Smart Bear Implementation Guide
3.4.1 - ci-build

Smart Bear Implementation Guide - Local Development build (v3.4.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: AdversEventSB - Detailed Descriptions

Active as of 2024-09-17

Definitions for the AdverseEventSB resource profile.

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

0. AdverseEvent
2. AdverseEvent.actuality
Shortactual or potential
4. AdverseEvent.event
ShortAdverse Event with Snomed CT code and eventually text
6. AdverseEvent.subject
TypeReference(Smart Bear Patient)
Must Supporttrue
8. AdverseEvent.seriousness
Shortserious or non-serious
Control1..?
Must Supporttrue
10. AdverseEvent.severity
Control1..?
Must Supporttrue
12. AdverseEvent.suspectEntity
Control1..1
Must Supporttrue
14. AdverseEvent.suspectEntity.instance
16. AdverseEvent.suspectEntity.instance.reference
Shortit could specify whether it is a medication or a device for example
18. AdverseEvent.suspectEntity.causality
20. AdverseEvent.suspectEntity.causality.assessment
ShortIndicate causality, Possible, yes or not.
Control1..?

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

0. AdverseEvent
Definition

Actual 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.

ShortMedical care, research study or other healthcare event causing physical injury
Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesAE
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. AdverseEvent.implicitRules
Definition

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

ShortA set of rules under which this content was created
Comments

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

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

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

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

ShortExtensions that cannot be ignored
Comments

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

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. AdverseEvent.actuality
Definition

Whether 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.

Shortactual or potentialactual | potential
Control1..1
BindingThe codes SHALL be taken from AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
(required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1)

Overall nature of the adverse event, e.g. real or potential.

Typecode
Is Modifiertrue because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. AdverseEvent.event
Definition

This element defines the specific type of event that occurred or that was prevented from occurring.

ShortAdverse Event with Snomed CT code and eventually textType of the event itself in relation to the subject
Control0..1
BindingFor example codes, see SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/adverse-event-type
(example to http://hl7.org/fhir/ValueSet/adverse-event-type)

Detailed type of event.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. AdverseEvent.subject
Definition

This subject or group impacted by the event.

ShortSubject impacted by event
Comments

If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

Control1..1
TypeReference(Smart Bear Patient, Patient, Group, Practitioner, RelatedPerson)
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

Alternate Namespatient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. AdverseEvent.seriousness
Definition

Assessment whether this event was of real importance.

Shortserious or non-seriousSeriousness of the event
Control10..1
BindingFor example codes, see AdverseEventSeriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousness
(example to http://hl7.org/fhir/ValueSet/adverse-event-seriousness)

Overall seriousness of this event for the patient.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. AdverseEvent.severity
Definition

Describes 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.

Shortmild | moderate | severe
Control10..1
BindingThe codes SHALL be taken from AdverseEventSeverityhttp://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
(required to http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1)

The severity of the adverse event itself, in direct relation to the subject.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. AdverseEvent.suspectEntity
Definition

Describes the entity that is suspected to have caused the adverse event.

ShortThe suspected agent causing the adverse event
Control10..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. AdverseEvent.suspectEntity.modifierExtension
Definition

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

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

ShortExtensions that cannot be ignored even if unrecognized
Comments

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

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
20. AdverseEvent.suspectEntity.instance
Definition

Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

ShortRefers to the specific entity that caused the adverse event
Control1..1
TypeReference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)
Is Modifierfalse
Summarytrue
Alternate NamesSubstance or Medication or Device
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. AdverseEvent.suspectEntity.instance.reference
Definition

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.

Shortit could specify whether it is a medication or a device for exampleLiteral reference, Relative, internal or absolute URL
Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

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

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

0. AdverseEvent
Definition

Actual 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.

ShortMedical care, research study or other healthcare event causing physical injury
Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesAE
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. AdverseEvent.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
Comments

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

Control0..1
Typeid
Is Modifierfalse
Summarytrue
4. AdverseEvent.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. AdverseEvent.implicitRules
Definition

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

ShortA set of rules under which this content was created
Comments

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

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

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages
(preferred to http://hl7.org/fhir/ValueSet/languages)

A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. AdverseEvent.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

ShortText summary of the resource, for human interpretation
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Control0..1
TypeNarrative
Is Modifierfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. AdverseEvent.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

Control0..*
TypeResource
Is Modifierfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
14. AdverseEvent.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and 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.

