Implementierungsleitfaden ISiK-Formular-Modul

ISiKFormularDefinition

Metadaten

Canonical	https://gematik.de/fhir/isik/StructureDefinition/ISiKFormularDefinition
Status	active
Version	5.0.0-rc
Basis	http://hl7.org/fhir/StructureDefinition/Questionnaire

Inhalt

ISiKFormularDefinition (Questionnaire)	I		Questionnaire	There are no (further) constraints on this element Element id Questionnaire Short description A structured set of questions Alternate names Form, CRF, Survey Definition A structured set of questions intended to guide the collection of answers from end-users. Questionnaires provide detailed control over order, presentation, phraseology and grouping to allow coherent, consistent data collection. Data type Questionnaire Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() que-0: Name should be usable as an identifier for the module by machine processing applications such as code generation `name.matches('[A-Z]([A-Za-z0-9_]){0,254}')` que-2: The link ids for groups and questions must be unique within the questionnaire `descendants().linkId.isDistinct()` Mappings rim: Entity. Role, or Act workflow: Definition rim: Observation[moodCode=DEF]
id	Σ	0..1	string	There are no (further) constraints on this element Element id Questionnaire.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id Questionnaire.meta Short description Metadata about the resource 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. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id Questionnaire.implicitRules Short description A set of rules under which this content was created 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. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
language		0..1	codeBinding	There are no (further) constraints on this element Element id Questionnaire.language Short description Language of the resource content Definition The base language in which the resource is written. 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). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
text		0..1	Narrative	There are no (further) constraints on this element Element id Questionnaire.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display 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. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id Questionnaire.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. 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. Data type Resource Mappings rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Questionnaire.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
modifierExtension	?! I	1..*	Extension	Element id Questionnaire.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
MDR-Relevant	S ?! I	1..1	Extension(Coding)	Element id Questionnaire.modifierExtension:MDR-Relevant Short description Optional Extensions Element Alternate names extensions, user content Definition Optional Extension Element - found in all resources. 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. 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. Data type Extension(Coding) Extension URL https://gematik.de/fhir/isik/StructureDefinition/ISiKMDRRelevanzFormularExtension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Questionnaire.modifierExtension:MDR-Relevant.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..0	Extension	There are no (further) constraints on this element Element id Questionnaire.modifierExtension:MDR-Relevant.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
url		1..1	uriFixed Value	There are no (further) constraints on this element Element id Questionnaire.modifierExtension:MDR-Relevant.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Fixed value https://gematik.de/fhir/isik/StructureDefinition/ISiKMDRRelevanzFormularExtension Mappings rim: N/A
value[x]	S	1..1	Binding	There are no (further) constraints on this element Element id Questionnaire.modifierExtension:MDR-Relevant.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Binding ISiKMDRRelevanzFormularVS (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
valueCoding			Coding	There are no (further) constraints on this element Data type Coding
url	S Σ	1..1	uri	Element id Questionnaire.url Short description CanoncialURL des Formulars Definition An absolute URI that is used to identify this questionnaire when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which at which an authoritative instance of this questionnaire is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the questionnaire is stored on different servers. Requirements … This is the id that will be used to link a QuestionnaireResponse to the Questionnaire the response is for. Comments Weltweit eindeutiger Name des Formulars. Begründung Pflichtfeld: Wird für eindeutige Bezugnahme von FormularDaten auf FormularDefinition benötigt. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.url w5: FiveWs.identifier rim: .identifier[scope=BUSN;reliability=ISS]
identifier	Σ	0..*	Identifier	There are no (further) constraints on this element Element id Questionnaire.identifier Short description Additional identifier for the questionnaire Definition A formal identifier that is used to identify this questionnaire when it is represented in other formats, or referenced in a specification, model, design or an instance. Requirements Allows externally provided and/or usable business identifiers to be easily associated with the module. Comments Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this questionnaire outside of FHIR, where it is not possible to use the logical URI. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.identifier w5: FiveWs.identifier rim: .identifier objimpl: no-gen-base
version	S Σ	0..1	string	Element id Questionnaire.version Short description Version Definition The identifier that is used to identify this version of the questionnaire when it is referenced in a specification, model, design or instance. This is an arbitrary value managed by the questionnaire author and is not expected to be globally unique. For example, it might be a timestamp (e.g. yyyymmdd) if a managed version is not available. There is also no expectation that versions can be placed in a lexicographical sequence. Comments Versionsnummer des Formulars. Sollte gem. semVer-Regeln inkrementiert werden, je nach Schweregrad der Änderungen. Begründung MS: Wird benötigt, um FormularDefinitionen in unterschiedlichen Versionen zu differenzieren. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.version w5: FiveWs.version rim: N/A (to add?)
