Profile_R5_AdverseEvent_R4 - Definitions - Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1.0

Is Modifier false

Summary true

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.

Short Metadata about the resource

Control 0..1

Meta

Is Modifier false

Summary true

Invariants ele-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.

Short A 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.

Control 0..1

Is Modifier true 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 Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-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.

Short Language 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).

Control 0..1

The codes SHOULD be taken from CommonLanguages

(preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

A human language.

Additional Bindings

Purpose

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary false

Invariants ele-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.

Short Text 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.

Control 0..1

Narrative

Is Modifier false

Summary false

Alternate Names narrative, html, xhtml, display

Invariants ele-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.

Short Contained, 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.

Control 0..*

Resource

Is Modifier false

Summary false

Alternate Names inline resources, anonymous resources, contained resources

14. AdverseEvent.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

Invariants 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())

This element introduces a set of slices on AdverseEvent.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

16. AdverseEvent.extension:occurrence

Slice Name occurrence

Definition

R5: AdverseEvent.occurrence[x] additional types (Period, Timing)

Short R5: When the event occurred additional types

Comments

Element AdverseEvent.occurrence[x] is mapped to FHIR R4 element AdverseEvent.date as SourceIsBroaderThanTarget. The mappings for AdverseEvent.occurrence[x] do not cover the following types: Period, Timing.

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: When the event occurred additional types) (Extension Type: Choice of: Period, Timing)

Is Modifier false

Summary false

18. AdverseEvent.extension:participant

Slice Name participant

Definition

R5: AdverseEvent.participant (new:BackboneElement)

Short R5: Who was involved in the adverse event or the potential adverse event and what they did (new)

Comments

Element AdverseEvent.participant has a context of AdverseEvent based on following the parent source element upwards and mapping to AdverseEvent. Element AdverseEvent.participant has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Who was involved in the adverse event or the potential adverse event and what they did (new)) (Complex Extension)

Is Modifier false

20. AdverseEvent.extension:expectedInResearchStudy

Slice Name expectedInResearchStudy

Definition

R5: AdverseEvent.expectedInResearchStudy (new:boolean)

Short R5: Considered likely or probable or anticipated in the research study (new)

Comments

Element AdverseEvent.expectedInResearchStudy has a context of AdverseEvent based on following the parent source element upwards and mapping to AdverseEvent. Element AdverseEvent.expectedInResearchStudy has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Considered likely or probable or anticipated in the research study (new)) (Extension Type: boolean)

Is Modifier false

Summary false

22. AdverseEvent.extension:contributingFactor

Slice Name contributingFactor

Definition

R5: AdverseEvent.contributingFactor (new:BackboneElement)

Short R5: Contributing factors suspected to have increased the probability or severity of the adverse event (new)

Comments

Element AdverseEvent.contributingFactor has a context of AdverseEvent based on following the parent source element upwards and mapping to AdverseEvent. Element AdverseEvent.contributingFactor has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Contributing factors suspected to have increased the probability or severity of the adverse event (new)) (Complex Extension)

Is Modifier false

24. AdverseEvent.extension:preventiveAction

Slice Name preventiveAction

Definition

R5: AdverseEvent.preventiveAction (new:BackboneElement)

Short R5: Preventive actions that contributed to avoiding the adverse event (new)

Comments

Element AdverseEvent.preventiveAction has a context of AdverseEvent based on following the parent source element upwards and mapping to AdverseEvent. Element AdverseEvent.preventiveAction has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Preventive actions that contributed to avoiding the adverse event (new)) (Complex Extension)

Is Modifier false

26. AdverseEvent.extension:mitigatingAction

Slice Name mitigatingAction

Definition

R5: AdverseEvent.mitigatingAction (new:BackboneElement)

Short R5: Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm (new)

Comments

Element AdverseEvent.mitigatingAction has a context of AdverseEvent based on following the parent source element upwards and mapping to AdverseEvent. Element AdverseEvent.mitigatingAction has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm (new)) (Complex Extension)

Is Modifier false

28. AdverseEvent.extension:supportingInfo

Slice Name supportingInfo

Definition

R5: AdverseEvent.supportingInfo (new:BackboneElement)

Short R5: Supporting information relevant to the event (new)

Comments

Element AdverseEvent.supportingInfo has a context of AdverseEvent based on following the parent source element upwards and mapping to AdverseEvent. Element AdverseEvent.supportingInfo has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Supporting information relevant to the event (new)) (Complex Extension)

Is Modifier false

30. AdverseEvent.extension:note

Slice Name note

Definition

R5: AdverseEvent.note (new:Annotation)

Short R5: Comment on adverse event (new)

Comments

Element AdverseEvent.note has a context of AdverseEvent based on following the parent source element upwards and mapping to AdverseEvent. Element AdverseEvent.note has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Comment on adverse event (new)) (Extension Type: Annotation)

Is Modifier false

Summary false

32. AdverseEvent.modifierExtension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them

Summary false

This element introduces a set of slices on AdverseEvent.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

34. AdverseEvent.modifierExtension:status

Slice Name status

Definition

R5: AdverseEvent.status (new:code)

Short R5: in-progress | completed | entered-in-error | unknown (new)

Comments

Element AdverseEvent.status has a context of AdverseEvent based on following the parent source element upwards and mapping to AdverseEvent. Element AdverseEvent.status has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.

