HL7 Europe Imaging Study Report
0.1.0-ballot - ci-build 150

HL7 Europe Imaging Study Report, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.1.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/oijauregui/ehdsimaging/tree/master and changes regularly. See the Directory of published versions

Resource Profile: ImImagingDevice - Detailed Descriptions

Page standards status: Draft Maturity Level: 1

Definitions for the ImImagingDevice resource profile.

Guidance on how to interpret the contents of this table can be foundhere

0. Device
Definition

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.

ShortItem used in healthcare
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdev-1: only one Device.name.display SHALL be true when there is more than one Device.name (name.where(display=true).count() <= 1)
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. Device.implicitRules
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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
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. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Device.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
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. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. Device.modifierExtension
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 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 managable, 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).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. Device.identifier
Definition

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

ShortInstance identifier
Comments

Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. 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. The identifier is typically valued if the serialNumber or lotNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Device.status
Definition

The Device record status. This is not the status of the device like availability.

Shortactive | inactive | entered-in-error
Control10..1
BindingThe codes SHALL be taken from FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|5.0.0
(required to http://hl7.org/fhir/ValueSet/device-status|5.0.0)

The record status of the device.

Typecode
Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Device.manufacturer
Definition

A name of the manufacturer or entity legally responsible for the device.

ShortName of device manufacturer
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Device.serialNumber
Definition

The serial number assigned by the organization when the device was manufactured.

ShortSerial number assigned by the manufacturer
Comments

Alphanumeric Maximum 20. While a serial number is a type of identifier, in the context of devices for which a UDI is required, thus a serial number may be part of the production identifier, it is more informative to have the serial number as a dedicated attribute together with the other UDI production identifier. When the device is not subject to including the UDI (e.g., its presence and exchange is not mandated by local regulatory requirements or specific use case at hand), thus the concept of production identifiers is not relevant as a set, it remains helpful for consistency to still use Device.serialNumber rather than using Device.identifier with an appropriate type. Systems that do not realize an identifier is a serial number may place it in Device.identifier or if the identifier.system is known for the serial number, it may also be populated in the Device.identifier as a globally unique id_.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Device.name
Definition

This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.

ShortThe name or names of the device as known to the manufacturer and/or patient
Control0..*
This element is affected by the following invariants: dev-1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Device.name.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained 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 managable, 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. 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).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
20. Device.name.value
Definition

The actual name that identifies the device.

ShortThe term that names the device
Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Alternate NamesΣ
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Device.name.type
Definition

Indicates the kind of name. RegisteredName | UserFriendlyName | PatientReportedName.

Shortregistered-name | user-friendly-name | patient-reported-name
Control1..1
BindingThe codes SHALL be taken from DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|5.0.0
(required to http://hl7.org/fhir/ValueSet/device-nametype|5.0.0)

The type of name the device is referred by.

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Device.name.display
Definition

Indicates the default or preferred name to be displayed.

ShortThe preferred device name
Control0..1
This element is affected by the following invariants: dev-1
Typeboolean
Is Modifiertrue because This element is labelled as a modifier because it is a status element that can indicate that that a name is preferred.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Device.category
Definition

Devices may be associated with one or more categories.

ShortIndicates a high-level grouping of the device
Control10..*
BindingFor example codes, see FHIRDeviceCategoryhttp://hl7.org/fhir/ValueSet/device-category
(example to http://hl7.org/fhir/ValueSet/device-category)

Categories of medical devices.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Device.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ $this
  • 28. Device.category:imaging
    Slice Nameimaging
    Definition

    Devices may be associated with one or more categories.

    ShortIndicates a high-level grouping of the device
    Control10..1*
    BindingFor example codes, see FHIRDeviceCategoryhttp://hl7.org/fhir/ValueSet/device-category
    (example to http://hl7.org/fhir/ValueSet/device-category)

    Categories of medical devices.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Pattern Value{
      "coding" : [{
        "system" : "http://snomed.info/sct",
        "code" : "314789007",
        "display" : "Diagnostic imaging equipment"
      }]
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. Device.type
    Definition

    The kind or type of device. A device instance may have more than one type - in which case those are the types that apply to the specific instance of the device.