name	Σ I	0..1	string	There are no (further) constraints on this element Element id Questionnaire.name Short description Name for this questionnaire (computer friendly) Definition A natural language name identifying the questionnaire. This name should be usable as an identifier for the module by machine processing applications such as code generation. Requirements Support human navigation and code generation. Comments The name is not expected to be globally unique. The name should be a simple alphanumeric type name to ensure that it is machine-processing friendly. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
title	S Σ	1..1	string	Element id Questionnaire.title Short description Titel/Überschrift Definition A short, descriptive, user-friendly title for the questionnaire. Comments Dem Anwender angezeigter Titel des Formulars. Begründung MS: Wird für die Darstellung und Auffindbarkeit der FormularDefinition benötigt. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.title rim: .title
derivedFrom		0..*	canonical(Questionnaire)	There are no (further) constraints on this element Element id Questionnaire.derivedFrom Short description Instantiates protocol or definition Definition The URL of a Questionnaire that this Questionnaire is based on. Requirements Allows a Questionnaire to be created based on another Questionnaire. Data type canonical(Questionnaire) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.derivedFrom rim: .outboundRelationship[typeCode=DRIV].target[classCode=OBS, moodCode=DEFN]
status	S Σ ?!	1..1	codeBinding	Element id Questionnaire.status Short description active \| retired Definition The status of this questionnaire. Enables tracking the life-cycle of the content. Comments Die im ISiK-Kontext bereitgestellten Formulare sollten final ausspezifiziert sein und daher den Status 'active' haben. Formulare, die zurückgezogen oder durch neuere Versionen ersetzt wurden, können mit 'retired' gekennzeichnet werden. Data type code Binding The lifecycle status of an artifact. PublicationStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.status w5: FiveWs.status rim: .status
experimental	Σ	0..1	boolean	There are no (further) constraints on this element Element id Questionnaire.experimental Short description For testing purposes, not real usage Definition A Boolean value to indicate that this questionnaire is authored for testing purposes (or education/evaluation/marketing) and is not intended to be used for genuine usage. Requirements Enables experimental content to be developed following the same lifecycle that would be used for a production-level questionnaire. Comments Allows filtering of questionnaires that are appropriate for use versus not. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.experimental w5: FiveWs.class rim: N/A
subjectType	S Σ	1..1	codeBindingPattern	Element id Questionnaire.subjectType Short description Subject, über das in diesem Formular berichtet wird. Definition The types of subjects that can be the subject of responses created for the questionnaire. Comments Begründung Pflichtfeld: Zur Vereinfachung des Workflows werden zunächst nur Formulare mit Patientenbezug zugelassen. Dabei ist stets davon auszugehen, dass der Patient, für den dieses Formular ausgefüllt wird, identisch ist, mit dem Patient, der im Launch-Kontext übergeben wird. Diese Anforderung kann in künftigen Ausbaustufen gelockert werden. Data type code Binding One of the resource types defined as part of this version of FHIR. ResourceType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Pattern Patient Mappings workflow: Definition.subject[x] rim: .outboundRelationship[typeCode=META].target[classCode=OBS, moodCode=DEFN, isCriterion=true].participation.role.classCode
date	Σ	0..1	dateTime	There are no (further) constraints on this element Element id Questionnaire.date Short description Date last changed Alternate names Revision Date Definition The date (and optionally time) when the questionnaire was published. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the questionnaire changes. Comments Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the questionnaire. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.date w5: FiveWs.recorded rim: .participation[typeCode=AUT].time
publisher	Σ	0..1	string	There are no (further) constraints on this element Element id Questionnaire.publisher Short description Name of the publisher (organization or individual) Definition The name of the organization or individual that published the questionnaire. Requirements Helps establish the "authority/credibility" of the questionnaire. May also allow for contact. Comments Usually an organization but may be an individual. The publisher (or steward) of the questionnaire is the organization or individual primarily responsible for the maintenance and upkeep of the questionnaire. This is not necessarily the same individual or organization that developed and initially authored the content. The publisher is the primary point of contact for questions or issues with the questionnaire. This item SHOULD be populated unless the information is available from context. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.publisher w5: FiveWs.witness rim: .participation[typeCode=AUT].role
contact	Σ	0..*	ContactDetail	There are no (further) constraints on this element Element id Questionnaire.contact Short description Contact details for the publisher Definition Contact details to assist a user in finding and communicating with the publisher. Comments May be a web site, an email address, a telephone number, etc. Data type ContactDetail Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.contact rim: .participation[typeCode=CALLBCK].role
description	S	1..1	markdown	Element id Questionnaire.description Short description Beschreibung Definition A free text natural language description of the questionnaire from a consumer's perspective. Comments Begründung Pflichtfeld: Ausführliche Beschreibung des Formulars zur Verbesserung der Auffindbarkeit Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.description rim: .text
useContext	Σ	0..*	UsageContext	There are no (further) constraints on this element Element id Questionnaire.useContext Short description The context that the content is intended to support Definition The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate questionnaire instances. Requirements Assist in searching for appropriate content. Comments When multiple useContexts are specified, there is no expectation that all or any of the contexts apply. Data type UsageContext Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.useContext rim: N/A (to add?)
jurisdiction	Σ	0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id Questionnaire.jurisdiction Short description Intended jurisdiction for questionnaire (if applicable) Definition A legal or geographic region in which the questionnaire is intended to be used. Comments It may be possible for the questionnaire to be used in jurisdictions other than those for which it was originally designed or intended. Data type CodeableConcept Binding Countries and regions within which this artifact is targeted for use. Jurisdiction ValueSet (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.jurisdiction rim: N/A (to add?)
