| Package | hl7.fhir.us.spl |
| Resource Type | ImplementationGuide |
| Id | hl7.fhir.us.spl |
| FHIR Version | R5 |
| Source | http://hl7.org/fhir/us/spl/https://build.fhir.org/ig/HL7/fhir-spl/index.html |
| URL | http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl |
| Version | 0.2.8 |
| Status | active |
| Date | 2025-07-25T16:21:31+00:00 |
| Name | FHIR_SPL |
| Title | SPL Mapping FHIR R5 Implementation Guide |
| Realm | us |
| Authority | hl7 |
| Description | A guide that provides mapping from the FDA SPL Documents to FHIR Resources and operations. |
No resources found
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Note: links and images are rebased to the (stated) source
Generated Narrative: ImplementationGuide hl7.fhir.us.spl
The official URL for this implementation guide is:
http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl
A guide that provides mapping from the FDA SPL Documents to FHIR Resources and operations.
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"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/Enbrel25mgSolutionActiveIngredient"
},
"name": "Enbrel25mgSolutionActiveIngredient",
"description": "Active Ingredient Strength for Enbrel",
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"profile": [
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],
"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/Enbrel25mgSolutionIngredient1"
},
"name": "Enbrel25mgSolutionIngredient1",
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"profile": [
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],
"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/Enbrel25mgSolutionIngredient2"
},
"name": "Enbrel25mgSolutionIngredient2",
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"profile": [
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],
"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
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],
"reference": {
"reference": "Ingredient/Enbrel25mgSolutionIngredient3"
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"name": "Enbrel25mgSolutionIngredient3",
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"profile": [
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],
"groupingId": "EnbrelLabel"
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{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MedicinalProductDefinition"
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],
"reference": {
"reference": "MedicinalProductDefinition/Enbrel425Definition"
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"name": "Enbrel425Definition",
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],
"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "RegulatedAuthorization"
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"reference": "RegulatedAuthorization/Enbrel425Marketing"
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"profile": [
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"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PackagedProductDefinition"
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"reference": "PackagedProductDefinition/Enbrel425Package"
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"name": "Enbrel425Package",
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"profile": [
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},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MedicinalProductDefinition"
}
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"profile": [
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],
"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "RegulatedAuthorization"
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"reference": "RegulatedAuthorization/Enbrel425Part1Marketing"
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"profile": [
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"groupingId": "EnbrelLabel"
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{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PackagedProductDefinition"
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"name": "Enbrel425Part1Package",
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"profile": [
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"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MedicinalProductDefinition"
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"reference": "MedicinalProductDefinition/Enbrel425Part2Definition"
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"profile": [
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],
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},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "RegulatedAuthorization"
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{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PackagedProductDefinition"
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"name": "Enbrel425Part2Package",
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"profile": [
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],
"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MedicinalProductDefinition"
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"reference": "MedicinalProductDefinition/Enbrel435Definition"
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"profile": [
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},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "RegulatedAuthorization"
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},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PackagedProductDefinition"
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{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MedicinalProductDefinition"
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{
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
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{
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PackagedProductDefinition"
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{
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
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{
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
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{
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PackagedProductDefinition"
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{
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "RegulatedAuthorization"
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{
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PackagedProductDefinition"
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{
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
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{
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "RegulatedAuthorization"
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{
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{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PackagedProductDefinition"
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"reference": "PackagedProductDefinition/Enbrel456Package"
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"profile": [
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{
"extension": [
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ManufacturedItemDefinition"
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],
"reference": {
"reference": "ManufacturedItemDefinition/Enbrel50mgSolution"
},
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"profile": [
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],
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},
{
"extension": [
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