    ShortThe kind or type of device
    Comments

    Multiple device types are use when a device is categorized in more than one context – for example, hybrid devices in which the device is both of type gateway and sensor.

    Control0..*
    BindingUnless not suitable, these codes SHALL be taken from For example codes, see Imaging Device Typehttp://hl7.org/fhir/ValueSet/device-type
    (extensible to http://hl7.eu/fhir/imaging-r5/ValueSet/im-imaging-device-type)
    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    32. Device.version
    Definition

    The actual design of the device or software version running on the device.

    ShortThe actual design of the device or software version running on the device
    NoteThis is a business version Id, not a resource version Id (see discussion)
    Control0..*
    TypeBackboneElement
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    34. Device.version.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained 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 managable, 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. 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).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    36. Device.version.value
    Definition

    The version text.

    ShortThe version text
    Control1..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

    Guidance on how to interpret the contents of this table can be foundhere

    0. Device
    2. Device.identifier
    NoteThis is a business identifier, not a resource identifier (see discussion)
    4. Device.udiCarrier
    6. Device.udiCarrier.deviceIdentifier
    8. Device.status
    Control1..?
    10. Device.manufacturer
    12. Device.serialNumber
    14. Device.name
    16. Device.category
    Control1..?
    SlicingThis element introduces a set of slices on Device.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ $this
    • 18. Device.category:imaging
      Slice Nameimaging
      Control1..1
      Pattern Value{
        "coding" : [{
          "system" : "http://snomed.info/sct",
          "code" : "314789007",
          "display" : "Diagnostic imaging equipment"
        }]
      }
      20. Device.type
      BindingUnless not suitable, these codes SHALL be taken from Imaging Device Type
      (extensible to http://hl7.eu/fhir/imaging-r5/ValueSet/im-imaging-device-type)
      22. Device.version
      NoteThis is a business version Id, not a resource version Id (see discussion)

      Guidance on how to interpret the contents of this table can be foundhere

      0. Device
      Definition

      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.

      ShortItem used in healthcare
      Control0..*
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsdev-1: only one Device.name.display SHALL be true when there is more than one Device.name (name.where(display=true).count() <= 1)
      dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
      dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
      dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
      dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
      dom-6: A resource should have narrative for robust management (text.`div`.exists())
      2. Device.id
      Definition

      The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

      ShortLogical id of this artifact
      Comments

      Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

      Control0..1
      Typeid
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      4. Device.meta
      Definition

      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.

      ShortMetadata about the resource
      Control0..1
      TypeMeta
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      6. Device.implicitRules
      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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

      ShortA set of rules under which this content was created
      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. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

      Control0..1
      Typeuri
      Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      8. Device.language
      Definition

      The base language in which the resource is written.

      ShortLanguage of the resource content
      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).

      Control0..1
      BindingThe codes SHALL be taken from AllLanguages
      (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

      IETF language tag for a human language

      Typecode
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      10. Device.text
      Definition

      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.

      ShortText summary of the resource, for human interpretation
      Comments

      Contained resources do not have a 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.

      Control0..1
      This element is affected by the following invariants: dom-6
      TypeNarrative
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Alternate Namesnarrative, html, xhtml, display
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      12. Device.contained
      Definition

      These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

      ShortContained, inline Resources
      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. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

      Control0..*
      This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
      TypeResource
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Alternate Namesinline resources, anonymous resources, contained resources
      14. Device.extension
      Definition

      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 managable, 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.

      ShortAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      16. Device.modifierExtension
      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 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 managable, 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).

