IKNL PZP STU3
1.0.0-alpha1 - consultation International flag

IKNL PZP STU3, published by IKNL. This guide is not an authorized publication; it is the continuous build for version 1.0.0-alpha1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/IKNL/PZP-FHIR-STU3/ and changes regularly. See the Directory of published versions

Resource Profile: ACPMedicalDevice - Detailed Descriptions

Draft as of 2025-10-30

Definitions for the ACP-MedicalDevice resource profile.

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

0. DeviceUseStatement
Definition

A record of a device being used by a patient where the record is the result of a report from the patient or another clinician.


This is the base resource type for everything.

ShortMedicalDeviceBase Resource
Control0..*
Alternate NamesMedischHulpmiddel
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (contained.text.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-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource (contained.where(('#'+id in %resource.descendants().reference).not()).empty())
2. DeviceUseStatement.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.

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.

This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

Control0..1
Typeuri
Is Modifiertrue because No Modifier Reason provideed in previous versions of FHIR
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
4. DeviceUseStatement.extension:HealthcareProvider
Slice NameHealthcareProvider
Definition

Optional Extension Element - found in all resources.

ShortOptional Extensions Element
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(HCIM MedicalDevice Organization) (Extension Type: Reference(nl-core-organization))
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() | (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. DeviceUseStatement.extension:HealthProfessional
Slice NameHealthProfessional
Definition

Optional Extension Element - found in all resources.

ShortOptional Extensions Element
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(HCIM MedicalDevice Practitioner) (Extension Type: Reference(nl-core-practitioner, nl-core-practitionerrole))
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() | (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. DeviceUseStatement.extension:HealthProfessional.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

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..0*
TypeExtension
Alternate Namesextensions, user content
SlicingThis element introduces a set of slices on DeviceUseStatement.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 10. DeviceUseStatement.extension:HealthProfessional.url
    Definition

    Source of the definition for the extension code - a logical name or a URL.

    Shortidentifies the meaning of the extension
    Comments

    The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

    Control1..1
    Typeuri
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    XML FormatIn the XML format, this property is represented as an attribute.
    Fixed Valuehttp://nictiz.nl/fhir/StructureDefinition/zib-MedicalDevice-Practitioner
    12. DeviceUseStatement.extension:HealthProfessional.valueReference:valueReference
    Slice NamevalueReference
    Definition

    The healthcare provider involved in the indication for use of the medical device implant.


    Value of extension - may be a resource or one of a constrained set of the data types (see Extensibility in the spec for list).

    ShortHealthProfessionalValue of extension
    Control0..1
    TypeReference(nl-core-practitioner, nl-core-practitionerrole), date, dateTime, Meta, code, string, Address, Attachment, integer, oid, Count, instant, ContactPoint, HumanName, Money, Identifier, Coding, markdown, SampledData, Ratio, id, positiveInt, Age, Distance, Period, Quantity, Duration, Range, uri, Annotation, boolean, base64Binary, Signature, unsignedInt, time, Timing, decimal, CodeableConcept
    Alternate NamesZorgverlener
    14. DeviceUseStatement.extension:reasonReference
    Slice NamereasonReference
    Definition

    Another resource whose existence justifies this DeviceUseStatement.

    ShortWhy was DeviceUseStatement performed?
    Comments

    This extension is backported from the offical HL7 DeviceUseStatement specification in FHIR R4.

    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(Backported DeviceUseStatement.reasonReference for STU3) (Extension Type: Reference(Condition, Observation, DiagnosticReport, DocumentReference, Media))
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() | (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    16. DeviceUseStatement.extension:encounter
    Slice Nameencounter
    Definition

    An extension to link the Encounter during which the Consent, Goal or DeviceUseStatement was created or to which the creation is tightly associated.

