Generated Narrative: StructureDefinition ISiKFormularDaten Name Flags Card. Type Description & Constraints QuestionnaireResponse <a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R4/conformance-rules.html#constraints" title="This element has or is affected by constraints ( sdcqr-1, sdcqr-2 )">C 0..* QuestionnaireResponse A structured set of questions and their answers Constraints: sdcqr-1, sdcqr-2 #xD; id S 0..1 id serverseitige, interne ID des Datensatzes #xD; meta #xD; versionId 0..1 id Eindeutiger Name der serverseitigen Version des Datensatzes #xD; lastUpdated 0..1 instant Zeitpunkt der letzten Änderung #xD; implicitRules 0..0 Verweis auf die Regeln, nach denen die Ressource erstellt wurde #xD; Slices for modifierExtension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; modifierExtension:MDR-Relevant S 0..1 (Complex) MPG-Relevanz der Formulardaten URL: https://gematik.de/fhir/isik/StructureDefinition/ISiKMDRRelevanzFormularExtension #xD; value[x] S 1..1 Coding Value of extension #xD; identifier S 0..1 Identifier eindeutiger Identifier der FormularDaten #xD; questionnaire S 1..1 canonical(Questionnaire) Bezug zur FormularDefinition inkl. Version #xD; Slices for extension 1..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:questionnaireDisplay S 1..1 string Titel/Überschrift der zugrunde liegenden FormularDefinition URL: http://hl7.org/fhir/StructureDefinition/display #xD; status S 1..1 code Status #xD; subject S 1..1 Reference(Resource) Subject (Patient), über das in diesem Formular berichtet wird. #xD; reference S 1..1 string Patienten-Link #xD; authored S 1..1 dateTime Datum der FormularDaten #xD; author S 0..1 Reference(Device | Practitioner | PractitionerRole | Patient | RelatedPerson | Organization) Ersteller des Fromulars #xD; item S 0..* BackboneElement Formularelement #xD; linkId S 1..1 string Eindeutige ID des Formularelement #xD; text S 0..1 string Frage, die beantwortet wurde #xD; answer S 0..* BackboneElement Antwort #xD; value[x] S 0..1 boolean, decimal, integer, date, dateTime, time, string, uri, Attachment, Coding, Quantity, Reference(Resource) Inhalt der Antwort #xD; item S 0..* Untergeordnetes Item #xD; item S 0..* Untergeordnetes Item #xD; Documentation for this format
Im Profil `ISiKFormularDaten` sind Mindestanforderungen an ISiK kompatible, ausgefüllte Formulare definiert. Die verwendbaren Extensions sind nicht mit profiliert, sondern im IG unter Spezifikationen->Extensions beschrieben.
A structured set of questions and their answers
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.
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.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
not(parent::f:contained and f:contained)
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()
not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))
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()
not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
Subject SHOULD be present (searching is difficult without subject). Almost all QuestionnaireResponses should be with respect to some sort of subject.
When repeats=true for a group, it'll be represented with multiple items with the same linkId in the QuestionnaireResponse. For a question, it'll be represented by a single item with that linkId with multiple answers.
not(exists(for $item in descendant::f:item[f:answer] return $item/preceding-sibling::f:item[f:linkId/@value=$item/f:linkId/@value]))
serverseitige, interne ID des Datensatzes
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
**bedingtes Pflichtfeld/bedingtes MS:** Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine `id` verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine `id`verfügen.
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.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
Additional content defined by implementations
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.
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.
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
Eindeutiger Name der serverseitigen Version des Datensatzes
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.
Alle von einem Server bereitgestellten Ressourcen SOLLEN über eine `versionID` verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine `versionID`verfügen.
When the resource last changed - e.g. when the version changed.
Alle von einem Server bereitgestellten Ressourcen SOLLEN über ein `lastUpdate` verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über ein `lastUpdate`verfügen.
Identifies where the resource comes from
A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](http://hl7.org/fhir/R4/provenance.html#) 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.
In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.
Profiles this resource claims to conform to
A list of profiles (references to [StructureDefinition](http://hl7.org/fhir/R4/structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](http://hl7.org/fhir/R4/structuredefinition-definitions.html#StructureDefinition.url).
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.
Security Labels applied to this resource
Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.