      ShortExtensions that cannot be ignored
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
      Must Supportfalse
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      18. Device.identifier
      Definition

      Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

      ShortInstance identifier
      Comments

      Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. 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. The identifier is typically valued if the serialNumber or lotNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..*
      TypeIdentifier
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      20. Device.displayName
      Definition

      The name used to display by default when the device is referenced. Based on intent of use by the resource creator, this may reflect one of the names in Device.name, or may be another simple name.

      ShortThe name used to display by default when the device is referenced
      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. Device.definition
      Definition

      The reference to the definition for the device.

      ShortThe reference to the definition for the device
      Control0..1
      TypeCodeableReference(DeviceDefinition)
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      24. Device.udiCarrier
      Definition

      Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

      ShortUnique Device Identifier (UDI) Barcode string
      Comments

      UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      26. Device.udiCarrier.id
      Definition

      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

      ShortUnique id for inter-element referencing
      Control0..1
      This element is affected by the following invariants: ele-1
      Typestring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      28. Device.udiCarrier.extension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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.

      ShortAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      30. Device.udiCarrier.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained 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 managable, 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. 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).

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content, modifiers
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      32. Device.udiCarrier.deviceIdentifier
      Definition

      The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

      ShortMandatory fixed portion of UDI
      Control1..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Alternate NamesDI
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      34. Device.udiCarrier.issuer
      Definition

      Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include:

      1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
      2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-diI,
      3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
      4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di # Informationsstelle für Arzneispezialitäten (IFA GmbH) (EU only): http://hl7.org/fhir/NamingSystem/ifa-gmbh-di.
      ShortUDI Issuing Organization
      Control1..1
      Typeuri
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Alternate NamesBarcode System
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      36. Device.udiCarrier.jurisdiction
      Definition

      The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/us-fda-udi or in the European Union by the European Commission http://hl7.org/fhir/NamingSystem/eu-ec-udi.

      ShortRegional UDI authority
      Control0..1
      Typeuri
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Requirements

      Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      38. Device.udiCarrier.carrierAIDC
      Definition

      The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.

      ShortUDI Machine Readable Barcode String
      Comments

      The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

      Control0..1
      Typebase64Binary
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Alternate NamesAutomatic Identification and Data Capture
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      40. Device.udiCarrier.carrierHRF
      Definition

      The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

      ShortUDI Human Readable Barcode String
      Comments

      If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Alternate NamesHuman Readable Form
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      42. Device.udiCarrier.entryType
      Definition

      A coded entry to indicate how the data was entered.

      Shortbarcode | rfid | manual | card | self-reported | electronic-transmission | unknown
      Control0..1
      BindingThe codes SHALL be taken from UDIEntryType
      (required to http://hl7.org/fhir/ValueSet/udi-entry-type|5.0.0)

      Codes to identify how UDI data was entered.

      Typecode
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Requirements

      Supports a way to distinguish hand entered from machine read data.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      44. Device.status
      Definition

      The Device record status. This is not the status of the device like availability.

      Shortactive | inactive | entered-in-error
      Control1..1
      BindingThe codes SHALL be taken from FHIRDeviceStatus
      (required to http://hl7.org/fhir/ValueSet/device-status|5.0.0)

      The record status of the device.

      Typecode
      Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      46. Device.availabilityStatus
      Definition

      The availability of the device.

      Shortlost | damaged | destroyed | available
      Control0..1
      BindingUnless not suitable, these codes SHALL be taken from FHIRDeviceAvailabilityStatus
      (extensible to http://hl7.org/fhir/ValueSet/device-availability-status)

      The availability status reason of the device.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      48. Device.biologicalSourceEvent
      Definition

      An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled.

      ShortAn identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
      Comments

      Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa, while also satisfying donor anonymity requirements. The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. The identifier references an event that links to a single biological entity such as a blood donor, or to multiple biological entities (e.g. when the product is an embryo or a pooled platelet product). A single biologicalSourceEvent identifier may appear on multiple products of many types derived from a single donation event or source extraction. As an example, a single donation event may provide 2 kidneys and a liver for organ transplantation, 2 corneas for eye surgery, heart valves and arterial tissue for cardiovascular surgery, multiple skin grafts, tendons, multiple shaped bone grafts and a large number of bone putty/paste products; and each of them may be assigned to the same biological source event identifier.

