Advance Care Planning (PZP)
1.0.0-rc1 - trial-use

This page is part of the Advance Care Planning (PZP) (v1.0.0-rc1: Release 1) based on FHIR (HL7® FHIR® Standard) R4. No current official version has been published yet. For a full list of available versions, 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.

ShortMedicalDeviceRecord of use of a device
Control0..*
Is Modifierfalse
Alternate NamesMedischHulpmiddel, nl-core-MedicalDevice
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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 or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. 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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..1
This element is affected by the following invariants: ele-1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. 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(ext MedicalDevice.HealthProfessional) (Extension Type: Reference(zib HealthProfessional PractitionerRole))
Obligations
    ObligationsActor
    SHALL:populate-if-knownACP Actor Provider
    SHALL:no-errorACP Actor Consulter
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    6. 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
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Fixed Valuehttp://nictiz.nl/fhir/StructureDefinition/ext-MedicalDevice.HealthProfessional
    8. DeviceUseStatement.extension:healthProfessional.value[x]
    Definition

    The health professional involved in the indication for use of the medical device implant.


    Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

    ShortHealthProfessionalValue of extension
    Comments

    Each occurrence of the zib HealthProfessional is normally represented by two FHIR resources: a PractitionerRole resource (instance of nl-core-HealthProfessional-PractitionerRole) and a Practitioner resource (instance of nl-core-HealthProfessional-Practitioner). The Practitioner resource is referenced from the PractitionerRole instance. For this reason, sending systems should fill the reference to the PractitionerRole instance here, and not the Practitioner resource. Receiving systems can then retrieve the reference to the Practitioner resource from that PractitionerRole instance.

    In rare circumstances, there is only a Practitioner instance, in which case it is that instance which will be referenced here. However, since this should be the exception, the nl-core-HealthProfessional-Practitioner profile is not explicitly mentioned as a target profile.

    Control0..1
    This element is affected by the following invariants: ele-1
    TypeReference(nl core HealthProfessional PractitionerRole), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Alternate NamesZorgverlener
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. DeviceUseStatement.extension:location
    Slice Namelocation
    Definition

    Optional Extension Element - found in all resources.

    ShortOptional Extensions Element
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(ext MedicalDevice.Location) (Extension Type: Reference(zib HealthcareProvider))
    Obligations
      ObligationsActor
      SHALL:populate-if-knownACP Actor Provider
      SHALL:no-errorACP Actor Consulter
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      12. DeviceUseStatement.extension:location.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
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Fixed Valuehttp://nictiz.nl/fhir/StructureDefinition/ext-MedicalDevice.Location
      14. DeviceUseStatement.extension:location.value[x]
      Definition

      The healthcare provider at which use of the medical device was initiated or where the aid was implanted.


      Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

      ShortLocationValue of extension
      Comments

      Please note that this zib concept (Location::HealthcareProvider) is also mapped on the Procedure.location element in profile nl-core-Procedure-event. The reason for this is that this zib concept aligns with the Location::HealthcareProvider concept in zib Procedure (NL-CM:14.1.5), but only for the situation that the Procedure is about placing the implant which is described using this instance of zib MedicalDevice. In this situation, the current extension is redundant and it is advised to only use Procedure.location in profile nl-core-Procedure-event to represent the Location concept.

      Control0..1
      This element is affected by the following invariants: ele-1
      TypeReference(nl core HealthcareProvider), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Alternate NamesLocatie
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      16. DeviceUseStatement.extension:treatmentObjective
      Slice NametreatmentObjective
      Definition

      Indicates that the resource is related to either the measurement, achievement or progress towards the referenced goal. For example, a Procedure to exercise pertainsToGoal of losing weight.

      ShortPertains to goal
      Comments

      This extension is limited to subject-specific activity-related resources (events & intents). I.e. This can't be put on Goal or Patient. This association isn't for the purpose of goal management, but for things such as noting that a particular observation result, prescription or other activity is pertinent to the achievement (or possibly non-achievement) of the referenced goal.

      Control0..*
      This element is affected by the following invariants: ele-1
      TypeExtension(Resource Pertains To Goal) (Extension Type: Reference(Goal))
      Is Modifierfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      18. DeviceUseStatement.extension:treatmentObjective.extension
      Definition

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

      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*
      This element is affected by the following invariants: ele-1
      TypeExtension
      Is Modifierfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      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:treatmentObjective.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
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Fixed Valuehttp://hl7.org/fhir/StructureDefinition/resource-pertainsToGoal
        22. DeviceUseStatement.extension:treatmentObjective.value[x]
        Definition

        Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

        ShortValue of extension
        Comments

        Zib TreatmentObjective (represented by the Goal resource in FHIR) can use the data model of zib FunctionalOrMentalStatus to describe the desired treatment objective, which in turn may refer zib MedicalDevice to indicate the intent to use that device for reaching the treatment objective.

        In FHIR, the modeling deviates somewhat from this approach:

        • Both zib TreatmentObjective and the desired zib FunctionalOrMentalStatus are represented using the nl-core-TreatmentObjective profile on the Goal resource.
        • The reference from TreatmentObjective::FunctionalOrMentalStatus::MedicalDevice is in the opposite direction, to the Goal resource.

        This extension may thus be used to represent the link zib TreatmentObjective -> zib FunctionalOrMentalStatus -> zib MedicalDevice. In this situation, it is expected that DeviceUseStatement.status is set to intended.

