Da Vinci Clinical Data Exchange (CDex)
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Da Vinci Clinical Data Exchange (CDex), published by HL7 International / Payer/Provider Information Exchange Work Group. This guide is not an authorized publication; it is the continuous build for version 2.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/davinci-ecdx/ and changes regularly. See the Directory of published versions

Resource Profile: CDEXSDCQuestionnaireResponse - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 2

Definitions for the cdex-sdc-questionnaireresponse resource profile.

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

0. QuestionnaireResponse
2. QuestionnaireResponse.extension:signature
Slice Namesignature
4. QuestionnaireResponse.extension:signature.value[x]
TypeSignature(CDex Signature Profile)
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
6. QuestionnaireResponse.item
8. QuestionnaireResponse.item.extension:ItemSignature
Slice NameItemSignature
10. QuestionnaireResponse.item.extension:ItemSignature.value[x]
TypeSignature(CDex Signature Profile)
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]

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

0. QuestionnaireResponse
Definition

Sets expectations for supported capabilities for questionnaire responses for SDC-conformant systems.


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.

ShortUS Core Profile based on SDC QuestionnaireResponseA 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
Must Supportfalse
Summaryfalse
Alternate NamesForm, QuestionnaireAnswers, Form Data
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.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

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

Control0..1
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()))
4. QuestionnaireResponse.extension:signature
Slice Namesignature
Definition

Represents a wet or electronic signature for either the form overall or for the question or item it's associated with.

ShortA signature attesting to the content
Control0..*
TypeExtension(QuestionnaireResponse Signature) (Extension Type: Signature)
Is Modifierfalse
Must Supportfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. QuestionnaireResponse.extension:signature.extension
Definition

An Extension


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

ShortExtensionAdditional content defined by implementations
Comments

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

Control0..0*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on QuestionnaireResponse.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 8. QuestionnaireResponse.extension:signature.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 Valuehttp://hl7.org/fhir/StructureDefinition/questionnaireresponse-signature
    10. QuestionnaireResponse.extension:signature.value[x]
    Definition

    A JWS digital signature along with supporting context.


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

    ShortJWS Digital SignatureValue of extension
    Comments

    The elements of the Signature Resource are for ease of access of these elements. For digital signatures (Xml DigSig, JWS), the non-repudiation proof comes from the Signature validation, which includes validation of the referenced objects (e.g. Resources) (a.k.a., Content) in the XML-Signature Detached form.

    Control10..1
    This element is affected by the following invariants: ele-1
    TypeSignature(CDex Signature Profile), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, unsignedInt, time
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    cdex-13: The signature element must have either reference to the signer or the signer's identifier and name. (who.reference.exists() or (who.identifier.exists() and who.display.exists()))
    12. QuestionnaireResponse.extension:completionMode
    Slice NamecompletionMode
    Definition

    Indicates how the individual completing the QuestionnaireResponse provided their responses.

    ShortE.g. Verbal, written, electronic
    Control0..1
    TypeExtension(QuestionnaireResponse Completion Mode) (Extension Type: CodeableConcept)
    Is Modifierfalse
    Must Supportfalse
    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())
    14. QuestionnaireResponse.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

    ShortExtensions that cannot be ignored
    Comments

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

    Control0..*
    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())
    16. QuestionnaireResponse.identifier
    Definition

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

    ShortUnique id for this set of answers
    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.

    ShortForm being answered
    Comments

    For SDC, this SHALL be the version-specific URL of the form as hosted on the Form Manager.


    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(SDCBaseQuestionnaire, 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:questionnaireDisplay
    Slice NamequestionnaireDisplay
    Definition

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

    ShortDisplay name for canonical reference
    Comments

    This SHALL be the title of the Questionnaire at the time the QuestionnaireResponse was originally authored.

    Control0..1
    TypeExtension(Display Name) (Extension Type: string)
    Is Modifierfalse
    Must Supporttrue
    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())
    22. QuestionnaireResponse.questionnaire.extension:url
    Slice Nameurl
    Definition

    This extension is used when the survey,form, or questionnaire which is being anwered is not a FHIR Questionnaire, otherwise the canonical url for the FHIR Questionnaire is used.

