Response to Regulatory Questions (RTQ)
0.1.0 - ci-build

Response to Regulatory Questions (RTQ), published by HL7 International. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/rtq-ig/ and changes regularly. See the Directory of published versions

Resource Profile: RegulatoryQuestionnaireResponse - Detailed Descriptions

Active as of 2025-11-15

Definitions for the RegulatoryQuestionnaireResponse 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
Must Supportfalse
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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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())
qrs-1: Nested items can't be beneath both item and answer ((answer.exists() and item.exists()).not())
2. 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
Control10..1
TypeMeta
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. 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.

ShortVersion specific identifier
Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

Control10..1
Typeid
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()))
6. QuestionnaireResponse.meta.lastUpdated
Definition

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

ShortWhen the resource version last changed
Comments

This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

Control10..1
Typeinstant
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()))
8. 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.


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.

Control10..*
Typecanonical(StructureDefinition)
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Fixed Valuehttp://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaireResponse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. 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 its 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 its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. 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 a 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.

Control10..1
This element is affected by the following invariants: dom-6
TypeNarrative
Is Modifierfalse
Must Supporttrue
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. QuestionnaireResponse.text.status
Definition

The status of the narrative - whether it's entirely generated (from just the defined data or the extensions too), or whether a human authored it and it may contain additional data.

Shortgenerated | extensions | additional | empty
Control1..1
BindingThe codes SHALL be taken from NarrativeStatushttp://hl7.org/fhir/ValueSet/narrative-status|5.0.0
(required to http://hl7.org/fhir/ValueSet/narrative-status|5.0.0)

The status of a resource narrative.

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Pattern Valuegenerated
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. QuestionnaireResponse.text.div
Definition

The actual narrative content, a stripped down version of XHTML.

ShortLimited xhtml content
Comments

The contents of the html element are an XHTML fragment containing only the basic html formatting elements described in chapters 7-11 and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained stylesheets. The XHTML content SHALL NOT contain a head, a body, external stylesheet references, scripts, forms, base/link/xlink, frames, iframes and objects.

Control1..1
Typexhtml
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()))
txt-1: The narrative SHALL contain only the basic html formatting elements and attributes described in chapters 7-11 (except section 4 of chapter 9) and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained style attributes (htmlChecks())
txt-2: The narrative SHALL have some non-whitespace content (htmlChecks())
18. QuestionnaireResponse.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

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..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
20. 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 managable, 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
Must Supportfalse
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
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())
22. QuestionnaireResponse.identifier
Definition

Business identifiers assigned to this questionnaire response by the performer and/or other systems. These identifiers remain constant as the resource is updated and propagates from server to server.

ShortBusiness identifier for this set of answers
Comments

Note: This is a business identifier, not a resource identifier (see discussion).

NoteThis is a business identifier, not a resource identifier (see discussion)
Control20..*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

Allows identification of the questionnaire response as it is known by various participating systems and in a way that remains consistent across servers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on QuestionnaireResponse.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ system
  • 24. QuestionnaireResponse.identifier:qa-request
    Slice Nameqa-request
    Definition

    Business identifiers assigned to this questionnaire response by the performer and/or other systems. These identifiers remain constant as the resource is updated and propagates from server to server.

    ShortBusiness identifier for this set of answers
    Comments

    Note: This is a business identifier, not a resource identifier (see discussion).

    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control10..1*
    TypeIdentifier
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows identification of the questionnaire response as it is known by various participating systems and in a way that remains consistent across servers.

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

    The purpose of this identifier.

    Shortusual | official | temp | secondary | old (If known)
    Comments

    Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

    Control0..1
    BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
    (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

    Identifies the purpose for this identifier, if known .

    Typecode
    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    28. QuestionnaireResponse.identifier:qa-request.system
    Definition

    Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

    ShortThe namespace for the identifier value
    Comments

    Identifier.system is always case sensitive.

