{
"description": "FHIR implementation options and guidance for medication REMS participants",
"_filename": "ImplementationGuide-hl7.fhir.us.medication-rems.json",
"package_name": "hl7.fhir.us.medication",
"definition": {
"page": {
"page": [ {
"title": "REMS IG Home Page",
"nameUrl": "index.html",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
"valueUrl": "index.html"
} ],
"generation": "markdown"
}, {
"title": "REMS Steps and Terminology",
"nameUrl": "process.html",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
"valueUrl": "process.html"
} ],
"generation": "markdown"
}, {
"title": "Participant Roles and Needs",
"nameUrl": "roles.html",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
"valueUrl": "roles.html"
} ],
"generation": "markdown"
}, {
"title": "Use Cases",
"nameUrl": "use-cases.html",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
"valueUrl": "use-cases.html"
} ],
"generation": "markdown"
}, {
"title": "REMS Interaction Events and Triggers",
"nameUrl": "event-triggers.html",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
"valueUrl": "event-triggers.html"
} ],
"generation": "markdown"
}, {
"title": "Future Directions",
"nameUrl": "future-directions.html",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
"valueUrl": "future-directions.html"
} ],
"generation": "markdown"
}, {
"title": "Credits",
"nameUrl": "credits.html",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
"valueUrl": "credits.html"
} ],
"generation": "markdown"
}, {
"title": "Technical Background",
"nameUrl": "technical-background.html",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
"valueUrl": "technical-background.html"
} ],
"generation": "markdown"
}, {
"title": "Formal Specification",
"nameUrl": "specification.html",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
"valueUrl": "specification.html"
} ],
"generation": "markdown"
}, {
"title": "CDS Hooks Card Profiles",
"nameUrl": "cds-cards.html",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
"valueUrl": "cds-cards.html"
} ],
"generation": "markdown"
}, {
"title": "Downloads",
"nameUrl": "downloads.html",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
"valueUrl": "downloads.html"
} ],
"generation": "html"
}, {
"title": "Change History",
"nameUrl": "change-history.html",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
"valueUrl": "change-history.html"
} ],
"generation": "markdown"
} ],
"title": "Table of Contents",
"nameUrl": "toc.html",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-page-name",
"valueUrl": "toc.html"
} ],
"generation": "html"
},
"resource": [ {
"name": "example-patient-123",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Patient"
} ],
"reference": {
"reference": "Patient/example-patient-123"
},
"description": "Example of a US Core patient",
"exampleBoolean": true
}, {
"name": "example-rems-docref-1",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
} ],
"reference": {
"reference": "DocumentReference/example-rems-docref-1"
},
"description": "Example of a US Core document reference containing a patient's REMS program information",
"exampleBoolean": true
}, {
"name": "Medication REMS Capability Statement - Provider System",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CapabilityStatement"
} ],
"reference": {
"reference": "CapabilityStatement/provider-system"
},
"description": "This CapabilityStatement describes the expected capabilities of a Provider System that conforms to the conventions of the Medication REMS FHIR implementation guide.",
"exampleBoolean": false
}, {
"name": "Medication REMS Capability Statement - REMS Administrator System",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CapabilityStatement"
} ],
"reference": {
"reference": "CapabilityStatement/rems-administrator-system"
},
"description": "This CapabilityStatement describes the expected capabilities of a REMS Administrator System that conforms to the conventions of the Medication REMS FHIR implementation guide.",
"exampleBoolean": false
}, {
"name": "Medication REMS Task - SMART Launch",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"reference": {
"reference": "StructureDefinition/medication-rems-task-smart-launch"
},
"description": "This profile defines a Task to be returned in a REMS Administrator's CDS Hooks response - enabling the provider or staff to launch a SMART app from their work queue.",
"exampleBoolean": false
}, {
"name": "medication-rems-task-smart-launch-1",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
} ],
"reference": {
"reference": "Task/medication-rems-task-smart-launch-1"
},
"description": "Complete patient enrollment using the DRUG-X REMS SMART app",
"exampleCanonical": "http://hl7.org/fhir/us/medication-rems/StructureDefinition/medication-rems-task-smart-launch"
}, {
"name": "parameters-rems-etasu-input",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Parameters"
} ],
"reference": {
"reference": "Parameters/parameters-rems-etasu-input"
},
"description": "Example input parameters for the $rems-etasu operation",
"exampleBoolean": true
}, {
"name": "parameters-rems-etasu-output",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Parameters"
} ],
"reference": {
"reference": "Parameters/parameters-rems-etasu-output"
},
"description": "Example output parameters for the $rems-etasu operation",
