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"_filename": "StructureDefinition-pfe-device-request-clinical-justification.json",
"package_name": "hl7.fhir.us.pacio-pfe",
"date": "2026-08-05T03:51:48+10:00",
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} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:use-of-device.url",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-use-of-device" ]
} ],
"max": "1",
"id": "Extension.extension:use-of-device.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "Supporting information about the patient's goals that may influence fulfillment of the device request.",
"isModifier": false,
"short": "Supporting goal information",
"type": [ {
"code": "Extension"
} ],
"sliceName": "goal",
"max": "*",
"id": "Extension.extension:goal",
"comment": "Examples: \n- A patient at an inpatient rehabilitation facility has a goal of living independently at home after knee surgery, which requires limiting the range of motion of their knee. To support this goal, the physical therapist overseeing their rehab submits device requests for a knee brace that limits range of motion and a grabbing tool to help compensate for limited mobility due to the brace. Supporting information related to the goal can include: \n- Independent daily dressing assessment (e.g., items GG0130.F and G from the MDS captured in the LOINC panel 108256-9) and a pain assessment (e.g., section J from the MDS captured in the LOINC panel 108256-9) that are completed by the patient while wearing a knee brace and while using a grabbing tool (captured in the PFE Goal profile via an Observation under the “addresses” data element). \n- A patient in a skilled nursing facility has a goal to gain weight and maintain it. The patient’s dietitian orders an enteral nutrition-related device. Supporting information related to the goal can include: \n- Vital sign data regarding weight to assess gain/maintenance (captured in the PFE Goal profile via LOINC code 29463-7 under the “measure” data element) \n- Nutrition orders (captured in the PFE Goal profile via a NutritionOrder under the “addresses” data element) ",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:goal.id",
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension:goal.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "goal",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.extension:goal.url",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.value[x]",
"min": 0,
"definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-goal" ]
} ],
"max": "1",
"id": "Extension.extension:goal.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": false
}, {
"path": "Extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "http://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-device-request-clinical-justification",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.url",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.value[x]",
"min": 0,
"definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "base64Binary"
}, {
"code": "boolean"
}, {
"code": "canonical"
}, {
"code": "code"
}, {
"code": "date"
}, {
"code": "dateTime"
}, {
"code": "decimal"
}, {
"code": "id"
}, {
"code": "instant"
}, {
"code": "integer"
}, {
"code": "markdown"
}, {
"code": "oid"
}, {
"code": "positiveInt"
}, {
"code": "string"
}, {
"code": "time"
}, {
"code": "unsignedInt"
}, {
"code": "uri"
}, {
"code": "url"
}, {
"code": "uuid"
}, {
"code": "Address"
}, {
"code": "Age"
}, {
"code": "Annotation"
}, {
"code": "Attachment"
}, {
"code": "CodeableConcept"
}, {
"code": "Coding"
}, {
"code": "ContactPoint"
}, {
"code": "Count"
}, {
"code": "Distance"
}, {
"code": "Duration"
}, {
"code": "HumanName"
}, {
"code": "Identifier"
}, {
"code": "Money"
}, {
"code": "Period"
}, {
"code": "Quantity"
}, {
"code": "Range"
}, {
"code": "Ratio"
}, {
"code": "Reference"
}, {
"code": "SampledData"
}, {
"code": "Signature"
}, {
"code": "Timing"
}, {
"code": "ContactDetail"
}, {
"code": "Contributor"
}, {
"code": "DataRequirement"
}, {
"code": "Expression"
}, {
"code": "ParameterDefinition"
}, {
"code": "RelatedArtifact"