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

    There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

    Pattern Valuehttp://hl7.org/fhir/uv/brr/identifier/qa-request
    ExampleGeneral: http://www.acme.com/identifiers/patient
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. QuestionnaireResponse.identifier:procedure-number
    Slice Nameprocedure-number
    Definition

    Business identifiers assigned to this questionnaire response by the performer and/or other systems. These identifiers remain constant as the resource is updated and propagates from server to server.

    ShortBusiness identifier for this set of answers
    Comments

    Note: This is a business identifier, not a resource identifier (see discussion).

    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control10..1*
    TypeIdentifier
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Allows identification of the questionnaire response as it is known by various participating systems and in a way that remains consistent across servers.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    32. QuestionnaireResponse.identifier:procedure-number.use
    Definition

    The purpose of this identifier.

    Shortusual | official | temp | secondary | old (If known)
    Comments

    Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

    Control0..1
    BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
    (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

    Identifies the purpose for this identifier, if known .

    Typecode
    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    34. QuestionnaireResponse.identifier:procedure-number.system
    Definition

    Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

    ShortThe namespace for the identifier value
    Comments

    Identifier.system is always case sensitive.

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

    There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

    Pattern Valuehttps://ema.europa.eu/procedure-number
    ExampleGeneral: http://www.acme.com/identifiers/patient
    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.

    ShortCanonical URL of Questionnaire being answered
    Comments

    If a QuestionnaireResponse references a Questionnaire that can be resolved, 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.). It is possible to have a QuestionnaireResponse whose 'questionnaire' element does not resolve. It is also possible for the questionnaire element to not have a value but only extensions (e.g. conveying the title or identifier for the questionnaire). This may happen for legacy data. If there is no formally defined Questionnaire, it is undefined what the 'correct' values for the linkId elements should be and it is possible that linkIds might be inconsistent for QuestionnaireResponses for the same form if captured by distinct systems.

    Control1..1
    Typecanonical(BRR Regulatory Questionnaire Profile, 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()))
    38. QuestionnaireResponse.status
    Definition

    The current state of the questionnaire response.

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

    Unknown does not represent "other" - one of the defined statuses must apply. Unknown is used when the authoring system is not sure what the current status is.

    Control1..1
    BindingThe codes SHALL be taken from QuestionnaireResponseStatushttp://hl7.org/fhir/ValueSet/questionnaire-answers-status|5.0.0
    (required to http://hl7.org/fhir/ValueSet/questionnaire-answers-status|5.0.0)

    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()))
    40. 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(MedicinalProductDefinition, Resource)
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

    Links the questionnaire response to the Patient context. 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()))
    42. QuestionnaireResponse.authored
    Definition

    The date and/or time that this questionnaire response was last modified by the user - e.g. changing answers or revising status.

    ShortDate and time the response was authored (submission date)Date 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()))
    44. 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).\nWhen dealing with repeating items, each group repetition will be handled by a separate item. However, repeating questions are handled with a single question item and potentially multiple answers.

    Control10..*
    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: Item cannot contain both item and answer ((answer.exists() and item.exists()).not())
    qrs-2: Repeated answers are combined in the answers array of a single item (repeat(answer|item).select(item.where(answer.value.exists()).linkId.isDistinct()).allTrue())
    46. 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 managable, 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())
    48. 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
    This element is affected by the following invariants: qrs-2
    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()))
    50. 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
    Comments

    The text for an item SHOULD be identical to the text from the corresponding Questionnaire.item. This can't be strictly enforced because it's possible for the Questionnaire to be updated subsequent to the QuestionnaireResponse having been created, however the intention is that the text in the QuestionnaireResponse reflects what the user saw when completing the Questionnaire.

