MII_PR_Onko_Nebenwirkung_Adverse_Event (AdverseEvent) | C | | AdverseEvent | There are no (further) constraints on this element Element idAdverseEvent Short descriptionMedical care, research study or other healthcare event causing physical injury Alternate namesAE DefinitionActual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.
Data typeAdverseEvent 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() Mappings- rim: Entity. Role, or Act
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id | Σ | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.id Short descriptionLogical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
CommentsThe only time that a resource does not have an id is when it is being submitted to the server using a create operation.
Data typestring |
meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idAdverseEvent.meta Short descriptionMetadata about the resource DefinitionThe 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 typeMeta Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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id | | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.meta.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Data typestring Mappings |
extension | C | 0..* | Extension | There are no (further) constraints on this element Element idAdverseEvent.meta.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
CommentsThere 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 typeExtension SlicingUnordered, 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 |
versionId | Σ | 0..1 | id | There are no (further) constraints on this element Element idAdverseEvent.meta.versionId Short descriptionVersion specific identifier DefinitionThe version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.
CommentsThe server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.
Data typeid Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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lastUpdated | Σ | 0..1 | instant | There are no (further) constraints on this element Element idAdverseEvent.meta.lastUpdated Short descriptionWhen the resource version last changed DefinitionWhen the resource last changed - e.g. when the version changed.
CommentsThis value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.
Data typeinstant Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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source | Σ | 0..1 | uri | There are no (further) constraints on this element Element idAdverseEvent.meta.source Short descriptionIdentifies where the resource comes from DefinitionA uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.
CommentsIn 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.
Data typeuri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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profile | S Σ | 0..* | canonical(StructureDefinition) | There are no (further) constraints on this element Element idAdverseEvent.meta.profile Short descriptionProfiles this resource claims to conform to DefinitionCommentsIt 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.
Data typecanonical(StructureDefinition) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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security | Σ | 0..* | CodingBinding | There are no (further) constraints on this element Element idAdverseEvent.meta.security Short descriptionSecurity Labels applied to this resource DefinitionSecurity labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.
CommentsThe 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.
Data typeCoding BindingSecurity Labels from the Healthcare Privacy and Security Classification System.
All Security Labels (extensible) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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tag | Σ | 0..* | Coding | There are no (further) constraints on this element Element idAdverseEvent.meta.tag Short descriptionTags applied to this resource DefinitionTags 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.
CommentsThe 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.
Data typeCoding BindingCodes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
CommonTags (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idAdverseEvent.implicitRules Short descriptionA set of rules under which this content was created DefinitionA 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.
CommentsAsserting 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 typeuri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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language | | 0..1 | codeBinding | There are no (further) constraints on this element Element idAdverseEvent.language Short descriptionLanguage of the resource content DefinitionThe base language in which the resource is written.
CommentsLanguage 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 typecode BindingCommonLanguages (preferred) Binding extensionsConstraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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text | | 0..1 | Narrative | There are no (further) constraints on this element Element idAdverseEvent.text Short descriptionText summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA 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.
CommentsContained 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 typeNarrative Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
contained | | 0..* | Resource | There are no (further) constraints on this element Element idAdverseEvent.contained Short descriptionContained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese 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.
CommentsThis 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 typeResource Mappings |
extension | C | 0..* | Extension | There are no (further) constraints on this element Element idAdverseEvent.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
CommentsThere 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 typeExtension 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 |
modifierExtension | ?! C | 0..* | Extension | There are no (further) constraints on this element Element idAdverseEvent.modifierExtension Short descriptionExtensions that cannot be ignored Alternate namesextensions, user content DefinitionMay 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).
RequirementsModifier 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.
CommentsThere 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 typeExtension 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 |
identifier | Σ | 0..1 | Identifier | There are no (further) constraints on this element Element idAdverseEvent.identifier Short descriptionBusiness identifier for the event DefinitionBusiness identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.
RequirementsAllows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.
CommentsThis is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.
Data typeIdentifier Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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actuality | Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element idAdverseEvent.actuality Short descriptionactual | potential DefinitionWhether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.
Data typecode BindingOverall nature of the adverse event, e.g. real or potential.
AdverseEventActuality (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
category | Σ | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idAdverseEvent.category Short descriptionproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment DefinitionThe overall type of event, intended for search and filtering purposes.
Data typeCodeableConcept BindingOverall categorization of the event, e.g. product-related or situational.