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"reference": "Ingredient/Enbrel50mgSolutionActiveIngredient"
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"profile": [
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],
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{
"extension": [
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
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],
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"reference": "Ingredient/Enbrel50mgSolutionIngredient1"
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"profile": [
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"groupingId": "EnbrelLabel"
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{
"extension": [
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
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],
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"profile": [
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{
"extension": [
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
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],
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"reference": "Ingredient/Enbrel50mgSolutionIngredient3"
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"name": "Enbrel50mgSolutionIngredient3",
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{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
}
],
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"reference": "SubstanceDefinition/EnbrelIngredientDefinition"
},
"name": "EnbrelIngredientDefinition",
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"profile": [
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],
"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ManufacturedItemDefinition"
}
],
"reference": {
"reference": "ManufacturedItemDefinition/EnbrelKit"
},
"name": "EnbrelKit",
"isExample": true,
"profile": [
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]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ManufacturedItemDefinition"
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],
"reference": {
"reference": "ManufacturedItemDefinition/EnbrelPowder"
},
"name": "EnbrelPowder",
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"profile": [
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],
"groupingId": "EnbrelLabel"
},
{
"extension": [
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/EnbrelPowderActiveIngredient"
},
"name": "EnbrelPowderActiveIngredient",
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"profile": [
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],
"groupingId": "EnbrelLabel"
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{
"extension": [
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/EnbrelPowderIngredient1"
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"name": "EnbrelPowderIngredient1",
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"profile": [
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],
"groupingId": "EnbrelLabel"
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{
"extension": [
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
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"reference": "Ingredient/EnbrelPowderIngredient2"
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"profile": [
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"groupingId": "EnbrelLabel"
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{
"extension": [
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
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"reference": "Ingredient/EnbrelPowderIngredient3"
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"name": "EnbrelPowderIngredient3",
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"profile": [
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],
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{
"extension": [
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ManufacturedItemDefinition"
}
],
"reference": {
"reference": "ManufacturedItemDefinition/EnbrelSterileSolution"
},
"name": "EnbrelSterileSolution",
"isExample": true,
"profile": [
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],
"groupingId": "EnbrelLabel"
},
{
"extension": [
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
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"reference": "Ingredient/EnbrelSterileSolutionIngredient1"
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"name": "EnbrelSterileSolutionIngredient1",
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"profile": [
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],
"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/EnbrelSterileSolutionIngredient2"
},
"name": "EnbrelSterileSolutionIngredient2",
"description": "Inactive Ingredient #2 for Enbrel Sterile Solution",
"isExample": true,
"profile": [
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],
"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
}
],
"reference": {
"reference": "Bundle/EnbrelSyringeLabelBundle"
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"name": "EnbrelSyringeLabelBundle",
"description": "A bundle containing all of the information for the Enbrel Label",
"isExample": true,
"profile": [
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],
"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-establishmentBusinessOperations"
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"name": "Establishment Business Operations",
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"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:logical"
}
],
"reference": {
"reference": "StructureDefinition/EstablishmentRegistrationLogicalModel"
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"name": "Establishment Registration Logical Model",
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"groupingId": "LogicalModel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
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],
"reference": {
"reference": "StructureDefinition/EstablishmentAffiliation"
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"name": "EstablishmentAffiliation",
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"groupingId": "EstablishmentRegistration"
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{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
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],
"reference": {
"reference": "StructureDefinition/EstablishmentBusinessOperation"
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"name": "EstablishmentBusinessOperation",
"description": "A profile that associates an establishment to the set of business operations that it can perform.",
"isExample": false,
"groupingId": "EstablishmentRegistration"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/EstablishmentInactivationBundle"
},
"name": "EstablishmentInactivationBundle",
"description": "A profile that represents the Bundle that contains all of the resources for an Establishment Inactivation Request.",
"isExample": false,
"groupingId": "OperationBundles"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/EstablishmentInactivationMessage"
},
"name": "EstablishmentInactivationMessage",
"description": "A profile of an Establishment Inactivation message",
"isExample": false,
"groupingId": "OperationMessages"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/EstablishmentOrganization"
},
"name": "EstablishmentOrganization",
"description": "A profile for the data elements required to identify an organization that is registered as an Establishment.",
"isExample": false,
"groupingId": "EstablishmentRegistration"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/EstablishmentRegistrantOrganization"
},
"name": "EstablishmentRegistrantOrganization",