    ShortThe location where a non-FHIR questionnaire/survey form can be found.
    Control0..1
    TypeExtension(US Core Extension Questionnaire URI) (Extension Type: uri)
    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())
    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.

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

    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.

    ShortThe subject of the questions
    Comments

    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(US Core Patient Profile, Resource)
    Is Modifierfalse
    Must Supporttrue
    Must Support TypesReference(US Core Patient Profile)
    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.authored
    Definition

    Identifies when this version of the answer set was created. Changes whenever the answers are updated.


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

    ShortDate the answers were gathered
    Comments

    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()))
    30. QuestionnaireResponse.author
    Definition

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

    ShortPerson who received and recorded the answers
    Comments

    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(US Core Practitioner Profile, US Core Organization Profile, US Core Patient Profile, PractitionerRole, Device, US Core RelatedPerson Profile, Practitioner, Patient, RelatedPerson, Organization)
    Is Modifierfalse
    Must Supporttrue
    Must Support TypesReference(US Core Practitioner Profile)
    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()))
    32. QuestionnaireResponse.item
    Definition

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

    ShortGroups and questions
    Comments

    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())
    34. QuestionnaireResponse.item.extension:itemMedia
    Slice NameitemMedia
    Definition

    Media to render/make available as an accompaniment to the question being asked

    ShortMedia to display
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(Item Media) (Extension Type: Attachment)
    Is Modifierfalse
    Must Supportfalse
    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())
    36. QuestionnaireResponse.item.extension:ItemSignature
    Slice NameItemSignature
    Definition

    Represents a wet or electronic signature for either the form overall or for the question or item it's associated with.

    ShortA signature attesting to the content
    Control0..*
    TypeExtension(QuestionnaireResponse Signature) (Extension Type: Signature)
    Is Modifierfalse
    Must Supportfalse
    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())
    38. QuestionnaireResponse.item.extension:ItemSignature.extension
    Definition

    An Extension


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

    ShortExtensionAdditional content defined by implementations
    Comments

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

    Control0..0*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on QuestionnaireResponse.item.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 40. QuestionnaireResponse.item.extension:ItemSignature.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 Valuehttp://hl7.org/fhir/StructureDefinition/questionnaireresponse-signature
      42. QuestionnaireResponse.item.extension:ItemSignature.value[x]
      Definition

      A JWS digital signature along with supporting context.


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

      ShortJWS Digital SignatureValue of extension
      Comments

      The elements of the Signature Resource are for ease of access of these elements. For digital signatures (Xml DigSig, JWS), the non-repudiation proof comes from the Signature validation, which includes validation of the referenced objects (e.g. Resources) (a.k.a., Content) in the XML-Signature Detached form.

      Control10..1
      This element is affected by the following invariants: ele-1
      TypeSignature(CDex Signature Profile), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, unsignedInt, time
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      cdex-13: The signature element must have either reference to the signer or the signer's identifier and name. (who.reference.exists() or (who.identifier.exists() and who.display.exists()))
      44. 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())
      46. QuestionnaireResponse.item.linkId
      Definition

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

      ShortPointer to specific item from Questionnaire
      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()))
      48. QuestionnaireResponse.item.text
      Definition

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

      ShortName for group or question text
      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()))
      50. QuestionnaireResponse.item.answer
      Definition

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

      ShortThe response(s) to the question
      Comments

      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()))
      52. QuestionnaireResponse.item.answer.extension:itemAnswerMedia
      Slice NameitemAnswerMedia
      Definition

      Media to render/make available as an accompaniment to a specific answer option

      ShortAnswer Media to display
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Item Answer Media) (Extension Type: Attachment)
      Is Modifierfalse
      Must Supportfalse
      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())
      54. QuestionnaireResponse.item.answer.extension:ordinalValue
      Slice NameordinalValue
      Definition

      A numeric value that allows the comparison (less than, greater than) or other numerical manipulation of a concept (e.g. Adding up components of a score). Scores are usually a whole number, but occasionally decimals are encountered in scores.