purpose		0..1	markdown	There are no (further) constraints on this element Element id Questionnaire.purpose Short description Why this questionnaire is defined Definition Explanation of why this questionnaire is needed and why it has been designed as it has. Comments This element does not describe the usage of the questionnaire. Instead, it provides traceability of ''why'' the resource is either needed or ''why'' it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this questionnaire. Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.purpose w5: FiveWs.why[x] rim: .reasonCode.text objimpl: no-gen-base
copyright		0..1	markdown	There are no (further) constraints on this element Element id Questionnaire.copyright Short description Use and/or publishing restrictions Alternate names License, Restrictions Definition A copyright statement relating to the questionnaire and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the questionnaire. Requirements Consumers must be able to determine any legal restrictions on the use of the questionnaire and/or its content. Data type markdown Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.copyright rim: N/A (to add?) objimpl: no-gen-base
approvalDate		0..1	date	There are no (further) constraints on this element Element id Questionnaire.approvalDate Short description When the questionnaire was approved by publisher Definition The date on which the resource content was approved by the publisher. Approval happens once when the content is officially approved for usage. Comments The 'date' element may be more recent than the approval date because of minor changes or editorial corrections. Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.approvalDate rim: .outboundRelationship[typeCode="SUBJ"].act[classCode=CACT;moodCode=EVN;code="approval"].effectiveTime objimpl: no-gen-base
lastReviewDate		0..1	date	There are no (further) constraints on this element Element id Questionnaire.lastReviewDate Short description When the questionnaire was last reviewed Definition The date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date. Requirements Gives a sense of how "current" the content is. Resources that have not been reviewed in a long time may have a risk of being less appropriate/relevant. Comments If specified, this date follows the original approval date. Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.lastReviewDate rim: .outboundRelationship[typeCode="SUBJ"; subsetCode="RECENT"].act[classCode=CACT;moodCode=EVN;code="review"].effectiveTime objimpl: no-gen-base
effectivePeriod	Σ	0..1	Period	There are no (further) constraints on this element Element id Questionnaire.effectivePeriod Short description When the questionnaire is expected to be used Definition The period during which the questionnaire content was or is planned to be in active use. Requirements Allows establishing a transition before a resource comes into effect and also allows for a sunsetting process when new versions of the questionnaire are or are expected to be used instead. Comments The effective period for a questionnaire determines when the content is applicable for usage and is independent of publication and review dates. For example, a measure intended to be used for the year 2016 might be published in 2015. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Definition.effectivePeriod rim: N/A (to add?) objimpl: no-gen-base
code	Σ	0..*	Coding	There are no (further) constraints on this element Element id Questionnaire.code Short description Concept that represents the overall questionnaire Definition An identifier for this question or group of questions in a particular terminology such as LOINC. Requirements Allows linking of the complete Questionnaire resources to formal terminologies. It's common for "panels" of questions to be identified by a code. Data type Coding Binding Codes for questionnaires, groups and individual questions. QuestionnaireQuestionCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: .code
item	S I	0..*	BackboneElement	Element id Questionnaire.item Short description Formularfeld Definition A particular question, question grouping or display text that is part of the questionnaire. Comments Formularfeld, Anzeigetext oder Gruppe von Formularfeldern Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` que-1: Group items must have nested items, display items cannot have nested items `(type='group' implies item.empty().not()) and (type.trace('type')='display' implies item.trace('item').empty())` que-3: Display items cannot have a "code" asserted `type!='display' or code.empty()` que-4: A question cannot have both answerOption and answerValueSet `answerOption.empty() or answerValueSet.empty()` que-5: Only 'choice' and 'open-choice' items can have answerValueSet `(type ='choice' or type = 'open-choice' or type = 'decimal' or type = 'integer' or type = 'date' or type = 'dateTime' or type = 'time' or type = 'string' or type = 'quantity') or (answerValueSet.empty() and answerOption.empty())` que-6: Required and repeat aren't permitted for display items `type!='display' or (required.empty() and repeats.empty())` que-8: Initial values can't be specified for groups or display items `(type!='group' and type!='display') or initial.empty()` que-9: Read-only can't be specified for "display" items `type!='display' or readOnly.empty()` que-10: Maximum length can only be declared for simple question types `(type in ('boolean' \| 'decimal' \| 'integer' \| 'string' \| 'text' \| 'url' \| 'open-choice')) or maxLength.empty()` que-11: If one or more answerOption is present, initial[x] must be missing `answerOption.empty() or initial.empty()` que-12: If there are more than one enableWhen, enableBehavior must be specified `enableWhen.count() > 2 implies enableBehavior.exists()` que-13: Can only have multiple initial values for repeating items `repeats=true or initial.count() <= 1` Mappings rim: .outboundRelationship[typeCode=COMP].target[classCode=OBS, moodCode=DEF]
id		0..1	string	There are no (further) constraints on this element Element id Questionnaire.item.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Questionnaire.item.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Questionnaire.item.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). 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. 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. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
linkId	S	1..1	string	Element id Questionnaire.item.linkId Short description innerhalb dieses Formulars eindeutige ID dieses Feldes Definition An identifier that is unique within the Questionnaire allowing linkage to the equivalent item in a QuestionnaireResponse resource. Requirements QuestionnaireResponse does not require omitted items to be included and may have some items that repeat, so linkage based on position alone is not sufficient. Comments Begründung Pflichtfeld: Erforderlich für die Verlinkung der Antworten in der QuestionnaireRespons mit der Definition des Formularfeldes. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: .id