"description": "A specialization of the RegistrantOrganization profile that fixes the type to EstablishmentRegistrant",
"isExample": false,
"groupingId": "EstablishmentRegistration"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/EstablishmentRegistrationBundle"
},
"name": "EstablishmentRegistrationBundle",
"description": "A profile that represents the Bundle that contains all of the resources for an Estabishment Registration Request.",
"isExample": false,
"groupingId": "OperationBundles"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/EstablishmentRegistrationMessage"
},
"name": "EstablishmentRegistrationMessage",
"description": "A profile of an Establishment Registration message",
"isExample": false,
"groupingId": "OperationMessages"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/EstablishmentUSAgentAffiliation"
},
"name": "EstablishmentUSAgentAffiliation",
"description": "A profile that associates an establishment to its US Agent.",
"isExample": false,
"groupingId": "GeneralOrganization"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/ExampleEstablishment"
},
"name": "ExampleEstablishment",
"description": "An example of an Establishment Organization.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentOrganization"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "OrganizationAffiliation"
}
],
"reference": {
"reference": "OrganizationAffiliation/ExampleEstablishmentAffiliation"
},
"name": "ExampleEstablishmentAffiliation",
"description": "An example of an affiliation between a registrant and an establishment.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentAffiliation"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Provenance"
}
],
"reference": {
"reference": "Provenance/ExampleEstablishmentFHIRtoSPLProvenance"
},
"name": "ExampleEstablishmentFHIRtoSPLProvenance",
"description": "A Provenance record that associates a set of FHIR Registrant and Establishment Organizations with a generated SPL document.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/DualSubmissionProvenance"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "HealthcareService"
}
],
"reference": {
"reference": "HealthcareService/ExampleEstablishmentOperation"
},
"name": "ExampleEstablishmentOperation",
"description": "An example of a Establishment's business operations.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentBusinessOperation"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/ExampleEstablishmentRegistrant"
},
"name": "ExampleEstablishmentRegistrant",
"description": "An example of a Registrant Organization.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentRegistrantOrganization"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
}
],
"reference": {
"reference": "Bundle/ExampleEstablishmentRegistration"
},
"name": "ExampleEstablishmentRegistration",
"description": "An example of a Bundle containing a set of Establishment Registration resources to register.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentRegistrationBundle"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Provenance"
}
],
"reference": {
"reference": "Provenance/ExampleEstablishmentSPLtoFHIRProvenance"
},
"name": "ExampleEstablishmentSPLtoFHIRProvenance",
"description": "A Provenance record that associates a set of FHIR Registrant and Establishment Organizations with a submitted SPL document.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/DualSubmissionProvenance"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "OrganizationAffiliation"
}
],
"reference": {
"reference": "OrganizationAffiliation/ExampleEstablishmentUSAgentAffiliation"
},
"name": "ExampleEstablishmentUSAgentAffiliation",
"description": "An example of the linkage between an Establishment and a US Agent",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentUSAgentAffiliation"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/ExampleGDUFAFacility"
},
"name": "ExampleGDUFAFacility",
"description": "An example of an GDUFA Facility Organization.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityOrganization"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "OrganizationAffiliation"
}
],
"reference": {
"reference": "OrganizationAffiliation/ExampleGDUFAFacilityAffiliation"
},
"name": "ExampleGDUFAFacilityAffiliation",
"description": "An example of an affiliation between a registrant and a GDUFA facility.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityAffiliation"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
}
],
"reference": {
"reference": "Bundle/ExampleGDUFAFacilityIdentification"
},
"name": "ExampleGDUFAFacilityIdentification",
"description": "An example of a Bundle containing a set of GDUFA Facility resources to identify.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityIdentificationBundle"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
}
],
"reference": {
"reference": "Bundle/ExampleGDUFAFacilityInactivation"
},
"name": "ExampleGDUFAFacilityInactivation",
"description": "An example of a Bundle containing a set of GDUFA Facility resources to inactivate.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityInactivationBundle"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "HealthcareService"
}
],
"reference": {
"reference": "HealthcareService/ExampleGDUFAFacilityOperation"
},
"name": "ExampleGDUFAFacilityOperation",
"description": "An example of a GDUFA Facility's business operations.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityBusinessOperation"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/ExampleGDUFARegistrant"
},
"name": "ExampleGDUFARegistrant",
"description": "An example of a Registrant Organization.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/GDUFARegistrantOrganization"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/ExampleImporter"
},
"name": "ExampleImporter",
"description": "An example of an Importer Organization.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/ImporterOrganization"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "OrganizationAffiliation"
}
],
"reference": {
"reference": "OrganizationAffiliation/ExampleImporterAffiliation"
},
"name": "ExampleImporterAffiliation",
"description": "An example of the linkage between an Establishment and an Importer",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/ImporterAffiliation"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Provenance"
}
],
"reference": {
"reference": "Provenance/ExampleLabelerFHIRtoSPLProvenance"
},
"name": "ExampleLabelerFHIRtoSPLProvenance",
"description": "A Provenance record that associates a set of FHIR Labeler Organizations with a generated SPL document.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/DualSubmissionProvenance"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Provenance"
}
],
"reference": {
"reference": "Provenance/ExampleLabelerSPLtoFHIRProvenance"
},
"name": "ExampleLabelerSPLtoFHIRProvenance",
"description": "A Provenance record that associates a set of FHIR Labeler Organizations with a submitted SPL document.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/DualSubmissionProvenance"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
}
],
"reference": {
"reference": "DocumentReference/ExampleSPLDocumentReference"
},
"name": "ExampleSPLDocumentReference",
"description": "An example of an SPL document that will be attached to a FHIR Provenance.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SPLDocumentReference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
}
],
"reference": {
"reference": "CodeSystem/codesystem-fhirMessageTypes"
},
"name": "FHIR Specific SPL Message Types",
