| Left: | US Core Implantable Device Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device) |
| Right: | Device - At-Home In-Vitro Test (http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Device-at-home-in-vitro-test) |
| Error | StructureDefinition.url | Values for url differ: 'http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device' vs 'http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Device-at-home-in-vitro-test' |
| Error | StructureDefinition.version | Values for version differ: '7.0.0' vs '1.1.0' |
| Information | StructureDefinition.name | Values for name differ: 'USCoreImplantableDeviceProfile' vs 'DeviceAtHomeInVitroTest' |
| Information | StructureDefinition.title | Values for title differ: 'US Core Implantable Device Profile' vs 'Device - At-Home In-Vitro Test' |
| Information | StructureDefinition.date | Values for date differ: '2023-10-17' vs '2024-08-08T16:46:31+00:00' |
| Information | StructureDefinition.publisher | Values for publisher differ: 'HL7 International / Cross-Group Projects' vs 'HL7 International / Orders and Observations' |
| Information | StructureDefinition.comment | Values for comment differ: 'Some devices may not have UDI information (for example. historical data or patient reported data).' vs 'UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](device-mappings.html#udi) for a complete mapping of UDI parts to Device.' |
| Information | StructureDefinition.short | Values for short differ: 'Mandatory fixed portion of UDI' vs 'LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID V2: OBX-17.1' |
| Information | StructureDefinition.definition | Values for definition differ: 'The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.' vs 'At-Home Test Device identifier. Although most at home test kits will have a single UDI for the 'test kit' (all in one package of reagents, test card/device, etc.) it is possible for at home kits have a resuable 'reader device' which would need a distinct 'equipment id'. In this case, the reader device would have an 'equipment UID' that may be the same for multiple tests performed. For these cases record Equipment UID here, otherwise record Test Kit Name ID here. V2: OBX-17.1' |
| Information | StructureDefinition.short | Values for short differ: 'UDI Issuing Organization' vs 'Organization that issues the UDI for this test. Not included in V2 IG.' |
| Warning | Device.udiCarrier.issuer | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Warning | Device.udiCarrier.carrierHRF | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Warning | Device.distinctIdentifier | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Name of device manufacturer' vs 'LIVD Spreadsheet | LOINC Mapping.Manufacturer' |
| Warning | Device.manufacturer | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | StructureDefinition.short | Values for short differ: 'Date and time of expiry of this device (if applicable)' vs 'Expiration date of the test kit. Not included in V2 IG.' |
| Information | StructureDefinition.short | Values for short differ: 'Lot number of manufacture' vs 'Lot number of the test kit. Not included in V2 IG.' |
| Information | StructureDefinition.short | Values for short differ: 'Serial number assigned by the manufacturer' vs 'Serial number of the test kit. Not included in V2 IG.' |
| Information | Device.deviceName | Element minimum cardinalities differ: '0' vs '1' |
| Warning | Device.type | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | Device.type | Element minimum cardinalities differ: '1' vs '0' |
| Warning | Device.patient | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | Device.patient | Element minimum cardinalities differ: '1' vs '0' |
| Name | Value | Comments | |
|---|---|---|---|
 abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/Device | ||
| copyright | Used by permission of HL7 International, all rights reserved Creative Commons License |
| |
| date | 2023-10-17 | 2024-08-08T16:46:31+00:00 |
|
| description | The US Core Device Profile inherits from the FHIR [Device](https://hl7.org/fhir/R4/device.html) resource; refer to it for scope and usage definitions. This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) *Unique Device Identifier - Implantable* Data Element. It sets minimum expectations for the Device resource to record, search, and fetch UDI information associated with a patient's implantable device(s). It specifies which core elements, extensions, vocabularies, and value sets **SHALL** be present in the resource and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption. | This profile constrains the Device resource for At-Home In-Vitro Tests. |
|
| experimental | false |
| |
| fhirVersion | 4.0.1 | ||
| jurisdiction | |||
 jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | USCoreImplantableDeviceProfile | DeviceAtHomeInVitroTest |
|
| publisher | HL7 International / Cross-Group Projects | HL7 International / Orders and Observations |
|
| purpose | |||
| status | active | ||
| title | US Core Implantable Device Profile | Device - At-Home In-Vitro Test |
|
| type | Device | ||
| url | http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device | http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Device-at-home-in-vitro-test |
|
| version | 7.0.0 | 1.1.0 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 Device | 0..* | Device | Item used in healthcare | 0..* | Device | Item used in healthcare | |||||||||||
 id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
| language | 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| |||||||||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
 extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ?! | 0..* | Extension | Extensions that cannot be ignored | |||||||||
| identifier | 0..* | Identifier | Instance identifier | 0..* | Identifier | Instance identifier | |||||||||||
| definition | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||||||||
 udiCarrier | SΣ | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string | SΣ | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string | |||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| deviceIdentifier | SΣ | 1..1 | string | Mandatory fixed portion of UDI | SΣ | 1..1 | string | LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID V2: OBX-17.1 | |||||||||