      ShortAssigned Ordinal Value
      Comments

      Scores are commonly encountered in various clinical assessment scales. Assigning a value to a concept should generally be done in a formal code system that defines the value, or in an applicable value set for the concept, but some concepts do not have a formal definition (or are not even represented as a concept formally, especially in Questionnaires, so this extension is allowed to appear ouside those preferred contexts. Scores may even be assigned arbitrarily during use (hence, on Coding). The value may be constrained to an integer in some contexts of use. Todo: Scoring algorithms may also be defined directly, but how this is done is not yet defined.

      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Ordinal Value) (Extension Type: decimal)
      Is Modifierfalse
      Must Supportfalse
      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())
      56. 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())
      58. QuestionnaireResponse.item.answer.value[x]
      Definition

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

      ShortSingle-valued answer to the question
      Comments

      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
      (example to http://hl7.org/fhir/ValueSet/questionnaire-answers)

      Code indicating the response provided for a question.

      TypeChoice of: boolean, date, dateTime, time, decimal, integer, string, Coding, uri, Quantity, Attachment, 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 TypesChoice of: decimal, string, Coding
      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()))
      60. QuestionnaireResponse.item.answer.item
      Definition

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

      ShortNested groups and questions
      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()))
      62. QuestionnaireResponse.item.item
      Definition

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

      ShortNested questionnaire response items
      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 found here

      0. QuestionnaireResponse
      Definition

      Sets expectations for supported capabilities for questionnaire responses for SDC-conformant systems.

      ShortUS Core Profile based on SDC QuestionnaireResponse
      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
      Must Supportfalse
      Summaryfalse
      Alternate NamesForm, QuestionnaireAnswers, Form Data
      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.

      ShortLogical id of this artifact
      Comments

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

      Control0..1
      Typeid
      Is Modifierfalse
      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.implicitRules
      Definition

      A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

      ShortA set of rules under which this content was created
      Comments

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

      Control0..1
      Typeuri
      Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      8. 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)

      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()))
      10. 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()))
      12. 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
      14. QuestionnaireResponse.extension
      Definition

      An Extension

      ShortExtension
      Control0..*
      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.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 16. QuestionnaireResponse.extension:signature
        Slice Namesignature
        Definition

        Represents a wet or electronic signature for either the form overall or for the question or item it's associated with.

        ShortA signature attesting to the content
        Control0..*
        TypeExtension(QuestionnaireResponse Signature) (Extension Type: Signature)
        Is Modifierfalse
        Must Supportfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        18. QuestionnaireResponse.extension:signature.id
        Definition

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

        ShortUnique id for inter-element referencing
        Control0..1
        This element is affected by the following invariants: ele-1
        Typeid
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        20. QuestionnaireResponse.extension:signature.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.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 22. QuestionnaireResponse.extension:signature.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 Valuehttp://hl7.org/fhir/StructureDefinition/questionnaireresponse-signature
          24. QuestionnaireResponse.extension:signature.value[x]
          Definition

          A JWS digital signature along with supporting context.

          ShortJWS Digital Signature
          Comments

          The elements of the Signature Resource are for ease of access of these elements. For digital signatures (Xml DigSig, JWS), the non-repudiation proof comes from the Signature validation, which includes validation of the referenced objects (e.g. Resources) (a.k.a., Content) in the XML-Signature Detached form.

          Control1..1
          This element is affected by the following invariants: ele-1
          TypeSignature(CDex Signature Profile)
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          cdex-13: The signature element must have either reference to the signer or the signer's identifier and name. (who.reference.exists() or (who.identifier.exists() and who.display.exists()))
          26. QuestionnaireResponse.extension:completionMode
          Slice NamecompletionMode
          Definition

          Indicates how the individual completing the QuestionnaireResponse provided their responses.