"description": "Codes that are unique to the FHIR organization submissions, i.e. these are not current SPL submission types.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-gdufaFacilityBusinessOperationQualifiers"
},
"name": "GDUFA Facility Business Operation Qualifiers",
"description": "Codes that give further information about a GUDFA facility's business operation.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-gdufaFacilityBusinessOperations"
},
"name": "GDUFA Facility Business Operations",
"description": "The set of business operations that can be specified for a GDUFA facility.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:logical"
}
],
"reference": {
"reference": "StructureDefinition/GDUFAFacilityIdentificationLogicalModel"
},
"name": "GDUFA Facility Identification Logical Model",
"description": "An operation to provide details about a GDUFA Facility.",
"isExample": false,
"groupingId": "LogicalModel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/GDUFAFacilityAffiliation"
},
"name": "GDUFAFacilityAffiliation",
"description": "A profile that associates a GDUFA facility to its registrant.",
"isExample": false,
"groupingId": "GDUFAFacility"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/GDUFAFacilityBusinessOperation"
},
"name": "GDUFAFacilityBusinessOperation",
"description": "A profile that associates an establishment to the set of business operations that it can perform.",
"isExample": false,
"groupingId": "GDUFAFacility"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/GDUFAFacilityIdentificationBundle"
},
"name": "GDUFAFacilityIdentificationBundle",
"description": "A profile that represents the Bundle that contains all of the resources for a GDUFA Facility Identification Request.",
"isExample": false,
"groupingId": "OperationBundles"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/GDUFAFacilityIdentificationMessage"
},
"name": "GDUFAFacilityIdentificationMessage",
"description": "A profile of a GDUFA Facility Identification message",
"isExample": false,
"groupingId": "OperationMessages"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/GDUFAFacilityInactivationBundle"
},
"name": "GDUFAFacilityInactivationBundle",
"description": "A profile that represents the Bundle that contains all of the resources for an GDUFA Facility Inactivation Request.",
"isExample": false,
"groupingId": "OperationBundles"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/GDUFAFacilityInactivationMessage"
},
"name": "GDUFAFacilityInactivationMessage",
"description": "A profile of an GDUFA Facility Inactivation message",
"isExample": false,
"groupingId": "OperationMessages"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/GDUFAFacilityOrganization"
},
"name": "GDUFAFacilityOrganization",
"description": "A profile for the data elements required to identify an organization that is identified as a GDUFA Facility.",
"isExample": false,
"groupingId": "GDUFAFacility"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/GDUFARegistrantOrganization"
},
"name": "GDUFARegistrantOrganization",
"description": "A specialization of the RegistrantOrganization profile that fixes the type to GDUFARegistrant.",
"isExample": false,
"groupingId": "GDUFAFacility"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-genericFacilityMessageTypes"
},
"name": "Generic Facility Message Types",
"description": "The set of message types that are allowed as a Generic User Fee Facility submission.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/IdentifiedEstablishment"
},
"name": "IdentifiedEstablishment",
"description": "A profile for an identified establishment.",
"isExample": false,
"groupingId": "EstablishmentRegistration"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/IdentifiedEstablishmentRegistrant"
},
"name": "IdentifiedEstablishmentRegistrant",
"description": "A profile for an identified establishment registrant.",
"isExample": false,
"groupingId": "EstablishmentRegistration"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/IdentifiedGDUFAFacility"
},
"name": "IdentifiedGDUFAFacility",
"description": "A profile for an identified GDUFA facility.",
"isExample": false,
"groupingId": "GDUFAFacility"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/IdentifiedGDUFARegistrant"
},
"name": "IdentifiedGDUFARegistrant",
"description": "A profile for an identified GDUFA facility registrant.",
"isExample": false,
"groupingId": "GDUFAFacility"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/IdentifiedLabeler"
},
"name": "IdentifiedLabeler",
"description": "A profile for an identified labeler.",
"isExample": false,
"groupingId": "LabelerRequest"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/IdentifiedLabelerOrganization"
},
"name": "IdentifiedLabelerOrganization",
"description": "A sample Labeler organizaiton that just has the DUNS number and name.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedLabeler"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource:abstract"
}
],
"reference": {
"reference": "StructureDefinition/IdentifiedOrganization"
},
"name": "IdentifiedOrganization",
"description": "A profile on Organization that specifies a name and an identifier used to identify rather than specify the organization.",
"isExample": false,
"groupingId": "GeneralOrganization"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/ImmunexCorporation"
},
"name": "ImmunexCorporation",
"description": "Immunex Corporation - labeller for Enbrel",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedLabeler"
],
"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/ImporterAffiliation"
},
"name": "ImporterAffiliation",
"description": "A profile that associates an organization to its import organization.",
"isExample": false,
"groupingId": "GeneralOrganization"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/ImporterOrganization"
},
"name": "ImporterOrganization",
"description": "A profile for the data elements required for an organization fulfilling the role of an importer for another organization.",
"isExample": false,
"groupingId": "GeneralOrganization"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-labelerBusinessOperations"
},
"name": "Labeler Business Operations",
"description": "The set of business operations that can be specified for a labelling facility.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/LabelerBusinessOperation"
},
"name": "LabelerBusinessOperation",
"description": "A profile that associates a Labeler to the set of business operations that it can perform.",
"isExample": false,
"groupingId": "LabelerRequest"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/LabelerCodeRequestBundle"
},
"name": "LabelerCodeRequestBundle",
"description": "A profile that represents the Bundle that contains all of the resources for a Labeler NDC Code Request.",
"isExample": false,
"groupingId": "OperationBundles"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/LabelerCodeRequestMessage"
},
"name": "LabelerCodeRequestMessage",
"description": "An example of a message header for a Labeler Code Request",
"isExample": false,
"groupingId": "OperationMessages"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/LabelerInactivationBundle"
},
"name": "LabelerInactivationBundle",
"description": "A profile that represents the Bundle that contains all of the resources for a Labeler Inactivation.",
"isExample": false,
"groupingId": "OperationBundles"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/LabelerInactivationMessage"
},
"name": "LabelerInactivationMessage",
"description": "A profile for the Labeler Inactivation Message.",
"isExample": false,
"groupingId": "OperationMessages"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/LabelerOrganization"
},
"name": "LabelerOrganization",
"description": "A profile for the data elements required to identify a NDC Labeler organization.",
