PCDCareHub
FHIR-FIRST · EHDS-READY

Ready for the European Health Data Space — via a FHIR-first ecosystem.

From 2027 EHDS requires Dutch care organisations and healthtech vendors to make patient data interoperable across the EU. We build the FHIR bridge that makes that possible — without rip-and-replace of existing EHR/ECD systems.

  • FHIR R4 + R5 mapping
  • Regulation (EU) 2025/327
  • Wegiz-aligned
WHAT IS EHDS?

One European data framework for primary and secondary use of health data.

The European Health Data Space (EHDS) is the EU regulation connecting health data across member states. Primary use: clinicians access their patient's records even when treated abroad. Secondary use: researchers, policymakers and innovators get structured access to anonymised data for research, policy and the public interest. For the Netherlands, the interplay with Wegiz, the Wgbo and existing LSP exchanges shapes implementation.

Source: Regulation (EU) 2025/327 (EUR-Lex) — adopted 11 February 2025, published in the Official Journal of the EU.

  1. 2025 · Q1

    Regulation enters into force

    Regulation (EU) 2025/327 entered into force on 26 March 2025. The phased implementation period started from that date.

  2. 2027 · Q1

    Primary use becomes mandatory

    Mandatory cross-border exchange of patient summaries, e-prescriptions, imaging and lab results via MyHealth@EU. Dutch providers connect via the National Contact Point.

  3. 2028 · Q1

    Secondary use operational

    Health Data Access Bodies operational; structured access to anonymised data for research, policy and innovation via HealthData@EU.

HOW WE BUILD IT

Four concrete building blocks between EHR/ECD and EHDS.

No big-bang migration. We deliver a layer that connects existing systems to EHDS formats, with audit trails regulators can actually read.

FHIR-first integration layer

Mapping of existing EHR/ECD data to FHIR R4 and R5 — including Nictiz zibs, SNOMED CT and LOINC. Modelled once, reused across the portfolio.

Governance & consent

Opt-out registers, transparent consent flows and organisational roles aligned with EHDS articles 8–10. Works alongside existing BSN exchange and Wgbo.

Audit trails by design

Every data exchange is logged down to the user, in inspection-ready formats. Meets NEN 7510 and EHDS article 12 verifiability requirements.

Founder-friendly rollout

No forced buy-out of existing healthtech. Founders and clinical teams keep the wheel; we bring integration discipline and shared compliance.
WHAT TO ACT ON NOW

Checklist for care organisations and healthtech.

For care organisations

  • Inventory which patient summaries, e-prescriptions and imaging data you share today — and in which formats.
  • Identify EHR/ECD vendor(s) and their EHDS/FHIR roadmap. Lock the commitments contractually.
  • Build a processing register specific to EHDS exchange (GDPR article 30 + EHDS-specific logging).
  • Train clinicians on cross-border data exchange and consent flows.
  • Connect to the National Contact Point once it becomes operational via the Ministry of Health.

For healthtech vendors

  • Ship FHIR R4 and R5 export endpoints with a conformance statement.
  • Document how your software passes the EHDS Conformity Assessment.
  • Implement machine-readable consent via the FHIR Patient.consent resource.
  • Map your data models to Nictiz zibs, SNOMED CT and LOINC where relevant.
  • Determine which EHDS articles apply to your product (primary use, secondary use, or both).
FREQUENTLY ASKED

What does EHDS actually ask of you?

Primary use (exchange of patient summaries, e-prescriptions, lab and imaging data via MyHealth@EU) becomes mandatory from Q1 2027. Secondary use (structured access to anonymised data for research and policy) follows in Q1 2028. Dutch implementation runs via Wegiz and the future National Contact Point.

Wegiz (the Dutch act on electronic data exchange in healthcare) is Dutch law and mandates exchange between Dutch providers. EHDS is EU law and regulates cross-border exchange plus secondary use. Both use FHIR as the technical standard; PCD CareHub builds one integration layer that satisfies both.

No. Our approach is an integration layer on top of existing EHR/ECD systems. We map your existing data to FHIR R4/R5 and route EHDS exchanges through a standardised path. Rip-and-replace is not required.

EHDS article 8 gives patients the right to limit data exchange per provider or per data category (opt-out). Secondary use (articles 32 and onwards) requires structured consent. We implement machine-readable consent via the FHIR Patient.consent resource so that consent is auditable.

EHDS mandates cross-border exchange between member-state National Contact Points. PCD CareHub's architecture is designed around MyHealth@EU connectivity, particularly relevant for care organisations with cross-border activity (NL-BE, NL-DE).

EHDS does not have a single product certification; conformity is demonstrated through a Conformity Assessment per software product. The PCD CareHub platform is EHDS-ready (FHIR R4/R5 implementation, audit logging, machine-readable consent) and NEN 7510 certification is in preparation (target Q1 2027). For each portfolio company we document the specific EHDS articles the product must satisfy.

Ready to become EHDS-ready?

Plan a conversation. We map your current data exchanges and give you an honest read on what 2027 means for you.

  • 30 min
  • No commitment
  • No sales pitch
NEXT STEP

Make your organisation EHDS-ready — pragmatic and provable.

We don't build a presentation. We build the bridge.

Schedule an introductory meetingRead Trust & Compliance