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.
Security Labels from the Healthcare Privacy and Security Classification System.
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.
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.
Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
Verweis auf die Regeln, nach denen die Ressource erstellt wurde
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.
Begründung Constraint: In ISiK existiert kein Use-Case für dieses Element. Da es sich um ein Modifying Element handelt, wird es daher ausgeschlossen. Darüber hinaus werden die Regeln als URI vorgehalten. Dies führt dazu, dass sich hinter der URI eine beliebige Menge an Regeln befinden kann; wodurch nicht sichergestellt werden kann, dass alle Clients die Regeln korrekt interpretieren können.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
The base language in which the resource is written.
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).
Text summary of the resource, for human interpretation
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.
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.
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.
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.
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.
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
**Begründung MS:** In dieser Extension wird angegeben, dass die Formulardaten MDR-relevant sind. Für die Erhebung und/oder Darstellung müssen ggf. bestimmte Voraussetzungen erfüllt sein. Ist die Extension nicht vorhanden, liegt keine MDR-relevanmt vor.
exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
Ist in dieser Extension nicht der Code 'none' gesetzt, muss die Anzeige rechtlich geprüft werden, weil der FormularDefinitionErsteller eine Relevanz im Rahmen der MDR identifiziert hat.
Source of the definition for the extension code - a logical name or a URL.
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.
Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).
eindeutiger Identifier der FormularDaten
A business identifier assigned to a particular completed (or partially completed) questionnaire.
**Begründung MS:** Ein vom FormularRenderer vergebener, eindeutiger Identifier kann von weiterverarbeitenden Systemen genutzt werden, um Dubletten zu erkennen.
Used for tracking, registration and other business purposes.
Request fulfilled by this QuestionnaireResponse
The order, proposal or plan that is fulfilled in whole or in part by this QuestionnaireResponse. For example, a ServiceRequest seeking an intake assessment or a decision support recommendation to assess for post-partum depression.
Supports traceability of responsibility for the action and allows linkage of an action to the recommendations acted upon.
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.
Composition of questionnaire responses will be handled by the parent questionnaire having answers that reference the child questionnaire. For relationships to referrals, and other types of requests, use basedOn.
Bezug zur FormularDefinition inkl. Version
The Questionnaire that defines and organizes the questions for which answers are being provided.
Bei der Angabe der Canonical, sollte die Version der FormularDefinition, welche bei der Erstellung die Grundlage gebildet hat, angegeben sein. **Begründung MS:** Der Bezug zur Formulardefinition kann für die Interpretation und Darstellung der Formulardaten relevant sein.
Needed to allow editing of the questionnaire response in a manner that enforces the constraints of the original form.
./outboundRelationship[typeCode=INST]/target[classCode=OBS, moodCode=DEFN]
unique id for the element within a resource (for internal references)
Titel/Überschrift der zugrunde liegenden FormularDefinition
The title or other name to display when referencing a resource by canonical URL.
Wird für die Darstellung und Auffindbarkeit der FormularDaten benötigt.
The position of the questionnaire response within its overall lifecycle.
**Begründung Pflichtfeld:** Bei der Verarbeitung von FormularDaten ist es wichtig, den Status zu beachten. Falls die Instanz noch nicht `completed` ist, sollte von einer Weiterverarbeitung abgesehen werden.
The information on Questionnaire resources may possibly be gathered during multiple sessions and altered after considered being finished.
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
Lifecycle status of the questionnaire response.
.statusCode (also whether there's a revisionControlAct - and possibly mood to distinguish "in-progress" from "published)
Subject (Patient), über das in diesem Formular berichtet wird.
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.
**Begründung Pflichtfeld:** Zur Vereinfachung des Workflows werden zunächst nur Formulare mit Patientenbezug zugelassen. Diese Anforderung kann in künftigen Ausbaustufen gelockert werden.
Allows linking the answers to the individual the answers describe. May also affect access control.
A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.
**Begründung MS:** Die Verlinkung auf eine Patienten-Ressource dient der technischen Zuordnung der Dokumentation zu einem Patienten und ermöglicht wichtige API-Funktionen wie verkettete Suche, (Reverse-)Include etc. Im ISik Kontext MUSS die referenzierte Ressource konform zu [ISiKPatient](https://gematik.de/fhir/isik/StructureDefinition/ISiKPatient) sein. Jenseits von ISiK KÖNNEN weitere Instanzen mit anderen Profilen referenziert werden.