"isExample": false,
"groupingId": "LabelerRequest"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/LabelerUSAgentAffiliation"
},
"name": "LabelerUSAgentAffiliation",
"description": "A profile that associates a labeler to its US Agent.",
"isExample": false,
"groupingId": "GeneralOrganization"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/LantusActiveIngredient"
},
"name": "LantusActiveIngredient",
"description": "Active Ingredient Strength for Lantus",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/LantusIngredient1"
},
"name": "LantusIngredient1",
"description": "Inactive Ingredient #1 for Lantus",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/LantusIngredient2"
},
"name": "LantusIngredient2",
"description": "Inactive Ingredient #2 for Lantus",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/LantusIngredient3"
},
"name": "LantusIngredient3",
"description": "Inactive Ingredient #3 for Lantus",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/LantusIngredient4"
},
"name": "LantusIngredient4",
"description": "Inactive Ingredient #4 for Lantus",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/LantusIngredient5"
},
"name": "LantusIngredient5",
"description": "Inactive Ingredient #5 for Lantus",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/LantusIngredient6"
},
"name": "LantusIngredient6",
"description": "Inactive Ingredient #6 for Lantus",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
}
],
"reference": {
"reference": "Ingredient/LantusIngredient7"
},
"name": "LantusIngredient7",
"description": "Inactive Ingredient #7 for Lantus",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
}
],
"reference": {
"reference": "SubstanceDefinition/LantusIngredientDefinition"
},
"name": "LantusIngredientDefinition",
"description": "Active Ingredient Information for Lantus",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedIngredientDefinition"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
}
],
"reference": {
"reference": "Bundle/LantusInjectionLabelBundle"
},
"name": "LantusInjectionLabelBundle",
"description": "A bundle containing all of the information for the Lantus Injection Label",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionBundle"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ManufacturedItemDefinition"
}
],
"reference": {
"reference": "ManufacturedItemDefinition/LantusSolution"
},
"name": "LantusSolution",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MedicinalProductDefinition"
}
],
"reference": {
"reference": "MedicinalProductDefinition/LantusSyringeDefinition"
},
"name": "LantusSyringeDefinition",
"description": "Structured information for the Lantus Syringe product",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "RegulatedAuthorization"
}
],
"reference": {
"reference": "RegulatedAuthorization/LantusSyringeMarketing"
},
"name": "LantusSyringeMarketing",
"description": "Marketing information for Lantus Syringe",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PackagedProductDefinition"
}
],
"reference": {
"reference": "PackagedProductDefinition/LantusSyringePackage"
},
"name": "LantusSyringePackage",
"description": "Lantus Syringe Packaging",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MedicinalProductDefinition"
}
],
"reference": {
"reference": "MedicinalProductDefinition/LantusVialDefinition"
},
"name": "LantusVialDefinition",
"description": "Structured information for the Lantus Vial product",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "RegulatedAuthorization"
}
],
"reference": {
"reference": "RegulatedAuthorization/LantusVialMarketing"
},
"name": "LantusVialMarketing",
"description": "Marketing information for Lantus Vial",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PackagedProductDefinition"
}
],
"reference": {
"reference": "PackagedProductDefinition/LantusVialPackage"
},
"name": "LantusVialPackage",
"description": "Lantus Vial Packaging",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
}
],
"reference": {
"reference": "StructureDefinition/itemMarketingStatusDates"
},
"name": "Manufactured Item Marketing Status Date Range",
"description": "Used to indicate the date range of the marketing status of a manufactured item. This is being added in R5.",
"isExample": false,
"groupingId": "ProductSubmission"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
}
],
"reference": {
"reference": "CodeSystem/codesystem-submittedMedicinalProductNameTypes"
},
"name": "Medicinal Product Name Types CodeSystem",
"description": "Codes that types of names for a medicinal product.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:logical"
}
],
"reference": {
"reference": "StructureDefinition/LabelerCodeRequestLogicalModel"
},
"name": "NDC Labeler Code Request Logical Model",
"description": "An operation to request a NDC Labeler code for a registrant or private Labeler organization.",
"isExample": false,
"groupingId": "LogicalModel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/NoChangeNotificationBundle"
},
"name": "NoChangeNotificationBundle",
"description": "A profile that represents the Bundle that contains all of the resources for a No Change Notifcation.",
"isExample": false,
"groupingId": "OperationBundles"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/NoChangeNotificationMessage"
},
"name": "NoChangeNotificationMessage",
"description": "A profile of an No Change Notification message",
"isExample": false,
"groupingId": "OperationMessages"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
}
],
"reference": {
"reference": "CodeSystem/codesystem-organizationContactType"
},
"name": "Organization Contact Type",
"description": "A code that will distinguish the organizations's address from the contact party information.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
}
],
"reference": {
"reference": "CodeSystem/codesystem-organizationAffiliationCodes"
},
"name": "Organization Relationship Types",
"description": "Codes that identify the relationship between two organizations.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-organizationSubmissionMessageTypes"
},
"name": "Organization Submission Message Types",
"description": "The set of message types that are allowed as a FHIR organization submission.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource:abstract"
}
],
"reference": {
"reference": "StructureDefinition/OrganizationBundle"
},
"name": "OrganizationBundle",
"description": "A profile that provides the minimum set of information about a Bundle using for Organization messages.",
"isExample": false,
"groupingId": "OperationBundles"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource:abstract"
}
],
"reference": {
"reference": "StructureDefinition/OrganizationMessage"
},
"name": "OrganizationMessage",
"description": "An abstract profile that indicates what type of request is being made.",
"isExample": false,
"groupingId": "OperationMessages"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/OutOfBusinessBundle"
},
"name": "OutOfBusinessBundle",
"description": "A profile that represents the Bundle that contains all of the resources for an Out of Business Notifcation.",
"isExample": false,
"groupingId": "OperationBundles"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/OutOfBusinessMessage"
},
"name": "OutOfBusinessMessage",
"description": "A profile of an Out of Business message",
"isExample": false,
"groupingId": "OperationMessages"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
}
],
"reference": {
"reference": "StructureDefinition/packageInstanceOf"
},
"name": "Packaged Product Reference",
"description": "A reference to a packaged product that is represented in a packaging element.",
"isExample": false,
