EHDS Technical Readiness Review

The European Health Data Space sets concrete technical requirements for organisations that process or share health data. We assess whether and how your existing infrastructure meets these requirements — four core themes plus optional extension modules.

Consulting, async-first, Clinics · Pharma · Research

For decision makers

In short

Short plain-language context. GA4GH in one sentence. How inclusion fits us. The rest of this page keeps the full technical depth.

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We map your IT landscape to four themes that often matter in EHDS-related practice: pseudonymisation, catalog readiness, controlled processing baseline, interoperability. You get a report with prioritised technical steps. Legal interpretation and formal compliance sign-off stay with you — we flag where external expertise may be useful.

  • Clear baseline of current technical maturity instead of abstract compliance debates.
  • Prioritised roadmap with realistic implementation sequencing and effort orientation.
  • Explicit separation between technical findings and legal judgement.
  • Practical next step: optional follow-on implementation support only where it fits.

What is GA4GH?

The Global Alliance for Genomics and Health (GA4GH) is an international initiative that defines shared technical interfaces for genomic data and analyses. Partners connect under clear contracts instead of rebuilding bespoke integrations for every link.

Synaptic Four combines rigorous engineering with an explicit, lived commitment to neurodiversity and autism inclusion. That is part of who we are—not an add-on to the tech story. More: About us Autism

What the technical terms mean for you

The review maps your infrastructure to common GA4GH building blocks (e.g. DRS for discoverable datasets, WES/TES for controlled analysis, Beacon and htsget for controlled queries). What matters is the outcome: traceable data paths, credible partner interfaces, and clearer alignment between engineering and privacy governance—so EHDS and research discussions become actionable; still no legal or compliance guarantee from us.

EHDS is an evolving policy area: what applies to your organisation depends on applicable law, your role, and your contracts. We provide engineering and technical orientation. Legal assessment, formal compliance decisions, and DPO work remain with you and your professional advisors.

This page contains the full service description of the assessment (method, deliverables, boundaries).

What you receive

  • Written report (10–15 pages).
  • Assessment of your current IT infrastructure against GA4GH standards (DRS, WES, TES, Beacon v2, Passports, htsget).
  • Identification of gaps and risks.
  • Prioritised implementation plan with concrete next steps.
  • Recommendations on open-source options (including Ferrum).
  • Optional (separate scope): add-on findings for secondary-use intake readiness and/or MII/FDPG alignment when you book the extension modules.

Budget and timeline guidance

The review typically runs 3–5 weeks (depending on infrastructure complexity and your internal availability). Typical budget is €4,000–8,000 net for a mid-sized institute.

More complex environments (multiple sites, heterogeneous systems) are priced project-by-project — after a free initial call.

How it works

1. Questionnaire (async, about 30 minutes)

You complete a structured questionnaire on your current infrastructure, data processes, and regulatory context. No call required—everything in writing.

2. Analysis (about 2 weeks)

Synaptic Four analyses your inputs and produces the report.

3. Report handover + written Q&A

You receive the full report. Follow-up questions are answered in writing, or in an optional video call with a shared agenda.

Who this is for

  • University hospitals and academic research groups
  • Mid-sized biotech and pharmaceutical companies
  • Research institutes (e.g. Fraunhofer, Max Planck, Helmholtz)
  • Hospitals in the Medical Informatics Initiative context

What we analyse

1) Pseudonymisation maturity

Can your organisation pseudonymise health data at the data-holder side? Which technical gaps exist?

2) Dataset catalog capability

Can you generate a machine-readable HealthDCAT-AP-oriented dataset catalog? Do you maintain structured dataset metadata?

3) Secure processing environment baseline

Is your stack suitable for controlled secondary-use processing (audit logging, isolation, workflow control)? Which components are missing?

4) Interoperability

Which interfaces are missing for exchange with research partners and national programs (e.g. FHIR, GA4GH DRS/WES, htsget)?

Optional extension modules

You can extend the baseline review with two add-on modules (separate scope and pricing)—including EHDS2 secondary use readiness and MII/FDPG alignment. They are grounded in our research and product work—still technical orientation only, not legal advice or an official compliance verdict.

Extension module A — EHDS2 secondary use readiness

Are your data ready for secondary use applications? We review: dataset catalog completeness, metadata format (DCAT-AP Health, MII KDS), an HDAB-compatible application pathway, and whether a Secure Processing Environment (SPE) is reachable or plannable.

Extension module B — MII / FDPG readiness

Gap analysis of your FHIR implementation against the current MII core dataset (2025.x). Which modules matter for your use cases (molecular tumour board, genomics, pathology, biobanking)? What is missing for FDPG listing? A prioritised implementation plan.

What this assessment is not

  • • No legal ruling on EHDS compliance.
  • • No review of contracts, consent texts, or authority procedures.
  • • No formal certification procedure.
  • • No replacement for a data protection officer or legal counsel.

Technical consulting only: our report is for engineering and planning. It does not replace lawyers, DPOs, or official procedures.

Further reading: EHDS - technical requirements in detail →

Pricing & enquiry

Price on request (depending on organisation size and scope). Optional modules are priced separately.

First assessment is free.

Request EHDS review

After your message: a reply within two business days, then a free 30-minute intro call.

You can also contact us directly: contact@synapticfour.com

Response within 2 working days.

What happens next

  1. You send the request (topic, context, optional focus).
  2. We reply by email within 2 working days.
  3. Free 30-minute intro call: scope, expectations, next steps.
  4. Structured review report delivered according to the agreed workflow.

Verify the technical substance

Repositories, demos, and benchmarks are publicly inspectable; Ferrum and related artefacts are documented. This is not “trust us”—inspect the evidence.