Type the reference refers to (e.g. "Patient")
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent. The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.
Aa resource (or, for logical models, the URI of the logical model).
Logical reference, when literal reference is not known
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.
When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
Plain text narrative that identifies the resource in addition to the resource reference.
This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.
The Encounter during which this questionnaire response was created or to which the creation of this record is tightly associated.
This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. A questionnaire that was initiated during an encounter but not fully completed during the encounter would still generally be associated with the encounter.
Provides context for the information that was captured. May also affect access control.
.inboundRelationship(typeCode=COMP].source[classCode<=PCPR, moodCode=EVN]
The date and/or time that this set of answers were last changed.
**Begründung Pflichtfeld:** Relevant für die Suche und zeitliche Einordnung der FormularDaten
Clinicians need to be able to check the date that the information in the questionnaire was collected, to derive the context of the answers.
Person who received the answers to the questions in the QuestionnaireResponse and recorded them in the system.
Auch wenn hier keine Einschränkung vorgenommen wurde, ist zu empfehlen, hier die ausfüllende Person (Patient/Practitioner) zu referenzieren und nicht nur die Software (Device), mit der das Formular ausgefüllt wurde. **Begründung MS:** In den meisten Fällen ist relevant, wer Formulardaten erfasst hat.
Need to know who interpreted the subject's answers to the questions in the questionnaire, and selected the appropriate options for answers.
The person who answered the questions about the subject.
If not specified, no inference can be made about who provided the data.
When answering questions about a subject that is minor, incapable of answering or an animal, another human source may answer the questions.
A group or question item from the original questionnaire for which answers are provided.
**Begründung MS:** Es können beliebig viele Formularelemente hier abgebildet werden.
Nested item can't be beneath both item and answer
(answer.exists() and item.exists()).not()
not(exists(f:answer) and exists(f:item))
.outboundRelationship[typeCode=COMP].target[classCode=OBS, moodCode=EVN]
Extensions that cannot be ignored even if unrecognized
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).
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](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The item from the Questionnaire that corresponds to this item in the QuestionnaireResponse resource.
**Begründung Pflichtfeld:** Die LinkId ordnet die Information der Antwort einer Frage in der FormularDefinition zu und ist aus dem Grund zur Interpretation der Antwort unablässig.
Items can repeat in the answers, so a direct 1..1 correspondence by position might not exist - requiring correspondence by identifier.
.outboundRelationship[typeCode=DEFN].target[classCode=OBS, moodCode=DEFN].id
ElementDefinition - details for the item
A reference to an [ElementDefinition](http://hl7.org/fhir/R4/elementdefinition.html) that provides the details for the item.
The ElementDefinition must be in a [StructureDefinition](http://hl7.org/fhir/R4/structuredefinition.html#), 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.
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.
.outboundRelationship[typeCode=DEFN].target[classCode=OBS, moodCode=DEFN].code
Text that is displayed above the contents of the group or as the text of the question being answered.
**Begründung Pflichtfeld:** Die FormularDaten sollte pro Antwort auch die Fragestellung mitführen, damit die Daten auch von Systemen/Anwendern interpretiert werden können, die *keinen* Zugriff auf die zugrunde liegende FormularDefinition haben.
Allows the questionnaire response to be read without access to the questionnaire.
The respondent's answer(s) to the question.
**Begründung MS:** Die erfasste Antwort MUSS stets vorhanden sein.
The answer (or one of the answers) provided by the respondent to the question.
**Begründung MS:** Der Inhalt der jeweilig erfassten Antwort MUSS stehts vorhanden sein.
Ability to retain a single-valued answer to a question.
Code indicating the response provided for a question.
Nested groups and/or questions found within this particular answer.
**Begründung MS:** Items können beliebig verschachtelt und zu Gruppen zusammengefasst werden, um komplexere und umfangreichere Formulare zu strukturieren.
It is useful to have "sub-questions", questions which normally appear when certain answers are given and which collect additional details.
Questions or sub-groups nested beneath a question or group.
Reports can consist of complex nested groups.