    Shortext Encounter Reference
    Control0..1
    TypeExtension(ext Encounter Reference) (Extension Type: Reference(Encounter))
    18. DeviceUseStatement.extension:encounter.extension
    Definition

    An Extension


    May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    ShortExtensionAdditional 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..0*
    TypeExtension
    Alternate Namesextensions, user content
    SlicingThis element introduces a set of slices on DeviceUseStatement.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 20. DeviceUseStatement.extension:encounter.url
      Definition

      Source of the definition for the extension code - a logical name or a URL.

      Shortidentifies the meaning of the extension
      Comments

      The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

      Control1..1
      Typeuri
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      XML FormatIn the XML format, this property is represented as an attribute.
      Fixed Valuehttps://api.iknl.nl/docs/pzp/stu3/StructureDefinition/ext-EncounterReference
      22. DeviceUseStatement.extension:encounter.value[x]
      Definition

      The Encounter during which this resource was created or to which the creation is tightly associated.


      Value of extension - may be a resource or one of a constrained set of the data types (see Extensibility in the spec for list).

      ShortEncounterValue of extension
      Comments

      This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. completing the administrative registration after the encounter).

      Control0..1
      TypeReference(Encounter), date, dateTime, Meta, code, string, Address, Attachment, integer, oid, Count, instant, ContactPoint, HumanName, Money, Identifier, Coding, markdown, SampledData, Ratio, id, positiveInt, Age, Distance, Period, Quantity, Duration, Range, uri, Annotation, boolean, base64Binary, Signature, unsignedInt, time, Timing, decimal, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      24. DeviceUseStatement.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. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      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 No Modifier Reason provideed in previous versions of FHIR
      Alternate Namesextensions, user content
      26. DeviceUseStatement.status
      Definition

      A code representing the patient or other source's judgment about the state of the device used that this statement is about. Generally this will be active or completed.

      Shortactive | completed | entered-in-error +
      Comments

      DeviceUseStatment is a statement at a point in time. The status is only representative at the point when it was asserted. The value set for contains codes that assert the status of the use by the patient (for example, stopped or on hold) as well as codes that assert the status of the resource itself (for example, entered in error).

      This element is labeled as a modifier because the status contains the codes that mark the statement as not currently valid.

      Control1..1
      BindingThe codes SHALL be taken from DeviceUseStatementStatushttp://hl7.org/fhir/ValueSet/device-statement-status|3.0.2
      (required to http://hl7.org/fhir/ValueSet/device-statement-status|3.0.2)

      A coded concept indicating the current status of a the Device Usage

      Typecode
      Is Modifiertrue because No Modifier Reason provideed in previous versions of FHIR
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      28. DeviceUseStatement.subject
      Definition

      The patient who used the device.

      ShortPatient using device
      Control1..1
      TypeReference(Patient, Patient, Group)
      30. DeviceUseStatement.timing[x]
      Definition

      How often the device was used.

      ShortHow often the device was used
      Control0..1
      TypeChoice of: Timing, Period, dateTime
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      SlicingThis element introduces a set of slices on DeviceUseStatement.timing[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
      • type @ $this
      • 32. DeviceUseStatement.timing[x]:timingPeriod
        Slice NametimingPeriod
        Definition

        How often the device was used.

        ShortHow often the device was used
        Control0..1
        TypePeriod, dateTime, Timing
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        34. DeviceUseStatement.device
        Definition

        The details of the device used.

        ShortReference to device used
        Control1..1
        TypeReference(MedicalDevice Product ICD, Device)
        36. DeviceUseStatement.bodySite
        Definition

        Patient’s anatomical location of the medical device used.


        Indicates the site on the subject's body where the device was used ( i.e. the target site).

        ShortAnatomicalLocationTarget body site
        Control0..1
        BindingUnless not suitable, these codes SHALL be taken from For example codes, see HulpmiddelAnatomischeLocatieCodelijst (2017-12-31T00:00:00)http://hl7.org/fhir/ValueSet/body-site|3.0.2
        (extensible to http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.2--20171231000000|2017-12-31T00:00:00)

        Patient’s anatomical location of the medical aid used.


        Codes describing anatomical locations. May include laterality.

