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EHDS Readiness Check: dataset cataloguing and quality in 5-7 days

The EHDS (European Health Data Space) requires health data holders to catalogue their datasets and document their quality (Art. 60, 77 and 78 of Regulation (EU) 2025/327), with fines of up to €10M or 2% of annual turnover. The obligation is enforceable from 26 March 2029. A bounded diagnosis that tells you exactly where your organisation stands against it, before the deadline becomes an emergency.

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  • Delivered in 5-7 business days
  • Fixed, predictable scope
  • Entry point to the full Diagnosis if you need it
Only 1-2 active projects per month
Pablo Chanivet

Pablo Chanivet

Biomedical engineer specialised in clinical data architecture. Before assessing platforms independently, he took part in designing them for healthcare and pharmaceutical organisations.

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What's included

  • Dataset inventory: what clinical data you manage, where it lives and who's responsible for each dataset (the description Art. 60 EHDS requires you to communicate to the data access body).
  • Draft data quality/utility label: first version of the 6 elements required by Art. 78 EHDS, mandatory if the dataset has public funding, recommended otherwise.
  • Anonymisation/pseudonymisation assessment: which datasets are ready to be shared under the EHDS and which need further work.
  • Prioritised roadmap: what to resolve first and in what order, with estimated effort per block.

Is this service for you?

Built for EHDS data holders that need a fast first diagnosis.

  • Hospitals and hospital groups

    You manage clinical data that falls within EHDS scope as a data holder and need to know where to start.

  • Mid-large pharma

    You need to assess which real world data datasets could be shared under the EHDS and what needs prior work.

  • HealthTechs with proprietary data

    You generate or aggregate your own health data and want to get ahead of the cataloguing obligation before it becomes urgent.

From regulatory uncertainty to a concrete plan

What changes after the EHDS Readiness Check

Before

  • You don't know which datasets would fall within EHDS scope
  • There's no quality/utility documentation for your data
  • It's unclear which data could be shared as-is and which needs anonymisation
  • 26 March 2029 is an abstract date, with no action plan

After

  • Clear inventory of datasets within EHDS scope
  • Draft quality/utility label for priority datasets
  • Assessment of what requires anonymisation or pseudonymisation
  • Prioritised roadmap with concrete next steps

How timelines work

  • Only 1-2 active projects at a time to guarantee quality.
  • The timeline starts once scope and content are validated.
  • Changes outside the agreed scope may incur an extra charge.
  • I don't take on urgent work.

One pack: fixed scope, fixed price

Bounded diagnosis, no surprises. If your case needs more, I'll tell you before we start.

Most popular

EHDS Readiness Check

3,000–5,000 €
5-7 business days

EHDS dataset cataloguing and quality, with a prioritised roadmap.

Includes

  • Dataset inventory within EHDS scope
  • Draft quality/utility label for priority datasets
  • Anonymisation/pseudonymisation assessment

Key deliverable

Dataset inventory delivered and validated with you

Request proposal

⚡ Delivered in 5-7 business days

Need to go beyond EHDS scope?

Clinical Data Diagnosis

If your organisation also needs to resolve data architecture, interoperability or AI readiness, the Clinical Data Diagnosis is the full evaluation, the EHDS Readiness Check is a good first step towards it.

View Clinical Data Diagnosis

Sources and standards cited

Frequently asked questions

No. It's a technical diagnosis of dataset cataloguing and quality, you get an inventory, a draft quality/utility label and a roadmap. It doesn't replace a formal legal opinion on regulatory compliance.
If your organisation generates, manages or aggregates clinical or health data, hospital, health service, pharma or HealthTech with proprietary data, you're likely within scope. We confirm whether your case fits on the first call before starting.
From Regulation (EU) 2025/327 (EHDS): the cataloguing and data quality obligation for data holders is in Art. 60 (which references Art. 77 and 78), enforceable from 26 March 2029 (Art. 105), and non-compliance can be fined up to €10M or 2% of worldwide annual turnover, whichever is higher (Art. 64(4)). The higher tier (€20M/4%) exists in the same regulation, but applies to different infringements, misuse of data by data users, not cataloguing.
If your organisation also needs to resolve data architecture, interoperability or AI readiness, I'll tell you during the diagnosis and the natural next step is the full Clinical Data Diagnosis.
No. The diagnosis assesses which datasets require anonymisation or pseudonymisation and tells you how much work each implies. Technical implementation is a later step, inside or outside this service depending on the case.
The roadmap and draft quality label are validated with you during the final handover session. Substantial scope changes (more datasets, more depth) are quoted separately.

Ready for your EHDS Readiness Check?

Fixed scope, delivered in 5-7 business days. I'll confirm if your case fits before we start.

Assess my case

Does your organisation fit the EHDS Readiness Check?

Tell me what clinical data you manage and what you already know about your cataloguing obligation under the EHDS. I'll confirm if the pack is viable or if you need the full Diagnosis.

What happens next?

I will reply within 2–3 business days with a personalised proposal and the next steps for your project.

I work with limited availability and do not take on urgent projects. I will confirm availability before starting.

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