Control 1..1
This element is affected by the following invariants: ele-1

Type Extension(R5: in-progress | completed | entered-in-error | unknown (new)) (Extension Type: code)

Is Modifier true because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid

Summary false

36. 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.

Short Business 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.

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

Control 0..1

Is Modifier false

Summary true

Requirements

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

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

38. 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.

Short actual | potential

Control 1..1

The 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.

code

Is Modifier true because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

40. AdverseEvent.category

Definition

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

Control 0..*

Unless not suitable, these codes SHALL be taken from AdverseEventCategory
(extensible to http://hl7.org/fhir/ValueSet/adverse-event-category|4.0.1)

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

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

42. AdverseEvent.event

Definition

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

Short Type of the event itself in relation to the subject

Control 0..1

For example codes, see SNOMEDCTClinicalFindings
(example to http://hl7.org/fhir/ValueSet/adverse-event-type|4.0.1)

Detailed type of event.

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

44. AdverseEvent.subject

Definition

This subject or group impacted by the event.

Short Subject impacted by event

Comments

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

Control 1..1

Type Reference(Patient, Group, Practitioner, RelatedPerson)

Is Modifier false

Summary true

Requirements

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

Alternate Names patient

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

46. AdverseEvent.subject.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

48. AdverseEvent.subject.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on AdverseEvent.subject.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

50. AdverseEvent.subject.extension:subject

Slice Name subject

Definition

R5: AdverseEvent.subject

Short R5: subject

Comments

Element AdverseEvent.subject is mapped to FHIR R4 element AdverseEvent.subject as SourceIsBroaderThanTarget. The standard extension alternate-reference has been mapped as the representation of FHIR R5 element AdverseEvent.subject with unmapped reference targets: ResearchSubject. If AdverseEvent.resultingEffect differs among members of the group, then use Patient as the subject.

Control 0..1

Type Extension(Alternate Reference) (Extension Type: Reference(Resource))

Is Modifier false

Summary false

52. AdverseEvent.subject.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.

Short Literal 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.

Control 0..1
This element is affected by the following invariants: ref-1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

54. AdverseEvent.subject.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).

Short Type 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.

Control 0..1

Unless not suitable, these codes SHALL be taken from ResourceType

(extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

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

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

56. AdverseEvent.subject.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.

Short Logical 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).

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

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

58. AdverseEvent.subject.display

Definition

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

Short Text 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.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

60. AdverseEvent.encounter

Definition

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

Short Encounter 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.

Control 0..1

Type Reference(Encounter)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

62. AdverseEvent.date

Definition

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

Short When the event occurred

Control 0..1

dateTime

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

64. AdverseEvent.detected

Definition

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

Short When the event was detected

Control 0..1

dateTime

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

66. AdverseEvent.recordedDate

Definition

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

Short When 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.

Control 0..1

dateTime

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

68. 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).

Short Effect on the subject due to this event

Control 0..*

Type Reference(Condition)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

70. AdverseEvent.resultingCondition.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

72. AdverseEvent.resultingCondition.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on AdverseEvent.resultingCondition.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

74. AdverseEvent.resultingCondition.extension:resultingEffect

Slice Name resultingEffect

Definition

R5: AdverseEvent.resultingEffect additional types from child elements (display, identifier, reference, type)

Short R5: resultingEffect additional types

Comments

Element AdverseEvent.resultingEffect is mapped to FHIR R4 element AdverseEvent.resultingCondition as SourceIsBroaderThanTarget. The mappings for AdverseEvent.resultingEffect do not cover the following types based on type expansion: display, identifier, reference, type. The standard extension alternate-reference has been mapped as the representation of FHIR R5 element AdverseEvent.resultingEffect with unmapped reference targets: Observation.

Control 0..1

Type Extension(Alternate Reference) (Extension Type: Reference(Resource))

Is Modifier false

Summary false

76. AdverseEvent.resultingCondition.reference

Definition

Short Literal reference, Relative, internal or absolute URL

Comments

Control 0..1
This element is affected by the following invariants: ref-1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

78. AdverseEvent.resultingCondition.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.

Short Type the reference refers to (e.g. "Patient")

Comments

Control 0..1

Unless not suitable, these codes SHALL be taken from ResourceType

(extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

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

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

80. AdverseEvent.resultingCondition.identifier

Definition

Short Logical reference, when literal reference is not known

Comments

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

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

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

82. AdverseEvent.resultingCondition.display

Definition

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

Short Text 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.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

84. AdverseEvent.location

Definition

The information about where the adverse event occurred.