        TypeCodeableConcept
        Requirements

        Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/body-site-instance.


        Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/body-site-instance.

        Alternate NamesAnatomischeLocatie
        38. DeviceUseStatement.bodySite.extension:Laterality
        Slice NameLaterality
        Definition

        Qualifier to refine the anatomical location. These include qualifiers for laterality, relative location, directionality, number, and plane.

        ShortOptional Extensions Element
        Control0..1
        This element is affected by the following invariants: ele-1
        TypeExtension(BodySite Qualifier) (Extension Type: CodeableConcept)
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() | (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        40. DeviceUseStatement.bodySite.extension:Laterality.extension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        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..0*
        TypeExtension
        Alternate Namesextensions, user content
        SlicingThis element introduces a set of slices on DeviceUseStatement.bodySite.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 42. DeviceUseStatement.bodySite.extension:Laterality.url
          Definition

          Source of the definition for the extension code - a logical name or a URL.

          Shortidentifies the meaning of the extension
          Comments

          The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

          Control1..1
          Typeuri
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          XML FormatIn the XML format, this property is represented as an attribute.
          Fixed Valuehttp://nictiz.nl/fhir/StructureDefinition/BodySite-Qualifier

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

          0. DeviceUseStatement
          2. DeviceUseStatement.extension:HealthcareProvider
          Slice NameHealthcareProvider
          4. DeviceUseStatement.extension:HealthProfessional
          Slice NameHealthProfessional
          6. DeviceUseStatement.extension:encounter
          Slice Nameencounter
          Control0..1
          TypeExtension(ext Encounter Reference) (Extension Type: Reference(Encounter))
          8. DeviceUseStatement.extension:encounter.value[x]
          TypeReference(Encounter)
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          10. DeviceUseStatement.subject
          TypeReference(Patient)
          12. DeviceUseStatement.whenUsed
          14. DeviceUseStatement.whenUsed.start
          16. DeviceUseStatement.timing[x]:timingPeriod
          Slice NametimingPeriod
          TypePeriod
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          18. DeviceUseStatement.device
          TypeReference(MedicalDevice Product ICD)
          20. DeviceUseStatement.indication
          22. DeviceUseStatement.indication.extension:indication_Problem
          Slice Nameindication_Problem
          24. DeviceUseStatement.bodySite
          26. DeviceUseStatement.bodySite.extension:Laterality
          Slice NameLaterality
          28. DeviceUseStatement.note
          30. DeviceUseStatement.note.text

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

          0. DeviceUseStatement
          Definition

          A record of a device being used by a patient where the record is the result of a report from the patient or another clinician.

          ShortMedicalDevice
          Control0..*
          Alternate NamesMedischHulpmiddel
          Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
          dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (contained.text.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-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource (contained.where(('#'+id in %resource.descendants().reference).not()).empty())
          2. DeviceUseStatement.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

          The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

          Control0..1
          Typeid
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          4. DeviceUseStatement.meta
          Definition

          The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.

          ShortMetadata about the resource
          Control0..1
          TypeMeta
          Summarytrue
          6. DeviceUseStatement.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.

          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.

          This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

          Control0..1
          Typeuri
          Is Modifiertrue because No Modifier Reason provideed in previous versions of FHIR
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          8. DeviceUseStatement.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
          BindingUnless not suitable, these codes SHALL be taken from Common Languages
          (extensible to http://hl7.org/fhir/ValueSet/languages|3.0.2)

          A human language.

          Additional BindingsPurpose
          All LanguagesMax Binding
          Typecode
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          10. DeviceUseStatement.text
          Definition

          A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

          ShortText summary of the resource, for human interpretation
          Comments

          Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded in formation is added later.

          Control0..1
          This element is affected by the following invariants: dom-1
          TypeNarrative
          Alternate Namesnarrative, html, xhtml, display
          12. DeviceUseStatement.contained
          Definition

          These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

          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.