        Control10..1
        This element is affected by the following invariants: ele-1
        TypeReference(Goal, nl core TreatmentObjective), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        24. 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
        This element is affected by the following invariants: ele-1
        TypeExtension(ext Encounter Reference) (Extension Type: Reference(Encounter))
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        26. 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. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        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
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        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
        • 28. 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
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          Fixed Valuehttps://api.iknl.nl/docs/pzp/r4/StructureDefinition/ext-EncounterReference
          30. 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 - must be one of a constrained set of the data types (see Extensibility for a 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, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          32. 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 and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          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..*
          This element is affected by the following invariants: ele-1
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
          Requirements

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

          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on DeviceUseStatement.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 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

            This element is implictly mapped to the zib concepts NL-CM:10.1.11 (StartDate) and NL-CM:10.1.14 (EndDate). Unless the status is explicitly recorded, the following guidance applies:

            • When StartDate is in the future, .status will usually be set to intended.
            • When StartDate is in the past and EndDate has a value and in the future or EndDate has no value, .status will usually be set to active.
            • When EndDate has a value and is in the past, .status will usually be set to completed.

            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
            This element is affected by the following invariants: ele-1
            BindingThe codes SHALL be taken from DeviceUseStatementStatushttp://hl7.org/fhir/ValueSet/device-statement-status|4.0.1
            (required to http://hl7.org/fhir/ValueSet/device-statement-status|4.0.1)

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

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

            The patient who used the device.

            ShortPatient using device
            Comments

            References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

            Control1..1
            This element is affected by the following invariants: ele-1
            TypeReference(Patient, Patient, Group)
            Is Modifierfalse
            Obligations
              ObligationsActor
              SHALL:populate-if-knownACP Actor Provider
              SHALL:no-errorACP Actor Consulter
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
              ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              38. DeviceUseStatement.derivedFrom
              Definition

              Allows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement.

              ShortSupporting information
              Comments

              The most common use cases for deriving a DeviceUseStatement comes from creating it from a request or from an observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the DeviceUseStatement from.

              Control0..*
              This element is affected by the following invariants: ele-1
              TypeReference(ServiceRequest, Procedure, Claim, Observation, QuestionnaireResponse, DocumentReference)
              Is Modifierfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
              ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              SlicingThis element introduces a set of slices on DeviceUseStatement.derivedFrom. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • profile @ resolve()
              • 40. DeviceUseStatement.derivedFrom:procedure-request
                Slice Nameprocedure-request
                Definition

                The procedure which has the purpose of placing this product in or on the body.


                Allows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement.

                ShortProcedureSupporting information
                Comments
                • Note 1: on a functional level, zib Procedure references zib MedicalDevice, but in FHIR this direction is reversed.
                • Note 2: zib Procedure can represent a requested or (to be) performed procedure. This slice represents requested procedures, while slice procedure-event represents performed procedures.

                The most common use cases for deriving a DeviceUseStatement comes from creating it from a request or from an observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the DeviceUseStatement from.

                Control0..*
                This element is affected by the following invariants: ele-1
                TypeReference(nl core Procedure request, ServiceRequest, Procedure, Claim, Observation, QuestionnaireResponse, DocumentReference)
                Is Modifierfalse
                Summarytrue
                Alternate NamesVerrichting
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                42. DeviceUseStatement.derivedFrom:procedure-event
                Slice Nameprocedure-event
                Definition

                The procedure which has the purpose of placing this product in or on the body.


                Allows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement.

                ShortProcedureSupporting information
                Comments
                • Note 1: on a functional level, zib Procedure references zib MedicalDevice, but in FHIR this direction is reversed.
                • Note 2: zib Procedure can represent a requested or (to be) performed procedure. This slice represents performed procedures, while slice procedure-request represents requested procedures.

                The most common use cases for deriving a DeviceUseStatement comes from creating it from a request or from an observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the DeviceUseStatement from.

                Control0..*
                This element is affected by the following invariants: ele-1
                TypeReference(nl core Procedure event, ServiceRequest, Procedure, Claim, Observation, QuestionnaireResponse, DocumentReference)
                Is Modifierfalse
                Summarytrue
                Alternate NamesVerrichting
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                44. DeviceUseStatement.timing[x]
                Definition

                How often the device was used.

                ShortHow often the device was used
                Control0..1
                This element is affected by the following invariants: ele-1
                TypeChoice of: Timing, Period, dateTime
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                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
                • 46. DeviceUseStatement.timing[x]:timingPeriod
                  Slice NametimingPeriod
                  Definition

                  How often the device was used.

                  ShortHow often the device was used
                  Control0..1
                  This element is affected by the following invariants: ele-1
                  TypePeriod, dateTime, Timing
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  48. DeviceUseStatement.timing[x]:timingPeriod.start
                  Definition

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


                  The start of the period. The boundary is inclusive.

                  ShortStartDateStarting time with inclusive boundary
                  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: ele-1, per-1
                  TypedateTime
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Obligations
                    ObligationsActor
                    SHALL:populate-if-knownACP Actor Provider
                    SHALL:no-errorACP Actor Consulter
                    Summarytrue
                    Alternate NamesBeginDatum
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    50. DeviceUseStatement.timing[x]:timingPeriod.end
                    Definition

                    The end date of the last use or explant of the medical device. A "vague" date, such as only the year, is permitted.


                    The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. 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.

                    ShortEndDateEnd 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 an end value of 2012-02-03.

                    Control0..1
                    This element is affected by the following invariants: ele-1, per-1
                    TypedateTime
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Obligations
                      ObligationsActor
                      SHALL:populate-if-knownACP Actor Provider
                      SHALL:no-errorACP Actor Consulter
                      Summarytrue
                      Alternate NamesEindDatum
                      Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      52. DeviceUseStatement.device
                      Definition

                      The details of the device used.