"groupingId": "ProductSubmission"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:logical"
}
],
"reference": {
"reference": "StructureDefinition/ProductSubmissionDocumentLogicalModel"
},
"name": "Product Submission Document Logical Model",
"description": "A document that contains information about a product being submitted for approval to the FDA.",
"isExample": false,
"groupingId": "LogicalModel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/ProductSubmissionBundle"
},
"name": "ProductSubmissionBundle",
"description": "A profile that represents the Bundle that contains the Product Submission document.",
"isExample": false,
"groupingId": "ProductSubmission"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/ProductSubmissionDocument"
},
"name": "ProductSubmissionDocument",
"description": "A profile that represents a document that is required for Product Submission to the FDA.",
"isExample": false,
"groupingId": "ProductSubmission"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-registrantOrganizationTypes"
},
"name": "Registrant Organization Types",
"description": "Codes that are specifically used for Registration Organizations.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource:abstract"
}
],
"reference": {
"reference": "StructureDefinition/RegistrantOrganization"
},
"name": "RegistrantOrganization",
"description": "A profile for the data elements required to identify an organization that registers organizations and facilities.",
"isExample": false,
"groupingId": "GeneralOrganization"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
}
],
"reference": {
"reference": "Bundle/SampleEstablishmentInactivationBundle"
},
"name": "SampleEstablishmentInactivationBundle",
"description": "An example of a Bundle containing a set of Establishment resources to inactivate.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentInactivationBundle"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MessageHeader"
}
],
"reference": {
"reference": "MessageHeader/SampleEstablishmentInactivationMessage"
},
"name": "SampleEstablishmentInactivationMessage",
"description": "An example of a message header for a Establishment Inactivation",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentInactivationMessage"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MessageHeader"
}
],
"reference": {
"reference": "MessageHeader/SampleEstablishmentRegistrationMessage"
},
"name": "SampleEstablishmentRegistrationMessage",
"description": "An example of an Establishment Registration message",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentRegistrationMessage"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MessageHeader"
}
],
"reference": {
"reference": "MessageHeader/SampleGDUFAFacilityIdentificationMessage"
},
"name": "SampleGDUFAFacilityIdentificationMessage",
"description": "An example of a GDUFA Facility Identification message",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityIdentificationMessage"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MessageHeader"
}
],
"reference": {
"reference": "MessageHeader/SampleGDUFAFacilityInactivationMessage"
},
"name": "SampleGDUFAFacilityInactivationMessage",
"description": "An example of a GDUFA Facility Identification message",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityInactivationMessage"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MessageHeader"
}
],
"reference": {
"reference": "MessageHeader/SampleGDUFAOutOfBusinessMessage"
},
"name": "SampleGDUFAOutOfBusinessMessage",
"description": "An example of a message header for an Out of Business notification",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/OutOfBusinessMessage"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
}
],
"reference": {
"reference": "Bundle/SampleGDUFAOutOfBusinessNotificationBundle"
},
"name": "SampleGDUFAOutOfBusinessNotificationBundle",
"description": "An example of a Bundle containing a set of Establishment resources to inactivate.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/OutOfBusinessBundle"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/SampleIdentifiedEstablishment"
},
"name": "SampleIdentifiedEstablishment",
"description": "A sample Establishment organizaiton that just has the DUNS number and name.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/SampleIdentifiedEstablishmentRegistrant"
},
"name": "SampleIdentifiedEstablishmentRegistrant",
"description": "A sample Establishment Registrant organization that just has the DUNS number and name.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishmentRegistrant"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/SampleIdentifiedGDUFAFacility"
},
"name": "SampleIdentifiedGDUFAFacility",
"description": "An example of an Identified GDUFA Facility Organization.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedGDUFAFacility"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/SampleIdentifiedGDUFARegistrant"
},
"name": "SampleIdentifiedGDUFARegistrant",
"description": "An example of a Identified Registrant Organization.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedGDUFARegistrant"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "HealthcareService"
}
],
"reference": {
"reference": "HealthcareService/SampleLabelerBusinessOperation"
},
"name": "SampleLabelerBusinessOperation",
"description": "An example of a Labeler's business operations.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/LabelerBusinessOperation"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
}
],
"reference": {
"reference": "Bundle/SampleLabelerCodeRequestBundle"
},
"name": "SampleLabelerCodeRequestBundle",
"description": "An example of a Bundle containing a Labeler Code Request resource to register.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/LabelerCodeRequestBundle"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MessageHeader"
}
],
"reference": {
"reference": "MessageHeader/SampleLabelerCodeRequestMessage"
},
"name": "SampleLabelerCodeRequestMessage",
"description": "An example of a message header for a Labeler Code Request",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/LabelerCodeRequestMessage"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
}
],
"reference": {
"reference": "Bundle/SampleLabelerInactivationBundle"
},
"name": "SampleLabelerInactivationBundle",
"description": "An example of a Bundle containing a Labeler Code Request resource to inactivate.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/LabelerInactivationBundle"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MessageHeader"
}
],
"reference": {
"reference": "MessageHeader/SampleLabelerInactivationMessage"
},
"name": "SampleLabelerInactivationMessage",
"description": "An example of a message header for a Labeler Inactivation",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/LabelerInactivationMessage"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/SampleLabelerOrganization"
},
"name": "SampleLabelerOrganization",
"description": "An example of a Labeler Organization.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/LabelerOrganization"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "OrganizationAffiliation"
}
],
"reference": {
"reference": "OrganizationAffiliation/SampleLabelerUSAgentAffiliation"
},
"name": "SampleLabelerUSAgentAffiliation",
"description": "An example of the linkage between a Labeler and a US Agent",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/LabelerUSAgentAffiliation"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
}
],
"reference": {
"reference": "Bundle/SampleNoChangeNotificationBundle"
},
"name": "SampleNoChangeNotificationBundle",