Short Location where adverse event occurred

Control 0..1

Type Reference(Location)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

86. AdverseEvent.seriousness

Definition

Assessment whether this event was of real importance.

Short Seriousness of the event

Control 0..1

For example codes, see AdverseEventSeriousness
(example to http://hl7.org/fhir/ValueSet/adverse-event-seriousness|4.0.1)

Overall seriousness of this event for the patient.

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

88. 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.

Short mild | moderate | severe

Control 0..1

The 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.

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

90. AdverseEvent.outcome

Definition

Describes the type of outcome from the adverse event.

Control 0..1

The 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?).

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

92. AdverseEvent.recorder

Definition

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

Short Who recorded the adverse event

Control 0..1

Type Reference(Patient, Practitioner, PractitionerRole, RelatedPerson)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

94. AdverseEvent.recorder.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

96. AdverseEvent.recorder.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on AdverseEvent.recorder.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

98. AdverseEvent.recorder.extension:recorder

Slice Name recorder

Definition

R5: AdverseEvent.recorder

Short R5: recorder

Comments

Element AdverseEvent.recorder is mapped to FHIR R4 element AdverseEvent.recorder as SourceIsBroaderThanTarget. The standard extension alternate-reference has been mapped as the representation of FHIR R5 element AdverseEvent.recorder with unmapped reference targets: ResearchSubject.

Control 0..1

Type Extension(Alternate Reference) (Extension Type: Reference(Resource))

Is Modifier false

Summary false

100. AdverseEvent.recorder.reference

Definition

Short Literal reference, Relative, internal or absolute URL

Comments

Control 0..1
This element is affected by the following invariants: ref-1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

102. AdverseEvent.recorder.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.

Short Type the reference refers to (e.g. "Patient")

Comments

Control 0..1

Unless not suitable, these codes SHALL be taken from ResourceType

(extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

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

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

104. AdverseEvent.recorder.identifier

Definition

Short Logical reference, when literal reference is not known

Comments

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

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

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

106. AdverseEvent.recorder.display

Definition

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

Short Text 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.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

108. 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).

Short Who was involved in the adverse event or the potential adverse event

Control 0..*

Type Reference(Practitioner, PractitionerRole, Device)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

110. AdverseEvent.suspectEntity

Definition

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

Short The suspected agent causing the adverse event

Control 0..*

BackboneElement

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

112. 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.

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

114. 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.

Short Additional 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.

Control 0..*

Is Modifier false

Summary false

Alternate Names extensions, user content

116. 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).

Short Extensions that cannot be ignored even if unrecognized

Comments

Control 0..*

Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them

Summary true

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 Names extensions, user content, modifiers

118. 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.

Short Refers to the specific entity that caused the adverse event

Control 1..1

Type Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)

Is Modifier false

Summary true

Alternate Names Substance or Medication or Device

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

120. 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.

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

122. AdverseEvent.suspectEntity.instance.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This 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

124. AdverseEvent.suspectEntity.instance.extension:instance

Slice Name instance

Definition

R5: AdverseEvent.suspectEntity.instance[x] additional types (CodeableConcept)

Short R5: instance additional types

Comments

Element AdverseEvent.suspectEntity.instance[x] is mapped to FHIR R4 element AdverseEvent.suspectEntity.instance as SourceIsBroaderThanTarget. The mappings for AdverseEvent.suspectEntity.instance[x] do not cover the following types: CodeableConcept. The standard extension alternate-reference has been mapped as PART of the representation of FHIR R5 element AdverseEvent.suspectEntity.instance[x] with unmapped reference targets: BiologicallyDerivedProduct, ResearchStudy.

Control 1..1

Type Extension(R5: instance additional types) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

126. AdverseEvent.suspectEntity.instance.extension:instanceAlternateReference

Slice Name instanceAlternateReference

Definition

R5: AdverseEvent.suspectEntity.instance[x] additional types (CodeableConcept)

Short R5: instance additional types

Comments

Control 0..1

Type Extension(Alternate Reference) (Extension Type: Reference(Resource))

Is Modifier false

Summary false

128. AdverseEvent.suspectEntity.instance.reference

Definition

Short Literal reference, Relative, internal or absolute URL

Comments

Control 0..1
This element is affected by the following invariants: ref-1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

130. 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.

Short Type the reference refers to (e.g. "Patient")

Comments

Control 0..1

Unless not suitable, these codes SHALL be taken from ResourceType

(extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

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

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

132. AdverseEvent.suspectEntity.instance.identifier

Definition

Short Logical reference, when literal reference is not known

Comments

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

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

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

134. AdverseEvent.suspectEntity.instance.display

Definition

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

Short Text 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.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

136. AdverseEvent.suspectEntity.causality

Definition

Information on the possible cause of the event.