                      ShortReference to device used
                      Comments

                      References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                      Control1..1
                      This element is affected by the following invariants: ele-1
                      TypeReference(MedicalDevice Product ICD, nl core MedicalDevice.Product, Device)
                      Is Modifierfalse
                      Obligations
                        ObligationsActor
                        SHALL:populate-if-knownACP Actor Provider
                        SHALL:no-errorACP Actor Consulter
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                        ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        54. DeviceUseStatement.reasonReference
                        Definition

                        Indicates another resource whose existence justifies this DeviceUseStatement.

                        ShortWhy was DeviceUseStatement performed?
                        Comments

                        References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                        Control0..*
                        This element is affected by the following invariants: ele-1
                        TypeReference(Condition, Observation, DiagnosticReport, DocumentReference, Media)
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                        ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        SlicingThis element introduces a set of slices on DeviceUseStatement.reasonReference. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • profile @ resolve()
                        • 56. DeviceUseStatement.reasonReference:indication
                          Slice Nameindication
                          Definition

                          The medical reason for use of the medical device.


                          Indicates another resource whose existence justifies this DeviceUseStatement.

                          ShortIndicationWhy was DeviceUseStatement performed?
                          Comments

                          References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                          Control0..*
                          This element is affected by the following invariants: ele-1
                          TypeReference(nl core Problem, Condition, Observation, DiagnosticReport, DocumentReference, Media)
                          Is Modifierfalse
                          Obligations
                            ObligationsActor
                            SHALL:populate-if-knownACP Actor Provider
                            SHALL:no-errorACP Actor Consulter
                            Summarytrue
                            Alternate NamesIndicatie
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                            ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            58. DeviceUseStatement.reasonReference:stoma
                            Slice Namestoma
                            Definition

                            Indicates another resource whose existence justifies this DeviceUseStatement.

                            ShortStomaWhy was DeviceUseStatement performed?
                            Comments

                            Please note that on a functional level, zib Stoma references zib MedicalDevice, but in FHIR this direction is reversed.

                            Control0..*
                            This element is affected by the following invariants: ele-1
                            TypeReference(nl core Stoma, Condition, Observation, DiagnosticReport, DocumentReference, Media)
                            Is Modifierfalse
                            Summarytrue
                            Alternate NamesStoma
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                            ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            60. DeviceUseStatement.bodySite
                            Definition

                            Localisation on/in the body.


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

                            ShortLocationTarget body site
                            Comments

                            Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                            Control0..1
                            This element is affected by the following invariants: ele-1
                            BindingThe codes SHALL be taken from For example codes, see LocatieCodelijsten (2020-09-01T00:00:00)http://hl7.org/fhir/ValueSet/body-site|4.0.1
                            (required to http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.121.11.11--20200901000000|2020-09-01T00:00:00)

                            Codes describing anatomical locations. May include laterality.

                            TypeCodeableConcept(nl core AnatomicalLocation)
                            Is Modifierfalse
                            Obligations
                              ObligationsActor
                              SHALL:populate-if-knownACP Actor Provider
                              SHALL:no-errorACP Actor Consulter
                              Summarytrue
                              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/bodySite.


                              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/bodySite.

                              Alternate NamesLocatie, AnatomischeLocatie, nl-core-AnatomicalLocation
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              62. DeviceUseStatement.bodySite.extension:laterality
                              Slice Namelaterality
                              Definition

                              Optional Extension Element - found in all resources.

                              ShortOptional Extensions Element
                              Control0..1
                              This element is affected by the following invariants: ele-1
                              TypeExtension(ext AnatomicalLocation.Laterality) (Extension Type: CodeableConcept)
                              Obligations
                                ObligationsActor
                                SHALL:populate-if-knownACP Actor Provider
                                SHALL:no-errorACP Actor Consulter
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                64. 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
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Fixed Valuehttp://nictiz.nl/fhir/StructureDefinition/ext-AnatomicalLocation.Laterality
                                66. DeviceUseStatement.bodySite.extension:laterality.value[x]
                                Definition

                                Laterality adds information about body site to the anatomic location, e.g. left.


                                Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                                ShortLateralityValue of extension
                                Control0..1
                                This element is affected by the following invariants: ele-1
                                BindingThe codes SHALL be taken from For codes, see LateraliteitCodelijst (2020-09-01T00:00:00)
                                (required to http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.20.7.2--20200901000000|2020-09-01T00:00:00)
                                TypeCodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                Is Modifierfalse
                                Alternate NamesLateraliteit
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                68. 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)
                                Comments

                                For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).

                                Control0..1*
                                This element is affected by the following invariants: ele-1
                                TypeAnnotation
                                Is Modifierfalse
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                70. DeviceUseStatement.note.text
                                Definition

                                Comment about use or information on the medical device used.


                                The text of the annotation in markdown format.

                                ShortCommentThe annotation - text content (as markdown)
                                Comments

                                Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/

                                Control1..1
                                This element is affected by the following invariants: ele-1
                                Typemarkdown
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Obligations
                                  ObligationsActor
                                  SHALL:populate-if-knownACP Actor Provider
                                  SHALL:no-errorACP Actor Consulter
                                  Summarytrue
                                  Alternate NamesToelichting
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