AdverseEventCategory (extensible) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
event | S Σ | 1..1 | CodeableConcept | There are no (further) constraints on this element Element idAdverseEvent.event Short descriptionType of the event itself in relation to the subject DefinitionThis element defines the specific type of event that occurred or that was prevented from occurring.
Data typeCodeableConcept BindingSNOMEDCTClinicalFindings (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
id | | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.event.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Data typestring Mappings |
extension | C | 0..* | Extension | There are no (further) constraints on this element Element idAdverseEvent.event.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
CommentsThere 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 typeExtension SlicingUnordered, 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 |
coding | S Σ | 0..* | Coding | There are no (further) constraints on this element Element idAdverseEvent.event.coding Short descriptionCode defined by a terminology system DefinitionA reference to a code defined by a terminology system.
RequirementsAllows for alternative encodings within a code system, and translations to other code systems.
CommentsCodes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Data typeCoding Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: C*E.1-8, C*E.10-22
- rim: union(., ./translation)
- orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
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id | | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.event.coding.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Data typestring Mappings |
extension | C | 0..* | Extension | There are no (further) constraints on this element Element idAdverseEvent.event.coding.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
CommentsThere 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 typeExtension SlicingUnordered, 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 |
system | S Σ | 1..1 | uri | There are no (further) constraints on this element Element idAdverseEvent.event.coding.system Short descriptionIdentity of the terminology system DefinitionThe identification of the code system that defines the meaning of the symbol in the code.
RequirementsNeed to be unambiguous about the source of the definition of the symbol.
CommentsThe URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.
Data typeuri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: C*E.3
- rim: ./codeSystem
- orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
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version | S Σ | 0..1 | string | Element idAdverseEvent.event.coding.version Short descriptionCTCAE-Version DefinitionVersion der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021.
CommentsWhere the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
Data typestring Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: C*E.7
- rim: ./codeSystemVersion
- orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
- oBDS: 15.3
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code | S Σ | 0..1 | codeBinding | Element idAdverseEvent.event.coding.code Short descriptionArt der Nebenwirkung DefinitionArt der Nebenwirkung nach CTCAE / MedDRA. Abweichend von 15.2 oBDS 2021 kann dieses Feld leer sein falls eine Nebenwirkung des Schweregrads 1 oder 2 vorliegt und keine spezifische Art der Nebenwirkung dokumentiert wurde
RequirementsNeed to refer to a particular code in the system.
Data typecode BindingMII_VS_Onko_Nebenwirkung_Art (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: C*E.1
- rim: ./code
- orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
- oBDS: 15.2
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display | Σ | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.event.coding.display Short descriptionRepresentation defined by the system DefinitionA representation of the meaning of the code in the system, following the rules of the system.
RequirementsNeed to be able to carry a human-readable meaning of the code for readers that do not know the system.
Data typestring Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: C*E.2 - but note this is not well followed
- rim: CV.displayName
- orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
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userSelected | Σ | 0..1 | boolean | There are no (further) constraints on this element Element idAdverseEvent.event.coding.userSelected Short descriptionIf this coding was chosen directly by the user DefinitionIndicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
RequirementsThis has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
CommentsAmongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
Data typeboolean Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: Sometimes implied by being first
- rim: CD.codingRationale
- orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
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text | S Σ | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.event.text Short descriptionPlain text representation of the concept DefinitionA human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
RequirementsThe codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
CommentsVery often the text is the same as a displayName of one of the codings.
Data typestring Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: C*E.9. But note many systems use C*E.2 for this
- rim: ./originalText[mediaType/code="text/plain"]/data
- orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
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subject | S Σ | 1..1 | Reference(Patient) | Element idAdverseEvent.subject Short descriptionSubject impacted by event Alternate namespatient DefinitionThis subject or group impacted by the event.
RequirementsAllows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.
CommentsIf AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.
Data typeReference(Patient) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
encounter | S Σ | 0..1 | Reference(Encounter) | There are no (further) constraints on this element Element idAdverseEvent.encounter Short descriptionEncounter created as part of DefinitionThe Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.
CommentsThis 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. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.
Data typeReference(Encounter) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
date | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element idAdverseEvent.date Short descriptionWhen the event occurred DefinitionThe date (and perhaps time) when the adverse event occurred.
Data typedateTime Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
detected | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element idAdverseEvent.detected Short descriptionWhen the event was detected DefinitionEstimated or actual date the AdverseEvent began, in the opinion of the reporter.
