ISiK Formularmodul Implementation Guide
Version 6.0.0-rc - ci-build

Resource Profile: ISiKFormularDaten - Detailed Descriptions

Active as of 2026-04-03

Definitions for the ISiKFormularDaten resource profile.

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

0. QuestionnaireResponse
Definition

A structured set of questions and their answers. The questions are ordered and grouped into coherent subsets, corresponding to the structure of the grouping of the questionnaire being responded to.

ShortA structured set of questions and their answers
Comments

The QuestionnaireResponse contains enough information about the questions asked and their organization that it can be interpreted somewhat independently from the Questionnaire it is based on. I.e. You don't need access to the Questionnaire in order to extract basic information from a QuestionnaireResponse.

Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesForm, QuestionnaireAnswers
Invariantsdom-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())
sdcqr-1: Subject SHOULD be present (searching is difficult without subject). Almost all QuestionnaireResponses should be with respect to some sort of subject. (subject.exists())
sdcqr-2: When repeats=true for a group, it'll be represented with multiple items with the same linkId in the QuestionnaireResponse. For a question, it'll be represented by a single item with that linkId with multiple answers. ((QuestionnaireResponse|repeat(answer|item)).select(item.where(answer.value.exists()).linkId.isDistinct()).allTrue())
2. QuestionnaireResponse.id
Definition

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

Shortserverseitige, interne ID des DatensatzesLogical id of this artifact
Comments

bedingtes Pflichtfeld/bedingtes MS: Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine id verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine idverfügen.


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
Typeidstring
Is Modifierfalse
Must Supporttrue
Summarytrue
4. QuestionnaireResponse.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.

ShortVerweis auf die Regeln, nach denen die Ressource erstellt wurdeA set of rules under which this content was created
Comments

Begründung Constraint: In ISiK existiert kein Use-Case für dieses Element. Da es sich um ein Modifying Element handelt, wird es daher ausgeschlossen. Darüber hinaus werden die Regeln als URI vorgehalten. Dies führt dazu, dass sich hinter der URI eine beliebige Menge an Regeln befinden kann; wodurch nicht sichergestellt werden kann, dass alle Clients die Regeln korrekt interpretieren können.


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..01
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()))
6. QuestionnaireResponse.modifierExtension
Definition

An Extension


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).

ShortExtensionExtensions that cannot be ignored
Comments

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

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
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 QuestionnaireResponse.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 8. QuestionnaireResponse.modifierExtension:MDR-Relevant
    Slice NameMDR-Relevant
    Definition

    An Extension

    ShortMPG-Relevanz der Formulardaten
    Comments

    Begründung MS: In dieser Extension wird angegeben, dass die Formulardaten MDR-relevant sind. Für die Erhebung und/oder Darstellung müssen ggf. bestimmte Voraussetzungen erfüllt sein. Ist die Extension nicht vorhanden, liegt keine MDR-relevanmt vor.

    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(ISiKMDRRelevanzFormularExtension) (Extension Type: Coding)
    Is Modifiertrue because Ist in dieser Extension nicht der Code 'none' gesetzt, muss die Anzeige rechtlich geprüft werden, weil der FormularDefinitionErsteller eine Relevanz im Rahmen der MDR identifiziert hat.
    Must Supporttrue
    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())
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    10. QuestionnaireResponse.modifierExtension:MDR-Relevant.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())
    SlicingThis element introduces a set of slices on QuestionnaireResponse.modifierExtension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 12. QuestionnaireResponse.modifierExtension:MDR-Relevant.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://gematik.de/fhir/isik/StructureDefinition/ISiKMDRRelevanzFormularExtension
      14. QuestionnaireResponse.modifierExtension:MDR-Relevant.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
      Control10..1
      BindingUnless not suitable, these codes SHALL be taken from For codes, see ISiKMDRRelevanzFormularVS
      (extensible to https://gematik.de/fhir/isik/ValueSet/ISiKMDRRelevanzFormularVS)
      TypeCoding, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, 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, 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
      Must Supporttrue
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      16. QuestionnaireResponse.identifier
      Definition

      A business identifier assigned to a particular completed (or partially completed) questionnaire.

      Shorteindeutiger Identifier der FormularDatenUnique id for this set of answers
      Comments

      Begründung MS: Ein vom FormularRenderer vergebener, eindeutiger Identifier kann von weiterverarbeitenden Systemen genutzt werden, um Dubletten zu erkennen.

      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..1
      TypeIdentifier
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      Used for tracking, registration and other business purposes.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      18. QuestionnaireResponse.questionnaire
      Definition

      The Questionnaire that defines and organizes the questions for which answers are being provided.

      ShortBezug zur FormularDefinition inkl. VersionForm being answered
      Comments

      Bei der Angabe der Canonical, sollte die Version der FormularDefinition, welche bei der Erstellung die Grundlage gebildet hat, angegeben sein. Begründung MS: Der Bezug zur Formulardefinition kann für die Interpretation und Darstellung der Formulardaten relevant sein.


      If a QuestionnaireResponse references a Questionnaire, then the QuestionnaireResponse structure must be consistent with the Questionnaire (i.e. questions must be organized into the same groups, nested questions must still be nested, etc.).

      Control10..1
      Typecanonical(Questionnaire)
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Requirements

      Needed to allow editing of the questionnaire response in a manner that enforces the constraints of the original form.

      Alternate NamesForm
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      20. QuestionnaireResponse.questionnaire.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.