}, {
"code": "TriggerDefinition"
}, {
"code": "UsageContext"
}, {
"code": "Dosage"
}, {
"code": "Meta"
} ],
"max": "0",
"id": "Extension.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": false
} ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "4.0.1"
} ]
},
"status": "active",
"id": "c98f3b37-7c13-414b-b858-1bd6ef030893",
"kind": "complex-type",
"url": "http://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-device-request-clinical-justification",
"identifier": [ {
"value": "urn:oid:2.16.840.1.113883.4.642.40.67.42.8",
"system": "urn:ietf:rfc:3986"
} ],
"context": [ {
"type": "element",
"expression": "DeviceRequest"
} ],
"version": "3.0.0-ballot",
"differential": {
"element": [ {
"id": "Extension",
"path": "Extension",
"definition": "Groups information that supports the clinical justification for the device request. These can include assessment findings, and goals that may influence fulfillment of the device request.\n- assessments documenting the patient’s ability to use/interact with the device related to: \n - Cognition: If the patient has the cognitive capacity to use the device via the Brief Cognitive Assessment Tool (BCAT®) short form (LOINC 95872-8) \n - Physical Functioning: If the patient is physically able to use the device via the 9-Hole Pegboard Dexterity Test (LOINC 83141-2) \n - Vision: If the patient's visual capabilities are aligned with the device features via the Motor Free Visual Perception test (MFVP) (SNOMED-CT 396216003) \n - Health Literacy: If the patient has the ability learn how to use the device via the BRIEF health literacy screening tool (LOINC 95866-0) \n - Disability: If the patient has a disability that would need to be accommodated in the selection of a device via an indication in the patient’s demographic record of having a disability (ICD-10 Z73.6) \n- Documented observation of the patient’s usage of the requested device during an assessment that may influence the fulfillment of the device. \n - Example: A patient at a long-term care facility uses a cane to complete a walking assessment (e.g., the Centers for Medicare & Medicaid Services [CMS] Minimum Data Set [MDS] section GG items on walking distance) that is captured as observation data (via the derivedFrom data element within the PFE Use of Device profile). \n- Supporting information about the patient's goals that may influence fulfillment of the device request. \n - Example: A patient at an inpatient rehabilitation facility has a goal of living independently at home after knee surgery, which requires limiting the range of motion of their knee. To support this goal, the physical therapist overseeing their rehab submits device requests for a knee brace that limits range of motion and a grabbing tool to help compensate for limited mobility due to the brace. Supporting information related to the goal can include: Independent daily dressing assessment (e.g., items GG0130.F and G from the MDS captured in the LOINC panel 108256-9) and a pain assessment (e.g., section J from the MDS captured in the LOINC panel 108256-9) that are completed by the patient while wearing a knee brace and while using a grabbing tool (captured in the PFE Goal profile via an Observation under the “addresses” data element). \n - Example: A patient in a skilled nursing facility has a goal to gain weight and maintain it. The patient’s dietitian orders an enteral nutrition-related device. Supporting information related to the goal can include: Vital sign data regarding weight to assess gain/maintenance (captured in the PFE Goal profile via LOINC code 29463-7 under the “measure” data element), Nutrition orders (captured in the PFE Goal profile via a NutritionOrder under the “addresses” data element) "
}, {
"id": "Extension.extension:note",
"max": "*",
"min": 0,
"path": "Extension.extension",
"short": "Clinical justification note",
"sliceName": "note",
"definition": "Captures the clinical justification or rationale for the medical necessity of a device request. Complements the DeviceRequest.reasonCode and DeviceRequest.reasonReference data elements."
