EHDS¶

In one sentence¶

The European Health Data Space: an EU framework for primary use (patient access to and control over their electronic health records) and secondary use (research, policy, regulatory work) of health data across member states.

Who does it apply to?¶

Healthcare providers and EHR system manufacturers in the EU.
Data holders (anyone holding electronic health data in the EU).
Data users (researchers, policymakers, regulators applying for secondary use permits).
Non-EU entities offering EHR products to EU healthcare providers.

If your agent processes EU electronic health data — clinical free text, imaging, demographic codes, NHS or other patient identifiers — you're adjacent to EHDS and likely in scope.

The two-minute explainer¶

EHDS (Regulation EU 2025/327) is the youngest of the EU rulebooks in this list and the most ambitious for health data. Its two halves:

Primary use. Patients get cross-border access to their EHR data, interoperability is mandatory for EHR systems, and certain priority data categories (patient summary, e-prescription, imaging, lab results) must be shareable in a common format.

Secondary use. A regulated pathway for researchers, policymakers, and regulators to access pseudonymised health data via national Health Data Access Bodies, with a permit and quality / utility labels on the data.

EHDS sits on top of GDPR (which still applies to personal health data), not in place of it. The AI Act overlays where the use case is AI.

What it actually requires of an engineer¶

Patient access (Chapter II). Surface an erasure / access path that respects EHDS-specific timelines.
Secondary use permit (Chapter IV). If the agent operates in a research context, the permit reference must be recorded on every event.
Data quality labels (Art. 56). Provenance and utility tagging on AI- assisted records. Auditable.
EHR interoperability (Chapter III). FHIR-shaped audit events; if the agent reads/writes EHR systems, conformity to the European EHR Exchange Format.

What Regulus does for you¶

RegulusAuditPlugin emits patient_pseudonym, permit_ref, data_quality_label, care_setting on every event when ehds is active.
Retention defaults to 10 years (raw) + 30 years (summary) with SIGNED immutability — reflective of clinical record management.
Erasure path on Regulus session/memory services aligns with EHDS primary- use control.

Saves you ~¶

EHDS-specific audit schema and permit linkage: ~3 engineer-weeks.
Long-retention pipeline with signing: shared with DORA / FCA pipelines.
Data quality / utility labelling on AI-assisted records: ~2 engineer- weeks.

Net: ~5 engineer-weeks incremental over the GDPR baseline.

Code: minimal¶

regulus:
  compliance:
    profiles: [ehds]

Code: production¶

regulus:
  compliance:
    profiles: [ehds, gdpr, eu-ai-act]
  adk:
    audit:
      sink: kafka
      kafka-topic: audit.ehds.v1
    residency:
      allowed-regions: [europe-west1, europe-west3]
      require-cmek: true
    kill-switch:
      enabled: true
      dual-control: true

How to verify¶

Audit events carry patient_pseudonym, permit_ref, quality labels.
Erasure flow on a sample session removes payloads, retains a tombstone.
Quality labels propagate to downstream EHR write attempts.

What an auditor will ask¶

"Show me a secondary-use permit and the linked events." Permit reference per event.
"What quality label did this AI-assisted record receive?" Per-event data quality field.
"How does primary-use access work end to end?" Demo: patient request, Regulus erasure / access path, audit trail.

What this doesn't cover¶

FHIR mapping. Off-scope; we provide an FHIR-AuditEvent-compatible schema as guidance.
EHR conformity certification. EU-level scheme; external.
Medical-device classification. MHRA / MDR / IVDR; separate regulatory layer.

Framework mapping¶

NIST AI RMF — secondary-use permit linkage ↔ GOVERN-1.5 (monitoring). Art. 56 (data quality) ↔ MEASURE-2.8.
ISO/IEC 42001 — Chapter II/IV ↔ A.9.4 (intended-use boundaries). Art. 56 ↔ A.7.3 (data quality).

Citations¶

Regulation (EU) 2025/327 — https://eur-lex.europa.eu/eli/reg/2025/327/oj
Chapter II — primary use.
Chapter III — interoperability of EHR systems.
Chapter IV — secondary use.
Art. 56 — data quality and utility labels.