      Control10..*
      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())
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on QuestionnaireResponse.questionnaire.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 22. QuestionnaireResponse.questionnaire.extension:questionnaireDisplay
        Slice NamequestionnaireDisplay
        Definition

        The title or other name to display when referencing a resource by canonical URL.

        ShortTitel/Überschrift der zugrunde liegenden FormularDefinition
        Comments

        Wird für die Darstellung und Auffindbarkeit der FormularDaten benötigt.

        Control1..1
        TypeExtension(Display Name) (Extension Type: string)
        Is Modifierfalse
        Must Supporttrue
        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())
        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())
        24. QuestionnaireResponse.status
        Definition

        The position of the questionnaire response within its overall lifecycle.

        ShortStatusin-progress | completed | amended | entered-in-error | stopped
        Comments

        Begründung Pflichtfeld: Bei der Verarbeitung von FormularDaten ist es wichtig, den Status zu beachten. Falls die Instanz noch nicht completed ist, sollte von einer Weiterverarbeitung abgesehen werden.


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

        Control1..1
        BindingThe codes SHALL be taken from QuestionnaireResponseStatushttp://hl7.org/fhir/ValueSet/questionnaire-answers-status|4.0.1
        (required to http://hl7.org/fhir/ValueSet/questionnaire-answers-status|4.0.1)

        Lifecycle status of the questionnaire response.

        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
        Must Supporttrue
        Summarytrue
        Requirements

        The information on Questionnaire resources may possibly be gathered during multiple sessions and altered after considered being finished.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        26. QuestionnaireResponse.subject
        Definition

        The subject of the questionnaire response. This could be a patient, organization, practitioner, device, etc. This is who/what the answers apply to, but is not necessarily the source of information.

        ShortSubject (Patient), über das in diesem Formular berichtet wird.The subject of the questions
        Comments

        Begründung Pflichtfeld:
        Zur Vereinfachung des Workflows werden zunächst nur Formulare mit Patientenbezug zugelassen.
        Diese Anforderung kann in künftigen Ausbaustufen gelockert werden.


        If the Questionnaire declared a subjectType, the resource pointed to by this element must be an instance of one of the listed types.

        Control10..1
        TypeReference(Resource)
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Requirements

        Allows linking the answers to the individual the answers describe. May also affect access control.

        Alternate NamesPatient, Focus
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        28. QuestionnaireResponse.subject.reference
        Definition

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

        ShortPatienten-LinkLiteral reference, Relative, internal or absolute URL
        Comments

        Begründung MS: Die Verlinkung auf eine Patienten-Ressource dient der technischen Zuordnung der Dokumentation zu einem Patienten und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKPatient sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.


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

        Control10..1
        This element is affected by the following invariants: ref-1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        30. QuestionnaireResponse.authored
        Definition

        The date and/or time that this set of answers were last changed.

        ShortDatum der FormularDatenDate the answers were gathered
        Comments

        Begründung Pflichtfeld: Relevant für die Suche und zeitliche Einordnung der FormularDaten


        May be different from the lastUpdateTime of the resource itself, because that reflects when the data was known to the server, not when the data was captured.

        This element is optional to allow for systems that might not know the value, however it SHOULD be populated if possible.

        Control10..1
        TypedateTime
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summarytrue
        Requirements

        Clinicians need to be able to check the date that the information in the questionnaire was collected, to derive the context of the answers.

        Alternate NamesDate Created, Date published, Date Issued, Date updated
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        32. QuestionnaireResponse.author
        Definition

        Person who received the answers to the questions in the QuestionnaireResponse and recorded them in the system.

        ShortErsteller des FromularsPerson who received and recorded the answers
        Comments

        Auch wenn hier keine Einschränkung vorgenommen wurde, ist zu empfehlen, hier die ausfüllende Person (Patient/Practitioner) zu referenzieren und nicht nur die Software (Device), mit der das Formular ausgefüllt wurde. Begründung MS: In den meisten Fällen ist relevant, wer Formulardaten erfasst hat.


        Mapping a subject's answers to multiple choice options and determining what to put in the textual answer is a matter of interpretation. Authoring by device would indicate that some portion of the questionnaire had been auto-populated.

        Control0..1
        TypeReference(Device, Practitioner, PractitionerRole, Patient, RelatedPerson, Organization)
        Is Modifierfalse
        Must Supporttrue
        Must Support TypesNo must-support rules about the choice of types/profiles
        Summarytrue
        Requirements

        Need to know who interpreted the subject's answers to the questions in the questionnaire, and selected the appropriate options for answers.

        Alternate NamesLaboratory, Service, Practitioner, Department, Company, Performer
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        34. QuestionnaireResponse.item
        Definition

        A group or question item from the original questionnaire for which answers are provided.

        ShortFormularelementGroups and questions
        Comments

        Begründung MS: Es können beliebig viele Formularelemente hier abgebildet werden.


        Groups cannot have answers and therefore must nest directly within item. When dealing with questions, nesting must occur within each answer because some questions may have multiple answers (and the nesting occurs for each answer).

        Control0..*
        TypeBackboneElement
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        qrs-1: Nested item can't be beneath both item and answer ((answer.exists() and item.exists()).not())
        qrs-1: Nested item can't be beneath both item and answer ((answer.exists() and item.exists()).not())
        36. QuestionnaireResponse.item.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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. Applications processing a resource are required to check for modifier extensions.

