Left: | US Core Implantable Device Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device) |
Right: | US Core Implantable Device Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device) |
Error | StructureDefinition.version | Values for version differ: '3.1.1' vs '7.0.0' |
Information | StructureDefinition.date | Values for date differ: '2019-09-17' vs '2023-10-17' |
Information | StructureDefinition.publisher | Values for publisher differ: 'HL7 US Realm Steering Committee' vs 'HL7 International / Cross-Group Projects' |
Information | StructureDefinition.definition | Values for definition differ: 'The US Core Implantable Device Profile is based upon the core FHIR Device Resource and created to meet the 2015 Edition Common Clinical Data Set 'Unique device identifier(s) for a patient’s implantable device(s)' requirements.' 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.carrierAIDC | Elements differ in definition for mustSupport: 'true' vs 'false' |
Name | Value | Comments | |
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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 | 2019-09-17 | 2023-10-17 |
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description | Defines constraints and extensions on the Device resource for the minimal set of data to query and retrieve a patient's implantable device(s). | 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. |
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experimental | false | ||
fhirVersion | 4.0.1 | ||
jurisdiction | |||
jurisdiction[0] | urn:iso:std:iso:3166#US | ||
kind | resource | ||
name | USCoreImplantableDeviceProfile | ||
publisher | HL7 US Realm Steering Committee | HL7 International / Cross-Group Projects |
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purpose | |||
status | active | ||
title | US Core Implantable Device Profile | ||
type | Device | ||
url | http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device | ||
version | 3.1.1 | 7.0.0 |
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Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Device | C | 0..* | Device | Item used in healthcare us-core-12: Implantable medical devices that have UDI information SHALL represent this information in either carrierAIDC or carrierHRF. us-core-9: For implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) SHALL be present. | 0..* | Device | Item used in healthcare | ||||||||||
id | Σ | 0..1 | string | 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 | 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 | SΣC | 0..1 | base64Binary | UDI Machine Readable Barcode String | Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String |
| ||||||||
carrierHRF | SΣC | 0..1 | string | UDI Human Readable Barcode String | SΣ | 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 | SC | 0..1 | string | The distinct identification string | S | 0..1 | string | The distinct identification string | |||||||||
manufacturer | 0..1 | string | Name of device manufacturer | 0..1 | string | Name of device manufacturer | |||||||||||
manufactureDate | SC | 0..1 | dateTime | Date when the device was made | S | 0..1 | dateTime | Date when the device was made | |||||||||
expirationDate | SC | 0..1 | dateTime | Date and time of expiry of this device (if applicable) | S | 0..1 | dateTime | Date and time of expiry of this device (if applicable) | |||||||||
lotNumber | SC | 0..1 | string | Lot number of manufacture | S | 0..1 | string | Lot number of manufacture | |||||||||
serialNumber | SC | 0..1 | string | Serial number assigned by the manufacturer | S | 0..1 | string | Serial number assigned by the manufacturer | |||||||||
deviceName | 0..* | BackboneElement | The name of the device as given by the manufacturer | 0..* | BackboneElement | The name of the device as given by the manufacturer | |||||||||||
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 | S | 1..1 | CodeableConcept | The kind or type of device Binding: ?? (extensible): 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 | S | 1..1 | Reference(US Core Patient Profile) | 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 |