| Left: | US Core Implantable Device Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device) | 
| Right: | CQFM Device (http://hl7.org/fhir/us/cqfmeasures/StructureDefinition/device-softwaresystem-cqfm) | 
| Error | StructureDefinition.url | Values for url differ: 'http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device' vs 'http://hl7.org/fhir/us/cqfmeasures/StructureDefinition/device-softwaresystem-cqfm' | 
| Error | StructureDefinition.version | Values for version differ: '7.0.0' vs '4.0.0' | 
| Information | StructureDefinition.name | Values for name differ: 'USCoreImplantableDeviceProfile' vs 'CQFMDevice' | 
| Information | StructureDefinition.title | Values for title differ: 'US Core Implantable Device Profile' vs 'CQFM Device' | 
| Information | StructureDefinition.date | Values for date differ: '2023-10-17' vs '2024-11-04T20:11:26+00:00' | 
| Information | StructureDefinition.publisher | Values for publisher differ: 'HL7 International / Cross-Group Projects' vs 'HL7 International / Clinical Quality Information' | 
| 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](http://hl7.org/fhir/R4/device-mappings.html#udi) for a complete mapping of UDI parts to Device.' | 
| Warning | Device.udiCarrier | Elements differ in definition for mustSupport: 'true' vs 'false' | 
| Information | Device.udiCarrier | Element maximum cardinalities differ: '1' vs '2147483647' | 
| Warning | Device.udiCarrier.deviceIdentifier | Elements differ in definition for mustSupport: 'true' vs 'false' | 
| Information | Device.udiCarrier.deviceIdentifier | Element minimum cardinalities differ: '1' vs '0' | 
| 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 'The developers of the Software System' | 
| Warning | Device.manufactureDate | Elements differ in definition for mustSupport: 'true' vs 'false' | 
| Warning | Device.expirationDate | Elements differ in definition for mustSupport: 'true' vs 'false' | 
| Warning | Device.lotNumber | Elements differ in definition for mustSupport: 'true' vs 'false' | 
| Warning | Device.serialNumber | Elements differ in definition for mustSupport: 'true' vs 'false' | 
| Information | StructureDefinition.short | Values for short differ: 'The name of the device as given by the manufacturer' vs 'The name of the software' | 
| Information | Device.deviceName | Element minimum cardinalities differ: '0' vs '1' | 
| Information | Device.deviceName | Element maximum cardinalities differ: '2147483647' vs '1' | 
| Information | StructureDefinition.short | Values for short differ: 'The kind or type of device' vs 'authoring | testing | tooling | evaluation | reporting | data-capture' | 
| Warning | Device.type | Elements differ in definition for mustSupport: 'true' vs 'false' | 
| Information | Device.type | Element minimum cardinalities differ: '1' vs '0' | 
| Information | Device.version | Element maximum cardinalities differ: '2147483647' vs '1' | 
| Information | Device.version.type | Element maximum cardinalities differ: '1' vs '0' | 
| Information | Device.version.component | Element maximum 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 | 2024-11-04T20:11:26+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. | The SoftwareSystem device profile is used to capture software details about the various systems used in authoring, testing, packaging, or evaluation of a knowledge artifact | 
 | 
|  experimental | false | ||
|  fhirVersion | 4.0.1 | ||
|  jurisdiction | |||
|   jurisdiction[0] | urn:iso:std:iso:3166#US | ||
|  kind | resource | ||
|  name | USCoreImplantableDeviceProfile | CQFMDevice | 
 | 
|  publisher | HL7 International / Cross-Group Projects | HL7 International / Clinical Quality Information | 
 | 
|  purpose | |||
|  status | active | ||
|  title | US Core Implantable Device Profile | CQFM Device | 
 | 
|  type | Device | ||
|  url | http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device | http://hl7.org/fhir/us/cqfmeasures/StructureDefinition/device-softwaresystem-cqfm | 
 | 
|  version | 7.0.0 | 4.0.0 | 
 | 
| 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 | Σ | 0..* | 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 | Σ | 0..1 | string | Mandatory fixed portion of UDI | 
 | ||||||||
|     issuer | 0..1 | uri | UDI Issuing Organization | 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 | 
 | |||||||||
|    manufacturer | 0..1 | string | Name of device manufacturer | 0..1 | string | The developers of the Software System | |||||||||||
|    manufactureDate | S | 0..1 | dateTime | Date when the device was made | 0..1 | dateTime | Date when the device was made | 
 | |||||||||
|    expirationDate | S | 0..1 | dateTime | Date and time of expiry of this device (if applicable) | 0..1 | dateTime | Date and time of expiry of this device (if applicable) | 
 | |||||||||
|    lotNumber | S | 0..1 | string | Lot number of manufacture | 0..1 | string | Lot number of manufacture | 
 | |||||||||
|    serialNumber | S | 0..1 | string | Serial number assigned by the manufacturer | 0..1 | string | Serial number assigned by the manufacturer | 
 | |||||||||
|    deviceName | 0..* | BackboneElement | The name of the device as given by the manufacturer | 1..1 | BackboneElement | The name of the software | 
 | ||||||||||
|     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. Fixed Value: manufacturer-name | |||||||||||
|    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 | authoring | testing | tooling | evaluation | reporting | data-capture Binding: ?? (extensible): The software system type | 
 | |||||||||
|    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..1 | 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..0 | 
 | ||||||||||||
|     component | 0..1 | Identifier | A single component of the device version | 0..0 | 
 | ||||||||||||
|     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 | |||||||||||||||||