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

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

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

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

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

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

        The item from the Questionnaire that corresponds to this item in the QuestionnaireResponse resource.

        ShortEindeutige ID des FormularelementPointer to specific item from Questionnaire
        Comments

        Begründung Pflichtfeld: Die LinkId ordnet die Information der Antwort einer Frage in der FormularDefinition zu und ist aus dem Grund zur Interpretation der Antwort unablässig.

        Control1..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summaryfalse
        Requirements

        Items can repeat in the answers, so a direct 1..1 correspondence by position might not exist - requiring correspondence by identifier.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        40. QuestionnaireResponse.item.text
        Definition

        Text that is displayed above the contents of the group or as the text of the question being answered.

        ShortFrage, die beantwortet wurdeName for group or question text
        Comments

        Begründung Pflichtfeld:
        Die FormularDaten sollte pro Antwort auch die Fragestellung mitführen, damit die Daten auch von Systemen/Anwendern interpretiert werden können, die keinen Zugriff auf die zugrunde liegende FormularDefinition haben.

        Control0..1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Summaryfalse
        Requirements

        Allows the questionnaire response to be read without access to the questionnaire.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        42. QuestionnaireResponse.item.answer
        Definition

        The respondent's answer(s) to the question.

        ShortAntwortThe response(s) to the question
        Comments

        Begründung MS: Die erfasste Antwort MUSS stets vorhanden sein.


        The value is nested because we cannot have a repeating structure that has variable type.

        Control0..*
        TypeBackboneElement
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        44. QuestionnaireResponse.item.answer.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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. Applications processing a resource are required to check for modifier extensions.

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

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

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

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

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

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

        The answer (or one of the answers) provided by the respondent to the question.

        ShortInhalt der AntwortSingle-valued answer to the question
        Comments

        Begründung MS: Der Inhalt der jeweilig erfassten Antwort MUSS stehts vorhanden sein.


        More complex structures (Attachment, Resource and Quantity) will typically be limited to electronic forms that can expose an appropriate user interface to capture the components and enforce the constraints of a complex data type. Additional complex types can be introduced through extensions. Must match the datatype specified by Questionnaire.item.type in the corresponding Questionnaire.

        Control0..1
        BindingFor example codes, see QuestionnaireAnswerCodeshttp://hl7.org/fhir/ValueSet/questionnaire-answers|4.0.1
        (example to http://hl7.org/fhir/ValueSet/questionnaire-answers|4.0.1)

        Code indicating the response provided for a question.

        TypeChoice of: boolean, decimal, integer, date, dateTime, time, string, uri, Attachment, Coding, Quantity, Reference(Resource)
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        Must Support TypesNo must-support rules about the choice of types/profiles
        Summaryfalse
        Requirements

        Ability to retain a single-valued answer to a question.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        48. QuestionnaireResponse.item.answer.item
        Definition

        Nested groups and/or questions found within this particular answer.

        ShortUntergeordnetes ItemNested groups and questions
        Comments

        Begründung MS:
        Items können beliebig verschachtelt und zu Gruppen zusammengefasst werden, um komplexere und umfangreichere Formulare zu strukturieren.

        Control0..*
        TypeSeettp://hl7.org/fhir/StructureDefinition/QuestionnaireResponse#QuestionnaireResponse.item
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Requirements

        It is useful to have "sub-questions", questions which normally appear when certain answers are given and which collect additional details.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        50. QuestionnaireResponse.item.item
        Definition

        Questions or sub-groups nested beneath a question or group.

        ShortUntergeordnetes ItemNested questionnaire response items
        Comments

        Begründung MS:
        Items können beliebig verschachtelt und zu Gruppen zusammengefasst werden, um komplexere und umfangreichere Formulare zu strukturieren.

        Control0..*
        TypeSeettp://hl7.org/fhir/StructureDefinition/QuestionnaireResponse#QuestionnaireResponse.item
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Requirements

        Reports can consist of complex nested groups.

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

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

        0. QuestionnaireResponse
        Invariantssdcqr-1: Subject SHOULD be present (searching is difficult without subject). Almost all QuestionnaireResponses should be with respect to some sort of subject. (subject.exists())
        sdcqr-2: When repeats=true for a group, it'll be represented with multiple items with the same linkId in the QuestionnaireResponse. For a question, it'll be represented by a single item with that linkId with multiple answers. ((QuestionnaireResponse|repeat(answer|item)).select(item.where(answer.value.exists()).linkId.isDistinct()).allTrue())
        2. QuestionnaireResponse.id
        Shortserverseitige, interne ID des Datensatzes
        Comments

        bedingtes Pflichtfeld/bedingtes MS: Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine id verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine idverfügen.

        Must Supporttrue
        4. QuestionnaireResponse.meta
        6. QuestionnaireResponse.meta.versionId
        ShortEindeutiger Name der serverseitigen Version des Datensatzes
        Comments

        Alle von einem Server bereitgestellten Ressourcen SOLLEN über eine versionID verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine versionIDverfügen.

        8. QuestionnaireResponse.meta.lastUpdated
        ShortZeitpunkt der letzten Änderung
        Comments

        Alle von einem Server bereitgestellten Ressourcen SOLLEN über ein lastUpdate verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über ein lastUpdateverfügen.