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

                                  0. DeviceUseStatement
                                  2. DeviceUseStatement.extension:healthProfessional
                                  Slice NamehealthProfessional
                                  Obligations
                                    ObligationsActor
                                    SHALL:populate-if-knownACP Actor Provider
                                    SHALL:no-errorACP Actor Consulter
                                    4. DeviceUseStatement.extension:healthProfessional.value[x]
                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                    6. DeviceUseStatement.extension:location
                                    Slice Namelocation
                                    Obligations
                                      ObligationsActor
                                      SHALL:populate-if-knownACP Actor Provider
                                      SHALL:no-errorACP Actor Consulter
                                      8. DeviceUseStatement.extension:location.value[x]
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                      10. DeviceUseStatement.extension:encounter
                                      Slice Nameencounter
                                      Control0..1
                                      TypeExtension(ext Encounter Reference) (Extension Type: Reference(Encounter))
                                      12. DeviceUseStatement.extension:encounter.value[x]
                                      TypeReference(Encounter)
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                      14. DeviceUseStatement.subject
                                      TypeReference(Patient)
                                      Obligations
                                        ObligationsActor
                                        SHALL:populate-if-knownACP Actor Provider
                                        SHALL:no-errorACP Actor Consulter
                                        16. DeviceUseStatement.timing[x]:timingPeriod
                                        Slice NametimingPeriod
                                        TypePeriod
                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                        18. DeviceUseStatement.timing[x]:timingPeriod.start
                                        Obligations
                                          ObligationsActor
                                          SHALL:populate-if-knownACP Actor Provider
                                          SHALL:no-errorACP Actor Consulter
                                          20. DeviceUseStatement.timing[x]:timingPeriod.end
                                          Obligations
                                            ObligationsActor
                                            SHALL:populate-if-knownACP Actor Provider
                                            SHALL:no-errorACP Actor Consulter
                                            22. DeviceUseStatement.device
                                            TypeReference(MedicalDevice Product ICD, nl core MedicalDevice.Product)
                                            Obligations
                                              ObligationsActor
                                              SHALL:populate-if-knownACP Actor Provider
                                              SHALL:no-errorACP Actor Consulter
                                              24. DeviceUseStatement.reasonReference:indication
                                              Slice Nameindication
                                              Obligations
                                                ObligationsActor
                                                SHALL:populate-if-knownACP Actor Provider
                                                SHALL:no-errorACP Actor Consulter
                                                26. DeviceUseStatement.bodySite
                                                Obligations
                                                  ObligationsActor
                                                  SHALL:populate-if-knownACP Actor Provider
                                                  SHALL:no-errorACP Actor Consulter
                                                  28. DeviceUseStatement.bodySite.extension:laterality
                                                  Slice Namelaterality
                                                  Obligations
                                                    ObligationsActor
                                                    SHALL:populate-if-knownACP Actor Provider
                                                    SHALL:no-errorACP Actor Consulter
                                                    30. DeviceUseStatement.bodySite.extension:laterality.value[x]
                                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                    32. DeviceUseStatement.note
                                                    34. DeviceUseStatement.note.text
                                                    Obligations
                                                      ObligationsActor
                                                      SHALL:populate-if-knownACP Actor Provider
                                                      SHALL:no-errorACP Actor Consulter

                                                      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, nl-core-MedicalDevice
                                                      Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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 or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
                                                      dom-6: A resource should have narrative for robust management (text.`div`.exists())
                                                      dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.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
                                                      Summarytrue
                                                      4. DeviceUseStatement.meta
                                                      Definition

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

                                                      ShortMetadata about the resource
                                                      Control0..1
                                                      This element is affected by the following invariants: ele-1
                                                      TypeMeta
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

                                                      ShortA set of rules under which this content was created
                                                      Comments

                                                      Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

                                                      Control0..1
                                                      This element is affected by the following invariants: ele-1
                                                      Typeuri
                                                      Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      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
                                                      This element is affected by the following invariants: ele-1
                                                      BindingThe codes SHOULD be taken from CommonLanguages
                                                      (preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

                                                      A human language.

                                                      Additional BindingsPurpose
                                                      AllLanguagesMax Binding
                                                      Typecode
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      10. DeviceUseStatement.text
                                                      Definition

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

                                                      ShortText summary of the resource, for human interpretation
                                                      Comments

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

                                                      Control0..1
                                                      This element is affected by the following invariants: ele-1
                                                      TypeNarrative
                                                      Alternate Namesnarrative, html, xhtml, display
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      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. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

                                                      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. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                      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..*
                                                      This element is affected by the following invariants: ele-1
                                                      TypeExtension
                                                      Alternate Namesextensions, user content
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                      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: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(ext MedicalDevice.HealthProfessional) (Extension Type: Reference(zib HealthProfessional PractitionerRole))
                                                        Obligations
                                                          ObligationsActor
                                                          SHALL:populate-if-knownACP Actor Provider
                                                          SHALL:no-errorACP Actor Consulter
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                          18. 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.

                                                          ShortUnique id for inter-element referencing
                                                          Control0..1
                                                          Typestring
                                                          XML FormatIn the XML format, this property is represented as an attribute.
                                                          20. DeviceUseStatement.extension:healthProfessional.extension
                                                          Definition

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

                                                          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..*
                                                          This element is affected by the following invariants: ele-1
                                                          TypeExtension
                                                          Alternate Namesextensions, user content
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                          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
                                                          • 22. 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
                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                            Fixed Valuehttp://nictiz.nl/fhir/StructureDefinition/ext-MedicalDevice.HealthProfessional
                                                            24. DeviceUseStatement.extension:healthProfessional.value[x]
                                                            Definition

                                                            The health professional involved in the indication for use of the medical device implant.

                                                            ShortHealthProfessional
                                                            Comments

                                                            Each occurrence of the zib HealthProfessional is normally represented by two FHIR resources: a PractitionerRole resource (instance of nl-core-HealthProfessional-PractitionerRole) and a Practitioner resource (instance of nl-core-HealthProfessional-Practitioner). The Practitioner resource is referenced from the PractitionerRole instance. For this reason, sending systems should fill the reference to the PractitionerRole instance here, and not the Practitioner resource. Receiving systems can then retrieve the reference to the Practitioner resource from that PractitionerRole instance.