          Control0..*
          TypeResource
          Alternate Namesinline resources, anonymous resources, contained resources
          14. DeviceUseStatement.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          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
          Alternate Namesextensions, user content
          SlicingThis element introduces a set of slices on DeviceUseStatement.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 16. DeviceUseStatement.extension:HealthcareProvider
            Slice NameHealthcareProvider
            Definition

            Optional Extension Element - found in all resources.

            ShortOptional Extensions Element
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(HCIM MedicalDevice Organization) (Extension Type: Reference(nl-core-organization))
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() | (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            18. DeviceUseStatement.extension:HealthProfessional
            Slice NameHealthProfessional
            Definition

            Optional Extension Element - found in all resources.

            ShortOptional Extensions Element
            Control0..1
            This element is affected by the following invariants: ele-1
            TypeExtension(HCIM MedicalDevice Practitioner) (Extension Type: Reference(nl-core-practitioner, nl-core-practitionerrole))
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() | (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            20. DeviceUseStatement.extension:HealthProfessional.id
            Definition

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

            Shortxml:id (or equivalent in JSON)
            Control0..1
            Typestring
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            XML FormatIn the XML format, this property is represented as an attribute.
            22. DeviceUseStatement.extension:HealthProfessional.extension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

            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..0
            TypeExtension
            Alternate Namesextensions, user content
            SlicingThis element introduces a set of slices on DeviceUseStatement.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 24. DeviceUseStatement.extension:HealthProfessional.url
              Definition

              Source of the definition for the extension code - a logical name or a URL.

              Shortidentifies the meaning of the extension
              Comments

              The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

              Control1..1
              Typeuri
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              XML FormatIn the XML format, this property is represented as an attribute.
              Fixed Valuehttp://nictiz.nl/fhir/StructureDefinition/zib-MedicalDevice-Practitioner
              26. DeviceUseStatement.extension:HealthProfessional.valueReference:valueReference
              Slice NamevalueReference
              Definition

              The healthcare provider involved in the indication for use of the medical device implant.

              ShortHealthProfessional
              Control0..1
              TypeReference(nl-core-practitioner, nl-core-practitionerrole)
              Alternate NamesZorgverlener
              28. DeviceUseStatement.extension:reasonReference
              Slice NamereasonReference
              Definition

              Another resource whose existence justifies this DeviceUseStatement.

              ShortWhy was DeviceUseStatement performed?
              Comments

              This extension is backported from the offical HL7 DeviceUseStatement specification in FHIR R4.

              Control0..*
              This element is affected by the following invariants: ele-1
              TypeExtension(Backported DeviceUseStatement.reasonReference for STU3) (Extension Type: Reference(Condition, Observation, DiagnosticReport, DocumentReference, Media))
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() | (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              30. DeviceUseStatement.extension:encounter
              Slice Nameencounter
              Definition

              An extension to link the Encounter during which the Consent, Goal or DeviceUseStatement was created or to which the creation is tightly associated.

              Shortext Encounter Reference
              Control0..1
              TypeExtension(ext Encounter Reference) (Extension Type: Reference(Encounter))
              32. DeviceUseStatement.extension:encounter.id
              Definition

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

              Shortxml:id (or equivalent in JSON)
              Control0..1
              Typestring
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              XML FormatIn the XML format, this property is represented as an attribute.
              34. DeviceUseStatement.extension:encounter.extension
              Definition

              An Extension

              ShortExtension
              Control0..0
              TypeExtension
              SlicingThis element introduces a set of slices on DeviceUseStatement.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 36. DeviceUseStatement.extension:encounter.url
                Definition

                Source of the definition for the extension code - a logical name or a URL.

                Shortidentifies the meaning of the extension
                Comments

                The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                Control1..1
                Typeuri
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                XML FormatIn the XML format, this property is represented as an attribute.
                Fixed Valuehttps://api.iknl.nl/docs/pzp/stu3/StructureDefinition/ext-EncounterReference
                38. DeviceUseStatement.extension:encounter.value[x]
                Definition

                The Encounter during which this resource was created or to which the creation is tightly associated.

