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Requirements

A structured list of functional or non-functional requirements for a FHIR project: IG conformance, integration scope.

Purpose

Requirements formalises the requirements of a FHIR integration or implementation project in a structured, testable form. Each requirement carries a description, importance (must-have, nice-to-have), a reference text, and may be satisfied by a Conformance element (CapabilityStatement, StructureDefinition, OperationDefinition). It is the FHIR layer of documentary traceability between business needs and technical implementation.

Key elements

FieldTypeCardinalityRole
urluri0..1Canonical URL.
identifierIdentifier[]0..*External identifiers.
versionstring0..1Version.
namestring0..1Technical name.
titlestring0..1Human-readable title.
statuscode1..1`draft`, `active`, `retired`, `unknown`.
experimentalboolean0..1Experimental.
datedateTime0..1Date.
publisherstring0..1Publisher.
descriptionmarkdown0..1Description.
purposemarkdown0..1Purpose.
actorcanonical(ActorDefinition)[]0..*Concerned actors.
statementBackboneElement[]0..*List of individual statements.

JSON example

json requirements-example.json
{
  "resourceType": "Requirements",
  "id": "example-requirements-onc",
  "url": "https://example.org/fhir/Requirements/onc-2026",
  "version": "1.0.0",
  "name": "OncRequirements2026",
  "title": "Exigences ONC 2026 — Patient & Encounter",
  "status": "active",
  "date": "2026-05-15",
  "publisher": "HL7 US Realm",
  "description": "Exigences obligatoires pour les EHR ONC-certifiés en 2026.",
  "statement": [{
    "key": "REQ-001",
    "label": "Patient.identifier MR obligatoire",
    "conformance": ["SHALL"],
    "requirement": "Tout EHR doit exposer Patient.identifier de type MR pour chaque patient stocké."
  }, {
    "key": "REQ-002",
    "label": "Encounter.status à jour",
    "conformance": ["SHALL"],
    "requirement": "Encounter.status doit être synchronisé en temps réel avec le statut administratif."
  }]
}

Common pitfalls

  • Requirements confused with ImplementationGuide: Requirements lists requirements; ImplementationGuide implements them.
  • Conformance levels not aligned with RFC 2119 (SHALL, SHOULD, MAY): ambiguous for validators.
  • No date or version: review tracking impossible.