German Practice Management FHIR Profiles (R4)
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German Practice Management FHIR Profiles (R4) - Local Development build (v0.49.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Strahlenschutz-Compliance

Strahlenschutz-Compliance (83/83/

This page explains how the profiles in this IG map to the German radiation protection law requirements (Strahlenschutzgesetz — StrlSchG and Strahlenschutzverordnung — StrlSchV).

Paragraph Requirement FHIR Mapping
83 StrlSchG / 83 StrlSchG / Rechtfertigende Indikation — a physician must justify every radiation exposure Procedure.reasonCode[rechtfertigende-indikation] (1..* required, ICD-10-GM)
85 StrlSchG / 85 StrlSchG / Aufzeichnungspflicht — records must document date, exposure parameters, and responsible personnel Procedure.performedDateTime (1..1 MS), extension[radiationDose], Procedure.performer[anwender]
§14 StrlSchV Fachkunde Strahlenschutz — the person applying radiation must hold the appropriate qualification extension[anwender-fachkunde] on Procedure.performer[anwender]

Profiles

RoentgenProcedurePraxisDe

The RoentgenProcedurePraxisDe profile extends the IPS Procedure-uv-ips profile to represent a radiation procedure in German ambulatory radiology.

Key constraints:

  • category fixed to SNOMED 103693007 (Diagnostic procedure)
  • code bound to ImagingProcedureVS (extensible) — covers DVT, OPG, conventional X-ray, CT, and other modalities
  • performedDateTime 1..1 MS — mandatory date/time of exposure (§85 StrlSchV)
  • performer[anwender] (1..*) — the person performing the radiation application; function coded as RadiologyRoleCS#MTR; optional extension[anwender-fachkunde] holds the Fachkunde Strahlenschutz category
  • performer[strahlenschutzverantwortlicher] (0..1) — the supervising physician; function coded as RadiologyRoleCS#SupervisingRadiologist
  • reasonCode[rechtfertigende-indikation] (1..*) — required binding to RechtfertigendeIndikationVS (ICD-10-GM codes); carries the rechtfertigende-indikation-attest extension for attestation metadata

Extensions

Extension URL Context Purpose
radiation-dose https://fhir.cognovis.de/praxis/StructureDefinition/radiation-dose Procedure DAP, effective dose, kVp, tube current, exposure time
rechtfertigende-indikation-attest https://fhir.cognovis.de/praxis/StructureDefinition/rechtfertigende-indikation-attest Procedure.reasonCode Assessor (Practitioner), assessment date, free-text justification
anwender-fachkunde https://fhir.cognovis.de/praxis/StructureDefinition/anwender-fachkunde Procedure.performer Fachkunde Strahlenschutz category (from FachkundeStrahlenschutzVS)

FHIR Linkage Pattern: ChargeItem.service → RoentgenProcedurePraxisDe

For billing codes that represent radiation procedures (contained in RadiationRelevantBillingCodeVS), the ChargeItemPraxisDe profile enforces via FHIRPath invariant radiation-service-required that ChargeItem.service must reference a Procedure resource:

code.coding.where(memberOf('https://fhir.cognovis.de/imaging/ValueSet/radiation-relevant-billing-codes')).empty()
or service.where(resolve() is Procedure).exists()

This ensures that every billable radiation service (e.g. GOÄ 5370 — CT Schädel) is linked to the corresponding RoentgenProcedurePraxisDe documentation record, creating a complete audit trail.

ChargeItem (GOÄ 5370)
  └── service ──► RoentgenProcedurePraxisDe
                    ├── performedDateTime (§85 StrlSchV)
                    ├── performer[anwender] → MTR + Fachkunde
                    ├── performer[strahlenschutzverantwortlicher] → Facharzt
                    ├── reasonCode[rechtfertigende-indikation] → ICD-10-GM + Attest
                    └── extension[radiation-dose] → DAP, kVp, …

Röntgenbuch (§85 StrlSchV)

The §85 StrlSchV Röntgenbuch requirement is fulfilled through a search-based aggregation pattern — not by a dedicated FHIR resource:

GET [base]/Procedure?
  _profile=https://fhir.cognovis.de/praxis/StructureDefinition/roentgen-procedure-praxis-de
  &performer.organization=[organization-id]
  &date=ge2026-01-01&date=le2026-12-31

This returns all RoentgenProcedurePraxisDe instances for a given organization and time period, forming the Röntgenbuch. Each record contains:

  • Patient reference
  • Date/time of exposure (performedDateTime)
  • Radiation application personnel (performer[anwender]) with Fachkunde
  • Supervising physician (performer[strahlenschutzverantwortlicher])
  • Justifying indication (reasonCode[rechtfertigende-indikation]) with attestation metadata
  • Radiation dose parameters (extension[radiation-dose])

Reference

See architecture.md (ADR-001) for the Plan-Library vs. Rule-Execution boundary decision that governs how ChargeItemPraxisDe integrates with the billing workflow.