Short Information on the possible cause of the event

Control 0..*

BackboneElement

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

138. 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.

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

140. AdverseEvent.suspectEntity.causality.extension

Definition

Short Additional content defined by implementations

Comments

Control 0..*

Is Modifier false

Summary false

Alternate Names extensions, user content

142. AdverseEvent.suspectEntity.causality.modifierExtension

Definition

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

Short Extensions that cannot be ignored even if unrecognized

Comments

Control 0..*

Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them

Summary true

Requirements

Alternate Names extensions, user content, modifiers

144. AdverseEvent.suspectEntity.causality.assessment

Definition

Assessment of if the entity caused the event.

Short Assessment of if the entity caused the event

Control 0..1

For example codes, see AdverseEventCausalityAssessment
(example to http://hl7.org/fhir/ValueSet/adverse-event-causality-assess|4.0.1)

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

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

146. AdverseEvent.suspectEntity.causality.productRelatedness

Definition

AdverseEvent.suspectEntity.causalityProductRelatedness.

Short AdverseEvent.suspectEntity.causalityProductRelatedness

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

148. AdverseEvent.suspectEntity.causality.productRelatedness.id

Definition

unique id for the element within a resource (for internal references)

Short xml:id (or equivalent in JSON)

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

150. AdverseEvent.suspectEntity.causality.productRelatedness.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on AdverseEvent.suspectEntity.causality.productRelatedness.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

152. AdverseEvent.suspectEntity.causality.productRelatedness.extension:entityRelatedness

Slice Name entityRelatedness

Definition

R5: AdverseEvent.suspectEntity.causality.entityRelatedness additional types (CodeableConcept) additional types from child elements (coding)

Short R5: Result of the assessment regarding the relatedness of the suspected entity to the event additional types

Comments

Element AdverseEvent.suspectEntity.causality.entityRelatedness is mapped to FHIR R4 element AdverseEvent.suspectEntity.causality.productRelatedness as SourceIsBroaderThanTarget. The mappings for AdverseEvent.suspectEntity.causality.entityRelatedness do not cover the following types: CodeableConcept. The mappings for AdverseEvent.suspectEntity.causality.entityRelatedness do not cover the following types based on type expansion: coding.

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Result of the assessment regarding the relatedness of the suspected entity to the event additional types) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

154. AdverseEvent.suspectEntity.causality.productRelatedness.value

Definition

The actual value

Short Primitive value for string

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

Max Length: 1048576

156. AdverseEvent.suspectEntity.causality.author

Definition

AdverseEvent.suspectEntity.causalityAuthor.

Short AdverseEvent.suspectEntity.causalityAuthor

Control 0..1

Type Reference(Practitioner, PractitionerRole)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

158. AdverseEvent.suspectEntity.causality.author.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

160. AdverseEvent.suspectEntity.causality.author.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on AdverseEvent.suspectEntity.causality.author.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

162. AdverseEvent.suspectEntity.causality.author.extension:author

Slice Name author

Definition

R5: AdverseEvent.suspectEntity.causality.author

Short R5: Author of the information on the possible cause of the event

Comments

Element AdverseEvent.suspectEntity.causality.author is mapped to FHIR R4 element AdverseEvent.suspectEntity.causality.author as SourceIsBroaderThanTarget. The standard extension alternate-reference has been mapped as the representation of FHIR R5 element AdverseEvent.suspectEntity.causality.author with unmapped reference targets: Patient, RelatedPerson, ResearchSubject.

Control 0..1

Type Extension(Alternate Reference) (Extension Type: Reference(Resource))

Is Modifier false

Summary false

164. AdverseEvent.suspectEntity.causality.author.reference

Definition

Short Literal reference, Relative, internal or absolute URL

Comments

Control 0..1
This element is affected by the following invariants: ref-1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

166. AdverseEvent.suspectEntity.causality.author.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.

Short Type the reference refers to (e.g. "Patient")

Comments

Control 0..1

Unless not suitable, these codes SHALL be taken from ResourceType

(extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

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

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

168. AdverseEvent.suspectEntity.causality.author.identifier

Definition

Short Logical reference, when literal reference is not known

Comments

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

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

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

170. AdverseEvent.suspectEntity.causality.author.display

Definition

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

Short Text 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.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

172. AdverseEvent.suspectEntity.causality.method

Definition

ProbabilityScale | Bayesian | Checklist.

Short ProbabilityScale | Bayesian | Checklist

Control 0..1

For example codes, see AdverseEventCausalityMethod
(example to http://hl7.org/fhir/ValueSet/adverse-event-causality-method|4.0.1)

TODO.