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: '5.0.1' vs '1.0.0-ballot' |
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: '2022-04-20' vs '2022-08-08T23:58:46+00:00' |
Information | StructureDefinition.publisher | Values for publisher differ: 'HL7 International - Cross-Group Projects' vs 'Orders and Observations' |
Warning | Device | Elements differ in definition: '\-' vs 'A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.' |
Warning | Device.udiCarrier | Elements differ in comments: '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] for a complete mapping of UDI parts to Device.' |
Warning | Device.udiCarrier.deviceIdentifier | Elements differ in short: 'Mandatory fixed portion of UDI' vs 'LIVD Spreadsheet | LOINC Mapping.Testkit Name ID' |
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' |
Warning | Device.manufacturer | Elements differ in short: 'Name of device manufacturer' vs 'LIVD Spreadsheet | LOINC Mapping.Manufacturer' |
Warning | Device.manufacturer | Elements differ in definition for mustSupport: 'false' vs 'true' |
Warning | Device.manufactureDate | Elements differ in definition for mustSupport: 'true' vs 'false' |
Warning | Device.expirationDate | Elements differ in short: 'Date and time of expiry of this device (if applicable)' vs 'Expiration date of the test kit' |
Warning | Device.lotNumber | Elements differ in short: 'Lot number of manufacture' vs 'Lot number of the test kit' |
Warning | Device.serialNumber | Elements differ in short: 'Serial number assigned by the manufacturer' vs 'Serial number of the test kit' |
Warning | Device.deviceName | Elements differ in short: 'The name of the device as given by the manufacturer' vs 'LIVD Spreadsheet | LOINC Mapping.Model' |
Warning | Device.deviceName | Elements differ in definition for mustSupport: 'false' vs 'true' |
Information | Device.deviceName | Element maximum cardinalities differ: '2147483647' vs '1' |
Warning | Device.deviceName.type | Elements differ in definition for mustSupport: 'false' vs 'true' |
Warning | Device.type | Elements differ in definition for mustSupport: 'true' vs 'false' |
Information | Device.type | Element minimum cardinalities differ: '1' vs '0' |
Warning | Device.type | Elements differ in binding.description: 'Codes to identify medical devices' vs 'Codes to identify medical devices.' |
Warning | Device.patient | Elements differ in definition for mustSupport: 'true' vs 'false' |
Information | Device.patient | Element minimum cardinalities differ: '1' vs '0' |
Warning | Device.owner | Elements differ in definition for mustSupport: 'false' vs 'true' |
Name | Value | Comments | |
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![]() | false | ||
![]() | http://hl7.org/fhir/StructureDefinition/Device | ||
![]() | Used by permission of HL7 International, all rights reserved Creative Commons License |
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![]() | 2022-04-20 | 2022-08-08T23:58:46+00:00 |
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![]() | The US Core Implantable Device Profile is based upon the core FHIR Device Resource and meets the U.S. Core Data for Interoperability (USCDI) v2 ‘Unique Device Identifier(s) for a Patient’s Implantable Device(s)’ requirements. To promote interoperability and adoption through common implementation, this profile sets minimum expectations for the Device resource to record, search, and fetch UDI information associated with a patient's implantable device(s). It identifies which core elements, extensions, vocabularies and value sets **SHALL** be present in the resource when using this profile. It provides the floor for standards development for specific uses cases. | This profile constrains the Device resource for At-Home In-Vitro Tests. |
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![]() | false |
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![]() | 4.0.1 | ||
![]() | |||
![]() ![]() | urn:iso:std:iso:3166#US | ||
![]() | resource | ||
![]() | USCoreImplantableDeviceProfile | DeviceAtHomeInVitroTest |
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![]() | HL7 International - Cross-Group Projects | Orders and Observations |
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![]() | |||
![]() | active | ||
![]() | US Core Implantable Device Profile | Device - At-Home In-Vitro Test |
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![]() | Device | ||
![]() | 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 |
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![]() | 5.0.1 | 1.0.0-ballot |
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Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | L Type | L Description & Constraints | Comments![]() | ||||||||
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![]() ![]() | 0..* | Device | Item used in healthcare | 0..* | Device | Item used in healthcare |
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![]() ![]() ![]() | Σ | 0..1 | string | Logical id of this artifact | Σ | 0..1 | string | Logical id of this artifact | |||||||||
![]() ![]() ![]() | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
![]() ![]() ![]() | ?!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 | |||||||||
![]() ![]() ![]() | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
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![]() ![]() ![]() | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
![]() ![]() ![]() | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
![]() ![]() ![]() | ?! | 0..* | Extension | Extensions that cannot be ignored | ?! | 0..* | Extension | Extensions that cannot be ignored | |||||||||
![]() ![]() ![]() | 0..* | Identifier | Instance identifier | 0..* | Identifier | Instance identifier | |||||||||||
![]() ![]() ![]() | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||||||||
![]() ![]() ![]() | SΣ | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string | SΣ | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string |
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![]() ![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
![]() ![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
![]() ![]() ![]() ![]() | SΣ | 1..1 | string | Mandatory fixed portion of UDI | SΣ | 1..1 | string | LIVD Spreadsheet | LOINC Mapping.Testkit Name ID |