"exampleBoolean": true
}, {
"name": "pra1234",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Practitioner"
} ],
"reference": {
"reference": "Practitioner/pra1234"
},
"description": "Example of a Practitioner",
"exampleBoolean": true
} ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "copyrightyear"
}, {
"url": "value",
"valueString": "2023+"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "releaselabel"
}, {
"url": "value",
"valueString": "STU 2 Ballot"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "path-history"
}, {
"url": "value",
"valueString": "http://hl7.org/fhir/us/medication-rems/history.html"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "autoload-resources"
}, {
"url": "value",
"valueString": "true"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "path-liquid"
}, {
"url": "value",
"valueString": "template/liquid"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "path-liquid"
}, {
"url": "value",
"valueString": "input/liquid"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "path-qa"
}, {
"url": "value",
"valueString": "temp/qa"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "path-temp"
}, {
"url": "value",
"valueString": "temp/pages"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "path-output"
}, {
"url": "value",
"valueString": "output"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "path-suppressed-warnings"
}, {
"url": "value",
"valueString": "input/ignoreWarnings.txt"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "template-html"
}, {
"url": "value",
"valueString": "template-page.html"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "template-md"
}, {
"url": "value",
"valueString": "template-page-md.html"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "apply-contact"
}, {
"url": "value",
"valueString": "true"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "apply-context"
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"url": "value",
"valueString": "true"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "apply-copyright"
}, {
"url": "value",
"valueString": "true"
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}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "apply-jurisdiction"
}, {
"url": "value",
"valueString": "true"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "apply-license"
}, {
"url": "value",
"valueString": "true"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "apply-publisher"
}, {
"url": "value",
"valueString": "true"
} ]
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "apply-version"
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"url": "value",
"valueString": "true"
} ]
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "apply-wg"
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"url": "value",
"valueString": "true"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
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"url": "code",
"valueString": "active-tables"
}, {
"url": "value",
"valueString": "true"
} ]
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
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"url": "code",
"valueString": "fmm-definition"
}, {
"url": "value",
"valueString": "http://hl7.org/fhir/versions.html#maturity"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
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"extension": [ {
"url": "code",
"valueString": "excludelogbinaryformat"
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"url": "value",
"valueString": "true"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueString": "tabbed-snapshots"
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"url": "value",
"valueString": "true"
} ]
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-internal-dependency",
"valueCode": "hl7.fhir.uv.tools.r4#0.7.1"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueCode": "copyrightyear"
}, {
"url": "value",
"valueString": "2023+"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueCode": "releaselabel"
}, {
"url": "value",
"valueString": "STU 2 Ballot"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueCode": "path-history"
}, {
"url": "value",
"valueString": "http://hl7.org/fhir/us/medication-rems/history.html"
} ]
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
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"url": "code",
"valueCode": "autoload-resources"
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"url": "value",
"valueString": "true"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueCode": "path-liquid"
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"url": "value",
"valueString": "template/liquid"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
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"url": "code",
"valueCode": "path-liquid"
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"url": "value",
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
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"valueCode": "path-qa"
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"url": "value",
"valueString": "temp/qa"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
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"url": "code",
"valueCode": "path-temp"
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"url": "value",