}, {
"id": "Extension.extension:note.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:note.url",
"path": "Extension.extension.url",
"fixedUri": "note"
}, {
"id": "Extension.extension:note.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "string"
}, {
"code": "Annotation"
} ]
}, {
"id": "Extension.extension:assessment",
"max": "*",
"min": 0,
"path": "Extension.extension",
"short": "Supporting assessment information",
"comment": "Examples:\n- Cognition: Brief Cognitive Assessment Tool (BCAT®) short form (LOINC 95872-8) \n- Physical functioning: 9-Hole Pegboard Dexterity Test (LOINC 83141-2) \n- Vision: Motor Free Visual Perception test (MFVP) (SNOMED-CT 396216003) \n- Health Literacy: BRIEF health literacy screening tool (LOINC 95866-0) \n- Disability: Indication in the patient’s demographic record of having a disability (ICD-10 Z73.6) ",
"sliceName": "assessment",
"definition": "Supporting information about patient assessments that may influence fulfillment of the device request. This includes assessments documenting the patient's ability to use/interact with the device related to:\n- Cognition: If the patient has the cognitive capacity to use the device (e.g., via cognitive test/scale)\n- Physical Functioning: If the patient is physically able to use the device (e.g., assessment)\n- Vision: If the patient's visual capabilities are aligned with the device features (e.g., via ICD code) \n- Health Literacy: If the patient has the ability learn how to use the device (e.g., via health literacy scale) \n- Disability: If the patient has a disability that would need to be accommodated in the selection of a device (e.g., via an demographic disability item) "
}, {
"id": "Extension.extension:assessment.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:assessment.url",
"path": "Extension.extension.url",
"fixedUri": "assessment"
}, {
"id": "Extension.extension:assessment.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-observation-clinicaltest", "http://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-collection", "http://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-observation-single" ]
} ]
}, {
"id": "Extension.extension:use-of-device",
"max": "*",
"min": 0,
"path": "Extension.extension",
"short": "Supporting device usage information",
"comment": "Example: \n- A patient at a long-term care facility uses a cane to complete a walking assessment (e.g., the Centers for Medicare & Medicaid Services [CMS] Minimum Data Set [MDS] section GG items on walking distance) that is captured as observation data (via the derivedFrom data element within the PFE Use of Device profile). ",
"sliceName": "use-of-device",
"definition": "Supporting information about the patient's usage of the requested device during an assessment that may influence fulfillment of the device request."
}, {
"id": "Extension.extension:use-of-device.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:use-of-device.url",
"path": "Extension.extension.url",
"fixedUri": "use-of-device"
}, {
"id": "Extension.extension:use-of-device.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-use-of-device" ]
} ]
}, {
"id": "Extension.extension:goal",
"max": "*",
"min": 0,
"path": "Extension.extension",
"short": "Supporting goal information",
"comment": "Examples: \n- A patient at an inpatient rehabilitation facility has a goal of living independently at home after knee surgery, which requires limiting the range of motion of their knee. To support this goal, the physical therapist overseeing their rehab submits device requests for a knee brace that limits range of motion and a grabbing tool to help compensate for limited mobility due to the brace. Supporting information related to the goal can include: \n- Independent daily dressing assessment (e.g., items GG0130.F and G from the MDS captured in the LOINC panel 108256-9) and a pain assessment (e.g., section J from the MDS captured in the LOINC panel 108256-9) that are completed by the patient while wearing a knee brace and while using a grabbing tool (captured in the PFE Goal profile via an Observation under the “addresses” data element). \n- A patient in a skilled nursing facility has a goal to gain weight and maintain it. The patient’s dietitian orders an enteral nutrition-related device. Supporting information related to the goal can include: \n- Vital sign data regarding weight to assess gain/maintenance (captured in the PFE Goal profile via LOINC code 29463-7 under the “measure” data element) \n- Nutrition orders (captured in the PFE Goal profile via a NutritionOrder under the “addresses” data element) ",
"sliceName": "goal",
"definition": "Supporting information about the patient's goals that may influence fulfillment of the device request."
}, {
"id": "Extension.extension:goal.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:goal.url",
"path": "Extension.extension.url",
"fixedUri": "goal"
}, {
"id": "Extension.extension:goal.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-goal" ]
} ]
}, {
"id": "Extension.url",
"path": "Extension.url",
"fixedUri": "http://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-device-request-clinical-justification"
}, {
"id": "Extension.value[x]",
"max": "0",
"path": "Extension.value[x]"
} ]
},
"contact": [ {
"name": "HL7 International / Patient Care",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/patientcare",
"system": "url"
}, {
"value": "patientcare@lists.HL7.org",
"system": "email"
} ]
}, {
"name": "PACIO project",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/patientcare",
"system": "url"
}, {
"value": "info@pacioproject.org",
"system": "email"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension"
}