        10. QuestionnaireResponse.implicitRules
        ShortVerweis auf die Regeln, nach denen die Ressource erstellt wurde
        Comments

        Begründung Constraint: In ISiK existiert kein Use-Case für dieses Element. Da es sich um ein Modifying Element handelt, wird es daher ausgeschlossen. Darüber hinaus werden die Regeln als URI vorgehalten. Dies führt dazu, dass sich hinter der URI eine beliebige Menge an Regeln befinden kann; wodurch nicht sichergestellt werden kann, dass alle Clients die Regeln korrekt interpretieren können.

        Control0..0
        12. QuestionnaireResponse.modifierExtension
        SlicingThis element introduces a set of slices on QuestionnaireResponse.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 14. QuestionnaireResponse.modifierExtension:MDR-Relevant
          Slice NameMDR-Relevant
          ShortMPG-Relevanz der Formulardaten
          Comments

          Begründung MS: In dieser Extension wird angegeben, dass die Formulardaten MDR-relevant sind. Für die Erhebung und/oder Darstellung müssen ggf. bestimmte Voraussetzungen erfüllt sein. Ist die Extension nicht vorhanden, liegt keine MDR-relevanmt vor.

          Control0..1
          TypeExtension(ISiKMDRRelevanzFormularExtension) (Extension Type: Coding)
          Must Supporttrue
          16. QuestionnaireResponse.modifierExtension:MDR-Relevant.value[x]
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Must Supporttrue
          18. QuestionnaireResponse.identifier
          Shorteindeutiger Identifier der FormularDaten
          Comments

          Begründung MS: Ein vom FormularRenderer vergebener, eindeutiger Identifier kann von weiterverarbeitenden Systemen genutzt werden, um Dubletten zu erkennen.

          NoteThis is a business identifier, not a resource identifier (see discussion)
          Must Supporttrue
          20. QuestionnaireResponse.questionnaire
          ShortBezug zur FormularDefinition inkl. Version
          Comments

          Bei der Angabe der Canonical, sollte die Version der FormularDefinition, welche bei der Erstellung die Grundlage gebildet hat, angegeben sein. Begründung MS: Der Bezug zur Formulardefinition kann für die Interpretation und Darstellung der Formulardaten relevant sein.

          Control1..?
          Must Supporttrue
          22. QuestionnaireResponse.questionnaire.extension
          Control1..?
          SlicingThis element introduces a set of slices on QuestionnaireResponse.questionnaire.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 24. QuestionnaireResponse.questionnaire.extension:questionnaireDisplay
            Slice NamequestionnaireDisplay
            ShortTitel/Überschrift der zugrunde liegenden FormularDefinition
            Comments

            Wird für die Darstellung und Auffindbarkeit der FormularDaten benötigt.

            Control1..1
            TypeExtension(Display Name) (Extension Type: string)
            Must Supporttrue
            26. QuestionnaireResponse.status
            ShortStatus
            Comments

            Begründung Pflichtfeld: Bei der Verarbeitung von FormularDaten ist es wichtig, den Status zu beachten. Falls die Instanz noch nicht completed ist, sollte von einer Weiterverarbeitung abgesehen werden.

            Must Supporttrue
            28. QuestionnaireResponse.subject
            ShortSubject (Patient), über das in diesem Formular berichtet wird.
            Comments

            Begründung Pflichtfeld:
            Zur Vereinfachung des Workflows werden zunächst nur Formulare mit Patientenbezug zugelassen.
            Diese Anforderung kann in künftigen Ausbaustufen gelockert werden.

            Control1..?
            Must Supporttrue
            30. QuestionnaireResponse.subject.reference
            ShortPatienten-Link
            Comments

            Begründung MS: Die Verlinkung auf eine Patienten-Ressource dient der technischen Zuordnung der Dokumentation zu einem Patienten und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKPatient sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.

            Control1..?
            Must Supporttrue
            32. QuestionnaireResponse.authored
            ShortDatum der FormularDaten
            Comments

            Begründung Pflichtfeld: Relevant für die Suche und zeitliche Einordnung der FormularDaten

            Control1..?
            Must Supporttrue
            34. QuestionnaireResponse.author
            ShortErsteller des Fromulars
            Comments

            Auch wenn hier keine Einschränkung vorgenommen wurde, ist zu empfehlen, hier die ausfüllende Person (Patient/Practitioner) zu referenzieren und nicht nur die Software (Device), mit der das Formular ausgefüllt wurde. Begründung MS: In den meisten Fällen ist relevant, wer Formulardaten erfasst hat.

            Must Supporttrue
            36. QuestionnaireResponse.item
            ShortFormularelement
            Comments

            Begründung MS: Es können beliebig viele Formularelemente hier abgebildet werden.

            Must Supporttrue
            38. QuestionnaireResponse.item.linkId
            ShortEindeutige ID des Formularelement
            Comments

            Begründung Pflichtfeld: Die LinkId ordnet die Information der Antwort einer Frage in der FormularDefinition zu und ist aus dem Grund zur Interpretation der Antwort unablässig.

            Must Supporttrue
            40. QuestionnaireResponse.item.text
            ShortFrage, die beantwortet wurde
            Comments

            Begründung Pflichtfeld:
            Die FormularDaten sollte pro Antwort auch die Fragestellung mitführen, damit die Daten auch von Systemen/Anwendern interpretiert werden können, die keinen Zugriff auf die zugrunde liegende FormularDefinition haben.

            Must Supporttrue
            42. QuestionnaireResponse.item.answer
            ShortAntwort
            Comments

            Begründung MS: Die erfasste Antwort MUSS stets vorhanden sein.