          ShortE.g. Verbal, written, electronic
          Control0..1
          TypeExtension(QuestionnaireResponse Completion Mode) (Extension Type: CodeableConcept)
          Is Modifierfalse
          Must Supportfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          28. QuestionnaireResponse.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

          ShortExtensions that cannot be ignored
          Comments

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

          Control0..*
          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())
          30. QuestionnaireResponse.identifier
          Definition

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

          ShortUnique id for this set of answers
          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()))
          32. 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
          Must Supportfalse
          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()))
          34. 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
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          36. QuestionnaireResponse.questionnaire
          Definition

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

          ShortForm being answered
          Comments

          For SDC, this SHALL be the version-specific URL of the form as hosted on the Form Manager.

          Control1..1
          Typecanonical(SDCBaseQuestionnaire)
          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()))
          38. 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
          40. QuestionnaireResponse.questionnaire.extension
          Definition

          An Extension

          ShortExtension
          Control0..*
          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
          • 42. QuestionnaireResponse.questionnaire.extension:questionnaireDisplay
            Slice NamequestionnaireDisplay
            Definition

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

            ShortDisplay name for canonical reference
            Comments

            This SHALL be the title of the Questionnaire at the time the QuestionnaireResponse was originally authored.

            Control0..1
            TypeExtension(Display Name) (Extension Type: string)
            Is Modifierfalse
            Must Supporttrue
            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())
            44. QuestionnaireResponse.questionnaire.extension:url
            Slice Nameurl
            Definition

            This extension is used when the survey,form, or questionnaire which is being anwered is not a FHIR Questionnaire, otherwise the canonical url for the FHIR Questionnaire is used.

            ShortThe location where a non-FHIR questionnaire/survey form can be found.
            Control0..1
            TypeExtension(US Core Extension Questionnaire URI) (Extension Type: uri)
            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())
            46. 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
            48. QuestionnaireResponse.status
            Definition

            The position of the questionnaire response within its overall lifecycle.

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

            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 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()))
            50. 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.

            ShortThe subject of the questions
            Control1..1
            TypeReference(US Core Patient Profile, Resource)
            Is Modifierfalse
            Must Supporttrue
            Must Support TypesReference(US Core Patient Profile)
            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()))
            52. 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
            Must Supportfalse
            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()))
            54. QuestionnaireResponse.authored
            Definition

            Identifies when this version of the answer set was created. Changes whenever the answers are updated.

            ShortDate the answers were gathered
            Comments

            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.

            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()))
            56. QuestionnaireResponse.author
            Definition

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

            ShortPerson who received and recorded the answers
            Comments

            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(US Core Practitioner Profile, US Core Organization Profile, US Core Patient Profile, PractitionerRole, Device, US Core RelatedPerson Profile)
            Is Modifierfalse
            Must Supporttrue
            Must Support TypesReference(US Core Practitioner Profile)
            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()))
            58. 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
            Must Supportfalse
            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()))
            60. QuestionnaireResponse.item
            Definition

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

            ShortGroups and questions
            Comments

            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())
            62. 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
            64. QuestionnaireResponse.item.extension
            Definition

            An Extension

            ShortExtension
            Control0..*
            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.item.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 66. QuestionnaireResponse.item.extension:itemMedia
              Slice NameitemMedia
              Definition

              Media to render/make available as an accompaniment to the question being asked

              ShortMedia to display
              Control0..1
              This element is affected by the following invariants: ele-1
              TypeExtension(Item Media) (Extension Type: Attachment)
              Is Modifierfalse
              Must Supportfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              68. QuestionnaireResponse.item.extension:ItemSignature
              Slice NameItemSignature
              Definition

              Represents a wet or electronic signature for either the form overall or for the question or item it's associated with.