    Control10..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()))
    52. QuestionnaireResponse.item.text.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 managable, 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..*
    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.item.text.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 54. QuestionnaireResponse.item.text.extension:richText
      Slice NamerichText
      Definition

      An Extension

      ShortExtension
      Control0..*
      TypeExtension(http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText)
      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())
      56. 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..*
      This element is affected by the following invariants: qrs-1, qrs-2
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      58. 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 managable, 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())
      60. 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. Note that a question is answered using one of the possible choices defined with answerOption, answerValueSet or some other means and the answer has a complex data type, all elements within the answer in the QuestionnaireResponse SHOULD match the elements defined corresponding choice value in the Questionnaire. However, it is possible that not all elements will be propagated. Also, some systems might use language translations resulting in different displays. Comparison of value to the values defined in the Questionnaire (whether by answerOption, answerValueSet or answerExpression) SHALL NOT pay attention to Coding.display, Reference.display, Quantity.unit unless those are the only elements present. As well, systems are not required to check for a match on any extensions (e.g. ordinal values, translations, etc.). Systems MAY enforce that if extensions such as ordinal values are present in both Questionnaire and QuestionnaireResponse, they match.

      Control1..1
      This element is affected by the following invariants: qrs-2
      BindingFor example codes, see QuestionnaireAnswerCodeshttp://hl7.org/fhir/ValueSet/questionnaire-answers|5.0.0
      (example to http://hl7.org/fhir/ValueSet/questionnaire-answers|5.0.0)

      Binding this is problematic because one value set can't apply to both codes and quantities.

      TypeChoice of: boolean, decimal, integer, date, dateTime, time, string, uri, Attachment, Coding, Quantity(SimpleQuantity), 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 Supportfalse
      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()))
      62. QuestionnaireResponse.item.answer.value[x].extension:richText
      Slice NamerichText
      Definition

      An Extension

      ShortExtension
      Control0..*
      TypeExtension(http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText)
      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())