            Must Supporttrue
            44. QuestionnaireResponse.item.answer.value[x]
            ShortInhalt der Antwort
            Comments

            Begründung MS: Der Inhalt der jeweilig erfassten Antwort MUSS stehts vorhanden sein.

            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Must Supporttrue
            46. QuestionnaireResponse.item.answer.item
            ShortUntergeordnetes Item
            Comments

            Begründung MS:
            Items können beliebig verschachtelt und zu Gruppen zusammengefasst werden, um komplexere und umfangreichere Formulare zu strukturieren.

            Must Supporttrue
            48. QuestionnaireResponse.item.item
            ShortUntergeordnetes Item
            Comments

            Begründung MS:
            Items können beliebig verschachtelt und zu Gruppen zusammengefasst werden, um komplexere und umfangreichere Formulare zu strukturieren.

            Must Supporttrue

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

            0. QuestionnaireResponse
            Definition

            A structured set of questions and their answers. The questions are ordered and grouped into coherent subsets, corresponding to the structure of the grouping of the questionnaire being responded to.

            ShortA structured set of questions and their answers
            Comments

            The QuestionnaireResponse contains enough information about the questions asked and their organization that it can be interpreted somewhat independently from the Questionnaire it is based on. I.e. You don't need access to the Questionnaire in order to extract basic information from a QuestionnaireResponse.

            Control0..*
            Is Modifierfalse
            Summaryfalse
            Alternate NamesForm, QuestionnaireAnswers
            Invariantsdom-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())
            sdcqr-1: Subject SHOULD be present (searching is difficult without subject). Almost all QuestionnaireResponses should be with respect to some sort of subject. (subject.exists())
            sdcqr-2: When repeats=true for a group, it'll be represented with multiple items with the same linkId in the QuestionnaireResponse. For a question, it'll be represented by a single item with that linkId with multiple answers. ((QuestionnaireResponse|repeat(answer|item)).select(item.where(answer.value.exists()).linkId.isDistinct()).allTrue())
            2. QuestionnaireResponse.id
            Definition

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

            Shortserverseitige, interne ID des Datensatzes
            Comments

            bedingtes Pflichtfeld/bedingtes MS: Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine id verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine idverfügen.

            Control0..1
            Typeid
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            4. QuestionnaireResponse.meta
            Definition

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

            ShortMetadata about the resource
            Control0..1
            TypeMeta
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            6. QuestionnaireResponse.meta.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
            8. QuestionnaireResponse.meta.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..*
            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())
            SlicingThis element introduces a set of slices on QuestionnaireResponse.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 10. QuestionnaireResponse.meta.versionId
              Definition

              The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

              ShortEindeutiger Name der serverseitigen Version des Datensatzes
              Comments

              Alle von einem Server bereitgestellten Ressourcen SOLLEN über eine versionID verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine versionIDverfügen.

              Control0..1
              Typeid
              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()))
              12. QuestionnaireResponse.meta.lastUpdated
              Definition

              When the resource last changed - e.g. when the version changed.

              ShortZeitpunkt der letzten Änderung
              Comments

              Alle von einem Server bereitgestellten Ressourcen SOLLEN über ein lastUpdate verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über ein lastUpdateverfügen.

              Control0..1
              Typeinstant
              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()))
              14. QuestionnaireResponse.meta.source
              Definition

              A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

              ShortIdentifies where the resource comes from
              Comments

              In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

              This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

              Control0..1
              Typeuri
              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()))
              16. QuestionnaireResponse.meta.profile
              Definition

              A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

              ShortProfiles this resource claims to conform to
              Comments

              It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

              Control0..*
              Typecanonical(StructureDefinition)
              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()))
              18. QuestionnaireResponse.meta.security
              Definition

              Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

              ShortSecurity Labels applied to this resource
              Comments

              The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

              Control0..*
              BindingUnless not suitable, these codes SHALL be taken from All Security Labels
              (extensible to http://hl7.org/fhir/ValueSet/security-labels|4.0.1)

              Security Labels from the Healthcare Privacy and Security Classification System.

              TypeCoding
              Is Modifierfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              20. QuestionnaireResponse.meta.tag
              Definition

              Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

              ShortTags applied to this resource
              Comments

              The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

              Control0..*
              BindingFor example codes, see CommonTags
              (example to http://hl7.org/fhir/ValueSet/common-tags|4.0.1)

              Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

              TypeCoding
              Is Modifierfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              22. QuestionnaireResponse.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.

              ShortVerweis auf die Regeln, nach denen die Ressource erstellt wurde
              Comments

              Begründung Constraint: In ISiK existiert kein Use-Case für dieses Element. Da es sich um ein Modifying Element handelt, wird es daher ausgeschlossen. Darüber hinaus werden die Regeln als URI vorgehalten. Dies führt dazu, dass sich hinter der URI eine beliebige Menge an Regeln befinden kann; wodurch nicht sichergestellt werden kann, dass alle Clients die Regeln korrekt interpretieren können.

              Control0..0
              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()))
              24. QuestionnaireResponse.language
              Definition

              The base language in which the resource is written.

              ShortLanguage of the resource content
              Comments

              Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

              Control0..1
              BindingThe codes SHOULD be taken from CommonLanguages
              (preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

              A human language.

