Left: | Argonaut Device Profile (http://fhir.org/guides/argonaut/StructureDefinition/argo-device) |
Right: | US Core Implantable Device Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device) |
Error | StructureDefinition.url | Values for url differ: 'http://fhir.org/guides/argonaut/StructureDefinition/argo-device' vs 'http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device' |
Information | StructureDefinition.name | Values for name differ: 'Argonaut Device Profile' vs 'USCoreImplantableDeviceProfile' |
Information | StructureDefinition.status | Values for status differ: 'draft' vs 'active' |
Information | StructureDefinition.date | Values for date differ: '2016-10-18T00:00:00+11:00' vs '2022-04-20' |
Information | StructureDefinition.publisher | Values for publisher differ: 'Argonaut Project' vs 'HL7 International - Cross-Group Projects' |
Information | StructureDefinition.jurisdiction | Added the item 'urn:iso:std:iso:3166#US' |
Warning | StructureDefinition.fhirVersion | Values for fhirVersion differ: '1.0.2' vs '4.0.1' |
Warning | Device | Elements differ in short: 'Argonaut Device Profile' vs 'Item used in healthcare' |
Warning | Device | Elements differ in definition: 'This resource identifies an instance 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. Medical devices includes durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc.' vs '\-' |
Information | Device | StructureDefinition USCoreImplantableDeviceProfile has added constraint that is not found in Argonaut Device Profile and it is uncertain whether they are compatible (contained.contained.empty()) |
Information | Device | StructureDefinition USCoreImplantableDeviceProfile has added constraint that is not found in Argonaut Device Profile and it is uncertain whether they are compatible (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()) |
Information | Device | StructureDefinition USCoreImplantableDeviceProfile has added constraint that is not found in Argonaut Device Profile and it is uncertain whether they are compatible (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) |
Information | Device | StructureDefinition USCoreImplantableDeviceProfile has added constraint that is not found in Argonaut Device Profile and it is uncertain whether they are compatible (contained.meta.security.empty()) |
Information | Device | StructureDefinition USCoreImplantableDeviceProfile has added constraint that is not found in Argonaut Device Profile and it is uncertain whether they are compatible (text.`div`.exists()) |
Warning | Device.id | Elements differ in comments: 'The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Bundles always have an id, though it is usually a generated UUID.' vs 'The only time that a resource does not have an id is when it is being submitted to the server using a create operation.' |
Warning | Device.meta | Elements differ in definition: 'The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.' vs 'The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.' |
Warning | Device.implicitRules | Elements differ in definition: 'A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.' vs 'A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.' |
Warning | Device.implicitRules | Elements differ in comments: 'Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element as much as possible.' vs 'Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.' |
Warning | Device.language | Elements differ in comments: 'Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).' vs 'Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).' |
Warning | Device.text | Elements differ in definition: 'A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it 'clinically safe' for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.' vs 'A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it 'clinically safe' for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.' |
Warning | Device.text | Elements differ in comments: 'Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative.' vs 'Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a 'text blob' or where text is additionally entered raw or narrated and encoded information is added later.' |
Warning | Device.contained | Elements differ in comments: 'This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.' vs 'This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.' |
Warning | Device.extension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' |
Warning | Device.modifierExtension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.' vs 'May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' |
Warning | Device.identifier | Elements differ in short: 'Instance id from manufacturer, owner, and others' vs 'Instance identifier' |
Warning | Device.identifier | Elements differ in definition: 'Unique instance identifiers assigned to a device by organizations like manufacturers or owners. If the identifier identifies the type of device, Device.type should be used.' vs 'Unique instance identifiers assigned to a device by manufacturers other organizations or owners.' |
Warning | Device.identifier | Elements differ in comments: 'Often fixed to the device as a barcode and may include names given to the device in local usage. Note that some of the barcodes affixed to the device identify its type, not its instance. For the FDA mandated Unique Device Identifier (UDI) use the Device.udi element.' vs 'The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.' |
Warning | Device.type | Elements differ in short: 'What kind of device this is' vs '(USCDI) The kind or type of device' |
Warning | Device.type | Elements differ in definition: 'Code or identifier to identify a kind of device.' vs 'The kind or type of device.' |
Warning | Device.status | Elements differ in short: 'available | not-available | entered-in-error' vs 'active | inactive | entered-in-error | unknown' |
Error | Device.status | Unable to resolve left value set http://hl7.org/fhir/ValueSet/devicestatus at Device.status |
Warning | Device.version | Elements differ in short: 'Version number (i.e. software)' vs 'The actual design of the device or software version running on the device' |
Warning | Device.version | Elements differ in definition: 'The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware.' vs 'The actual design of the device or software version running on the device.' |
Information | Device.version | Element maximum cardinalities differ: '1' vs '2147483647' |
Warning | Device.manufactureDate | Elements differ in short: 'Manufacture date' vs '(USCDI) Date when the device was made' |
Warning | Device.manufactureDate | Elements differ in definition for mustSupport: 'false' vs 'true' |
Warning | Device.lotNumber | Elements differ in short: 'Lot number of manufacture' vs '(USCDI) Lot number of manufacture' |
Warning | Device.lotNumber | Elements differ in definition for mustSupport: 'false' vs 'true' |
Warning | Device.location | Elements differ in short: 'Where the resource is found' vs 'Where the device is found' |
Warning | Device.patient | Elements differ in short: 'If the resource is affixed to a person' vs '(USCDI) Patient to whom Device is affixed' |
Warning | Device.patient | Elements differ in definition: 'Patient information, if the resource is affixed to a person.' vs 'Patient information, If the device is affixed to a person.' |