definition		0..1	uri	There are no (further) constraints on this element Element id Questionnaire.item.definition Short description ElementDefinition - details for the item Definition This element is a URI that refers to an ElementDefinition that provides information about this item, including information that might otherwise be included in the instance of the Questionnaire resource. A detailed description of the construction of the URI is shown in Comments, below. If this element is present then the following element values MAY be derived from the Element Definition if the corresponding elements of this Questionnaire resource instance have no value: code (ElementDefinition.code) type (ElementDefinition.type) required (ElementDefinition.min) repeats (ElementDefinition.max) maxLength (ElementDefinition.maxLength) answerValueSet (ElementDefinition.binding) options (ElementDefinition.binding). Requirements A common pattern is to define a set of data elements and then build multiple questionnaires for different circumstances to gather the data. This element provides traceability to the common definition and allows the content for the question to come from the underlying definition. Comments The uri refers to an ElementDefinition in a StructureDefinition and always starts with the canonical URL for the target resource. When referring to a StructureDefinition, a fragment identifier is used to specify the element definition by its id Element.id. E.g. http://hl7.org/fhir/StructureDefinition/Observation#Observation.value[x]. In the absence of a fragment identifier, the first/root element definition in the target is the matching element definition. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: .outboundRelationship[typeCode=INST].target[classCode=OBS, moodCode=DEF]
code	I	0..*	Coding	There are no (further) constraints on this element Element id Questionnaire.item.code Short description Corresponding concept for this item in a terminology Definition A terminology code that corresponds to this group or question (e.g. a code from LOINC, which defines many questions and answers). Requirements Allows linking of groups of questions to formal terminologies. Comments The value may come from the ElementDefinition referred to by .definition. Data type Coding Binding Codes for questionnaires, groups and individual questions. QuestionnaireQuestionCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: .code
prefix	S	0..1	string	There are no (further) constraints on this element Element id Questionnaire.item.prefix Short description E.g. "1(a)", "2.5.3" Alternate names label Definition A short label for a particular group, question or set of display text within the questionnaire used for reference by the individual completing the questionnaire. Requirements Separating the label from the question text allows improved rendering. Also, instructions will often refer to specific prefixes, so there's a need for the questionnaire design to have control over what labels are used. Comments These are generally unique within a questionnaire, though this is not guaranteed. Some questionnaires may have multiple questions with the same label with logic to control which gets exposed. Typically, these won't be used for "display" items, though such use is not prohibited. Systems SHOULD NOT generate their own prefixes if prefixes are defined for any items within a Questionnaire. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Not supported
text	S	0..1	string	Element id Questionnaire.item.text Short description Text Definition The name of a section, the text of a question or text content for a display item. Comments Begründung MS: Je nach 'type' des items: Fragestellung, Anzeigetext oder Gruppenname Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: .text
type	S	1..1	codeBinding	Element id Questionnaire.item.type Short description group \| display \| boolean \| decimal \| integer \| date \| dateTime + Definition The type of questionnaire item this is - whether text for display, a grouping of other items or a particular type of data to be captured (string, integer, coded choice, etc.). Requirements Defines the format in which the user is to be prompted for the answer. Comments Time is handled using "string". File is handled using Attachment. (Content can be sent as a contained binary). Data type code Binding Distinguishes groups from questions and display text and indicates data type for questions. QuestionnaireItemType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
enableWhen	?! I	0..*	BackboneElement	There are no (further) constraints on this element Element id Questionnaire.item.enableWhen Short description Only allow data when Definition A constraint indicating that this item should only be enabled (displayed/allow answers to be captured) when the specified condition is true. Requirements Allows questionnaires to adapt based on answers to other questions. E.g. If physical gender is specified as a male, no need to capture pregnancy history. Also allows conditional display of instructions or groups of questions. Comments If multiple repetitions of this extension are present, the item should be enabled when the condition for any of the repetitions is true. I.e. treat "enableWhen"s as being joined by an "or" clause. This element is a modifier because if enableWhen is present for an item, "required" is ignored unless one of the enableWhen conditions is met. When an item is disabled, all of its descendants are disabled, regardless of what their own enableWhen logic might evaluate to. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` que-7: If the operator is 'exists', the value must be a boolean `operator = 'exists' implies (answer is Boolean)` Mappings rim: N/A - MIF rather than RIM level
id		0..1	string	There are no (further) constraints on this element Element id Questionnaire.item.enableWhen.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Questionnaire.item.enableWhen.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Questionnaire.item.enableWhen.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). 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. 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. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
question		1..1	string	There are no (further) constraints on this element Element id Questionnaire.item.enableWhen.question Short description Question that determines whether item is enabled Definition The linkId for the question whose answer (or lack of answer) governs whether this item is enabled. Comments If multiple question occurrences are present for the same question (same linkId), then this refers to the nearest question occurrence reachable by tracing first the "ancestor" axis and then the "preceding" axis and then the "following" axis. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