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![]() ![]() ![]() ![]() | 0..1 | uri | UDI Issuing Organization | S | 0..1 | uri | UDI Issuing Organization |
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![]() ![]() ![]() ![]() | 0..1 | uri | Regional UDI authority | 0..1 | uri | Regional UDI authority | |||||||||||
![]() ![]() ![]() ![]() | Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | |||||||||
![]() ![]() ![]() ![]() | SΣ | 0..1 | string | UDI Human Readable Barcode String | Σ | 0..1 | string | UDI Human Readable Barcode String |
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![]() ![]() ![]() ![]() | 0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | 0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | |||||||||||
![]() ![]() ![]() | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | |||||||||
![]() ![]() ![]() | 0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device. | 0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device. | |||||||||||
![]() ![]() ![]() | S | 0..1 | string | The distinct identification string | 0..1 | string | The distinct identification string |
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![]() ![]() ![]() | 0..1 | string | Name of device manufacturer | S | 0..1 | string | LIVD Spreadsheet | LOINC Mapping.Manufacturer |
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![]() ![]() ![]() | S | 0..1 | dateTime | Date when the device was made | 0..1 | dateTime | Date when the device was made |
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![]() ![]() ![]() | S | 0..1 | dateTime | Date and time of expiry of this device (if applicable) | S | 0..1 | dateTime | Expiration date of the test kit |
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![]() ![]() ![]() | S | 0..1 | string | Lot number of manufacture | S | 0..1 | string | Lot number of the test kit |
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![]() ![]() ![]() | S | 0..1 | string | Serial number assigned by the manufacturer | S | 0..1 | string | Serial number of the test kit |
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![]() ![]() ![]() | 0..* | BackboneElement | The name of the device as given by the manufacturer | S | 0..1 | BackboneElement | LIVD Spreadsheet | LOINC Mapping.Model |
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![]() ![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
![]() ![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
![]() ![]() ![]() ![]() | 1..1 | string | The name of the device | 1..1 | string | The name of the device | |||||||||||
![]() ![]() ![]() ![]() | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by. | S | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by. Fixed Value: manufacturer-name |
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![]() ![]() ![]() | 0..1 | string | The model number for the device | 0..1 | string | The model number for the device | |||||||||||
![]() ![]() ![]() | 0..1 | string | The part number of the device | 0..1 | string | The part number of the device | |||||||||||
![]() ![]() ![]() | S | 1..1 | CodeableConcept | The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices | 0..1 | CodeableConcept | The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. |
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![]() ![]() ![]() | 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 | |||||||||||
![]() ![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
![]() ![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
![]() ![]() ![]() ![]() | 1..1 | CodeableConcept | The standard that is used to operate and communicate | 1..1 | CodeableConcept | The standard that is used to operate and communicate | |||||||||||
![]() ![]() ![]() ![]() | 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 | |||||||||||
![]() ![]() ![]() | 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 | |||||||||||
![]() ![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
![]() ![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
![]() ![]() ![]() ![]() | 0..1 | CodeableConcept | The type of the device version | 0..1 | CodeableConcept | The type of the device version | |||||||||||
![]() ![]() ![]() ![]() | 0..1 | Identifier | A single component of the device version | 0..1 | Identifier | A single component of the device version | |||||||||||
![]() ![]() ![]() ![]() | 1..1 | string | The version text | 1..1 | string | The version text | |||||||||||
![]() ![]() ![]() | 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 | |||||||||||
![]() ![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
![]() ![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
![]() ![]() ![]() ![]() | 1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | 1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |||||||||||
![]() ![]() ![]() ![]() | 0..* | Quantity | Property value as a quantity | 0..* | Quantity | Property value as a quantity | |||||||||||
![]() ![]() ![]() ![]() | 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) | |||||||||||
![]() ![]() ![]() | S | 1..1 | Reference(US Core Patient Profile) | Patient to whom Device is affixed | 0..1 | Reference(Patient) | Patient to whom Device is affixed |
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![]() ![]() ![]() | 0..1 | Reference(Organization) | Organization responsible for device | S | 0..1 | Reference(US Core Organization Profile) | Organization responsible for device |
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![]() ![]() ![]() | 0..* | ContactPoint | Details for human/organization for support | 0..* | ContactPoint | Details for human/organization for support | |||||||||||
![]() ![]() ![]() | 0..1 | Reference(Location) | Where the device is found | 0..1 | Reference(Location) | Where the device is found | |||||||||||
![]() ![]() ![]() | 0..1 | uri | Network address to contact device | 0..1 | uri | Network address to contact device | |||||||||||
![]() ![]() ![]() | 0..* | Annotation | Device notes and comments | 0..* | Annotation | Device notes and comments | |||||||||||
![]() ![]() ![]() | Σ | 0..* | CodeableConcept | Safety Characteristics of Device | Σ | 0..* | CodeableConcept | Safety Characteristics of Device | |||||||||
![]() ![]() ![]() | 0..1 | Reference(Device) | The parent device | 0..1 | Reference(Device) | The parent device | |||||||||||
![]() |