ShortAdditional content defined by implementations
Comments

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

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
16. AdverseEvent.modifierExtension
Definition

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

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

ShortExtensions that cannot be ignored
Comments

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

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
18. AdverseEvent.identifier
Definition

Business 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.

ShortBusiness identifier for the event
Comments

This 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.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Is Modifierfalse
Summarytrue
Requirements

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

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. AdverseEvent.actuality
Definition

Whether 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.

Shortactual or potential
Control1..1
BindingThe codes SHALL be taken from AdverseEventActuality
(required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1)

Overall nature of the adverse event, e.g. real or potential.

Typecode
Is Modifiertrue because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. AdverseEvent.category
Definition

The overall type of event, intended for search and filtering purposes.

Shortproduct-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
Control0..*
BindingUnless not suitable, these codes SHALL be taken from AdverseEventCategory
(extensible to http://hl7.org/fhir/ValueSet/adverse-event-category)

Overall categorization of the event, e.g. product-related or situational.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. AdverseEvent.event
Definition

This element defines the specific type of event that occurred or that was prevented from occurring.

ShortAdverse Event with Snomed CT code and eventually text
Control0..1
BindingFor example codes, see SNOMEDCTClinicalFindings
(example to http://hl7.org/fhir/ValueSet/adverse-event-type)

Detailed type of event.

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. AdverseEvent.subject
Definition

This subject or group impacted by the event.

ShortSubject impacted by event
Comments

If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

Control1..1
TypeReference(Smart Bear Patient)
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

Alternate Namespatient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. AdverseEvent.encounter
Definition

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

ShortEncounter created as part of
Comments

This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. 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.

Control0..1
TypeReference(Encounter)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. AdverseEvent.date
Definition

The date (and perhaps time) when the adverse event occurred.

ShortWhen the event occurred
Control0..1
TypedateTime
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. AdverseEvent.detected
Definition

Estimated or actual date the AdverseEvent began, in the opinion of the reporter.

ShortWhen the event was detected
Control0..1
TypedateTime
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. AdverseEvent.recordedDate
Definition

The date on which the existence of the AdverseEvent was first recorded.

ShortWhen the event was recorded
Comments

The 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.

Control0..1
TypedateTime
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. AdverseEvent.resultingCondition
Definition

Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).

ShortEffect on the subject due to this event
Control0..*
TypeReference(Condition)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. AdverseEvent.location
Definition

The information about where the adverse event occurred.

ShortLocation where adverse event occurred
Control0..1
TypeReference(Location)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. AdverseEvent.seriousness
Definition

Assessment whether this event was of real importance.

Shortserious or non-serious
Control1..1
BindingFor example codes, see AdverseEventSeriousness
(example to http://hl7.org/fhir/ValueSet/adverse-event-seriousness)

Overall seriousness of this event for the patient.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. AdverseEvent.severity
Definition

Describes 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.

Shortmild | moderate | severe
Control1..1
BindingThe codes SHALL be taken from AdverseEventSeverity
(required to http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1)

The severity of the adverse event itself, in direct relation to the subject.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. AdverseEvent.outcome
Definition

Describes the type of outcome from the adverse event.

Shortresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Control0..1
BindingThe codes SHALL be taken from AdverseEventOutcome
(required to http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1)

TODO (and should this be required?).

TypeCodeableConcept
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. AdverseEvent.recorder
Definition

Information on who recorded the adverse event. May be the patient or a practitioner.

ShortWho recorded the adverse event
Control0..1
TypeReference(Patient, Practitioner, PractitionerRole, RelatedPerson)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. AdverseEvent.contributor
Definition

Parties 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).

ShortWho was involved in the adverse event or the potential adverse event
Control0..*
TypeReference(Practitioner, PractitionerRole, Device)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. AdverseEvent.suspectEntity
Definition

Describes the entity that is suspected to have caused the adverse event.

ShortThe suspected agent causing the adverse event
Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. AdverseEvent.suspectEntity.id
Definition

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

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
54. AdverseEvent.suspectEntity.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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.