                                                            In rare circumstances, there is only a Practitioner instance, in which case it is that instance which will be referenced here. However, since this should be the exception, the nl-core-HealthProfessional-Practitioner profile is not explicitly mentioned as a target profile.

                                                            Control0..1
                                                            This element is affected by the following invariants: ele-1
                                                            TypeReference(nl core HealthProfessional PractitionerRole)
                                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                            Alternate NamesZorgverlener
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            26. DeviceUseStatement.extension:location
                                                            Slice Namelocation
                                                            Definition

                                                            Optional Extension Element - found in all resources.

                                                            ShortOptional Extensions Element
                                                            Control0..1
                                                            This element is affected by the following invariants: ele-1
                                                            TypeExtension(ext MedicalDevice.Location) (Extension Type: Reference(zib HealthcareProvider))
                                                            Obligations
                                                              ObligationsActor
                                                              SHALL:populate-if-knownACP Actor Provider
                                                              SHALL:no-errorACP Actor Consulter
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              28. DeviceUseStatement.extension:location.id
                                                              Definition

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

                                                              ShortUnique id for inter-element referencing
                                                              Control0..1
                                                              Typestring
                                                              XML FormatIn the XML format, this property is represented as an attribute.
                                                              30. DeviceUseStatement.extension:location.extension
                                                              Definition

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

                                                              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..*
                                                              This element is affected by the following invariants: ele-1
                                                              TypeExtension
                                                              Alternate Namesextensions, user content
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              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
                                                              • 32. DeviceUseStatement.extension:location.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
                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                Fixed Valuehttp://nictiz.nl/fhir/StructureDefinition/ext-MedicalDevice.Location
                                                                34. DeviceUseStatement.extension:location.value[x]
                                                                Definition

                                                                The healthcare provider at which use of the medical device was initiated or where the aid was implanted.

                                                                ShortLocation
                                                                Comments

                                                                Please note that this zib concept (Location::HealthcareProvider) is also mapped on the Procedure.location element in profile nl-core-Procedure-event. The reason for this is that this zib concept aligns with the Location::HealthcareProvider concept in zib Procedure (NL-CM:14.1.5), but only for the situation that the Procedure is about placing the implant which is described using this instance of zib MedicalDevice. In this situation, the current extension is redundant and it is advised to only use Procedure.location in profile nl-core-Procedure-event to represent the Location concept.

                                                                Control0..1
                                                                This element is affected by the following invariants: ele-1
                                                                TypeReference(nl core HealthcareProvider)
                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                Alternate NamesLocatie
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                36. DeviceUseStatement.extension:treatmentObjective
                                                                Slice NametreatmentObjective
                                                                Definition

                                                                Indicates that the resource is related to either the measurement, achievement or progress towards the referenced goal. For example, a Procedure to exercise pertainsToGoal of losing weight.

                                                                ShortPertains to goal
                                                                Comments

                                                                This extension is limited to subject-specific activity-related resources (events & intents). I.e. This can't be put on Goal or Patient. This association isn't for the purpose of goal management, but for things such as noting that a particular observation result, prescription or other activity is pertinent to the achievement (or possibly non-achievement) of the referenced goal.

                                                                Control0..*
                                                                This element is affected by the following invariants: ele-1
                                                                TypeExtension(Resource Pertains To Goal) (Extension Type: Reference(Goal))
                                                                Is Modifierfalse
                                                                Alternate Namesextensions, user content
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                38. DeviceUseStatement.extension:treatmentObjective.id
                                                                Definition

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

                                                                ShortUnique id for inter-element referencing
                                                                Control0..1
                                                                Typestring
                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                40. DeviceUseStatement.extension:treatmentObjective.extension
                                                                Definition

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

                                                                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
                                                                This element is affected by the following invariants: ele-1
                                                                TypeExtension
                                                                Alternate Namesextensions, user content
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                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
                                                                • 42. DeviceUseStatement.extension:treatmentObjective.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
                                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                                  Fixed Valuehttp://hl7.org/fhir/StructureDefinition/resource-pertainsToGoal
                                                                  44. DeviceUseStatement.extension:treatmentObjective.value[x]
                                                                  Definition

                                                                  Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                                                                  ShortValue of extension
                                                                  Comments

                                                                  Zib TreatmentObjective (represented by the Goal resource in FHIR) can use the data model of zib FunctionalOrMentalStatus to describe the desired treatment objective, which in turn may refer zib MedicalDevice to indicate the intent to use that device for reaching the treatment objective.

                                                                  In FHIR, the modeling deviates somewhat from this approach:

                                                                  • Both zib TreatmentObjective and the desired zib FunctionalOrMentalStatus are represented using the nl-core-TreatmentObjective profile on the Goal resource.
                                                                  • The reference from TreatmentObjective::FunctionalOrMentalStatus::MedicalDevice is in the opposite direction, to the Goal resource.

                                                                  This extension may thus be used to represent the link zib TreatmentObjective -> zib FunctionalOrMentalStatus -> zib MedicalDevice. In this situation, it is expected that DeviceUseStatement.status is set to intended.

                                                                  Control1..1
                                                                  This element is affected by the following invariants: ele-1
                                                                  TypeReference(Goal, nl core TreatmentObjective)
                                                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  46. 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
                                                                  This element is affected by the following invariants: ele-1
                                                                  TypeExtension(ext Encounter Reference) (Extension Type: Reference(Encounter))
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                  48. 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.