      Control0..1
      TypeIdentifier
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Alternate NamesDistinct Identification Code (DIC)
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      50. Device.manufacturer
      Definition

      A name of the manufacturer or entity legally responsible for the device.

      ShortName of device manufacturer
      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      52. Device.manufactureDate
      Definition

      The date and time when the device was manufactured.

      ShortDate when the device was made
      Control0..1
      TypedateTime
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      54. Device.expirationDate
      Definition

      The date and time beyond which this device is no longer valid or should not be used (if applicable).

      ShortDate and time of expiry of this device (if applicable)
      Control0..1
      TypedateTime
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      56. Device.lotNumber
      Definition

      Lot number assigned by the manufacturer.

      ShortLot number of manufacture
      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      58. Device.serialNumber
      Definition

      The serial number assigned by the organization when the device was manufactured.

      ShortSerial number assigned by the manufacturer
      Comments

      Alphanumeric Maximum 20. While a serial number is a type of identifier, in the context of devices for which a UDI is required, thus a serial number may be part of the production identifier, it is more informative to have the serial number as a dedicated attribute together with the other UDI production identifier. When the device is not subject to including the UDI (e.g., its presence and exchange is not mandated by local regulatory requirements or specific use case at hand), thus the concept of production identifiers is not relevant as a set, it remains helpful for consistency to still use Device.serialNumber rather than using Device.identifier with an appropriate type. Systems that do not realize an identifier is a serial number may place it in Device.identifier or if the identifier.system is known for the serial number, it may also be populated in the Device.identifier as a globally unique id_.

      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      60. Device.name
      Definition

      This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.

      ShortThe name or names of the device as known to the manufacturer and/or patient
      Control0..*
      This element is affected by the following invariants: dev-1
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      62. Device.name.id
      Definition

      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

      ShortUnique id for inter-element referencing
      Control0..1
      This element is affected by the following invariants: ele-1
      Typestring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      64. Device.name.extension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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.

      ShortAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      66. Device.name.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained 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 managable, 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. 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).

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content, modifiers
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      68. Device.name.value
      Definition

      The actual name that identifies the device.

      ShortThe term that names the device
      Control1..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Alternate NamesΣ
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      70. Device.name.type
      Definition

      Indicates the kind of name. RegisteredName | UserFriendlyName | PatientReportedName.

      Shortregistered-name | user-friendly-name | patient-reported-name
      Control1..1
      BindingThe codes SHALL be taken from DeviceNameType
      (required to http://hl7.org/fhir/ValueSet/device-nametype|5.0.0)

      The type of name the device is referred by.

      Typecode
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      72. Device.name.display
      Definition

      Indicates the default or preferred name to be displayed.

      ShortThe preferred device name
      Control0..1
      This element is affected by the following invariants: dev-1
      Typeboolean
      Is Modifiertrue because This element is labelled as a modifier because it is a status element that can indicate that that a name is preferred.
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      74. Device.modelNumber
      Definition

      The manufacturer's model number for the device.

      ShortThe manufacturer's model number for the device
      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      76. Device.partNumber
      Definition

      The part number or catalog number of the device.

      ShortThe part number or catalog number of the device
      Comments

      Alphanumeric Maximum 20.

      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      78. Device.category
      Definition

      Devices may be associated with one or more categories.

      ShortIndicates a high-level grouping of the device
      Control1..*
      BindingFor example codes, see FHIRDeviceCategory
      (example to http://hl7.org/fhir/ValueSet/device-category)

      Categories of medical devices.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      SlicingThis element introduces a set of slices on Device.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ $this
      • 80. Device.category:imaging
        Slice Nameimaging
        Definition

        Devices may be associated with one or more categories.

