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: '6.0.0-ballot' vs '1.0.0' |
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: '2022-04-20' vs '2023-03-25T16:46:40+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 or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID' |
Warning | Device.udiCarrier.deviceIdentifier | Elements differ in definition: '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 '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.' |
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.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' |
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.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' |
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 |
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date | 2022-04-20 | 2023-03-25T16:46:40+00:00 |
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description | 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 use cases. | This profile constrains the Device resource for At-Home In-Vitro Tests. |
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experimental | false |
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fhirVersion | 4.0.1 | ||
jurisdiction | |||
jurisdiction[0] | urn:iso:std:iso:3166#US | ||
kind | resource | ||
name | USCoreImplantableDeviceProfile | DeviceAtHomeInVitroTest |
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publisher | HL7 International - Cross-Group Projects | Orders and Observations |
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purpose | |||
status | active | ||
title | US Core Implantable Device Profile | Device - At-Home In-Vitro Test |
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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 |
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version | 6.0.0-ballot | 1.0.0 |
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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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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 |
| ||||||||
issuer | 0..1 | uri | UDI Issuing Organization | S | 0..1 | uri | UDI Issuing Organization |
| |||||||||
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 |
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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 |
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lotNumber | S | 0..1 | string | Lot number of manufacture | S | 0..1 | string | Lot number of the test kit |
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serialNumber | S | 0..1 | string | Serial number assigned by the manufacturer | S | 0..1 | string | Serial number of the test kit |
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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 |
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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 |
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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 |