"description": "An example of a Bundle containing a set of Establishment resources to indicate no change required.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/NoChangeNotificationBundle"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MessageHeader"
}
],
"reference": {
"reference": "MessageHeader/SampleNoChangeNotificationMessage"
},
"name": "SampleNoChangeNotificationMessage",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/NoChangeNotificationMessage"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MessageHeader"
}
],
"reference": {
"reference": "MessageHeader/SampleOutOfBusinessMessage"
},
"name": "SampleOutOfBusinessMessage",
"description": "An example of a message header for an Out of Business notification",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/OutOfBusinessMessage"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
}
],
"reference": {
"reference": "Bundle/SampleOutOfBusinessNotificationBundle"
},
"name": "SampleOutOfBusinessNotificationBundle",
"description": "An example of a Bundle containing a set of Establishment resources to inactivate.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/OutOfBusinessBundle"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/SampleUSAgent"
},
"name": "SampleUSAgent",
"description": "An example of a US Agent Organization.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/USAgentOrganization"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/SanofiAventisDeutschland"
},
"name": "SanofiAventisDeutschland",
"description": "Sanifo-Aventis Deutschland - establishment for Lantus Injection",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/SanofiAventisSRL"
},
"name": "SanofiAventisSRL",
"description": "Sanifo-Aventis SRL - establishment for Lantus Injection",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/SanofiAventisUS"
},
"name": "SanofiAventisUS",
"description": "Sanifo-Aventis US - labeller for Lantus Injection",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedLabeler"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
}
],
"reference": {
"reference": "StructureDefinition/sectionEffectiveTime"
},
"name": "SectionEffectiveTime",
"description": "Providing an effective time for a section.",
"isExample": false,
"groupingId": "ProductSubmission"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
}
],
"reference": {
"reference": "StructureDefinition/sectionLinkId"
},
"name": "SectionLinkId",
"description": "Provide the ID that is using for linking between sections. NOTE: This will also be contained in the section text as a link.",
"isExample": false,
"groupingId": "ProductSubmission"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-splColor"
},
"name": "SPL Color",
"description": "Codes from NCI Thesaurus for SPL Color (C54453 Subset)",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-splComboProductType"
},
"name": "SPL Combo Product Type",
"description": "Codes from NCI Thesaurus for SPL Combo Product Type (C102833 Subset)",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/splDocumentCodes"
},
"name": "SPL Document Codes",
"description": "Document Codes for SPL Product Submission documents",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-splDoseForm"
},
"name": "SPL Dose Form",
"description": "Codes from NCI Thesaurus for SPL Dose Form (C54456 Subset)",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-splFlavor"
},
"name": "SPL Flavor",
"description": "Codes from NCI Thesaurus for SPL Flavor (C73339 Subset)",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-splMarketingCategories"
},
"name": "SPL Marketing Categories",
"description": "Codes from NCI Thesaurus for SPL Marketing Categories (C43164 Subset)",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
}
],
"reference": {
"reference": "CodeSystem/codesystem-splMarketingStatuses"
},
"name": "SPL Marketing Statuses CodeSystem",
"description": "Marketing Status Status Codes",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-splMarketingStatuses"
},
"name": "SPL Marketing Statuses ValueSet",
"description": "Marketing Status Status Codes",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-splOperationType"
},
"name": "SPL Operation Type",
"description": "Codes from NCI Thesaurus for SPL Operation Type (C73600 Subset)",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
}
],
"reference": {
"reference": "CodeSystem/codesystem-organizationTypes"
},
"name": "SPL Organization Types",
"description": "Codes that identify the types of organizations involved in a SPL submission.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-splPackageTypes"
},
"name": "SPL Package Types",
"description": "Codes from NCI Thesaurus for SPL Package Types (C43164 Subset)",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
}
],
"reference": {
"reference": "CodeSystem/codesystem-characteristicTypes"
},
"name": "SPL Product Characteristic Types CodeSystem",
"description": "Codes that were specified in the SPL guide for characteristic types.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-SubmittedMedicinalProductCharacteristicCodes"
},
"name": "SPL Product Characteristic Types ValueSet",
"description": "Codes that identify the types of characteristics allowed for Submitted Medicinal Product.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-splRouteOfAdministration"
},
"name": "SPL Route of Administration",
"description": "Codes from NCI Thesaurus for SPL Route of Administration (C54455 Subset)",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/splSectionCodes"
},
"name": "SPL Section Codes",
"description": "Section Codes for SPL Product Submission documents",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-splShape"
},
"name": "SPL Shape",
"description": "Codes from NCI Thesaurus for SPL Shape (C54454 Subset)",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-splSpecialMeasures"
},
"name": "SPL Special Measures",
"description": "Codes from NCI Thesaurus for SPL Special Measures (C54459 Subset)",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:complex-type"
}
],
"reference": {
"reference": "StructureDefinition/SPLAddress"
},
"name": "SPLAddress",
"description": "SPL-specific Constraints on the Address datatype dealing with US addresses.",
"isExample": false,
"groupingId": "GeneralOrganization"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:complex-type"
}
],
"reference": {
"reference": "StructureDefinition/SPLContactPoint"
},
"name": "SPLContactPoint",
"description": "SPL-specific Constraints on the ContactPoint dealing with proper formatting",
"isExample": false,
"groupingId": "GeneralOrganization"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
}
],
"reference": {
"reference": "StructureDefinition/splDocumentDate"
},
"name": "SPLDocumentDate",
"description": "Adding a SPL creation date to the document reference.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/SPLDocumentReference"
},
"name": "SPLDocumentReference",
"description": "A profile that represents the SPL document that was either created by or was the source for the Organization FHIR Bundle.",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:logical"
}
],
"reference": {
"reference": "StructureDefinition/SubmittedMedicationLogicalModel"
},
"name": "Submitted Medication Logical Model",
"description": "Details about the Medication that is submitted to the FDA.",
"isExample": false,
"groupingId": "LogicalModel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/SubmittedIngredientDefinition"
},
"name": "SubmittedIngredientDefinition",
"description": "Used to represent an substance's active moiety.",
"isExample": false,
"groupingId": "ProductSubmission"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/SubmittedManufacturedItem"
},
"name": "SubmittedManufacturedItem",