                ShortEncounter
                Comments

                This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. completing the administrative registration after the encounter).

                Control0..1
                TypeReference(Encounter)
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                40. DeviceUseStatement.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. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                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 No Modifier Reason provideed in previous versions of FHIR
                Alternate Namesextensions, user content
                42. DeviceUseStatement.identifier
                Definition

                An external identifier for this statement such as an IRI.

                ShortExternal identifier for this record
                NoteThis is a business identifier, not a resource identifier (see discussion)
                Control0..*
                TypeIdentifier
                44. DeviceUseStatement.status
                Definition

                A code representing the patient or other source's judgment about the state of the device used that this statement is about. Generally this will be active or completed.

                Shortactive | completed | entered-in-error +
                Comments

                DeviceUseStatment is a statement at a point in time. The status is only representative at the point when it was asserted. The value set for contains codes that assert the status of the use by the patient (for example, stopped or on hold) as well as codes that assert the status of the resource itself (for example, entered in error).

                This element is labeled as a modifier because the status contains the codes that mark the statement as not currently valid.

                Control1..1
                BindingThe codes SHALL be taken from DeviceUseStatementStatus
                (required to http://hl7.org/fhir/ValueSet/device-statement-status|3.0.2)

                A coded concept indicating the current status of a the Device Usage

                Typecode
                Is Modifiertrue because No Modifier Reason provideed in previous versions of FHIR
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                46. DeviceUseStatement.subject
                Definition

                The patient who used the device.

                ShortPatient using device
                Control1..1
                TypeReference(Patient)
                48. DeviceUseStatement.whenUsed
                Definition

                The time period over which the device was used.

                ShortTime range defined by start and end date/time
                Control0..1
                TypePeriod
                Alternate NamesTijdsduur gedefinieerd door start- en einddatum/tijd
                50. DeviceUseStatement.whenUsed.id
                Definition

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

                Shortxml:id (or equivalent in JSON)
                Control0..1
                Typestring
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                XML FormatIn the XML format, this property is represented as an attribute.
                52. DeviceUseStatement.whenUsed.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                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
                Alternate Namesextensions, user content
                SlicingThis element introduces a set of slices on DeviceUseStatement.whenUsed.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 54. DeviceUseStatement.whenUsed.start
                  Definition

                  The start date of the first use or implant of the medical aid. A ‘vague’ date, such as only the year, is permitted.

                  ShortStartDate
                  Comments

                  If the low element is missing, the meaning is that the low boundary is not known.

                  Control0..1
                  This element is affected by the following invariants: per-1
                  TypedateTime
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Alternate NamesBeginDatum
                  56. DeviceUseStatement.whenUsed.end
                  Definition

                  The end of the period. If the end of the period is missing, it means that the period is ongoing. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.

                  ShortEnd time with inclusive boundary, if not ongoing
                  Comments

                  The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has a end value of 2012-02-03.

                  Control0..1
                  This element is affected by the following invariants: per-1
                  TypedateTime
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
                  58. DeviceUseStatement.timing[x]
                  Definition

                  How often the device was used.

                  ShortHow often the device was used
                  Control0..1
                  TypeChoice of: Timing, Period, dateTime
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  SlicingThis element introduces a set of slices on DeviceUseStatement.timing[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                  • type @ $this
                  • 60. DeviceUseStatement.timing[x]:timingPeriod
                    Slice NametimingPeriod
                    Definition

                    How often the device was used.

                    ShortHow often the device was used
                    Control0..1
                    TypePeriod
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    62. DeviceUseStatement.recordedOn
                    Definition

                    The time at which the statement was made/recorded.

                    ShortWhen statement was recorded
                    Control0..1
                    TypedateTime
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    64. DeviceUseStatement.source
                    Definition

                    Who reported the device was being used by the patient.