ShortAdditional content defined by implementations
Comments

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

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
56. AdverseEvent.suspectEntity.modifierExtension
Definition

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

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

ShortExtensions that cannot be ignored even if unrecognized
Comments

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

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
58. AdverseEvent.suspectEntity.instance
Definition

Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

ShortRefers to the specific entity that caused the adverse event
Control1..1
TypeReference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)
Is Modifierfalse
Summarytrue
Alternate NamesSubstance or Medication or Device
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. AdverseEvent.suspectEntity.instance.id
Definition

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

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
62. AdverseEvent.suspectEntity.instance.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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.

ShortAdditional content defined by implementations
Comments

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

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on AdverseEvent.suspectEntity.instance.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 64. AdverseEvent.suspectEntity.instance.reference
    Definition

    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.

    Shortit could specify whether it is a medication or a device for example
    Comments

    Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

    Control0..1
    This element is affected by the following invariants: ref-1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    66. AdverseEvent.suspectEntity.instance.type
    Definition

    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).

    ShortType the reference refers to (e.g. "Patient")
    Comments

    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.

    Control0..1
    BindingUnless not suitable, these codes SHALL be taken from ResourceType
    (extensible to http://hl7.org/fhir/ValueSet/resource-types)

    Aa resource (or, for logical models, the URI of the logical model).

    Typeuri
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    68. AdverseEvent.suspectEntity.instance.identifier
    Definition

    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.

    ShortLogical reference, when literal reference is not known
    Comments

    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).

    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control0..1
    TypeIdentifier
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    70. AdverseEvent.suspectEntity.instance.display
    Definition

    Plain text narrative that identifies the resource in addition to the resource reference.

    ShortText alternative for the resource
    Comments

    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.

    Control0..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    72. AdverseEvent.suspectEntity.causality
    Definition

    Information on the possible cause of the event.

    ShortInformation on the possible cause of the event
    Control0..*
    TypeBackboneElement
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    74. AdverseEvent.suspectEntity.causality.id
    Definition

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

    ShortUnique id for inter-element referencing
    Control0..1
    Typestring
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    76. AdverseEvent.suspectEntity.causality.extension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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.

    ShortAdditional content defined by implementations
    Comments

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

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    78. AdverseEvent.suspectEntity.causality.modifierExtension
    Definition

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

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

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

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

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    80. AdverseEvent.suspectEntity.causality.assessment
    Definition

    Assessment of if the entity caused the event.

    ShortIndicate causality, Possible, yes or not.
    Control1..1
    BindingFor example codes, see AdverseEventCausalityAssessment
    (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-assess)

    Codes for the assessment of whether the entity caused the event.

    TypeCodeableConcept
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    82. AdverseEvent.suspectEntity.causality.productRelatedness
    Definition

    AdverseEvent.suspectEntity.causalityProductRelatedness.

    ShortAdverseEvent.suspectEntity.causalityProductRelatedness
    Control0..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    84. AdverseEvent.suspectEntity.causality.author
    Definition

    AdverseEvent.suspectEntity.causalityAuthor.

    ShortAdverseEvent.suspectEntity.causalityAuthor
    Control0..1
    TypeReference(Practitioner, PractitionerRole)
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    86. AdverseEvent.suspectEntity.causality.method
    Definition

    ProbabilityScale | Bayesian | Checklist.

    ShortProbabilityScale | Bayesian | Checklist
    Control0..1
    BindingFor example codes, see AdverseEventCausalityMethod
    (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-method)

    TODO.

    TypeCodeableConcept
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    88. AdverseEvent.subjectMedicalHistory
    Definition

    AdverseEvent.subjectMedicalHistory.

    ShortAdverseEvent.subjectMedicalHistory
    Control0..*
    TypeReference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Media, DocumentReference)
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    90. AdverseEvent.referenceDocument
    Definition

    AdverseEvent.referenceDocument.

    ShortAdverseEvent.referenceDocument
    Control0..*
    TypeReference(DocumentReference)
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    92. AdverseEvent.study
    Definition

    AdverseEvent.study.

    ShortAdverseEvent.study
    Control0..*
    TypeReference(ResearchStudy)
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))