                                                                  ShortUnique id for inter-element referencing
                                                                  Control0..1
                                                                  Typestring
                                                                  Is Modifierfalse
                                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                                  Summaryfalse
                                                                  50. DeviceUseStatement.extension:encounter.extension
                                                                  Definition

                                                                  An Extension

                                                                  ShortExtension
                                                                  Control0..0
                                                                  TypeExtension
                                                                  Is Modifierfalse
                                                                  Summaryfalse
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                  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
                                                                  • 52. 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
                                                                    Is Modifierfalse
                                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                                    Summaryfalse
                                                                    Fixed Valuehttps://api.iknl.nl/docs/pzp/r4/StructureDefinition/ext-EncounterReference
                                                                    54. 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]
                                                                    Is Modifierfalse
                                                                    Summaryfalse
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    56. 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 and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                    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..*
                                                                    This element is affected by the following invariants: ele-1
                                                                    TypeExtension
                                                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                                                                    Requirements

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

                                                                    Alternate Namesextensions, user content
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                    SlicingThis element introduces a set of slices on DeviceUseStatement.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                    • value @ url
                                                                    • 58. 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..*
                                                                      This element is affected by the following invariants: ele-1
                                                                      TypeIdentifier
                                                                      Summarytrue
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      60. DeviceUseStatement.basedOn
                                                                      Definition

                                                                      A plan, proposal or order that is fulfilled in whole or in part by this DeviceUseStatement.

                                                                      ShortFulfills plan, proposal or order
                                                                      Comments

                                                                      References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                                                                      Control0..*
                                                                      This element is affected by the following invariants: ele-1
                                                                      TypeReference(ServiceRequest)
                                                                      Summarytrue
                                                                      Requirements

                                                                      Allows tracing of authorization for the DeviceUseStatement and tracking whether proposals/recommendations were acted upon.

                                                                      Alternate Namesfulfills
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                                                      62. 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

                                                                      This element is implictly mapped to the zib concepts NL-CM:10.1.11 (StartDate) and NL-CM:10.1.14 (EndDate). Unless the status is explicitly recorded, the following guidance applies:

                                                                      • When StartDate is in the future, .status will usually be set to intended.
                                                                      • When StartDate is in the past and EndDate has a value and in the future or EndDate has no value, .status will usually be set to active.
                                                                      • When EndDate has a value and is in the past, .status will usually be set to completed.
                                                                      Control1..1
                                                                      This element is affected by the following invariants: ele-1
                                                                      BindingThe codes SHALL be taken from DeviceUseStatementStatus
                                                                      (required to http://hl7.org/fhir/ValueSet/device-statement-status|4.0.1)

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

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

                                                                      The patient who used the device.

                                                                      ShortPatient using device
                                                                      Comments

                                                                      References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                                                                      Control1..1
                                                                      This element is affected by the following invariants: ele-1
                                                                      TypeReference(Patient)
                                                                      Obligations
                                                                        ObligationsActor
                                                                        SHALL:populate-if-knownACP Actor Provider
                                                                        SHALL:no-errorACP Actor Consulter
                                                                        Summarytrue
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                                                        66. DeviceUseStatement.derivedFrom
                                                                        Definition

                                                                        Allows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement.

                                                                        ShortSupporting information
                                                                        Comments

                                                                        The most common use cases for deriving a DeviceUseStatement comes from creating it from a request or from an observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the DeviceUseStatement from.

                                                                        Control0..*
                                                                        This element is affected by the following invariants: ele-1
                                                                        TypeReference(ServiceRequest, Procedure, Claim, Observation, QuestionnaireResponse, DocumentReference)
                                                                        Summarytrue
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                                                        SlicingThis element introduces a set of slices on DeviceUseStatement.derivedFrom. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                        • profile @ resolve()
                                                                        • 68. DeviceUseStatement.derivedFrom:procedure-request
                                                                          Slice Nameprocedure-request
                                                                          Definition

                                                                          The procedure which has the purpose of placing this product in or on the body.

                                                                          ShortProcedure
                                                                          Comments
                                                                          • Note 1: on a functional level, zib Procedure references zib MedicalDevice, but in FHIR this direction is reversed.
                                                                          • Note 2: zib Procedure can represent a requested or (to be) performed procedure. This slice represents requested procedures, while slice procedure-event represents performed procedures.
                                                                          Control0..*
                                                                          This element is affected by the following invariants: ele-1
                                                                          TypeReference(nl core Procedure request)
                                                                          Summarytrue
                                                                          Alternate NamesVerrichting
                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                          ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                                                          70. DeviceUseStatement.derivedFrom:procedure-event
                                                                          Slice Nameprocedure-event
                                                                          Definition

                                                                          The procedure which has the purpose of placing this product in or on the body.

                                                                          ShortProcedure
                                                                          Comments
                                                                          • Note 1: on a functional level, zib Procedure references zib MedicalDevice, but in FHIR this direction is reversed.
                                                                          • Note 2: zib Procedure can represent a requested or (to be) performed procedure. This slice represents performed procedures, while slice procedure-request represents requested procedures.
                                                                          Control0..*
                                                                          This element is affected by the following invariants: ele-1
                                                                          TypeReference(nl core Procedure event)
                                                                          Summarytrue
                                                                          Alternate NamesVerrichting
                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                          ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                                                          72. DeviceUseStatement.timing[x]
                                                                          Definition

                                                                          How often the device was used.

                                                                          ShortHow often the device was used
                                                                          Control0..1
                                                                          This element is affected by the following invariants: ele-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
                                                                          Summarytrue
                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                          SlicingThis element introduces a set of slices on DeviceUseStatement.timing[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                                                          • type @ $this
                                                                          • 74. DeviceUseStatement.timing[x]:timingPeriod
                                                                            Slice NametimingPeriod
                                                                            Definition

                                                                            How often the device was used.