              Additional BindingsPurpose
              AllLanguagesMax Binding
              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              26. QuestionnaireResponse.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
              TypeNarrative
              Is Modifierfalse
              Summaryfalse
              Alternate Namesnarrative, html, xhtml, display
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              28. QuestionnaireResponse.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
              Is Modifierfalse
              Summaryfalse
              Alternate Namesinline resources, anonymous resources, contained resources
              30. QuestionnaireResponse.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..*
              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())
              32. QuestionnaireResponse.modifierExtension
              Definition

              An Extension

              ShortExtension
              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
              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 QuestionnaireResponse.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 34. QuestionnaireResponse.modifierExtension:MDR-Relevant
                Slice NameMDR-Relevant
                Definition

                An Extension

                ShortMPG-Relevanz der Formulardaten
                Comments

                Begründung MS: In dieser Extension wird angegeben, dass die Formulardaten MDR-relevant sind. Für die Erhebung und/oder Darstellung müssen ggf. bestimmte Voraussetzungen erfüllt sein. Ist die Extension nicht vorhanden, liegt keine MDR-relevanmt vor.

                Control0..1
                This element is affected by the following invariants: ele-1
                TypeExtension(ISiKMDRRelevanzFormularExtension) (Extension Type: Coding)
                Is Modifiertrue because Ist in dieser Extension nicht der Code 'none' gesetzt, muss die Anzeige rechtlich geprüft werden, weil der FormularDefinitionErsteller eine Relevanz im Rahmen der MDR identifiziert hat.
                Must Supporttrue
                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())
                36. QuestionnaireResponse.modifierExtension:MDR-Relevant.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
                38. QuestionnaireResponse.modifierExtension:MDR-Relevant.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 QuestionnaireResponse.modifierExtension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 40. QuestionnaireResponse.modifierExtension:MDR-Relevant.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://gematik.de/fhir/isik/StructureDefinition/ISiKMDRRelevanzFormularExtension
                  42. QuestionnaireResponse.modifierExtension:MDR-Relevant.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
                  Control1..1
                  BindingUnless not suitable, these codes SHALL be taken from ISiKMDRRelevanzFormularVS
                  (extensible to https://gematik.de/fhir/isik/ValueSet/ISiKMDRRelevanzFormularVS)
                  TypeCoding
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Must Supporttrue
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  44. QuestionnaireResponse.identifier
                  Definition

                  A business identifier assigned to a particular completed (or partially completed) questionnaire.

                  Shorteindeutiger Identifier der FormularDaten
                  Comments

                  Begründung MS: Ein vom FormularRenderer vergebener, eindeutiger Identifier kann von weiterverarbeitenden Systemen genutzt werden, um Dubletten zu erkennen.

                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Control0..1
                  TypeIdentifier
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  Used for tracking, registration and other business purposes.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  46. QuestionnaireResponse.basedOn
                  Definition

                  The order, proposal or plan that is fulfilled in whole or in part by this QuestionnaireResponse. For example, a ServiceRequest seeking an intake assessment or a decision support recommendation to assess for post-partum depression.

                  ShortRequest fulfilled by this QuestionnaireResponse
                  Control0..*
                  TypeReference(CarePlan, ServiceRequest)
                  Is Modifierfalse
                  Summarytrue
                  Requirements

                  Supports traceability of responsibility for the action and allows linkage of an action to the recommendations acted upon.

                  Alternate Namesorder
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  48. QuestionnaireResponse.partOf
                  Definition

                  A procedure or observation that this questionnaire was performed as part of the execution of. For example, the surgery a checklist was executed as part of.

                  ShortPart of this action
                  Comments

                  Composition of questionnaire responses will be handled by the parent questionnaire having answers that reference the child questionnaire. For relationships to referrals, and other types of requests, use basedOn.

                  Control0..*
                  TypeReference(Observation, Procedure)
                  Is Modifierfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  50. QuestionnaireResponse.questionnaire
                  Definition

                  The Questionnaire that defines and organizes the questions for which answers are being provided.

                  ShortBezug zur FormularDefinition inkl. Version
                  Comments

                  Bei der Angabe der Canonical, sollte die Version der FormularDefinition, welche bei der Erstellung die Grundlage gebildet hat, angegeben sein. Begründung MS: Der Bezug zur Formulardefinition kann für die Interpretation und Darstellung der Formulardaten relevant sein.

                  Control1..1
                  Typecanonical(Questionnaire)
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  Needed to allow editing of the questionnaire response in a manner that enforces the constraints of the original form.

                  Alternate NamesForm
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  52. QuestionnaireResponse.questionnaire.id
                  Definition

                  unique id for the element within a resource (for internal references)

                  Shortxml:id (or equivalent in JSON)
                  Control0..1
                  Typestring
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  54. QuestionnaireResponse.questionnaire.extension
                  Definition

                  An Extension

                  ShortExtension
                  Control1..*
                  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 QuestionnaireResponse.questionnaire.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 56. QuestionnaireResponse.questionnaire.extension:questionnaireDisplay
                    Slice NamequestionnaireDisplay
                    Definition

                    The title or other name to display when referencing a resource by canonical URL.

                    ShortTitel/Überschrift der zugrunde liegenden FormularDefinition
                    Comments

                    Wird für die Darstellung und Auffindbarkeit der FormularDaten benötigt.

                    Control1..1
                    TypeExtension(Display Name) (Extension Type: string)
                    Is Modifierfalse
                    Must Supporttrue
                    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())
                    58. QuestionnaireResponse.questionnaire.value
                    Definition

                    Primitive value for canonical

                    ShortPrimitive value for canonical
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    60. QuestionnaireResponse.status
                    Definition

                    The position of the questionnaire response within its overall lifecycle.