                    ShortWho made the statement
                    Control0..1
                    TypeReference(nl-core-patient, nl-core-practitioner, nl-core-relatedperson)
                    66. DeviceUseStatement.source.id
                    Definition

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

                    Shortxml:id (or equivalent in JSON)
                    Control0..1
                    Typestring
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    XML FormatIn the XML format, this property is represented as an attribute.
                    68. DeviceUseStatement.source.extension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                    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
                    Alternate Namesextensions, user content
                    SlicingThis element introduces a set of slices on DeviceUseStatement.source.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 70. DeviceUseStatement.source.extension:practitionerRole
                      Slice NamepractitionerRole
                      Definition

                      Optional Extension Element - found in all resources.

                      ShortOptional Extensions Element
                      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..1
                      This element is affected by the following invariants: ele-1
                      TypeExtension(PractitionerRole Reference) (Extension Type: Reference(nl-core-practitionerrole))
                      Alternate Namesextensions, user content
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() | (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      72. DeviceUseStatement.source.reference
                      Definition

                      A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

                      ShortLiteral reference, Relative, internal or absolute URL
                      Comments

                      Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

                      Control0..1
                      This element is affected by the following invariants: ref-1
                      Typestring
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      74. DeviceUseStatement.source.identifier
                      Definition

                      An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

                      ShortLogical reference, when literal reference is not known
                      Comments

                      When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

                      When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

                      Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

                      NoteThis is a business identifier, not a resource identifier (see discussion)
                      Control0..1
                      TypeIdentifier
                      Summarytrue
                      76. DeviceUseStatement.source.display
                      Definition

                      Plain text narrative that identifies the resource in addition to the resource reference.

                      ShortText alternative for the resource
                      Comments

                      This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

                      Control0..1
                      Typestring
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      78. DeviceUseStatement.device
                      Definition

                      The details of the device used.

                      ShortReference to device used
                      Control1..1
                      TypeReference(MedicalDevice Product ICD)
                      80. DeviceUseStatement.indication
                      Definition

                      Reason or justification for the use of the device.

                      ShortWhy device was used
                      Control0..*
                      TypeCodeableConcept
                      82. DeviceUseStatement.indication.id
                      Definition

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

                      Shortxml:id (or equivalent in JSON)
                      Control0..1
                      Typestring
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      XML FormatIn the XML format, this property is represented as an attribute.
                      84. DeviceUseStatement.indication.extension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                      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
                      Alternate Namesextensions, user content
                      SlicingThis element introduces a set of slices on DeviceUseStatement.indication.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 86. DeviceUseStatement.indication.extension:indication_Problem
                        Slice Nameindication_Problem
                        Definition

                        Optional Extension Element - found in all resources.

                        ShortOptional Extensions Element
                        Control0..*
                        This element is affected by the following invariants: ele-1
                        TypeExtension(HCIM MedicalDevice Problem) (Extension Type: Reference(HCIM Problem))
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() | (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        88. DeviceUseStatement.indication.coding
                        Definition

                        A reference to a code defined by a terminology system.

                        ShortCode defined by a terminology system
                        Comments

                        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                        Control0..*
                        TypeCoding
                        Summarytrue
                        Requirements

                        Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

                        90. DeviceUseStatement.indication.text
                        Definition

                        A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                        ShortPlain text representation of the concept
                        Comments

                        Very often the text is the same as a displayName of one of the codings.

                        Control0..1
                        Typestring
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Summarytrue
                        Requirements

                        The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                        92. DeviceUseStatement.bodySite
                        Definition

                        Patient’s anatomical location of the medical device used.

                        ShortAnatomicalLocation
                        Control0..1
                        BindingUnless not suitable, these codes SHALL be taken from HulpmiddelAnatomischeLocatieCodelijst (2017-12-31T00:00:00)
                        (extensible to http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.2--20171231000000|2017-12-31T00:00:00)

                        Patient’s anatomical location of the medical aid used.

                        TypeCodeableConcept
                        Requirements

                        Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/body-site-instance.