Data typedateTime Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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recordedDate | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element idAdverseEvent.recordedDate Short descriptionWhen the event was recorded DefinitionThe date on which the existence of the AdverseEvent was first recorded.
CommentsThe recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.
Data typedateTime Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
resultingCondition | Σ | 0..* | Reference(Condition) | There are no (further) constraints on this element Element idAdverseEvent.resultingCondition Short descriptionEffect on the subject due to this event DefinitionIncludes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).
Data typeReference(Condition) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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location | Σ | 0..1 | Reference(Location) | There are no (further) constraints on this element Element idAdverseEvent.location Short descriptionLocation where adverse event occurred DefinitionThe information about where the adverse event occurred.
Data typeReference(Location) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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seriousness | S Σ | 1..1 | CodeableConceptBinding | Element idAdverseEvent.seriousness Short descriptionSeriousness of the event DefinitionAssessment whether this event was of real importance.
Data typeCodeableConcept BindingOverall seriousness of this event for the patient.
MII_VS_Onko_Nebenwirkung_CTCAE_Grad (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
id | | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.seriousness.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Data typestring Mappings |
extension | C | 0..* | Extension | There are no (further) constraints on this element Element idAdverseEvent.seriousness.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
CommentsThere 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 typeExtension SlicingUnordered, 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 |
coding | S Σ | 0..* | Coding | Element idAdverseEvent.seriousness.coding Short descriptionSchweregrad der Nebenwirkung nach CTCAE DefinitionSchweregrad der Nebenwirkung nach CTCAE gemäß 15.1 oBDS 2021.
RequirementsAllows for alternative encodings within a code system, and translations to other code systems.
CommentsCodes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Data typeCoding Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: C*E.1-8, C*E.10-22
- rim: union(., ./translation)
- orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
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id | | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.seriousness.coding.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Data typestring Mappings |
extension | C | 0..* | Extension | There are no (further) constraints on this element Element idAdverseEvent.seriousness.coding.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
CommentsThere 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 typeExtension SlicingUnordered, 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 |
system | S Σ | 1..1 | uri | There are no (further) constraints on this element Element idAdverseEvent.seriousness.coding.system Short descriptionIdentity of the terminology system DefinitionThe identification of the code system that defines the meaning of the symbol in the code.
RequirementsNeed to be unambiguous about the source of the definition of the symbol.
CommentsThe URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.
Data typeuri Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: C*E.3
- rim: ./codeSystem
- orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
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version | Σ | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.seriousness.coding.version Short descriptionVersion of the system - if relevant DefinitionThe version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
CommentsWhere the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
Data typestring Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: C*E.7
- rim: ./codeSystemVersion
- orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
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code | S Σ | 1..1 | code | There are no (further) constraints on this element Element idAdverseEvent.seriousness.coding.code Short descriptionSymbol in syntax defined by the system DefinitionA symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
RequirementsNeed to refer to a particular code in the system.
Data typecode Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: C*E.1
- rim: ./code
- orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
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display | Σ | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.seriousness.coding.display Short descriptionRepresentation defined by the system DefinitionA representation of the meaning of the code in the system, following the rules of the system.
RequirementsNeed to be able to carry a human-readable meaning of the code for readers that do not know the system.
Data typestring Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: C*E.2 - but note this is not well followed
- rim: CV.displayName
- orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
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userSelected | Σ | 0..1 | boolean | There are no (further) constraints on this element Element idAdverseEvent.seriousness.coding.userSelected Short descriptionIf this coding was chosen directly by the user DefinitionIndicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
RequirementsThis has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
CommentsAmongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
Data typeboolean Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: Sometimes implied by being first
- rim: CD.codingRationale
- orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
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text | S Σ | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.seriousness.text Short descriptionPlain text representation of the concept DefinitionA human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
RequirementsThe codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
CommentsVery often the text is the same as a displayName of one of the codings.
Data typestring Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- v2: C*E.9. But note many systems use C*E.2 for this
- rim: ./originalText[mediaType/code="text/plain"]/data
- orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
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severity | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idAdverseEvent.severity Short descriptionmild | moderate | severe DefinitionDescribes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is.
Data typeCodeableConcept BindingThe severity of the adverse event itself, in direct relation to the subject.
AdverseEventSeverity (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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outcome | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idAdverseEvent.outcome Short descriptionresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown DefinitionDescribes the type of outcome from the adverse event.