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

      0. QuestionnaireResponse
      Invariantsqrs-1: Nested items can't be beneath both item and answer ((answer.exists() and item.exists()).not())
      2. QuestionnaireResponse.contact
      Control2..2
      Must Supporttrue
      SlicingThis element introduces a set of slices on QuestionnaireResponse.contact. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
      • value @ purpose.coding.code
      • 4. QuestionnaireResponse.contact:sender
        Slice Namesender
        ShortSender: Market Authorization Holder (MAH) submitting the response
        Control1..1
        Must Supporttrue
        6. QuestionnaireResponse.contact:sender.purpose
        Control1..?
        Must Supporttrue
        Pattern Value{
          "system" : "http://hl7.org/fhir/uv/brr/CodeSystem/contact-purpose",
          "code" : "SENDER",
          "display" : "Sender (Marketing Authorization Holder)"
        }
        8. QuestionnaireResponse.contact:sender.organization
        Control1..?
        Must Supporttrue
        10. QuestionnaireResponse.contact:sender.telecom
        Control1..?
        Must Supporttrue
        12. QuestionnaireResponse.contact:sender.extension
        SlicingThis element introduces a set of slices on QuestionnaireResponse.contact.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 14. QuestionnaireResponse.contact:sender.extension:signature
          Slice Namesignature
          Control0..1
          TypeExtension(http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature)
          16. QuestionnaireResponse.contact:recipient
          Slice Namerecipient
          ShortRecipient: Health Authority that issued the questionnaire
          Control1..1
          Must Supporttrue
          18. QuestionnaireResponse.contact:recipient.purpose
          Control1..?
          Must Supporttrue
          Pattern Value{
            "system" : "http://hl7.org/fhir/uv/brr/CodeSystem/contact-purpose",
            "code" : "RECIPIENT",
            "display" : "Recipient (Health Authority)"
          }
          20. QuestionnaireResponse.contact:recipient.organization
          Control1..?
          Must Supporttrue
          22. QuestionnaireResponse.contact:recipient.telecom
          Control1..?
          Must Supporttrue
          24. QuestionnaireResponse.contact:recipient.extension
          SlicingThis element introduces a set of slices on QuestionnaireResponse.contact.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 26. QuestionnaireResponse.contact:recipient.extension:signature
            Slice Namesignature
            Control0..1
            TypeExtension(http://hl7.org/fhir/uv/brr/StructureDefinition/contact-signature)
            28. QuestionnaireResponse.meta
            Control1..?
            30. QuestionnaireResponse.meta.versionId
            Control1..?
            Must Supporttrue
            32. QuestionnaireResponse.meta.lastUpdated
            Control1..?
            Must Supporttrue
            34. QuestionnaireResponse.meta.profile
            Control1..?
            Fixed Valuehttp://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaireResponse
            36. QuestionnaireResponse.text
            Control1..?
            Must Supporttrue
            38. QuestionnaireResponse.text.status
            Pattern Valuegenerated
            40. QuestionnaireResponse.identifier
            NoteThis is a business identifier, not a resource identifier (see discussion)
            Control2..?
            SlicingThis element introduces a set of slices on QuestionnaireResponse.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ system
            • 42. QuestionnaireResponse.identifier:qa-request
              Slice Nameqa-request
              NoteThis is a business identifier, not a resource identifier (see discussion)
              Control1..1
              Must Supporttrue
              44. QuestionnaireResponse.identifier:qa-request.system
              Pattern Valuehttp://hl7.org/fhir/uv/brr/identifier/qa-request
              46. QuestionnaireResponse.identifier:procedure-number
              Slice Nameprocedure-number
              NoteThis is a business identifier, not a resource identifier (see discussion)
              Control1..1
              Must Supporttrue
              48. QuestionnaireResponse.identifier:procedure-number.system
              Pattern Valuehttps://ema.europa.eu/procedure-number
              50. QuestionnaireResponse.questionnaire
              Control1..?
              Typecanonical(BRR Regulatory Questionnaire Profile)
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              52. QuestionnaireResponse.status
              Control1..?
              Must Supporttrue
              54. QuestionnaireResponse.subject
              Control1..?
              TypeReference(MedicinalProductDefinition)
              Must Supporttrue
              56. QuestionnaireResponse.authored
              ShortDate and time the response was authored (submission date)
              Control1..?
              Must Supporttrue
              58. QuestionnaireResponse.item
              Control1..?
              Must Supporttrue
              60. QuestionnaireResponse.item.code
              Control1..?
              BindingThe codes SHALL be taken from http://hl7.org/fhir/uv/brr/ValueSet/ctd-section
              (required to http://hl7.org/fhir/uv/brr/ValueSet/ctd-section)
              Must Supporttrue
              62. QuestionnaireResponse.item.linkId
              Control1..?
              Must Supporttrue
              64. QuestionnaireResponse.item.text
              Control1..?
              Must Supporttrue
              66. QuestionnaireResponse.item.text.extension
              Control0..?
              SlicingThis element introduces a set of slices on QuestionnaireResponse.item.text.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 68. QuestionnaireResponse.item.text.extension:richText
                Slice NamerichText
                Control0..?
                TypeExtension(http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText)
                70. QuestionnaireResponse.item.answer
                72. QuestionnaireResponse.item.answer.valueString
                74. QuestionnaireResponse.item.answer.valueString.extension
                SlicingThis element introduces a set of slices on QuestionnaireResponse.item.answer.valueString.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 76. QuestionnaireResponse.item.answer.valueString.extension:richText
                  Slice NamerichText
                  Control0..?
                  TypeExtension(http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText)

                  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
                  Must Supportfalse
                  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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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())
                  qrs-1: Nested items can't be beneath both item and answer ((answer.exists() and item.exists()).not())
                  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

                  Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

                  Control0..1
                  Typeid
                  Is Modifierfalse
                  Must Supportfalse
                  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
                  Control1..1
                  TypeMeta
                  Is Modifierfalse
                  Must Supportfalse
                  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
                  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
                  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 managable, 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.

                    ShortVersion specific identifier
                    Comments

                    The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

                    Control1..1
                    Typeid
                    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()))
                    12. QuestionnaireResponse.meta.lastUpdated
                    Definition

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

                    ShortWhen the resource version last changed
                    Comments

                    This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

                    Control1..1
                    Typeinstant
                    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()))
                    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

                    The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference.

                    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.

                    Control1..*
                    Typecanonical(StructureDefinition)
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Fixed Valuehttp://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaireResponse
                    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 AllSecurityLabels
                    (extensible to http://hl7.org/fhir/ValueSet/security-labels|5.0.0)

                    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|5.0.0)

                    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.

