Profile Comparison between http://hl7.org/fhir/us/core/StructureDefinition/us-core-device vs http://hl7.org/fhir/us/davinci-pdex/StructureDefinition/pdex-device

Messages

Metadata

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	2026-11-06T14:49:18+00:00	Values Differ
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. 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.	The PDex Device profile is provided to enable payers to record information about devices used by a member that may not have a UDI number. FHIR-29796 PDex Device uses base resource not US Core Implantable Device Profile. Pdex-Device enables payers to record non-implantable device data. CGP Voted on variance approval: Drew Torres/Eric Haas: 9-0-0	Values Differ
experimental	false	true	Values Differ
fhirVersion	4.0.1
jurisdiction
jurisdiction / jurisdiction[0]	urn:iso:std:iso:3166#US
kind	resource
name	USCoreDeviceProfile	PdexDevice	Values Differ
publisher	HL7 International / Cross-Group Projects	HL7 International / Financial Management	Values Differ
purpose
status	active
title	US Core Device Profile	PDex Device	Values Differ
type	Device
url	http://hl7.org/fhir/us/core/StructureDefinition/us-core-device	http://hl7.org/fhir/us/davinci-pdex/StructureDefinition/pdex-device	Values Differ
version	9.0.0	2.2.1	Values Differ

Structure

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
Device.id	Σ This element is included in summaries.	0..1	id	Logical id of this artifact	Σ This element is included in summaries.	0..1	id	Logical id of this artifact
Device.meta	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource
Device.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Device.language		0..1	code	Language of the resource content Binding: ?? (preferred): A human language. Additional Bindings Purpose ?? Max Binding		0..1	code	Language of the resource content Binding: ?? (preferred): A human language. Additional Bindings Purpose ?? Max Binding
Device.text		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
Device.contained		0..*	Resource	Contained, inline Resources		0..*	Resource	Contained, inline Resources
Device.extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
Device.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Device.identifier		0..*	Identifier	Instance identifier		0..*	Identifier	Instance identifier
Device.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
Device.udiCarrier	Σ This element is included in summaries.	0..1	BackboneElement	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string	S This element must be supported. Σ This element is included in summaries.	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string	Elements differ in definition for mustSupport: 'false' vs 'true'
Device.udiCarrier.id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
Device.udiCarrier.extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
Device.udiCarrier.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.udiCarrier.deviceIdentifier	S This element must be supported. Σ This element is included in summaries.	1..1	string	Mandatory fixed portion of UDI	S This element must be supported. Σ This element is included in summaries.	1..1	string	Mandatory fixed portion of UDI
Device.udiCarrier.issuer		0..1	uri	UDI Issuing Organization		0..1	uri	UDI Issuing Organization
Device.udiCarrier.jurisdiction		0..1	uri	Regional UDI authority		0..1	uri	Regional UDI authority
Device.udiCarrier.carrierAIDC	Σ This element is included in summaries.	0..1	base64Binary	UDI Machine Readable Barcode String	S This element must be supported. Σ This element is included in summaries.	0..1	base64Binary	UDI Machine Readable Barcode String	Elements differ in definition for mustSupport: 'false' vs 'true'
Device.udiCarrier.carrierHRF	S This element must be supported. Σ This element is included in summaries.	0..1	string	UDI Human Readable Barcode String	S This element must be supported. Σ This element is included in summaries.	0..1	string	UDI Human Readable Barcode String
Device.udiCarrier.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.
Device.status	?! This element is a modifier element. Σ This element is included in summaries.	0..1	code	active | inactive | entered-in-error | unknown Binding: ?? (required): The availability status of the device.	?! This element is a modifier element. S This element must be supported. Σ This element is included in summaries.	0..1	code	active | inactive | entered-in-error | unknown Binding: ?? (required)	Elements differ in definition for mustSupport: 'false' vs 'true'
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.
Device.distinctIdentifier		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string	S This element must be supported.	0..1	string	The distinct identification string	Elements differ in definition for mustSupport: 'false' vs 'true'
Device.manufacturer		0..1	string	Name of device manufacturer		0..1	string	Name of device manufacturer
Device.manufactureDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made		0..1	dateTime	Date when the device was made
Device.expirationDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)	S This element must be supported.	0..1	dateTime	Date and time of expiry of this device (if applicable)	Elements differ in definition for mustSupport: 'false' vs 'true'
Device.lotNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture	S This element must be supported.	0..1	string	Lot number of manufacture	Elements differ in definition for mustSupport: 'false' vs 'true'
Device.serialNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer	S This element must be supported.	0..1	string	Serial number assigned by the manufacturer	Elements differ in definition for mustSupport: 'false' vs 'true'
Device.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
Device.deviceName.id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
Device.deviceName.extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
Device.deviceName.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.deviceName.name		1..1	string	The name of the device		1..1	string	The name of the device
Device.deviceName.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.
Device.modelNumber		0..1	string	The model number for the device		0..1	string	The model number for the device
Device.partNumber		0..1	string	The part number of the device		0..1	string	The part number of the device
Device.type	S This element must be supported.	1..1	CodeableConcept	The kind or type of device Binding: ?? (extensible): Codes to identify medical devices	S This element must be supported.	1..1	CodeableConcept	The kind or type of device Binding: ?? (extensible)
Device.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
Device.specialization.id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
Device.specialization.extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
Device.specialization.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.specialization.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
Device.specialization.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
Device.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
Device.version.id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
Device.version.extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
Device.version.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.version.type		0..1	CodeableConcept	The type of the device version		0..1	CodeableConcept	The type of the device version
Device.version.component		0..1	Identifier	A single component of the device version		0..1	Identifier	A single component of the device version
Device.version.value		1..1	string	The version text		1..1	string	The version text
Device.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
Device.property.id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
Device.property.extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
Device.property.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.property.type		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
Device.property.valueQuantity		0..*	Quantity	Property value as a quantity		0..*	Quantity	Property value as a quantity
Device.property.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)
Device.patient	S This element must be supported.	0..1	Reference(US Core Patient Profile(7.0.0))	Patient to whom Device is assigned	S This element must be supported.	1..1	Reference(US Core Patient Profile(7.0.0))	Patient to whom Device is affixed	Element minimum cardinalities differ: '0' vs '1'
Device.owner		0..1	Reference(Organization)	Organization responsible for device		0..1	Reference(Organization)	Organization responsible for device
Device.contact		0..*	ContactPoint	Details for human/organization for support		0..*	ContactPoint	Details for human/organization for support
Device.location		0..1	Reference(Location)	Where the device is found		0..1	Reference(Location)	Where the device is found
Device.url		0..1	uri	Network address to contact device	S This element must be supported.	0..1	uri	Network address to contact device	Elements differ in definition for mustSupport: 'false' vs 'true'
Device.note		0..*	Annotation	Device notes and comments		0..*	Annotation	Device notes and comments
Device.safety	Σ This element is included in summaries.	0..*	CodeableConcept	Safety Characteristics of Device	Σ This element is included in summaries.	0..*	CodeableConcept	Safety Characteristics of Device
Device.parent		0..1	Reference(Device)	The parent device		0..1	Reference(Device)	The parent device
Documentation for this format