Data typeCodeableConcept BindingTODO (and should this be required?).
AdverseEventOutcome (required) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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recorder | Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | There are no (further) constraints on this element Element idAdverseEvent.recorder Short descriptionWho recorded the adverse event DefinitionInformation on who recorded the adverse event. May be the patient or a practitioner.
Data typeReference(Patient | Practitioner | PractitionerRole | RelatedPerson) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
contributor | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | There are no (further) constraints on this element Element idAdverseEvent.contributor Short descriptionWho was involved in the adverse event or the potential adverse event DefinitionParties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness).
Data typeReference(Practitioner | PractitionerRole | Device) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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suspectEntity | S Σ | 1..* | BackboneElement | There are no (further) constraints on this element Element idAdverseEvent.suspectEntity Short descriptionThe suspected agent causing the adverse event DefinitionDescribes the entity that is suspected to have caused the adverse event.
Data typeBackboneElement Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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id | | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.suspectEntity.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Data typestring Mappings |
extension | C | 0..* | Extension | There are no (further) constraints on this element Element idAdverseEvent.suspectEntity.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
CommentsThere 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 typeExtension 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 |
modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idAdverseEvent.suspectEntity.modifierExtension Short descriptionExtensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay 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).
RequirementsModifier 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.
CommentsThere 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 typeExtension 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 |
instance | S Σ | 1..1 | Reference(Procedure | MedicationStatement) | Element idAdverseEvent.suspectEntity.instance Short descriptionRefers to the specific entity that caused the adverse event Alternate namesSubstance or Medication or Device DefinitionIdentifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.
Data typeReference(Procedure | MedicationStatement) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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causality | Σ | 0..* | BackboneElement | There are no (further) constraints on this element Element idAdverseEvent.suspectEntity.causality Short descriptionInformation on the possible cause of the event DefinitionInformation on the possible cause of the event.
Data typeBackboneElement Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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id | | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.suspectEntity.causality.id Short descriptionUnique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Data typestring Mappings |
extension | C | 0..* | Extension | There are no (further) constraints on this element Element idAdverseEvent.suspectEntity.causality.extension Short descriptionAdditional content defined by implementations Alternate namesextensions, user content DefinitionMay 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.
CommentsThere 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 typeExtension 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 |
modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idAdverseEvent.suspectEntity.causality.modifierExtension Short descriptionExtensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay 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).
RequirementsModifier 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.
CommentsThere 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 typeExtension 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 |
assessment | Σ | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idAdverseEvent.suspectEntity.causality.assessment Short descriptionAssessment of if the entity caused the event DefinitionAssessment of if the entity caused the event.
Data typeCodeableConcept BindingCodes for the assessment of whether the entity caused the event.
AdverseEventCausalityAssessment (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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productRelatedness | Σ | 0..1 | string | There are no (further) constraints on this element Element idAdverseEvent.suspectEntity.causality.productRelatedness Short descriptionAdverseEvent.suspectEntity.causalityProductRelatedness DefinitionAdverseEvent.suspectEntity.causalityProductRelatedness.
Data typestring Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | There are no (further) constraints on this element Element idAdverseEvent.suspectEntity.causality.author Short descriptionAdverseEvent.suspectEntity.causalityAuthor DefinitionAdverseEvent.suspectEntity.causalityAuthor.
Data typeReference(Practitioner | PractitionerRole) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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method | Σ | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idAdverseEvent.suspectEntity.causality.method Short descriptionProbabilityScale | Bayesian | Checklist DefinitionProbabilityScale | Bayesian | Checklist.
Data typeCodeableConcept BindingAdverseEventCausalityMethod (example) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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subjectMedicalHistory | Σ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | There are no (further) constraints on this element Element idAdverseEvent.subjectMedicalHistory Short descriptionAdverseEvent.subjectMedicalHistory DefinitionAdverseEvent.subjectMedicalHistory.
Data typeReference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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referenceDocument | Σ | 0..* | Reference(DocumentReference) | There are no (further) constraints on this element Element idAdverseEvent.referenceDocument Short descriptionAdverseEvent.referenceDocument DefinitionAdverseEvent.referenceDocument.
Data typeReference(DocumentReference) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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study | Σ | 0..* | Reference(ResearchStudy) | There are no (further) constraints on this element Element idAdverseEvent.study Short descriptionAdverseEvent.study DefinitionData typeReference(ResearchStudy) Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
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