              ShortA signature attesting to the content
              Control0..*
              TypeExtension(QuestionnaireResponse Signature) (Extension Type: Signature)
              Is Modifierfalse
              Must Supportfalse
              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())
              70. QuestionnaireResponse.item.extension:ItemSignature.id
              Definition

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

              ShortUnique id for inter-element referencing
              Control0..1
              This element is affected by the following invariants: ele-1
              Typeid
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              72. QuestionnaireResponse.item.extension:ItemSignature.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.item.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 74. QuestionnaireResponse.item.extension:ItemSignature.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 Valuehttp://hl7.org/fhir/StructureDefinition/questionnaireresponse-signature
                76. QuestionnaireResponse.item.extension:ItemSignature.value[x]
                Definition

                A JWS digital signature along with supporting context.

                ShortJWS Digital Signature
                Comments

                The elements of the Signature Resource are for ease of access of these elements. For digital signatures (Xml DigSig, JWS), the non-repudiation proof comes from the Signature validation, which includes validation of the referenced objects (e.g. Resources) (a.k.a., Content) in the XML-Signature Detached form.

                Control1..1
                This element is affected by the following invariants: ele-1
                TypeSignature(CDex Signature Profile)
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                cdex-13: The signature element must have either reference to the signer or the signer's identifier and name. (who.reference.exists() or (who.identifier.exists() and who.display.exists()))
                78. 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())
                80. QuestionnaireResponse.item.linkId
                Definition

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

                ShortPointer to specific item from Questionnaire
                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()))
                82. 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()))
                84. QuestionnaireResponse.item.text
                Definition

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

                ShortName for group or question text
                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()))
                86. QuestionnaireResponse.item.answer
                Definition

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

                ShortThe response(s) to the question
                Comments

                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()))
                88. 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
                90. QuestionnaireResponse.item.answer.extension
                Definition

                An Extension

                ShortExtension
                Control0..*
                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.item.answer.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 92. QuestionnaireResponse.item.answer.extension:itemAnswerMedia
                  Slice NameitemAnswerMedia
                  Definition

                  Media to render/make available as an accompaniment to a specific answer option

                  ShortAnswer Media to display
                  Control0..1
                  This element is affected by the following invariants: ele-1
                  TypeExtension(Item Answer Media) (Extension Type: Attachment)
                  Is Modifierfalse
                  Must Supportfalse
                  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())
                  94. QuestionnaireResponse.item.answer.extension:ordinalValue
                  Slice NameordinalValue
                  Definition

                  A numeric value that allows the comparison (less than, greater than) or other numerical manipulation of a concept (e.g. Adding up components of a score). Scores are usually a whole number, but occasionally decimals are encountered in scores.

                  ShortAssigned Ordinal Value
                  Comments

                  Scores are commonly encountered in various clinical assessment scales. Assigning a value to a concept should generally be done in a formal code system that defines the value, or in an applicable value set for the concept, but some concepts do not have a formal definition (or are not even represented as a concept formally, especially in Questionnaires, so this extension is allowed to appear ouside those preferred contexts. Scores may even be assigned arbitrarily during use (hence, on Coding). The value may be constrained to an integer in some contexts of use. Todo: Scoring algorithms may also be defined directly, but how this is done is not yet defined.

                  Control0..1
                  This element is affected by the following invariants: ele-1
                  TypeExtension(Ordinal Value) (Extension Type: decimal)
                  Is Modifierfalse
                  Must Supportfalse
                  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())
                  96. 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())
                  98. QuestionnaireResponse.item.answer.value[x]
                  Definition

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

                  ShortSingle-valued answer to the question
                  Comments

                  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 QuestionnaireAnswerCodes
                  (example to http://hl7.org/fhir/ValueSet/questionnaire-answers)

                  Code indicating the response provided for a question.

                  TypeChoice of: boolean, date, dateTime, time, decimal, integer, string, Coding, uri, Quantity, Attachment, Reference
                  [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 TypesChoice of: decimal, string, Coding
                  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()))
                  100. QuestionnaireResponse.item.answer.item
                  Definition

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

                  ShortNested groups and questions
                  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()))
                  102. QuestionnaireResponse.item.item
                  Definition

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

                  ShortNested questionnaire response items
                  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()))