IKNL PZP STU3
1.0.0-rc1 - 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-rc1 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 2026-01-16

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.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
    18. 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
    20. DeviceUseStatement.subject
    Definition

    The patient who used the device.

    ShortPatient using device
    Control1..1
    TypeReference(Patient, Patient, Group)
    22. 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
    • 24. 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]
      26. DeviceUseStatement.device
      Definition

      The details of the device used.

      ShortReference to device used
      Control1..1
      TypeReference(MedicalDevice Product ICD, Device)
      28. 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
      30. 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())
      32. 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
      • 34. 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.subject
        TypeReference(Patient)
        8. DeviceUseStatement.whenUsed
        10. DeviceUseStatement.whenUsed.start
        12. DeviceUseStatement.timing[x]:timingPeriod
        Slice NametimingPeriod
        TypePeriod
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        14. DeviceUseStatement.device
        TypeReference(MedicalDevice Product ICD)
        16. DeviceUseStatement.indication
        18. DeviceUseStatement.indication.extension:indication_Problem
        Slice Nameindication_Problem
        20. DeviceUseStatement.bodySite
        22. DeviceUseStatement.bodySite.extension:Laterality
        Slice NameLaterality
        24. DeviceUseStatement.note
        26. 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.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
            32. 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
            34. 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
            36. DeviceUseStatement.subject
            Definition

            The patient who used the device.

            ShortPatient using device
            Control1..1
            TypeReference(Patient)
            38. 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
            40. 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.
            42. 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
            • 44. 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
              46. 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
              48. 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
              • 50. 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]
                52. 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
                54. 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)
                56. 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.
                58. 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
                • 60. 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())
                  62. 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
                  64. 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
                  66. 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
                  68. DeviceUseStatement.device
                  Definition

                  The details of the device used.

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

                  Reason or justification for the use of the device.

                  ShortWhy device was used
                  Control0..*
                  TypeCodeableConcept
                  72. 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.
                  74. 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
                  • 76. 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())
                    78. 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.

                    80. 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.

                    82. 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
                    84. 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.
                    86. 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
                    • 88. 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())
                      90. 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.
                      92. 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
                      • 94. 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
                        96. 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]
                        98. 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.

                        100. 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.

                        102. 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
                        104. 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.
                        106. 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
                        • 108. 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
                          110. 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
                          112. 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