                    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 its 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 its meaning or interpretation
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supportfalse
                    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 SHALL be taken from AllLanguages
                    (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                    IETF language tag for a human language

                    Typecode
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supportfalse
                    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 a 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.

                    Control1..1
                    This element is affected by the following invariants: dom-6
                    TypeNarrative
                    Is Modifierfalse
                    Must Supporttrue
                    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.text.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
                    30. QuestionnaireResponse.text.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 managable, 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.text.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 32. QuestionnaireResponse.text.status
                      Definition

                      The status of the narrative - whether it's entirely generated (from just the defined data or the extensions too), or whether a human authored it and it may contain additional data.

                      Shortgenerated | extensions | additional | empty
                      Control1..1
                      BindingThe codes SHALL be taken from NarrativeStatus
                      (required to http://hl7.org/fhir/ValueSet/narrative-status|5.0.0)

                      The status of a resource narrative.

                      Typecode
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summaryfalse
                      Pattern Valuegenerated
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      34. QuestionnaireResponse.text.div
                      Definition

                      The actual narrative content, a stripped down version of XHTML.

                      ShortLimited xhtml content
                      Comments

                      The contents of the html element are an XHTML fragment containing only the basic html formatting elements described in chapters 7-11 and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained stylesheets. The XHTML content SHALL NOT contain a head, a body, external stylesheet references, scripts, forms, base/link/xlink, frames, iframes and objects.

                      Control1..1
                      Typexhtml
                      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()))
                      txt-1: The narrative SHALL contain only the basic html formatting elements and attributes described in chapters 7-11 (except section 4 of chapter 9) and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained style attributes (htmlChecks())
                      txt-2: The narrative SHALL have some non-whitespace content (htmlChecks())
                      36. QuestionnaireResponse.contained
                      Definition

                      These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

                      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..*
                      This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
                      TypeResource
                      Is Modifierfalse
                      Must Supportfalse
                      Summaryfalse
                      Alternate Namesinline resources, anonymous resources, contained resources
                      38. 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 managable, 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
                      Must Supportfalse
                      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())
                      40. 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 managable, 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
                      Must Supportfalse
                      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
                      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())
                      42. QuestionnaireResponse.identifier
                      Definition

                      Business identifiers assigned to this questionnaire response by the performer and/or other systems. These identifiers remain constant as the resource is updated and propagates from server to server.

                      ShortBusiness identifier for this set of answers
                      Comments

                      Note: This is a business identifier, not a resource identifier (see discussion).

                      NoteThis is a business identifier, not a resource identifier (see discussion)
                      Control2..*
                      TypeIdentifier
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Requirements

                      Allows identification of the questionnaire response as it is known by various participating systems and in a way that remains consistent across servers.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      SlicingThis element introduces a set of slices on QuestionnaireResponse.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ system
                      • 44. QuestionnaireResponse.identifier:qa-request
                        Slice Nameqa-request
                        Definition

                        Business identifiers assigned to this questionnaire response by the performer and/or other systems. These identifiers remain constant as the resource is updated and propagates from server to server.

                        ShortBusiness identifier for this set of answers
                        Comments

                        Note: This is a business identifier, not a resource identifier (see discussion).

                        NoteThis is a business identifier, not a resource identifier (see discussion)
                        Control1..1
                        TypeIdentifier
                        Is Modifierfalse
                        Must Supporttrue
                        Summarytrue
                        Requirements

                        Allows identification of the questionnaire response as it is known by various participating systems and in a way that remains consistent across servers.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        46. QuestionnaireResponse.identifier:qa-request.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
                        48. QuestionnaireResponse.identifier:qa-request.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 managable, 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.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 50. QuestionnaireResponse.identifier:qa-request.use
                          Definition

                          The purpose of this identifier.

                          Shortusual | official | temp | secondary | old (If known)
                          Comments

                          Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                          Control0..1
                          BindingThe codes SHALL be taken from IdentifierUse
                          (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                          Identifies the purpose for this identifier, if known .