operator		1..1	codeBinding	There are no (further) constraints on this element Element id Questionnaire.item.enableWhen.operator Short description exists \| = \| != \| > \| < \| >= \| <= Definition Specifies the criteria by which the question is enabled. Data type code Binding The criteria by which a question is enabled. QuestionnaireItemOperator (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
answer[x]	I	1..1		There are no (further) constraints on this element Element id Questionnaire.item.enableWhen.answer[x] Short description Value for question comparison based on operator Definition A value that the referenced question is tested using the specified operator in order for the item to be enabled. Binding Allowed values to answer questions. QuestionnaireAnswerCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
answerBoolean			boolean	There are no (further) constraints on this element Data type boolean
answerDecimal			decimal	There are no (further) constraints on this element Data type decimal
answerInteger			integer	There are no (further) constraints on this element Data type integer
answerDate			date	There are no (further) constraints on this element Data type date
answerDateTime			dateTime	There are no (further) constraints on this element Data type dateTime
answerTime			time	There are no (further) constraints on this element Data type time
answerString			string	There are no (further) constraints on this element Data type string
answerCoding			Coding	There are no (further) constraints on this element Data type Coding
answerQuantity			Quantity	There are no (further) constraints on this element Data type Quantity
answerReference			Reference(Resource)	There are no (further) constraints on this element Data type Reference(Resource)
enableBehavior	I	0..1	codeBinding	There are no (further) constraints on this element Element id Questionnaire.item.enableBehavior Short description all \| any Definition Controls how multiple enableWhen values are interpreted - whether all or any must be true. Comments This element must be specified if more than one enableWhen value is provided. Data type code Binding Controls how multiple enableWhen values are interpreted - whether all or any must be true. EnableWhenBehavior (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
required	S I	0..1	boolean	Element id Questionnaire.item.required Short description Pflichtfeld? Definition An indication, if true, that the item must be present in a "completed" QuestionnaireResponse. If false, the item may be skipped when answering the questionnaire. Comments Begründung MS: FormularRenderer sollen sicherstellen können, dass Formulare vom Anwender vollständig ausgefüllt werden. Meaning when missing Items are generally assumed not to be required unless explicitly specified. Systems SHOULD always populate this value Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
repeats	S I	0..1	boolean	Element id Questionnaire.item.repeats Short description Mehrfachangaben erlaubt? Definition An indication, if true, that the item may occur multiple times in the response, collecting multiple answers for questions or multiple sets of answers for groups. Requirements Items may be used to create set of (related) questions that can be repeated to give multiple answers to such a set. Comments Begründung MS: FormularRenderer sollen in der Lage sein zwischen Einfach- und Mehrfachangaben unterscheiden zu können. Meaning when missing Items are generally assumed not to repeat unless explicitly specified. Systems SHOULD always populate this value Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
readOnly	S I	0..1	boolean	Element id Questionnaire.item.readOnly Short description Keine Eingabe erlaubt? Definition An indication, when true, that the value cannot be changed by a human respondent to the Questionnaire. Requirements Allows certain information to be phrased (and rendered) as a question and an answer, while keeping users from changing it. May also be useful for preventing changes to pre-populated portions of a questionnaire, for calculated values, etc. Comments Antwort wird automatisch vorbelegt/berechnet und darf nicht vom Anwender editiert/überschrieben werden. Begründung MS: Automatisch vorbelegte Items sollen gegen Veränderung durch den Benutzer geschützt werden können (z.B. für Patientenstammdaten). Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
maxLength	I	0..1	integer	There are no (further) constraints on this element Element id Questionnaire.item.maxLength Short description No more than this many characters Definition The maximum number of characters that are permitted in the answer to be considered a "valid" QuestionnaireResponse. Comments For base64binary, reflects the number of characters representing the encoded data, not the number of bytes of the binary data. The value may come from the ElementDefinition referred to by .definition. Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: N/A - MIF rather than RIM level
answerValueSet	S I	0..1	canonical(ValueSet)	Element id Questionnaire.item.answerValueSet Short description Festlegung der Antwortmöglichkeiten durch Verweis auf ValueSet Definition A reference to a value set containing a list of codes representing permitted answers for a "choice" or "open-choice" question. Comments Begründung MS: Wo geeignete ValueSets vorhanden sind, die die Antwortmöglichkeiten hinreichend repräsentieren, sollte auf diese verwiesen werden. Data type canonical(ValueSet) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
answerOption	S I	0..*	BackboneElement	Element id Questionnaire.item.answerOption Short description Festlegung der Antwortmöglichkeiten durch Aufzählung Definition One of the permitted answers for a "choice" or "open-choice" question. Comments Begründung MS: Wo keine geeignete ValueSets vorhanden sind, die die Antwortmöglichkeiten hinreichen repräsentieren, können Antworten alternativ in der FormularDefinition explizit aufgezählt werden.. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
id		0..1	string	There are no (further) constraints on this element Element id Questionnaire.item.answerOption.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Questionnaire.item.answerOption.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Questionnaire.item.answerOption.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). 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. 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. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