                        Alternate NamesAnatomischeLocatie
                        94. DeviceUseStatement.bodySite.id
                        Definition

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

                        Shortxml:id (or equivalent in JSON)
                        Control0..1
                        Typestring
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        XML FormatIn the XML format, this property is represented as an attribute.
                        96. DeviceUseStatement.bodySite.extension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                        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
                        Alternate Namesextensions, user content
                        SlicingThis element introduces a set of slices on DeviceUseStatement.bodySite.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 98. DeviceUseStatement.bodySite.extension:Laterality
                          Slice NameLaterality
                          Definition

                          Qualifier to refine the anatomical location. These include qualifiers for laterality, relative location, directionality, number, and plane.

                          ShortOptional Extensions Element
                          Control0..1
                          This element is affected by the following invariants: ele-1
                          TypeExtension(BodySite Qualifier) (Extension Type: CodeableConcept)
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() | (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          100. DeviceUseStatement.bodySite.extension:Laterality.id
                          Definition

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

                          Shortxml:id (or equivalent in JSON)
                          Control0..1
                          Typestring
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          XML FormatIn the XML format, this property is represented as an attribute.
                          102. DeviceUseStatement.bodySite.extension:Laterality.extension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                          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..0
                          TypeExtension
                          Alternate Namesextensions, user content
                          SlicingThis element introduces a set of slices on DeviceUseStatement.bodySite.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 104. DeviceUseStatement.bodySite.extension:Laterality.url
                            Definition

                            Source of the definition for the extension code - a logical name or a URL.

                            Shortidentifies the meaning of the extension
                            Comments

                            The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                            Control1..1
                            Typeuri
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            XML FormatIn the XML format, this property is represented as an attribute.
                            Fixed Valuehttp://nictiz.nl/fhir/StructureDefinition/BodySite-Qualifier
                            106. DeviceUseStatement.bodySite.extension:Laterality.value[x]
                            Definition

                            Qualifier to refine the anatomical location. These include qualifiers for laterality, relative location, directionality, number, and plane.

                            ShortBodySite qualifier
                            Control0..1
                            BindingUnless not suitable, these codes SHALL be taken from MedischHulpmiddelLateraliteitCodelijst (2017-12-31T00:00:00)
                            (extensible to http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.4--20171231000000|2017-12-31T00:00:00)

                            MedicalDeviceLateralityCodelist

                            TypeCodeableConcept
                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                            108. DeviceUseStatement.bodySite.coding
                            Definition

                            A reference to a code defined by a terminology system.

                            ShortCode defined by a terminology system
                            Comments

                            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                            Control0..*
                            TypeCoding
                            Summarytrue
                            Requirements

                            Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

                            110. DeviceUseStatement.bodySite.text
                            Definition

                            A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                            ShortPlain text representation of the concept
                            Comments

                            Very often the text is the same as a displayName of one of the codings.

                            Control0..1
                            Typestring
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

                            The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                            112. DeviceUseStatement.note
                            Definition

                            Details about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement.

                            ShortAddition details (comments, instructions)
                            Control0..*
                            TypeAnnotation
                            114. DeviceUseStatement.note.id
                            Definition

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

                            Shortxml:id (or equivalent in JSON)
                            Control0..1
                            Typestring
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            XML FormatIn the XML format, this property is represented as an attribute.
                            116. DeviceUseStatement.note.extension
                            Definition

                            May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                            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
                            Alternate Namesextensions, user content
                            SlicingThis element introduces a set of slices on DeviceUseStatement.note.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 118. DeviceUseStatement.note.author[x]
                              Definition

                              The individual responsible for making the annotation.

                              ShortIndividual responsible for the annotation
                              Control0..1
                              TypeChoice of: Reference(Practitioner, Patient, RelatedPerson), string
                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              120. DeviceUseStatement.note.time
                              Definition

                              Indicates when this particular annotation was made.

                              ShortWhen the annotation was made
                              Control0..1
                              TypedateTime
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              122. DeviceUseStatement.note.text
                              Definition

                              Comment about use or information on the medical aid used.

                              ShortComment
                              Control1..1
                              Typestring
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Alternate NamesToelichting