                    ShortStatus
                    Comments

                    Begründung Pflichtfeld: Bei der Verarbeitung von FormularDaten ist es wichtig, den Status zu beachten. Falls die Instanz noch nicht completed ist, sollte von einer Weiterverarbeitung abgesehen werden.

                    Control1..1
                    BindingThe codes SHALL be taken from QuestionnaireResponseStatus
                    (required to http://hl7.org/fhir/ValueSet/questionnaire-answers-status|4.0.1)

                    Lifecycle status of the questionnaire response.

                    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
                    Must Supporttrue
                    Summarytrue
                    Requirements

                    The information on Questionnaire resources may possibly be gathered during multiple sessions and altered after considered being finished.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    62. QuestionnaireResponse.subject
                    Definition

                    The subject of the questionnaire response. This could be a patient, organization, practitioner, device, etc. This is who/what the answers apply to, but is not necessarily the source of information.

                    ShortSubject (Patient), über das in diesem Formular berichtet wird.
                    Comments

                    Begründung Pflichtfeld:
                    Zur Vereinfachung des Workflows werden zunächst nur Formulare mit Patientenbezug zugelassen.
                    Diese Anforderung kann in künftigen Ausbaustufen gelockert werden.

                    Control1..1
                    TypeReference(Resource)
                    Is Modifierfalse
                    Must Supporttrue
                    Summarytrue
                    Requirements

                    Allows linking the answers to the individual the answers describe. May also affect access control.

                    Alternate NamesPatient, Focus
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    64. QuestionnaireResponse.subject.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
                    66. QuestionnaireResponse.subject.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..*
                    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())
                    SlicingThis element introduces a set of slices on QuestionnaireResponse.subject.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 68. QuestionnaireResponse.subject.reference
                      Definition

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

                      ShortPatienten-Link
                      Comments

                      Begründung MS: Die Verlinkung auf eine Patienten-Ressource dient der technischen Zuordnung der Dokumentation zu einem Patienten und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. Im ISik Kontext MUSS die referenzierte Ressource konform zu ISiKPatient sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.

                      Control1..1
                      This element is affected by the following invariants: ref-1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      70. QuestionnaireResponse.subject.type
                      Definition

                      The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

                      The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

                      ShortType the reference refers to (e.g. "Patient")
                      Comments

                      This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

                      Control0..1
                      BindingUnless not suitable, these codes SHALL be taken from ResourceType
                      (extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

                      Aa resource (or, for logical models, the URI of the logical model).

                      Typeuri
                      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()))
                      72. QuestionnaireResponse.subject.identifier
                      Definition

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

                      ShortLogical reference, when literal reference is not known
                      Comments

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

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

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

                      Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

                      NoteThis is a business identifier, not a resource identifier (see discussion)
                      Control0..1
                      TypeIdentifier
                      Is Modifierfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      74. QuestionnaireResponse.subject.display
                      Definition

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

                      ShortText alternative for the resource
                      Comments

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

                      Control0..1
                      Typestring
                      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()))
                      76. QuestionnaireResponse.encounter
                      Definition

                      The Encounter during which this questionnaire response was created or to which the creation of this record is tightly associated.

                      ShortEncounter created as part of
                      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. A questionnaire that was initiated during an encounter but not fully completed during the encounter would still generally be associated with the encounter.

                      Control0..1
                      TypeReference(Encounter)
                      Is Modifierfalse
                      Summarytrue
                      Requirements

                      Provides context for the information that was captured. May also affect access control.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      78. QuestionnaireResponse.authored
                      Definition

                      The date and/or time that this set of answers were last changed.

                      ShortDatum der FormularDaten
                      Comments

                      Begründung Pflichtfeld: Relevant für die Suche und zeitliche Einordnung der FormularDaten

                      Control1..1
                      TypedateTime
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supporttrue
                      Summarytrue
                      Requirements

                      Clinicians need to be able to check the date that the information in the questionnaire was collected, to derive the context of the answers.

                      Alternate NamesDate Created, Date published, Date Issued, Date updated
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      80. QuestionnaireResponse.author
                      Definition

                      Person who received the answers to the questions in the QuestionnaireResponse and recorded them in the system.

                      ShortErsteller des Fromulars
                      Comments

                      Auch wenn hier keine Einschränkung vorgenommen wurde, ist zu empfehlen, hier die ausfüllende Person (Patient/Practitioner) zu referenzieren und nicht nur die Software (Device), mit der das Formular ausgefüllt wurde. Begründung MS: In den meisten Fällen ist relevant, wer Formulardaten erfasst hat.

                      Control0..1
                      TypeReference(Device, Practitioner, PractitionerRole, Patient, RelatedPerson, Organization)
                      Is Modifierfalse
                      Must Supporttrue
                      Must Support TypesNo must-support rules about the choice of types/profiles
                      Summarytrue
                      Requirements

                      Need to know who interpreted the subject's answers to the questions in the questionnaire, and selected the appropriate options for answers.

                      Alternate NamesLaboratory, Service, Practitioner, Department, Company, Performer
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      82. QuestionnaireResponse.source
                      Definition

                      The person who answered the questions about the subject.

                      ShortThe person who answered the questions
                      Comments

                      If not specified, no inference can be made about who provided the data.