value[x]		1..1		There are no (further) constraints on this element Element id Questionnaire.item.answerOption.value[x] Short description Answer value Definition A potential answer that's allowed as the answer to this question. Comments The data type of the value must agree with the item.type. Binding Allowed values to answer questions. QuestionnaireAnswerCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
valueInteger			integer	There are no (further) constraints on this element Data type integer
valueDate			date	There are no (further) constraints on this element Data type date
valueTime			time	There are no (further) constraints on this element Data type time
valueString			string	There are no (further) constraints on this element Data type string
valueCoding			Coding	There are no (further) constraints on this element Data type Coding
valueReference			Reference(Resource)	There are no (further) constraints on this element Data type Reference(Resource)
initialSelected		0..1	boolean	There are no (further) constraints on this element Element id Questionnaire.item.answerOption.initialSelected Short description Whether option is selected by default Definition Indicates whether the answer value is selected when the list of possible answers is initially shown. Comments Use this instead of initial[v] if answerValueSet is present. Meaning when missing Only selected items explicitly marked to be selected Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
initial	I	0..*	BackboneElement	There are no (further) constraints on this element Element id Questionnaire.item.initial Short description Initial value(s) when item is first rendered Definition One or more values that should be pre-populated in the answer when initially rendering the questionnaire for user input. Requirements In some workflows, having defaults saves time. Comments The user is allowed to change the value and override the default (unless marked as read-only). If the user doesn't change the value, then this initial value will be persisted when the QuestionnaireResponse is initially created. Note that initial values can influence results. The data type of initial[x] must agree with the item.type, and only repeating items can have more then one initial value. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
id		0..1	string	There are no (further) constraints on this element Element id Questionnaire.item.initial.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Questionnaire.item.initial.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Questionnaire.item.initial.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). 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. 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. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: N/A
value[x]		1..1		There are no (further) constraints on this element Element id Questionnaire.item.initial.value[x] Short description Actual value for initializing the question Definition The actual value to for an initial answer. Comments The type of the initial value must be consistent with the type of the item. Binding Allowed values to answer questions. QuestionnaireAnswerCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A - MIF rather than RIM level
valueBoolean			boolean	There are no (further) constraints on this element Data type boolean
valueDecimal			decimal	There are no (further) constraints on this element Data type decimal
valueInteger			integer	There are no (further) constraints on this element Data type integer
valueDate			date	There are no (further) constraints on this element Data type date
valueDateTime			dateTime	There are no (further) constraints on this element Data type dateTime
valueTime			time	There are no (further) constraints on this element Data type time
valueString			string	There are no (further) constraints on this element Data type string
valueUri			uri	There are no (further) constraints on this element Data type uri
valueAttachment			Attachment	There are no (further) constraints on this element Data type Attachment
valueCoding			Coding	There are no (further) constraints on this element Data type Coding
valueQuantity			Quantity	There are no (further) constraints on this element Data type Quantity
valueReference			Reference(Resource)	There are no (further) constraints on this element Data type Reference(Resource)
item	S I	0..*	see (item)	Element id Questionnaire.item.item Short description Untergeordnetes Item Definition Text, questions and other groups to be nested beneath a question or group. Requirements Reports can consist of complex nested groups. Comments Begründung MS: Items können beliebig verschachtelt und zu Gruppen zusammengefasst werden, um komplexere und umfangreichere Formulare zu strukturieren. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: .outboundRelationship[typeCode=COMP].target

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<StructureDefinition xmlns="http://hl7.org/fhir">
    <id value="ISiKFormularDefinition" />
    <url value="https://gematik.de/fhir/isik/StructureDefinition/ISiKFormularDefinition" />
    <version value="5.0.0-rc" />
    <name value="ISiKFormularDefinition" />
    <status value="active" />
    <experimental value="false" />
    <date value="2025-04-09" />
    <publisher value="gematik GmbH" />
    <fhirVersion value="4.0.1" />
    <kind value="resource" />
    <abstract value="false" />
    <type value="Questionnaire" />
    <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Questionnaire" />
    <derivation value="constraint" />
    <differential>
        <element id="Questionnaire.modifierExtension">
            <path value="Questionnaire.modifierExtension" />
            <min value="1" />
        </element>
        <element id="Questionnaire.modifierExtension:MDR-Relevant">
            <path value="Questionnaire.modifierExtension" />
            <sliceName value="MDR-Relevant" />
            <min value="1" />
            <max value="1" />
            <type>
                <code value="Extension" />
                <profile value="https://gematik.de/fhir/isik/StructureDefinition/ISiKMDRRelevanzFormularExtension" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.modifierExtension:MDR-Relevant.value[x]">
            <path value="Questionnaire.modifierExtension.value[x]" />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.url">
            <path value="Questionnaire.url" />
            <short value="CanoncialURL des Formulars" />
            <comment value="Weltweit eindeutiger Name des Formulars.\n  **Begr&#252;ndung Pflichtfeld:**\n  Wird f&#252;r eindeutige Bezugnahme von FormularDaten auf FormularDefinition ben&#246;tigt." />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.version">
            <path value="Questionnaire.version" />
            <short value="Version" />