                          Typecode
                          Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summarytrue
                          Requirements

                          Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          52. QuestionnaireResponse.identifier:qa-request.type
                          Definition

                          A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                          ShortDescription of identifier
                          Comments

                          This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

                          Control0..1
                          BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                          (extensible to http://hl7.org/fhir/ValueSet/identifier-type|5.0.0)

                          A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Summarytrue
                          Requirements

                          Allows users to make use of identifiers when the identifier system is not known.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          54. QuestionnaireResponse.identifier:qa-request.system
                          Definition

                          Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

                          ShortThe namespace for the identifier value
                          Comments

                          Identifier.system is always case sensitive.

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

                          There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

                          Pattern Valuehttp://hl7.org/fhir/uv/brr/identifier/qa-request
                          ExampleGeneral: http://www.acme.com/identifiers/patient
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          56. QuestionnaireResponse.identifier:qa-request.value
                          Definition

                          The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                          ShortThe value that is unique
                          Comments

                          If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

                          Control0..1
                          This element is affected by the following invariants: ident-1
                          Typestring
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summarytrue
                          ExampleGeneral: 123456
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          58. QuestionnaireResponse.identifier:qa-request.period
                          Definition

                          Time period during which identifier is/was valid for use.

                          ShortTime period when id is/was valid for use
                          Control0..1
                          TypePeriod
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          60. QuestionnaireResponse.identifier:qa-request.assigner
                          Definition

                          Organization that issued/manages the identifier.

                          ShortOrganization that issued id (may be just text)
                          Comments

                          The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

                          Control0..1
                          TypeReference(Organization)
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          62. QuestionnaireResponse.identifier:procedure-number
                          Slice Nameprocedure-number
                          Definition

                          Business identifiers assigned to this questionnaire response by the performer and/or other systems. These identifiers remain constant as the resource is updated and propagates from server to server.

                          ShortBusiness identifier for this set of answers
                          Comments

                          Note: This is a business identifier, not a resource identifier (see discussion).

                          NoteThis is a business identifier, not a resource identifier (see discussion)
                          Control1..1
                          TypeIdentifier
                          Is Modifierfalse
                          Must Supporttrue
                          Summarytrue
                          Requirements

                          Allows identification of the questionnaire response as it is known by various participating systems and in a way that remains consistent across servers.

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          64. QuestionnaireResponse.identifier:procedure-number.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
                          66. QuestionnaireResponse.identifier:procedure-number.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 managable, 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.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 68. QuestionnaireResponse.identifier:procedure-number.use
                            Definition

                            The purpose of this identifier.

                            Shortusual | official | temp | secondary | old (If known)
                            Comments

                            Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                            Control0..1
                            BindingThe codes SHALL be taken from IdentifierUse
                            (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                            Identifies the purpose for this identifier, if known .

                            Typecode
                            Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

                            Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            70. QuestionnaireResponse.identifier:procedure-number.type
                            Definition

                            A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                            ShortDescription of identifier
                            Comments

                            This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

                            Control0..1
                            BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                            (extensible to http://hl7.org/fhir/ValueSet/identifier-type|5.0.0)

                            A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                            TypeCodeableConcept
                            Is Modifierfalse
                            Summarytrue
                            Requirements

                            Allows users to make use of identifiers when the identifier system is not known.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            72. QuestionnaireResponse.identifier:procedure-number.system
                            Definition

                            Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

                            ShortThe namespace for the identifier value
                            Comments

                            Identifier.system is always case sensitive.

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

                            There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

                            Pattern Valuehttps://ema.europa.eu/procedure-number
                            ExampleGeneral: http://www.acme.com/identifiers/patient
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            74. QuestionnaireResponse.identifier:procedure-number.value
                            Definition

                            The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                            ShortThe value that is unique
                            Comments

                            If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

                            Control0..1
                            This element is affected by the following invariants: ident-1
                            Typestring
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            ExampleGeneral: 123456
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            76. QuestionnaireResponse.identifier:procedure-number.period
                            Definition

                            Time period during which identifier is/was valid for use.

                            ShortTime period when id is/was valid for use
                            Control0..1
                            TypePeriod
                            Is Modifierfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            78. QuestionnaireResponse.identifier:procedure-number.assigner
                            Definition

                            Organization that issued/manages the identifier.