                      Control0..1
                      TypeReference(Patient, Practitioner, PractitionerRole, RelatedPerson)
                      Is Modifierfalse
                      Summarytrue
                      Requirements

                      When answering questions about a subject that is minor, incapable of answering or an animal, another human source may answer the questions.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      84. QuestionnaireResponse.item
                      Definition

                      A group or question item from the original questionnaire for which answers are provided.

                      ShortFormularelement
                      Comments

                      Begründung MS: Es können beliebig viele Formularelemente hier abgebildet werden.

                      Control0..*
                      TypeBackboneElement
                      Is Modifierfalse
                      Must Supporttrue
                      Summaryfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      qrs-1: Nested item can't be beneath both item and answer ((answer.exists() and item.exists()).not())
                      86. QuestionnaireResponse.item.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
                      88. QuestionnaireResponse.item.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..*
                      TypeExtension
                      Is Modifierfalse
                      Summaryfalse
                      Alternate Namesextensions, user content
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      90. QuestionnaireResponse.item.modifierExtension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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. Applications processing a resource are required to check for modifier extensions.

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

                      ShortExtensions that cannot be ignored even if unrecognized
                      Comments

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

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

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

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

                      The item from the Questionnaire that corresponds to this item in the QuestionnaireResponse resource.

                      ShortEindeutige ID des Formularelement
                      Comments

                      Begründung Pflichtfeld: Die LinkId ordnet die Information der Antwort einer Frage in der FormularDefinition zu und ist aus dem Grund zur Interpretation der Antwort unablässig.

                      Control1..1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supporttrue
                      Summaryfalse
                      Requirements

                      Items can repeat in the answers, so a direct 1..1 correspondence by position might not exist - requiring correspondence by identifier.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      94. QuestionnaireResponse.item.definition
                      Definition

                      A reference to an ElementDefinition that provides the details for the item.

                      ShortElementDefinition - details for the item
                      Comments

                      The ElementDefinition must be in a StructureDefinition, and must have a fragment identifier that identifies the specific data element by its id (Element.id). E.g. http://hl7.org/fhir/StructureDefinition/Observation#Observation.value[x].

                      There is no need for this element if the item pointed to by the linkId has a definition listed.

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

                      A common pattern is to define a set of data elements, and then build multiple different questionnaires for different circumstances to gather the data. This element provides traceability to the common definition.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      96. QuestionnaireResponse.item.text
                      Definition

                      Text that is displayed above the contents of the group or as the text of the question being answered.

                      ShortFrage, die beantwortet wurde
                      Comments

                      Begründung Pflichtfeld:
                      Die FormularDaten sollte pro Antwort auch die Fragestellung mitführen, damit die Daten auch von Systemen/Anwendern interpretiert werden können, die keinen Zugriff auf die zugrunde liegende FormularDefinition haben.

                      Control0..1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supporttrue
                      Summaryfalse
                      Requirements

                      Allows the questionnaire response to be read without access to the questionnaire.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      98. QuestionnaireResponse.item.answer
                      Definition

                      The respondent's answer(s) to the question.

                      ShortAntwort
                      Comments

                      Begründung MS: Die erfasste Antwort MUSS stets vorhanden sein.

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

                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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. Applications processing a resource are required to check for modifier extensions.

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

                      ShortExtensions that cannot be ignored even if unrecognized
                      Comments

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

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

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

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

                      The answer (or one of the answers) provided by the respondent to the question.

                      ShortInhalt der Antwort
                      Comments

                      Begründung MS: Der Inhalt der jeweilig erfassten Antwort MUSS stehts vorhanden sein.

                      Control0..1
                      BindingFor example codes, see QuestionnaireAnswerCodes
                      (example to http://hl7.org/fhir/ValueSet/questionnaire-answers|4.0.1)

                      Code indicating the response provided for a question.

                      TypeChoice of: boolean, decimal, integer, date, dateTime, time, string, uri, Attachment, Coding, Quantity, Reference(Resource)
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supporttrue
                      Must Support TypesNo must-support rules about the choice of types/profiles
                      Summaryfalse
                      Requirements

                      Ability to retain a single-valued answer to a question.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      108. QuestionnaireResponse.item.answer.item
                      Definition

                      Nested groups and/or questions found within this particular answer.

                      ShortUntergeordnetes Item
                      Comments

                      Begründung MS:
                      Items können beliebig verschachtelt und zu Gruppen zusammengefasst werden, um komplexere und umfangreichere Formulare zu strukturieren.

                      Control0..*
                      TypeSeettp://hl7.org/fhir/StructureDefinition/QuestionnaireResponse#QuestionnaireResponse.item
                      Is Modifierfalse
                      Must Supporttrue
                      Summaryfalse
                      Requirements

                      It is useful to have "sub-questions", questions which normally appear when certain answers are given and which collect additional details.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      110. QuestionnaireResponse.item.item
                      Definition

                      Questions or sub-groups nested beneath a question or group.

                      ShortUntergeordnetes Item
                      Comments

                      Begründung MS:
                      Items können beliebig verschachtelt und zu Gruppen zusammengefasst werden, um komplexere und umfangreichere Formulare zu strukturieren.

                      Control0..*
                      TypeSeettp://hl7.org/fhir/StructureDefinition/QuestionnaireResponse#QuestionnaireResponse.item
                      Is Modifierfalse
                      Must Supporttrue
                      Summaryfalse
                      Requirements

                      Reports can consist of complex nested groups.

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