| Left: | Device - Performer or Observer (IPS) (http://hl7.org/fhir/uv/ips/StructureDefinition/Device-observer-uv-ips) |
| Right: | US Core Device Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-device) |
| Error | StructureDefinition.url | Values for url differ: 'http://hl7.org/fhir/uv/ips/StructureDefinition/Device-observer-uv-ips' vs 'http://hl7.org/fhir/us/core/StructureDefinition/us-core-device' |
| Error | StructureDefinition.version | Values for version differ: '2.0.0' vs '9.0.0-ballot' |
| Information | StructureDefinition.name | Values for name differ: 'DeviceObserverUvIps' vs 'USCoreDeviceProfile' |
| Information | StructureDefinition.title | Values for title differ: 'Device - Performer or Observer (IPS)' vs 'US Core Device Profile' |
| Information | StructureDefinition.date | Values for date differ: '2024-06-19T10:50:07-05:00' vs '2023-10-17' |
| Information | StructureDefinition.publisher | Values for publisher differ: 'HL7 International / Patient Care' vs 'HL7 International / Cross-Group Projects' |
| Information | StructureDefinition.jurisdiction | Removed the item 'http://unstats.un.org/unsd/methods/m49/m49.htm#001' |
| Information | StructureDefinition.jurisdiction | Added the item 'urn:iso:std:iso:3166#US' |
| Warning | Device.identifier | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Unique Device Identifier (UDI) Barcode string' vs '𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string' |
| Information | StructureDefinition.comment | Values for comment differ: '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.' vs 'Some devices may not have UDI information (for example. historical data or patient reported data).' |
| Information | Device.udiCarrier | Element maximum cardinalities differ: '2147483647' vs '1' |
| Warning | Device.udiCarrier.deviceIdentifier | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | Device.udiCarrier.deviceIdentifier | Element minimum cardinalities differ: '0' vs '1' |
| Warning | Device.udiCarrier.carrierHRF | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | StructureDefinition.short | Values for short differ: 'The distinct identification string' vs '𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string' |
| Warning | Device.manufacturer | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'Date when the device was made' vs '𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made' |
| Information | StructureDefinition.short | Values for short differ: 'Date and time of expiry of this device (if applicable)' vs '𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)' |
| Information | StructureDefinition.short | Values for short differ: 'Lot number of manufacture' vs '𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture' |
| Information | StructureDefinition.short | Values for short differ: 'Serial number assigned by the manufacturer' vs '𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer' |
| Warning | Device.modelNumber | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Warning | Device.type | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | Device.type | Element minimum cardinalities differ: '0' vs '1' |
| Warning | Device.patient | Elements differ in definition for mustSupport: 'false' vs 'true' |
| 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 | 2024-06-19T10:50:07-05:00 | 2023-10-17 |
|
description | This profile represents the constraints applied to the Device resource by the IPS project, which specifies an international patient summary based on the FHIR standard R4. This profile describes a device that plays the role of observer or performer. | 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. It sets minimum expectations for the Device resource to record, search, and fetch medical and non-medical devices (for example, software or crutches). This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) *Medical Device* Data Class, including FDA Unique Device Identification (UDI) information associated with a patient's medical 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 and provides the floor for standards development for specific use cases promotes interoperability and adoption. |
|
experimental | false |
| |
fhirVersion | 4.0.1 | ||
jurisdiction | |||
![]() jurisdiction[0] | http://unstats.un.org/unsd/methods/m49/m49.htm#001 |
| |
![]() jurisdiction[1] | urn:iso:std:iso:3166#US |
| |
kind | resource | ||
name | DeviceObserverUvIps | USCoreDeviceProfile |
|
publisher | HL7 International / Patient Care | HL7 International / Cross-Group Projects |
|
purpose | This profile constrains the representation of a device acting as observer in the international patient summary as specified by the IPS project. |
| |
status | active | ||
title | Device - Performer or Observer (IPS) | US Core Device Profile |
|
type | Device | ||
url | http://hl7.org/fhir/uv/ips/StructureDefinition/Device-observer-uv-ips | http://hl7.org/fhir/us/core/StructureDefinition/us-core-device |
|
version | 2.0.0 | 9.0.0-ballot |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments![]() | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
![]() | 0..* | Device | Item used in healthcare | 0..* | Device | Item used in healthcare | |||||||||||
![]() ![]() | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | 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: ?? (preferred): A human language.
| 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| |||||||||||
![]() ![]() | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||||||||
![]() ![]() | 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 | |||||||||
![]() ![]() | SO | 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 | |||||||||||
![]() ![]() | Σ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string | Σ | 0..1 | BackboneElement | 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string |
| ||||||||
![]() ![]() ![]() | 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 | |||||||||
![]() ![]() ![]() | Σ | 0..1 | string | Mandatory fixed portion of UDI | SΣ | 1..1 | string | Mandatory fixed portion of UDI |
| ||||||||
![]() ![]() ![]() | 0..1 | uri | UDI Issuing Organization | 0..1 | uri | UDI Issuing Organization | |||||||||||
![]() ![]() ![]() | 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 | |||||||||
![]() ![]() ![]() | Σ | 0..1 | string | UDI Human Readable Barcode String | SΣ | 0..1 | string | UDI Human Readable Barcode String |
| ||||||||
![]() ![]() ![]() | 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. | |||||||||||
![]() ![]() | ?!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. | |||||||||
![]() ![]() | 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. | |||||||||||
![]() ![]() | 0..1 | string | The distinct identification string | 0..1 | string | 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string | |||||||||||
![]() ![]() | SO | 0..1 | string | Name of device manufacturer
| 0..1 | string | Name of device manufacturer |
| |||||||||
![]() ![]() | 0..1 | dateTime | Date when the device was made | 0..1 | dateTime | 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made | |||||||||||
![]() ![]() | 0..1 | dateTime | Date and time of expiry of this device (if applicable) | 0..1 | dateTime | 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable) | |||||||||||
![]() ![]() | 0..1 | string | Lot number of manufacture | 0..1 | string | 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture | |||||||||||
![]() ![]() | 0..1 | string | Serial number assigned by the manufacturer | 0..1 | string | 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer | |||||||||||
![]() ![]() | 0..* | BackboneElement | The name of the device as given by the manufacturer | 0..* | BackboneElement | The name of the device as given by the manufacturer | |||||||||||
![]() ![]() ![]() | 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: ?? (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. | |||||||||||
![]() ![]() | SO | 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 | |||||||||||
![]() ![]() | 0..1 | CodeableConcept | The kind or type of device Binding: ?? (example): Codes to identify medical devices. | S | 1..1 | CodeableConcept | The kind or type of device Binding: ?? (extensible): Codes to identify medical devices |
| |||||||||
![]() ![]() | 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) | |||||||||||
![]() ![]() | 0..1 | Reference(Patient) | Patient to whom Device is affixed | S | 0..1 | Reference(US Core Patient Profile) | Patient to whom Device is affixed |
| |||||||||
![]() ![]() | 0..1 | Reference(Organization) | Organization responsible for device | 0..1 | Reference(Organization) | Organization responsible for device | |||||||||||
![]() ![]() | 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 | |||||||||||
Documentation for this format | |||||||||||||||||