                            ShortOrganization that issued id (may be just text)
                            Comments

                            The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

                            Control0..1
                            TypeReference(Organization)
                            Is Modifierfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            80. QuestionnaireResponse.basedOn
                            Definition

                            A plan, proposal or order that is fulfilled in whole or in part by this questionnaire response. 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 questionnaire response and allows linkage of the response to the proposals/recommendations acted upon.

                            Alternate Namesorder
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            82. 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 referenced event
                            Comments

                            Not to be used to link an questionnaire response to an Encounter - use 'context' for that.

                            Composition of questionnaire responses will be handled using the Assemble operation defined in the SDC IG. 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()))
                            84. QuestionnaireResponse.questionnaire
                            Definition

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

                            ShortCanonical URL of Questionnaire being answered
                            Comments

                            If a QuestionnaireResponse references a Questionnaire that can be resolved, 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.). It is possible to have a QuestionnaireResponse whose 'questionnaire' element does not resolve. It is also possible for the questionnaire element to not have a value but only extensions (e.g. conveying the title or identifier for the questionnaire). This may happen for legacy data. If there is no formally defined Questionnaire, it is undefined what the 'correct' values for the linkId elements should be and it is possible that linkIds might be inconsistent for QuestionnaireResponses for the same form if captured by distinct systems.

                            Control1..1
                            Typecanonical(BRR Regulatory Questionnaire Profile)
                            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()))
                            86. QuestionnaireResponse.status
                            Definition

                            The current state of the questionnaire response.

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

                            Unknown does not represent "other" - one of the defined statuses must apply. Unknown is used when the authoring system is not sure what the current status is.

                            Control1..1
                            BindingThe codes SHALL be taken from QuestionnaireResponseStatus
                            (required to http://hl7.org/fhir/ValueSet/questionnaire-answers-status|5.0.0)

                            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()))
                            88. 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.

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

                            Links the questionnaire response to the Patient context. 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()))
                            90. QuestionnaireResponse.encounter
                            Definition

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

                            ShortEncounter the questionnaire response is part of
                            Comments

                            This will typically be the encounter the questionnaire response was created during, but some questionnaire responses may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission forms). 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

                            Links the questionnaire response to the Encounter context. May also affect access control.

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

                            The date and/or time that this questionnaire response was last modified by the user - e.g. changing answers or revising status.

                            ShortDate and time the response was authored (submission date)
                            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()))
                            94. QuestionnaireResponse.author
                            Definition

                            The individual or device that received the answers to the questions in the QuestionnaireResponse and recorded them in the system.

                            ShortThe individual or device that 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. Device should only be used if it directly determined the answers, not if it was merely used as a capture tool to record answers provided by others. In the latter case, information about the physical device, software, etc. would be captured using Provenance.

                            Control0..1
                            TypeReference(Device, Practitioner, PractitionerRole, Patient, RelatedPerson, Organization)
                            Is Modifierfalse
                            Must Supportfalse
                            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()))
                            96. QuestionnaireResponse.source
                            Definition

                            The individual or device that answered the questions about the subject.

                            ShortThe individual or device that answered the questions
                            Comments

                            If not specified, no inference can be made about who provided the data. Device should only be used if it directly determined the answers, not if it was merely used as a capture tool to record answers provided by others. In the latter case, information about the physical device, software, etc. would be captured using Provenance.

                            Control0..1
                            TypeReference(Device, Organization, 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()))
                            98. 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).\nWhen dealing with repeating items, each group repetition will be handled by a separate item. However, repeating questions are handled with a single question item and potentially multiple answers.