                                                                            ShortHow often the device was used
                                                                            Control0..1
                                                                            This element is affected by the following invariants: ele-1
                                                                            TypePeriod
                                                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                            Summarytrue
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            76. DeviceUseStatement.timing[x]:timingPeriod.id
                                                                            Definition

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

                                                                            ShortUnique id for inter-element referencing
                                                                            Control0..1
                                                                            Typestring
                                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                                            78. DeviceUseStatement.timing[x]:timingPeriod.extension
                                                                            Definition

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

                                                                            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..*
                                                                            This element is affected by the following invariants: ele-1
                                                                            TypeExtension
                                                                            Alternate Namesextensions, user content
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                            SlicingThis element introduces a set of slices on DeviceUseStatement.timing[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                            • value @ url
                                                                            • 80. DeviceUseStatement.timing[x]:timingPeriod.start
                                                                              Definition

                                                                              The start date of the first use or implant of the medical device. 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: ele-1, per-1
                                                                              TypedateTime
                                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                              Obligations
                                                                                ObligationsActor
                                                                                SHALL:populate-if-knownACP Actor Provider
                                                                                SHALL:no-errorACP Actor Consulter
                                                                                Summarytrue
                                                                                Alternate NamesBeginDatum
                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                82. DeviceUseStatement.timing[x]:timingPeriod.end
                                                                                Definition

                                                                                The end date of the last use or explant of the medical device. A "vague" date, such as only the year, is permitted.

                                                                                ShortEndDate
                                                                                Comments

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

                                                                                Control0..1
                                                                                This element is affected by the following invariants: ele-1, per-1
                                                                                TypedateTime
                                                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                Obligations
                                                                                  ObligationsActor
                                                                                  SHALL:populate-if-knownACP Actor Provider
                                                                                  SHALL:no-errorACP Actor Consulter
                                                                                  Summarytrue
                                                                                  Alternate NamesEindDatum
                                                                                  Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                  84. DeviceUseStatement.recordedOn
                                                                                  Definition

                                                                                  The time at which the statement was made/recorded.

                                                                                  ShortWhen statement was recorded
                                                                                  Control0..1
                                                                                  This element is affected by the following invariants: ele-1
                                                                                  TypedateTime
                                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                  Summarytrue
                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                  86. DeviceUseStatement.source
                                                                                  Definition

                                                                                  Who reported the device was being used by the patient.

                                                                                  ShortWho made the statement
                                                                                  Comments

                                                                                  References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                                                                                  Control0..1
                                                                                  This element is affected by the following invariants: ele-1
                                                                                  TypeReference(Patient, Practitioner, PractitionerRole, RelatedPerson)
                                                                                  Summarytrue
                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                  ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                                                                  88. DeviceUseStatement.device
                                                                                  Definition

                                                                                  The details of the device used.

                                                                                  ShortReference to device used
                                                                                  Comments

                                                                                  References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                                                                                  Control1..1
                                                                                  This element is affected by the following invariants: ele-1
                                                                                  TypeReference(MedicalDevice Product ICD, nl core MedicalDevice.Product)
                                                                                  Obligations
                                                                                    ObligationsActor
                                                                                    SHALL:populate-if-knownACP Actor Provider
                                                                                    SHALL:no-errorACP Actor Consulter
                                                                                    Summarytrue
                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                                                                    90. DeviceUseStatement.reasonCode
                                                                                    Definition

                                                                                    Reason or justification for the use of the device.

                                                                                    ShortWhy device was used
                                                                                    Comments

                                                                                    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                                                                                    Control0..*
                                                                                    This element is affected by the following invariants: ele-1
                                                                                    TypeCodeableConcept
                                                                                    Summarytrue
                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                    92. DeviceUseStatement.reasonReference
                                                                                    Definition

                                                                                    Indicates another resource whose existence justifies this DeviceUseStatement.

                                                                                    ShortWhy was DeviceUseStatement performed?
                                                                                    Comments

                                                                                    References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                                                                                    Control0..*
                                                                                    This element is affected by the following invariants: ele-1
                                                                                    TypeReference(Condition, Observation, DiagnosticReport, DocumentReference, Media)
                                                                                    Summarytrue
                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                                                                    SlicingThis element introduces a set of slices on DeviceUseStatement.reasonReference. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                                    • profile @ resolve()
                                                                                    • 94. DeviceUseStatement.reasonReference:indication
                                                                                      Slice Nameindication
                                                                                      Definition

                                                                                      The medical reason for use of the medical device.

                                                                                      ShortIndication
                                                                                      Comments

                                                                                      References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                                                                                      Control0..*
                                                                                      This element is affected by the following invariants: ele-1
                                                                                      TypeReference(nl core Problem)
                                                                                      Obligations
                                                                                        ObligationsActor
                                                                                        SHALL:populate-if-knownACP Actor Provider
                                                                                        SHALL:no-errorACP Actor Consulter
                                                                                        Summarytrue
                                                                                        Alternate NamesIndicatie
                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                                                                        96. DeviceUseStatement.reasonReference:stoma
                                                                                        Slice Namestoma
                                                                                        Definition

                                                                                        Indicates another resource whose existence justifies this DeviceUseStatement.

                                                                                        ShortStoma
                                                                                        Comments

                                                                                        Please note that on a functional level, zib Stoma references zib MedicalDevice, but in FHIR this direction is reversed.

                                                                                        Control0..*
                                                                                        This element is affected by the following invariants: ele-1
                                                                                        TypeReference(nl core Stoma)
                                                                                        Summarytrue
                                                                                        Alternate NamesStoma
                                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                                                                                        98. DeviceUseStatement.bodySite
                                                                                        Definition

                                                                                        Localisation on/in the body.