"valueString": "temp/pages"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
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"url": "code",
"valueCode": "path-output"
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"url": "value",
"valueString": "output"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueCode": "path-suppressed-warnings"
}, {
"url": "value",
"valueString": "input/ignoreWarnings.txt"
} ]
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueCode": "template-html"
}, {
"url": "value",
"valueString": "template-page.html"
} ]
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueCode": "template-md"
}, {
"url": "value",
"valueString": "template-page-md.html"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueCode": "apply-contact"
}, {
"url": "value",
"valueString": "true"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueCode": "apply-context"
}, {
"url": "value",
"valueString": "true"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueCode": "apply-copyright"
}, {
"url": "value",
"valueString": "true"
} ]
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueCode": "apply-jurisdiction"
}, {
"url": "value",
"valueString": "true"
} ]
}, {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
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"url": "code",
"valueCode": "apply-license"
}, {
"url": "value",
"valueString": "true"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
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"url": "code",
"valueCode": "apply-publisher"
}, {
"url": "value",
"valueString": "true"
} ]
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
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"url": "value",
"valueString": "true"
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
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"valueCode": "apply-wg"
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"valueString": "true"
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"url": "code",
"valueCode": "active-tables"
}, {
"url": "value",
"valueString": "true"
} ]
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
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"valueCode": "fmm-definition"
}, {
"url": "value",
"valueString": "http://hl7.org/fhir/versions.html#maturity"
} ]
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"valueCode": "propagate-status"
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"url": "value",
"valueString": "true"
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"url": "code",
"valueCode": "excludelogbinaryformat"
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"url": "value",
"valueString": "true"
} ]
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"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
"extension": [ {
"url": "code",
"valueCode": "tabbed-snapshots"
}, {
"url": "value",
"valueString": "true"
} ]
} ],
"parameter": [ {
"code": "path-resource",
"value": "input/capabilities"
}, {
"code": "path-resource",
"value": "input/examples"
}, {
"code": "path-resource",
"value": "input/extensions"
}, {
"code": "path-resource",
"value": "input/models"
}, {
"code": "path-resource",
"value": "input/operations"
}, {
"code": "path-resource",
"value": "input/profiles"
}, {
"code": "path-resource",
"value": "input/resources"
}, {
"code": "path-resource",
"value": "input/vocabulary"
}, {
"code": "path-resource",
"value": "input/maps"
}, {
"code": "path-resource",
"value": "input/testing"
}, {
"code": "path-resource",
"value": "input/history"
}, {
"code": "path-resource",
"value": "fsh-generated/resources"
}, {
"code": "path-pages",
"value": "template/config"
}, {
"code": "path-pages",
"value": "input/images"
}, {
"code": "path-tx-cache",
"value": "input-cache/txcache"
} ]
},
"date": "2025-07-31T17:49:58+00:00",
"publisher": "HL7 International / Pharmacy",
"fhirVersion": [ "4.0.1" ],
"license": "CC0-1.0",
"jurisdiction": [ {
"coding": [ {
"code": "US",
"system": "urn:iso:std:iso:3166",
"display": "United States of America"
} ]
} ],
"dependsOn": [ {
"id": "hl7tx",
"uri": "http://terminology.hl7.org/ImplementationGuide/hl7.terminology",
"version": "6.5.0",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/implementationguide-dependency-comment",
"valueMarkdown": "Automatically added as a dependency - all IGs depend on HL7 Terminology"
} ],
"packageId": "hl7.terminology.r4"
}, {
"id": "hl7ext",
"uri": "http://hl7.org/fhir/extensions/ImplementationGuide/hl7.fhir.uv.extensions",
"version": "5.2.0",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/implementationguide-dependency-comment",
"valueMarkdown": "Automatically added as a dependency - all IGs depend on the HL7 Extension Pack"
} ],
"packageId": "hl7.fhir.uv.extensions.r4"
}, {
"id": "uscore",
"uri": "http://hl7.org/fhir/us/core/ImplementationGuide/hl7.fhir.us.core",
"version": "3.1.1",
"extension": [ {
"url": "http://hl7.org/fhir/5.0/StructureDefinition/extension-ImplementationGuide.dependsOn.reason",
"valueMarkdown": "Defines U.S. EHR expectations on a range of resources that will be passed to and/or queried by REMS CDS servers\n"
} ],
"packageId": "hl7.fhir.us.core"
}, {
"id": "SmartAppLaunch",
"uri": "http://hl7.org/fhir/smart-app-launch/ImplementationGuide/hl7.fhir.uv.smart-app-launch",
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