        ShortIndicates a high-level grouping of the device
        Control1..1
        BindingFor example codes, see FHIRDeviceCategory
        (example to http://hl7.org/fhir/ValueSet/device-category)

        Categories of medical devices.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Pattern Value{
          "coding" : [{
            "system" : "http://snomed.info/sct",
            "code" : "314789007",
            "display" : "Diagnostic imaging equipment"
          }]
        }
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        82. Device.type
        Definition

        The kind or type of device. A device instance may have more than one type - in which case those are the types that apply to the specific instance of the device.

        ShortThe kind or type of device
        Comments

        Multiple device types are use when a device is categorized in more than one context – for example, hybrid devices in which the device is both of type gateway and sensor.

        Control0..*
        BindingUnless not suitable, these codes SHALL be taken from Imaging Device Type
        (extensible to http://hl7.eu/fhir/imaging-r5/ValueSet/im-imaging-device-type)
        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        84. Device.version
        Definition

        The actual design of the device or software version running on the device.

        ShortThe actual design of the device or software version running on the device
        NoteThis is a business version Id, not a resource version Id (see discussion)
        Control0..*
        TypeBackboneElement
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        86. Device.version.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        This element is affected by the following invariants: ele-1
        Typestring
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        88. Device.version.extension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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.

        ShortAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        90. Device.version.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained 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 managable, 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. 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).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        92. Device.version.type
        Definition

        The type of the device version, e.g. manufacturer, approved, internal.

        ShortThe type of the device version, e.g. manufacturer, approved, internal
        Control0..1
        BindingFor example codes, see DeviceVersionType
        (example to http://hl7.org/fhir/ValueSet/device-versiontype)

        The type of version indicated for the device.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Alternate NamesΣ
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        94. Device.version.component
        Definition

        The hardware or software module of the device to which the version applies.

        ShortThe hardware or software module of the device to which the version applies
        Comments

        Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.

        Control0..1
        TypeIdentifier
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        96. Device.version.installDate
        Definition

        The date the version was installed on the device.

        ShortThe date the version was installed on the device
        Control0..1
        TypedateTime
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        98. Device.version.value
        Definition

        The version text.

        ShortThe version text
        Control1..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        100. Device.conformsTo
        Definition

        Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.

        ShortIdentifies the standards, specifications, or formal guidances for the capabilities supported by the device
        Control0..*
        TypeBackboneElement
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        102. Device.conformsTo.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        This element is affected by the following invariants: ele-1
        Typestring
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        104. Device.conformsTo.extension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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.

        ShortAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        106. Device.conformsTo.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained 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 managable, 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. 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).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        108. Device.conformsTo.category
        Definition

        Describes the type of the standard, specification, or formal guidance.

        ShortDescribes the common type of the standard, specification, or formal guidance. communication | performance | measurement
        Control0..1
        BindingFor example codes, see DeviceSpecificationCategory
        (example to http://hl7.org/fhir/ValueSet/device-specification-category)

        The kind of standards used by the device.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        110. Device.conformsTo.specification
        Definition

        Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.

        ShortIdentifies the standard, specification, or formal guidance that the device adheres to
        Control1..1
        BindingFor example codes, see DeviceSpecificationType
        (example to http://hl7.org/fhir/ValueSet/device-specification-type)

        The type of version indicated for the device.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        112. Device.conformsTo.version
        Definition

        Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label.

        ShortSpecific form or variant of the standard
        NoteThis is a business version Id, not a resource version Id (see discussion)
        Control0..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        114. Device.property
        Definition

        Static or essentially fixed characteristics or features of the device (e.g., time or timing attributes, resolution, accuracy, intended use or instructions for use, and physical attributes) that are not otherwise captured in more specific attributes.

        ShortInherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
        Comments

        Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific [DeviceMetric] and recorded using [Observation]. Static characteristics of a device could also be documented in an associated [DeviceDefinition] instance. The Device instance's properties, and their values, could be, but need not be, the same as those described in an associated DeviceDefinition.