            <comment value="Versionsnummer des Formulars. Sollte gem. semVer-Regeln inkrementiert werden, je nach Schweregrad der &#196;nderungen.\n  **Begr&#252;ndung MS:**  \n  Wird ben&#246;tigt, um FormularDefinitionen in unterschiedlichen Versionen zu differenzieren." />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.title">
            <path value="Questionnaire.title" />
            <short value="Titel/&#220;berschrift" />
            <comment value="Dem Anwender angezeigter Titel des Formulars.  \n  **Begr&#252;ndung MS:**  \n  Wird f&#252;r die Darstellung und Auffindbarkeit der FormularDefinition ben&#246;tigt." />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.status">
            <path value="Questionnaire.status" />
            <short value="active | retired" />
            <comment value="Die im ISiK-Kontext bereitgestellten Formulare sollten final ausspezifiziert sein und daher den Status &#39;active&#39; haben. \n  Formulare, die zur&#252;ckgezogen oder durch neuere Versionen ersetzt wurden, k&#246;nnen mit &#39;retired&#39; gekennzeichnet werden." />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.subjectType">
            <path value="Questionnaire.subjectType" />
            <short value="Subject, &#252;ber das in diesem Formular berichtet wird." />
            <comment value="**Begr&#252;ndung Pflichtfeld:**  \n  Zur Vereinfachung des Workflows werden zun&#228;chst nur Formulare mit Patientenbezug zugelassen. \n  Dabei ist stets davon auszugehen, dass der Patient, f&#252;r den dieses Formular ausgef&#252;llt wird, \n  identisch ist, mit dem Patient, der im Launch-Kontext &#252;bergeben wird. \n  Diese Anforderung kann in k&#252;nftigen Ausbaustufen gelockert werden." />
            <min value="1" />
            <max value="1" />
            <patternCode value="Patient" />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.description">
            <path value="Questionnaire.description" />
            <short value="Beschreibung" />
            <comment value="**Begr&#252;ndung Pflichtfeld:**  \n  Ausf&#252;hrliche Beschreibung des Formulars zur Verbesserung der Auffindbarkeit" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.item">
            <path value="Questionnaire.item" />
            <short value="Formularfeld" />
            <comment value="Formularfeld, Anzeigetext oder Gruppe von Formularfeldern" />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.item.linkId">
            <path value="Questionnaire.item.linkId" />
            <short value="innerhalb dieses Formulars eindeutige ID dieses Feldes" />
            <comment value="**Begr&#252;ndung Pflichtfeld:**  \n    Erforderlich f&#252;r die Verlinkung der Antworten in der QuestionnaireRespons mit der Definition des Formularfeldes." />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.item.prefix">
            <path value="Questionnaire.item.prefix" />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.item.text">
            <path value="Questionnaire.item.text" />
            <short value="Text" />
            <comment value="**Begr&#252;ndung MS:**  \n    Je nach &#39;type&#39; des items: Fragestellung, Anzeigetext oder Gruppenname" />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.item.type">
            <path value="Questionnaire.item.type" />
            <comment value="Time is handled using &quot;string&quot;.  File is handled using Attachment.  (Content can be sent as a contained binary)." />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.item.required">
            <path value="Questionnaire.item.required" />
            <short value="Pflichtfeld?" />
            <comment value="**Begr&#252;ndung MS:**  \n    FormularRenderer sollen sicherstellen k&#246;nnen, dass Formulare vom Anwender vollst&#228;ndig ausgef&#252;llt werden." />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.item.repeats">
            <path value="Questionnaire.item.repeats" />
            <short value="Mehrfachangaben erlaubt?" />
            <comment value="**Begr&#252;ndung MS:**  FormularRenderer sollen in der Lage sein zwischen Einfach- und Mehrfachangaben unterscheiden zu k&#246;nnen." />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.item.readOnly">
            <path value="Questionnaire.item.readOnly" />
            <short value="Keine Eingabe erlaubt?" />
            <comment value="Antwort wird automatisch vorbelegt/berechnet und darf nicht vom Anwender editiert/&#252;berschrieben werden.\n    **Begr&#252;ndung MS:** Automatisch vorbelegte Items sollen gegen Ver&#228;nderung durch den Benutzer gesch&#252;tzt werden k&#246;nnen (z.B. f&#252;r Patientenstammdaten)." />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.item.answerValueSet">
            <path value="Questionnaire.item.answerValueSet" />
            <short value="Festlegung der Antwortm&#246;glichkeiten durch Verweis auf ValueSet" />
            <comment value="**Begr&#252;ndung MS:**  Wo geeignete ValueSets vorhanden sind, die die Antwortm&#246;glichkeiten hinreichend repr&#228;sentieren, sollte auf diese verwiesen werden." />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.item.answerOption">
            <path value="Questionnaire.item.answerOption" />
            <short value="Festlegung der Antwortm&#246;glichkeiten durch Aufz&#228;hlung" />
            <comment value="**Begr&#252;ndung MS:**  Wo *keine* geeignete ValueSets vorhanden sind, die die Antwortm&#246;glichkeiten hinreichen repr&#228;sentieren, \n    k&#246;nnen Antworten alternativ in der FormularDefinition explizit aufgez&#228;hlt werden.." />
            <mustSupport value="true" />
        </element>
        <element id="Questionnaire.item.item">
            <path value="Questionnaire.item.item" />
            <short value="Untergeordnetes Item" />
            <comment value="**Begr&#252;ndung MS:**  \n   Items k&#246;nnen beliebig verschachtelt und zu Gruppen zusammengefasst werden, um komplexere und umfangreichere Formulare zu strukturieren." />
            <mustSupport value="true" />
        </element>
    </differential>
</StructureDefinition>

{
    "resourceType": "StructureDefinition",
    "id": "ISiKFormularDefinition",
    "url": "https://gematik.de/fhir/isik/StructureDefinition/ISiKFormularDefinition",
    "version": "5.0.0-rc",
    "name": "ISiKFormularDefinition",
    "status": "active",
    "experimental": false,
    "date": "2025-04-09",
    "publisher": "gematik GmbH",
    "fhirVersion": "4.0.1",
    "kind": "resource",
    "abstract": false,
    "type": "Questionnaire",
    "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Questionnaire",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "Questionnaire.modifierExtension",
                "path": "Questionnaire.modifierExtension",
                "min": 1
            },
            {
                "id": "Questionnaire.modifierExtension:MDR-Relevant",
