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: Report_EuDevice - Detailed Descriptions

Draft as of 2025-07-02

Definitions for the Report-EuDevice 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
Obligations
    ObligationsActorDocumentation
    SHALL:populate-if-knownImaging study report provider

    EHDSDevice.identifier

    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
    Control0..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
    Obligations
      ObligationsActorDocumentation
      SHALL:populate-if-knownImaging study report provider

      EHDSDevice.manufacturer

      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      14. 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
      Obligations
        ObligationsActorDocumentation
        SHALL:populate-if-knownImaging study report provider

        EHDSDevice.manufactureDate

        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        16. 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
        Obligations
          ObligationsActorDocumentation
          SHALL:populate-if-knownImaging study report provider

          EHDSDevice.expiryDate

          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          18. 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
          Obligations
            ObligationsActorDocumentation
            SHALL:populate-if-knownImaging study report provider

            EHDSDevice.lotNumber

            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            20. 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
            Obligations
              ObligationsActorDocumentation
              SHALL:populate-if-knownImaging study report provider

              EHDSDevice.serialNumber

              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              22. 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
              Obligations
                ObligationsActorDocumentation
                SHALL:populate-if-knownImaging study report provider

                EHDSDevice.name, EHDSMedia.deviceName

                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                24. 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())
                26. 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()))
                28. 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()))
                30. 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()))
                32. 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
                Obligations
                  ObligationsActorDocumentation
                  SHALL:populate-if-knownImaging study report provider

                  EHDSDevice.modelNumber

                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  34. 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..*
                  BindingFor example codes, see DeviceTypehttp://hl7.org/fhir/ValueSet/device-type
                  (example to http://hl7.org/fhir/ValueSet/device-type)

                  Codes to identify medical devices.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Obligations
                    ObligationsActorDocumentation
                    SHALL:populate-if-knownImaging study report provider

                    EHDSDevice.type

                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    36. 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
                    Obligations
                      ObligationsActorDocumentation
                      SHALL:populate-if-knownImaging study report provider

                      EHDSDevice.version

                      Summaryfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      38. 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())
                      40. 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()))
                      42. 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
                      Obligations
                        ObligationsActorDocumentation
                        SHALL:populate-if-knownImaging study report provider

                        EHDSDevice.note

                        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)
                        Obligations
                          ObligationsActorDocumentation
                          SHALL:populate-if-knownImaging study report provider

                          EHDSDevice.identifier

                          4. Device.manufacturer
                          Obligations
                            ObligationsActorDocumentation
                            SHALL:populate-if-knownImaging study report provider

                            EHDSDevice.manufacturer

                            6. Device.manufactureDate
                            Obligations
                              ObligationsActorDocumentation
                              SHALL:populate-if-knownImaging study report provider

                              EHDSDevice.manufactureDate

                              8. Device.expirationDate
                              Obligations
                                ObligationsActorDocumentation
                                SHALL:populate-if-knownImaging study report provider

                                EHDSDevice.expiryDate

                                10. Device.lotNumber
                                Obligations
                                  ObligationsActorDocumentation
                                  SHALL:populate-if-knownImaging study report provider

                                  EHDSDevice.lotNumber

                                  12. Device.serialNumber
                                  Obligations
                                    ObligationsActorDocumentation
                                    SHALL:populate-if-knownImaging study report provider

                                    EHDSDevice.serialNumber

                                    14. Device.name
                                    Obligations
                                      ObligationsActorDocumentation
                                      SHALL:populate-if-knownImaging study report provider

                                      EHDSDevice.name, EHDSMedia.deviceName

                                      16. Device.modelNumber
                                      Obligations
                                        ObligationsActorDocumentation
                                        SHALL:populate-if-knownImaging study report provider

                                        EHDSDevice.modelNumber

                                        18. Device.type
                                        Obligations
                                          ObligationsActorDocumentation
                                          SHALL:populate-if-knownImaging study report provider