        Control0..*
        TypeBackboneElement
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        116. Device.property.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        This element is affected by the following invariants: ele-1
        Typestring
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        118. Device.property.extension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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.

        ShortAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        120. Device.property.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained 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 managable, 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. 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).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        122. Device.property.type
        Definition

        Code that specifies the property, such as resolution, color, size, being represented.

        ShortCode that specifies the property being represented
        Control1..1
        BindingFor example codes, see DeviceType
        (example to http://hl7.org/fhir/ValueSet/device-property-type)

        Device property type.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        124. Device.property.value[x]
        Definition

        The value of the property specified by the associated property.type code.

        ShortValue of the property
        Comments

        The text element in CodeableConcept.text is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g. a custom implant size, or a security classification which depends on configuration). Otherwise the string choice type is used for descriptive properties, or instructions.

        Control1..1
        TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Attachment
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        126. Device.mode
        Definition

        The designated condition for performing a task with the device.

        ShortThe designated condition for performing a task
        Control0..1
        BindingFor example codes, see FHIRDeviceOperationMode
        (example to http://hl7.org/fhir/ValueSet/device-operation-mode)

        Operational mode of a device.

        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        128. Device.cycle
        Definition

        The series of occurrences that repeats during the operation of the device.

        ShortThe series of occurrences that repeats during the operation of the device
        Control0..1
        TypeCount
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        130. Device.duration
        Definition

        A measurement of time during the device's operation (e.g., days, hours, mins, etc.).

        ShortA measurement of time during the device's operation (e.g., days, hours, mins, etc.)
        Control0..1
        TypeDuration
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        132. Device.owner
        Definition

        An organization that is responsible for the provision and ongoing maintenance of the device.

        ShortOrganization responsible for device
        Control0..1
        TypeReference(Organization)
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        134. Device.contact
        Definition

        Contact details for an organization or a particular human that is responsible for the device.

        ShortDetails for human/organization for support
        Comments

        used for troubleshooting etc.

        Control0..*
        TypeContactPoint
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        136. Device.location
        Definition

        The place where the device can be found.

        ShortWhere the device is found
        Control0..1
        TypeReference(Location)
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Requirements

        Device.location can be used to track device location.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        138. Device.url
        Definition

        A network address on which the device may be contacted directly.

        ShortNetwork address to contact device
        Comments

        If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

        Control0..1
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        140. Device.endpoint
        Definition

        Technical endpoints providing access to services provided by the device defined at this resource.

        ShortTechnical endpoints providing access to electronic services provided by the device
        Control0..*
        TypeReference(Endpoint)
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        142. Device.gateway
        Definition

        The linked device acting as a communication controller, data collector, translator, or concentrator for the current device (e.g., mobile phone application that relays a blood pressure device's data).

        ShortLinked device acting as a communication/data collector, translator or controller
        Comments

        The Device.gateway may be used when the Device being referenced has a gateway and/or to capture one or more gateways associated with the device. If the Gateway is included in the Observation resource, the Observation.gatewayDevice should be used instead.

        Control0..*
        TypeCodeableReference(Device)
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        144. Device.note
        Definition

        Descriptive information, usage information or implantation information that is not captured in an existing element.

        ShortDevice notes and comments
        Control0..*
        TypeAnnotation
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        146. Device.safety
        Definition

        Provides additional safety characteristics about a medical device. For example devices containing latex.

        ShortSafety Characteristics of Device
        Control0..*
        BindingFor example codes, see DeviceSafety
        (example to http://hl7.org/fhir/ValueSet/device-safety)
        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        148. Device.parent
        Definition

        The higher level or encompassing device that this device is a logical part of.

        ShortThe higher level or encompassing device that this device is a logical part of
        Comments

        For example a vital signs monitor (parent) where three separate modules can be plugged into such as interchangeable blood pressure, oximeter, temperature modules. These modules are represented as devices with the .parent valued to the vital signs monitor when plugged in.

        Control0..1
        TypeReference(Device)
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))