"description": "Details around the actual item, i.e tablet, solution, etc. that is packaged as part of the medicinal product.",
"isExample": false,
"groupingId": "ProductSubmission"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/SubmittedMedicinalPackaging"
},
"name": "SubmittedMedicinalPackaging",
"description": "Details around the packaging of submitted medicinal products.",
"isExample": false,
"groupingId": "ProductSubmission"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/SubmittedMedicinalProduct"
},
"name": "SubmittedMedicinalProduct",
"description": "A profile that allows for the submission of Medicinal Product information to the FDA.",
"isExample": false,
"groupingId": "ProductSubmission"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/SubmittedMedicinalProductIngredient"
},
"name": "SubmittedMedicinalProductIngredient",
"description": "Details around the ingredients of a submitted medicinal product.",
"isExample": false,
"groupingId": "ProductSubmission"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/SubmittedMedicinalProductMarketing"
},
"name": "SubmittedMedicinalProductMarketing",
"description": "Details around the marketing of a submitted medicinal product.",
"isExample": false,
"groupingId": "ProductSubmission"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
}
],
"reference": {
"reference": "Bundle/TestEstablishmentRegistration"
},
"name": "TestEstablishmentRegistration",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentRegistrationBundle"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
}
],
"reference": {
"reference": "Composition/EnbrelSyringeLabelComposition"
},
"name": "These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. <br/>\n <br/>ENBREL<sup>®</sup> (etanercept) injection, for subcutaneous use <br/>ENBREL<sup>®</sup> (etanercept) for injection, for subcutaneous use <br/>Initial U.S. Approval: 1998",
"description": "Header information for the Enbrel Syringe Labels",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocument"
],
"groupingId": "EnbrelLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
}
],
"reference": {
"reference": "Composition/LantusInjectionLabelComposition"
},
"name": "These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. <br/>\n <br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000",
"description": "Header information for the Lantus Injection Label",
"isExample": true,
"profile": [
"http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocument"
],
"groupingId": "LantusLabel"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/valueset-topLevelOrganizationTypes"
},
"name": "Top-Level Organization Types",
"description": "Codes that identify organizations that are considered top-level",
"isExample": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/USAgentOrganization"
},
"name": "USAgentOrganization",
"description": "A profile for the data elements required for an organization fulfilling the role of a US Agent for another organization.",
"isExample": false,
"groupingId": "GeneralOrganization"
}
],
"page": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "toc.html",
"name": "toc.html",
"title": "Table of Contents",
"generation": "html",
"page": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "index.html",
"name": "index.html",
"title": "SPL Mapping Implementation Guide Home Page",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "organization.html",
"name": "organization.html",
"title": "Organization-Based Use Cases",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "druglabel.html",
"name": "druglabel.html",
"title": "Submit a Drug Label",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "howtolabel.html",
"name": "howtolabel.html",
"title": "How to Create a FHIR Drug Label",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "transforms.html",
"name": "transforms.html",
"title": "SPL / FHIR Transforms",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "downloads.html",
"name": "downloads.html",
"title": "Downloads",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "credits.html",
"name": "credits.html",
"title": "Credits",
"generation": "markdown"
}
]
},
"parameter": [
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "copyrightyear"
},
"value": "2020+"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "releaselabel"
},
"value": "Build CI"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "display-warnings"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "path-history"
},
"value": "http://hl7.org/fhir/us/spl/history.html"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "autoload-resources"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-resource"
},
"value": "input/capabilities"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-resource"
},
"value": "input/examples"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-resource"
},
"value": "input/extensions"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-resource"
},
"value": "input/models"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-resource"
},
"value": "input/operations"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-resource"
},
"value": "input/profiles"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-resource"
},
"value": "input/resources"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-resource"
},
"value": "input/vocabulary"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-resource"
},
"value": "input/maps"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-resource"
},
"value": "input/testing"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-resource"
},
"value": "input/history"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-resource"
},
"value": "fsh-generated/resources"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-pages"
},
"value": "template/config"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-pages"
},
"value": "input/images"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "path-liquid"
},
"value": "template/liquid"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "path-liquid"
},
"value": "input/liquid"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "path-qa"
},
"value": "temp/qa"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "path-temp"
},
"value": "temp/pages"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "path-output"
},
"value": "output"
},
{
"code": {
"system": "http://hl7.org/fhir/guide-parameter-code",
"code": "path-tx-cache"
},
"value": "input-cache/txcache"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "path-suppressed-warnings"
},
"value": "input/ignoreWarnings.txt"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "template-html"
},
"value": "template-page.html"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "template-md"
},
"value": "template-page-md.html"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "apply-contact"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "apply-context"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "apply-copyright"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "apply-jurisdiction"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "apply-license"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "apply-publisher"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "apply-version"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "apply-wg"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "active-tables"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "fmm-definition"
},
"value": "http://hl7.org/fhir/versions.html#maturity"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "propagate-status"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "excludelogbinaryformat"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "tabbed-snapshots"
},
"value": "true"
}
]
}
}