                            Control1..*
                            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: Item cannot contain both item and answer ((answer.exists() and item.exists()).not())
                            qrs-2: Repeated answers are combined in the answers array of a single item (repeat(answer|item).select(item.where(answer.value.exists()).linkId.isDistinct()).allTrue())
                            100. 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
                            This element is affected by the following invariants: ele-1
                            Typestring
                            Is Modifierfalse
                            XML FormatIn the XML format, this property is represented as an attribute.
                            Summaryfalse
                            102. 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 managable, 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.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 managable, 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.linkId
                            Definition

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

                            ShortPointer to specific item from Questionnaire
                            Control1..1
                            This element is affected by the following invariants: qrs-2
                            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()))
                            108. 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
                            Must Supportfalse
                            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()))
                            110. 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
                            Comments

                            The text for an item SHOULD be identical to the text from the corresponding Questionnaire.item. This can't be strictly enforced because it's possible for the Questionnaire to be updated subsequent to the QuestionnaireResponse having been created, however the intention is that the text in the QuestionnaireResponse reflects what the user saw when completing the Questionnaire.

                            Control1..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()))
                            112. QuestionnaireResponse.item.text.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
                            114. QuestionnaireResponse.item.text.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.text.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 116. QuestionnaireResponse.item.text.extension:richText
                              Slice NamerichText
                              Definition

                              An Extension

                              ShortExtension
                              Control0..*
                              TypeExtension(http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText)
                              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())
                              118. QuestionnaireResponse.item.text.value
                              Definition

                              The actual value

                              ShortPrimitive value for string
                              Control0..1
                              Typestring
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              Max Length:1048576
                              120. 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..*
                              This element is affected by the following invariants: qrs-1, qrs-2
                              TypeBackboneElement
                              Is Modifierfalse
                              Must Supportfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              122. 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
                              This element is affected by the following invariants: ele-1
                              Typestring
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              124. 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 managable, 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())
                              126. 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 managable, 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())
                              128. 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. Note that a question is answered using one of the possible choices defined with answerOption, answerValueSet or some other means and the answer has a complex data type, all elements within the answer in the QuestionnaireResponse SHOULD match the elements defined corresponding choice value in the Questionnaire. However, it is possible that not all elements will be propagated. Also, some systems might use language translations resulting in different displays. Comparison of value to the values defined in the Questionnaire (whether by answerOption, answerValueSet or answerExpression) SHALL NOT pay attention to Coding.display, Reference.display, Quantity.unit unless those are the only elements present. As well, systems are not required to check for a match on any extensions (e.g. ordinal values, translations, etc.). Systems MAY enforce that if extensions such as ordinal values are present in both Questionnaire and QuestionnaireResponse, they match.

                              Control1..1
                              This element is affected by the following invariants: qrs-2
                              BindingFor example codes, see QuestionnaireAnswerCodes
                              (example to http://hl7.org/fhir/ValueSet/questionnaire-answers|5.0.0)

                              Binding this is problematic because one value set can't apply to both codes and quantities.

                              TypeChoice of: boolean, decimal, integer, date, dateTime, time, string, uri, Attachment, Coding, Quantity(SimpleQuantity), 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 Supportfalse
                              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()))
                              130. QuestionnaireResponse.item.answer.value[x].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
                              Typestring
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              132. QuestionnaireResponse.item.answer.value[x].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.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 134. QuestionnaireResponse.item.answer.value[x].extension:richText
                                Slice NamerichText
                                Definition

                                An Extension

                                ShortExtension
                                Control0..*
                                TypeExtension(http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText)
                                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())
                                136. QuestionnaireResponse.item.answer.item
                                Definition

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

                                ShortChild items of question
                                Comments

                                Only used when nesting beneath a question - see item.item for nesting beneath groups

                                Control0..*
                                TypeSeettp://hl7.org/fhir/StructureDefinition/QuestionnaireResponse#QuestionnaireResponse.item
                                Is Modifierfalse
                                Must Supportfalse
                                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()))
                                138. QuestionnaireResponse.item.item
                                Definition

                                Sub-questions, sub-groups or display items nested beneath a group.

                                ShortChild items of group item
                                Comments

                                Only used when nesting beneath a group - see item.answer.item for nesting beneath questions

                                Control0..*
                                TypeSeettp://hl7.org/fhir/StructureDefinition/QuestionnaireResponse#QuestionnaireResponse.item
                                Is Modifierfalse
                                Must Supportfalse
                                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()))