| issuer | 0..1 | uri | UDI Issuing Organization | S | 0..1 | uri | Organization that issues the UDI for this test. Not included in V2 IG. |
| |||||||||
| jurisdiction | 0..1 | uri | Regional UDI authority | 0..1 | uri | Regional UDI authority | |||||||||||
| carrierAIDC | Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | |||||||||
| carrierHRF | SΣ | 0..1 | string | UDI Human Readable Barcode String | Σ | 0..1 | string | UDI Human Readable Barcode String |
| ||||||||
| entryType | 0..1 | code | barcode | rfid | manual + Binding: ?? (required): Codes to identify how UDI data was entered. | 0..1 | code | barcode | rfid | manual + Binding: ?? (required): Codes to identify how UDI data was entered. | |||||||||||
| status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: ?? (required): The availability status of the device. | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: ?? (required): The availability status of the device. | |||||||||
| statusReason | 0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: ?? (extensible): The availability status reason of the device. | 0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: ?? (extensible): The availability status reason of the device. | |||||||||||
| distinctIdentifier | S | 0..1 | string | The distinct identification string | 0..1 | string | The distinct identification string |
| |||||||||
| manufacturer | 0..1 | string | Name of device manufacturer | S | 0..1 | string | LIVD Spreadsheet | LOINC Mapping.Manufacturer |
| |||||||||
| manufactureDate | S | 0..1 | dateTime | Date when the device was made | S | 0..1 | dateTime | Date when the device was made | |||||||||
| expirationDate | S | 0..1 | dateTime | Date and time of expiry of this device (if applicable) | S | 0..1 | dateTime | Expiration date of the test kit. Not included in V2 IG. | |||||||||
| lotNumber | S | 0..1 | string | Lot number of manufacture | S | 0..1 | string | Lot number of the test kit. Not included in V2 IG. | |||||||||
| serialNumber | S | 0..1 | string | Serial number assigned by the manufacturer | S | 0..1 | string | Serial number of the test kit. Not included in V2 IG. | |||||||||
| deviceName | 0..* | BackboneElement | The name of the device as given by the manufacturer | 1..* | BackboneElement | The name of the device as given by the manufacturer Slice: Unordered, Open by value:type |
| ||||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| name | 1..1 | string | The name of the device | 1..1 | string | The name of the device | |||||||||||
| type | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: ?? (required): The type of name the device is referred by. | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: ?? (required): The type of name the device is referred by. | |||||||||||
| modelNumber | 0..1 | string | The model number for the device | 0..1 | string | The model number for the device | |||||||||||
| partNumber | 0..1 | string | The part number of the device | 0..1 | string | The part number of the device | |||||||||||
| type | S | 1..1 | CodeableConcept | The kind or type of device Binding: ?? (extensible): Codes to identify medical devices | 0..1 | CodeableConcept | The kind or type of device Binding: ?? (example): Codes to identify medical devices. |
| |||||||||
| specialization | 0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | 0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | |||||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| systemType | 1..1 | CodeableConcept | The standard that is used to operate and communicate | 1..1 | CodeableConcept | The standard that is used to operate and communicate | |||||||||||
| version | 0..1 | string | The version of the standard that is used to operate and communicate | 0..1 | string | The version of the standard that is used to operate and communicate | |||||||||||
| version | 0..* | BackboneElement | The actual design of the device or software version running on the device | 0..* | BackboneElement | The actual design of the device or software version running on the device | |||||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| type | 0..1 | CodeableConcept | The type of the device version | 0..1 | CodeableConcept | The type of the device version | |||||||||||
| component | 0..1 | Identifier | A single component of the device version | 0..1 | Identifier | A single component of the device version | |||||||||||
| value | 1..1 | string | The version text | 1..1 | string | The version text | |||||||||||
| property | 0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | 0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | |||||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| type | 1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | 1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |||||||||||
| valueQuantity | 0..* | Quantity | Property value as a quantity | 0..* | Quantity | Property value as a quantity | |||||||||||
| valueCode | 0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | 0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | |||||||||||
| patient | S | 1..1 | Reference(US Core Patient Profile) | Patient to whom Device is affixed | 0..1 | Reference(Patient) | Patient to whom Device is affixed |
| |||||||||
| owner | 0..1 | Reference(Organization) | Organization responsible for device | 0..1 | Reference(Organization) | Organization responsible for device | |||||||||||
| contact | 0..* | ContactPoint | Details for human/organization for support | 0..* | ContactPoint | Details for human/organization for support | |||||||||||
| location | 0..1 | Reference(Location) | Where the device is found | 0..1 | Reference(Location) | Where the device is found | |||||||||||
| url | 0..1 | uri | Network address to contact device | 0..1 | uri | Network address to contact device | |||||||||||
| note | 0..* | Annotation | Device notes and comments | 0..* | Annotation | Device notes and comments | |||||||||||
| safety | Σ | 0..* | CodeableConcept | Safety Characteristics of Device | Σ | 0..* | CodeableConcept | Safety Characteristics of Device | |||||||||
| parent | 0..1 | Reference(Device) | The parent device | 0..1 | Reference(Device) | The parent device | |||||||||||
| Documentation for this format | |||||||||||||||||