                                                                                        ShortLocation
                                                                                        Comments

                                                                                        Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                                                                                        Control0..1
                                                                                        This element is affected by the following invariants: ele-1
                                                                                        BindingThe codes SHALL be taken from LocatieCodelijsten (2020-09-01T00:00:00)
                                                                                        (required to http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.121.11.11--20200901000000|2020-09-01T00:00:00)

                                                                                        Codes describing anatomical locations. May include laterality.

                                                                                        TypeCodeableConcept(nl core AnatomicalLocation)
                                                                                        Obligations
                                                                                          ObligationsActor
                                                                                          SHALL:populate-if-knownACP Actor Provider
                                                                                          SHALL:no-errorACP Actor Consulter
                                                                                          Summarytrue
                                                                                          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/bodySite.

                                                                                          Alternate NamesLocatie, AnatomischeLocatie, nl-core-AnatomicalLocation
                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                          100. 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.

                                                                                          ShortUnique id for inter-element referencing
                                                                                          Control0..1
                                                                                          Typestring
                                                                                          XML FormatIn the XML format, this property is represented as an attribute.
                                                                                          102. DeviceUseStatement.bodySite.extension
                                                                                          Definition

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

                                                                                          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..*
                                                                                          This element is affected by the following invariants: ele-1
                                                                                          TypeExtension
                                                                                          Alternate Namesextensions, user content
                                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                          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
                                                                                          • 104. DeviceUseStatement.bodySite.extension:laterality
                                                                                            Slice Namelaterality
                                                                                            Definition

                                                                                            Optional Extension Element - found in all resources.

                                                                                            ShortOptional Extensions Element
                                                                                            Control0..1
                                                                                            This element is affected by the following invariants: ele-1
                                                                                            TypeExtension(ext AnatomicalLocation.Laterality) (Extension Type: CodeableConcept)
                                                                                            Obligations
                                                                                              ObligationsActor
                                                                                              SHALL:populate-if-knownACP Actor Provider
                                                                                              SHALL:no-errorACP Actor Consulter
                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                              106. 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.

                                                                                              ShortUnique id for inter-element referencing
                                                                                              Control0..1
                                                                                              Typestring
                                                                                              XML FormatIn the XML format, this property is represented as an attribute.
                                                                                              108. DeviceUseStatement.bodySite.extension:laterality.extension
                                                                                              Definition

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

                                                                                              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..*
                                                                                              This element is affected by the following invariants: ele-1
                                                                                              TypeExtension
                                                                                              Alternate Namesextensions, user content
                                                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                              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
                                                                                              • 110. 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
                                                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                Fixed Valuehttp://nictiz.nl/fhir/StructureDefinition/ext-AnatomicalLocation.Laterality
                                                                                                112. DeviceUseStatement.bodySite.extension:laterality.value[x]
                                                                                                Definition

                                                                                                Laterality adds information about body site to the anatomic location, e.g. left.

                                                                                                ShortLaterality
                                                                                                Control0..1
                                                                                                This element is affected by the following invariants: ele-1
                                                                                                BindingThe codes SHALL be taken from LateraliteitCodelijst (2020-09-01T00:00:00)
                                                                                                (required to http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.20.7.2--20200901000000|2020-09-01T00:00:00)
                                                                                                TypeCodeableConcept
                                                                                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                                                Alternate NamesLateraliteit
                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                114. 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..*
                                                                                                This element is affected by the following invariants: ele-1
                                                                                                TypeCoding
                                                                                                Summarytrue
                                                                                                Requirements

                                                                                                Allows for alternative encodings within a code system, and translations to other code systems.

                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                116. 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
                                                                                                This element is affected by the following invariants: ele-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.

                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                118. 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)
                                                                                                Comments

                                                                                                For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).

                                                                                                Control0..1
                                                                                                This element is affected by the following invariants: ele-1
                                                                                                TypeAnnotation
                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                120. 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.

                                                                                                ShortUnique id for inter-element referencing
                                                                                                Control0..1
                                                                                                Typestring
                                                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                                                122. DeviceUseStatement.note.extension
                                                                                                Definition

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

                                                                                                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..*
                                                                                                This element is affected by the following invariants: ele-1
                                                                                                TypeExtension
                                                                                                Alternate Namesextensions, user content
                                                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                                                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
                                                                                                • 124. DeviceUseStatement.note.author[x]
                                                                                                  Definition

                                                                                                  The individual responsible for making the annotation.

                                                                                                  ShortIndividual responsible for the annotation
                                                                                                  Comments

                                                                                                  Organization is used when there's no need for specific attribution as to who made the comment.

                                                                                                  Control0..1
                                                                                                  This element is affected by the following invariants: ele-1
                                                                                                  TypeChoice of: Reference(Practitioner, Patient, RelatedPerson, Organization), 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
                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                  126. DeviceUseStatement.note.time
                                                                                                  Definition

                                                                                                  Indicates when this particular annotation was made.

                                                                                                  ShortWhen the annotation was made
                                                                                                  Control0..1
                                                                                                  This element is affected by the following invariants: ele-1
                                                                                                  TypedateTime
                                                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                  Summarytrue
                                                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                                                  128. DeviceUseStatement.note.text
                                                                                                  Definition

                                                                                                  Comment about use or information on the medical device used.

                                                                                                  ShortComment
                                                                                                  Comments

                                                                                                  Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/

                                                                                                  Control1..1
                                                                                                  This element is affected by the following invariants: ele-1
                                                                                                  Typemarkdown
                                                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                                  Obligations
                                                                                                    ObligationsActor
                                                                                                    SHALL:populate-if-knownACP Actor Provider
                                                                                                    SHALL:no-errorACP Actor Consulter
                                                                                                    Summarytrue
                                                                                                    Alternate NamesToelichting
                                                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))