holder |
| Do you want one legal umbrella for many small hospitals? | Intermediation entity |
Bottom line
- A trusted health data holder is a single, expert data-holder that runs its own SPE and handles first-line permit assessment.
- A health-data intermediation entity is an outsourcing vehicle that can do the heavy lifting for many data-holders but must let the HDAB host the SPE.
- The SPE exclusion is not accidental; it enforces a clear separation between data preparation and controlled compute access.
- Your platform can fit either role: decide whether you want to manage the SPE yourself (trusted-holder path) or focus on aggregation and case management while the national HDAB provides the compute layer (intermediation path).
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