                                          EHDSDevice.type

                                          20. Device.version
                                          NoteThis is a business version Id, not a resource version Id (see discussion)
                                          Obligations
                                            ObligationsActorDocumentation
                                            SHALL:populate-if-knownImaging study report provider

                                            EHDSDevice.version

                                            22. Device.note
                                            Obligations
                                              ObligationsActorDocumentation
                                              SHALL:populate-if-knownImaging study report provider

                                              EHDSDevice.note

                                              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
                                              Obligations
                                                ObligationsActorDocumentation
                                                SHALL:populate-if-knownImaging study report provider

                                                EHDSDevice.identifier

                                                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
                                                Control0..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
                                                Obligations
                                                  ObligationsActorDocumentation
                                                  SHALL:populate-if-knownImaging study report provider

                                                  EHDSDevice.manufacturer

                                                  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
                                                  Obligations
                                                    ObligationsActorDocumentation
                                                    SHALL:populate-if-knownImaging study report provider

                                                    EHDSDevice.manufactureDate

                                                    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
                                                    Obligations
                                                      ObligationsActorDocumentation
                                                      SHALL:populate-if-knownImaging study report provider

                                                      EHDSDevice.expiryDate

                                                      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
                                                      Obligations
                                                        ObligationsActorDocumentation
                                                        SHALL:populate-if-knownImaging study report provider

                                                        EHDSDevice.lotNumber

                                                        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
                                                        Obligations
                                                          ObligationsActorDocumentation
                                                          SHALL:populate-if-knownImaging study report provider

                                                          EHDSDevice.serialNumber

                                                          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
                                                          Obligations
                                                            ObligationsActorDocumentation
                                                            SHALL:populate-if-knownImaging study report provider

                                                            EHDSDevice.name, EHDSMedia.deviceName

                                                            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
                                                            Obligations
                                                              ObligationsActorDocumentation
                                                              SHALL:populate-if-knownImaging study report provider

                                                              EHDSDevice.modelNumber

                                                              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
                                                              Control0..*
                                                              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()))
                                                              80. 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..*
                                                              BindingFor example codes, see DeviceType
                                                              (example to http://hl7.org/fhir/ValueSet/device-type)

                                                              Codes to identify medical devices.

                                                              TypeCodeableConcept
                                                              Is Modifierfalse
                                                              Must Supportfalse
                                                              Obligations
                                                                ObligationsActorDocumentation
                                                                SHALL:populate-if-knownImaging study report provider

                                                                EHDSDevice.type

                                                                Summaryfalse
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                82. 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
                                                                Obligations
                                                                  ObligationsActorDocumentation
                                                                  SHALL:populate-if-knownImaging study report provider

                                                                  EHDSDevice.version

                                                                  Summaryfalse
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  84. 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
                                                                  86. 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())
                                                                  88. 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())
                                                                  90. 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()))
                                                                  92. 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()))
                                                                  94. 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()))
                                                                  96. 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()))
                                                                  98. 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()))
                                                                  100. 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
                                                                  102. 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())
                                                                  104. 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())
                                                                  106. 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()))
                                                                  108. 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()))
                                                                  110. 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()))
                                                                  112. 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()))
                                                                  114. 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
                                                                  116. 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())
                                                                  118. 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())
                                                                  120. 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()))
                                                                  122. 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()))
                                                                  124. 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()))
                                                                  126. 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()))
                                                                  128. 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()))
                                                                  130. 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()))
                                                                  132. 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()))
                                                                  134. 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()))
                                                                  136. 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()))
                                                                  138. 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()))
                                                                  140. 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()))
                                                                  142. 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
                                                                  Obligations
                                                                    ObligationsActorDocumentation
                                                                    SHALL:populate-if-knownImaging study report provider

                                                                    EHDSDevice.note

                                                                    Summaryfalse
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    144. 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()))
                                                                    146. 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()))