Warning | Device.url | Elements differ in comments: 'If the device is running a FHIR server, the network address should be the root URL from which a conformance statement may be retrieved.' vs 'If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.' |
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 | 2016-10-18T00:00:00+11:00 | 2022-04-20 |
|
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 and constrains the way the elements are used when using this profile. It provides the floor for standards development for specific use cases. |
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experimental | false |
| |
fhirVersion | 1.0.2 | 4.0.1 |
|
jurisdiction | |||
jurisdiction[0] | urn:iso:std:iso:3166#US |
| |
kind | resource | ||
name | Argonaut Device Profile | USCoreImplantableDeviceProfile |
|
publisher | Argonaut Project | HL7 International - Cross-Group Projects |
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purpose | |||
status | draft | active |
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title | US Core Implantable Device Profile |
| |
type | Device | ||
url | http://fhir.org/guides/argonaut/StructureDefinition/argo-device | http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device |
|
version | 6.0.0 |
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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 | Argonaut Device Profile | 0..* | Device | Item used in healthcare |
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id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact |
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meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource |
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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 |
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language | 0..1 | code | Language of the resource content Binding: todo (required): A human language. | 0..1 | code | Language of the resource content Binding: todo (preferred): A human language.
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text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation |
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contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources |
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extension | 0..* | Extension | Additional Content defined by implementations | 0..* | Extension | Additional content defined by implementations |
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modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ?! | 0..* | Extension | Extensions that cannot be ignored |
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identifier | 0..* | Identifier | Instance id from manufacturer, owner, and others | 0..* | Identifier | Instance identifier |
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type | S | 1..1 | CodeableConcept | What kind of device this is Binding: todo (extensible): Codes to identify medical devices | S | 1..1 | CodeableConcept | (USCDI) The kind or type of device Binding: todo (extensible): Codes to identify medical devices |
| ||||
note | 0..* | Annotation | Device notes and comments | 0..* | Annotation | Device notes and comments | |||||||
status | ?!Σ | 0..1 | code | available | not-available | entered-in-error Binding: todo (required): The availability status of the device. | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: todo (required): The availability status of the device. |
| ||||
manufacturer | 0..1 | string | Name of device manufacturer | 0..1 | string | Name of device manufacturer | |||||||
model | 0..1 | string | Model id assigned by the manufacturer |
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version | 0..1 | string | Version number (i.e. software) | 0..* | BackboneElement | The actual design of the device or software version running on the device |
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id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 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 |
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component | 0..1 | Identifier | A single component of the device version |
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value | 1..1 | string | The version text |
| |||||||||
manufactureDate | 0..1 | dateTime | Manufacture date | S | 0..1 | dateTime | (USCDI) Date when the device was made |
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expiry | 0..1 | dateTime | Date and time of expiry of this device (if applicable) |
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udi | S | 1..1 | string | FDA mandated Unique Device Identifier |
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lotNumber | 0..1 | string | Lot number of manufacture | S | 0..1 | string | (USCDI) Lot number of manufacture |
| |||||
owner | 0..1 | Reference(Organization) | Organization responsible for device | 0..1 | Reference(Organization) | Organization responsible for device | |||||||
location | 0..1 | Reference(Location) | Where the resource is found | 0..1 | Reference(Location) | Where the device is found |
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patient | S | 1..1 | Reference(http://fhir.org/guides/argonaut/StructureDefinition/argo-patient) | If the resource is affixed to a person | S | 1..1 | Reference(http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient) | (USCDI) Patient to whom Device is affixed |
| ||||
contact | 0..* | ContactPoint | Details for human/organization for support | 0..* | ContactPoint | Details for human/organization for support | |||||||
url | 0..1 | uri | Network address to contact device | 0..1 | uri | Network address to contact device |
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definition | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device |
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udiCarrier | SΣ | 0..1 | BackboneElement | (USCDI) Unique Device Identifier (UDI) Barcode string |
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statusReason | 0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: todo (extensible): The availability status reason of the device. |
| |||||||||
distinctIdentifier | S | 0..1 | string | (USCDI) The distinct identification string |
| ||||||||
expirationDate | S | 0..1 | dateTime | (USCDI) Date and time of expiry of this device (if applicable) |
| ||||||||
serialNumber | S | 0..1 | string | (USCDI) Serial number assigned by the manufacturer |
| ||||||||
deviceName | 0..* | BackboneElement | The name of the device as given by the manufacturer |
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modelNumber | 0..1 | string | The model number for the device |
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partNumber | 0..1 | string | The part number of the device |
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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 |
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property | 0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties |
| |||||||||
safety | Σ | 0..* | CodeableConcept | Safety Characteristics of Device |
| ||||||||
parent | 0..1 | Reference(Device) | The parent device |
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Documentation for this format |