                "path": "Questionnaire.modifierExtension",
                "sliceName": "MDR-Relevant",
                "min": 1,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://gematik.de/fhir/isik/StructureDefinition/ISiKMDRRelevanzFormularExtension"
                        ]
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "Questionnaire.modifierExtension:MDR-Relevant.value[x]",
                "path": "Questionnaire.modifierExtension.value[x]",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.url",
                "path": "Questionnaire.url",
                "short": "CanoncialURL des Formulars",
                "comment": "Weltweit eindeutiger Name des Formulars.\n  **Begründung Pflichtfeld:**\n  Wird für eindeutige Bezugnahme von FormularDaten auf FormularDefinition benötigt.",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Questionnaire.version",
                "path": "Questionnaire.version",
                "short": "Version",
                "comment": "Versionsnummer des Formulars. Sollte gem. semVer-Regeln inkrementiert werden, je nach Schweregrad der Änderungen.\n  **Begründung MS:**  \n  Wird benötigt, um FormularDefinitionen in unterschiedlichen Versionen zu differenzieren. ",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.title",
                "path": "Questionnaire.title",
                "short": "Titel/Überschrift",
                "comment": "Dem Anwender angezeigter Titel des Formulars.  \n  **Begründung MS:**  \n  Wird für die Darstellung und Auffindbarkeit der FormularDefinition benötigt.",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Questionnaire.status",
                "path": "Questionnaire.status",
                "short": "active | retired",
                "comment": "Die im ISiK-Kontext bereitgestellten Formulare sollten final ausspezifiziert sein und daher den Status 'active' haben. \n  Formulare, die zurückgezogen oder durch neuere Versionen ersetzt wurden, können mit 'retired' gekennzeichnet werden.",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.subjectType",
                "path": "Questionnaire.subjectType",
                "short": "Subject, über das in diesem Formular berichtet wird.",
                "comment": "**Begründung Pflichtfeld:**  \n  Zur Vereinfachung des Workflows werden zunächst nur Formulare mit Patientenbezug zugelassen. \n  Dabei ist stets davon auszugehen, dass der Patient, für den dieses Formular ausgefüllt wird, \n  identisch ist, mit dem Patient, der im Launch-Kontext übergeben wird. \n  Diese Anforderung kann in künftigen Ausbaustufen gelockert werden.",
                "min": 1,
                "max": "1",
                "patternCode": "Patient",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.description",
                "path": "Questionnaire.description",
                "short": "Beschreibung",
                "comment": "**Begründung Pflichtfeld:**  \n  Ausführliche Beschreibung des Formulars zur Verbesserung der Auffindbarkeit",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "Questionnaire.item",
                "path": "Questionnaire.item",
                "short": "Formularfeld",
                "comment": "Formularfeld, Anzeigetext oder Gruppe von Formularfeldern",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.item.linkId",
                "path": "Questionnaire.item.linkId",
                "short": "innerhalb dieses Formulars eindeutige ID dieses Feldes",
                "comment": "**Begründung Pflichtfeld:**  \n    Erforderlich für die Verlinkung der Antworten in der QuestionnaireRespons mit der Definition des Formularfeldes.",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.item.prefix",
                "path": "Questionnaire.item.prefix",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.item.text",
                "path": "Questionnaire.item.text",
                "short": "Text",
                "comment": "**Begründung MS:**  \n    Je nach 'type' des items: Fragestellung, Anzeigetext oder Gruppenname",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.item.type",
                "path": "Questionnaire.item.type",
                "comment": "Time is handled using \"string\".  File is handled using Attachment.  (Content can be sent as a contained binary).",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.item.required",
                "path": "Questionnaire.item.required",
                "short": "Pflichtfeld?",
                "comment": "**Begründung MS:**  \n    FormularRenderer sollen sicherstellen können, dass Formulare vom Anwender vollständig ausgefüllt werden.",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.item.repeats",
                "path": "Questionnaire.item.repeats",
                "short": "Mehrfachangaben erlaubt?",
                "comment": "**Begründung MS:**  FormularRenderer sollen in der Lage sein zwischen Einfach- und Mehrfachangaben unterscheiden zu können.",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.item.readOnly",
                "path": "Questionnaire.item.readOnly",
                "short": "Keine Eingabe erlaubt?",
                "comment": "Antwort wird automatisch vorbelegt/berechnet und darf nicht vom Anwender editiert/überschrieben werden.\n    **Begründung MS:** Automatisch vorbelegte Items sollen gegen Veränderung durch den Benutzer geschützt werden können (z.B. für Patientenstammdaten).",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.item.answerValueSet",
                "path": "Questionnaire.item.answerValueSet",
                "short": "Festlegung der Antwortmöglichkeiten durch Verweis auf ValueSet",
                "comment": "**Begründung MS:**  Wo geeignete ValueSets vorhanden sind, die die Antwortmöglichkeiten hinreichend repräsentieren, sollte auf diese verwiesen werden.",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.item.answerOption",
                "path": "Questionnaire.item.answerOption",
                "short": "Festlegung der Antwortmöglichkeiten durch Aufzählung",
                "comment": "**Begründung MS:**  Wo *keine* geeignete ValueSets vorhanden sind, die die Antwortmöglichkeiten hinreichen repräsentieren, \n    können Antworten alternativ in der FormularDefinition explizit aufgezählt werden..",
                "mustSupport": true
            },
            {
                "id": "Questionnaire.item.item",
                "path": "Questionnaire.item.item",
                "short": "Untergeordnetes Item",
                "comment": "**Begründung MS:**  \n   Items können beliebig verschachtelt und zu Gruppen zusammengefasst werden, um komplexere und umfangreichere Formulare zu strukturieren.",
                "mustSupport": true
            }
        ]
    }
}

ISiKFormularDefinition

Constraints/Invarianten

Beispiele

DemoQuestionnaire