Adverse Event Clinical Care
0.2.0 - ci-build International flag

Adverse Event Clinical Care, published by HL7 International - Patient Care Work Group, Vulcan AdverseEvent groups. This is not an authorized publication; it is the continuous build for version 0.2.0). This version is based on the current content of https://github.com/HL7/fhir-ae-care-ig/ and changes regularly. See the Directory of published versions

Resource Profile: AdverseEventClinicalCare - Detailed Descriptions

Page standards status: Informative Maturity Level: 1

Definitions for the AdverseEvent-clinical-care resource profile.

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

1. AdverseEvent
2. AdverseEvent.subject
TypeReference(Patient|Group|Practitioner|RelatedPerson|ResearchSubject)
3. AdverseEvent.seriousness
Control0..01
4. AdverseEvent.recorder
TypeReference(Patient|PractitionerRole|Practitioner|RelatedPerson|ResearchSubject)
5. AdverseEvent.participant
Control0..?
6. AdverseEvent.participant.actor
TypeReference(Practitioner|PractitionerRole|Organization|CareTeam|Patient|Device|RelatedPerson|ResearchSubject)
7. AdverseEvent.study
Control0..0*
8. AdverseEvent.expectedInResearchStudy
Control0..01
9. AdverseEvent.suspectEntity
Control0..?
10. AdverseEvent.suspectEntity.causality
Control0..?
11. AdverseEvent.suspectEntity.causality.author
TypeReference(Practitioner|PractitionerRole|Patient|RelatedPerson|ResearchSubject)

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

1. AdverseEvent
Definition

An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.

Control0..*
Summaryfalse
Alternate NamesAE
InvariantsDefined on this element
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (: contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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.

Control0..1
Typeuri
Is Modifiertrue
Summarytrue
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 its narrative along with other profiles, value sets, etc.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
3. AdverseEvent.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

Control0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained 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.

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 managable, 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
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())
5. AdverseEvent.status
Definition

The current state of the adverse event or potential adverse event.

Control1..1
BindingThe codes SHALL be taken from AdverseEventStatus

Codes identifying the lifecycle stage of an event.

Typecode
Is Modifiertrue
Summarytrue
Comments

This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. AdverseEvent.actuality
Definition

Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely.

Control1..1
BindingThe codes SHALL be taken from AdverseEventActuality

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

Typecode
Is Modifiertrue
Summarytrue
Comments

AllergyIntolerance should be used for the initial capture or recording of the individual's propensity to an adverse reaction to a substance. If an AllergyIntolerance does not exist, then an adverse reaction should be recorded as an AllergyIntolerance. If an AllergyIntolerance does exist and the substance was given, then an adverse reaction should be recorded as an AdverseEvent due to the aberrant workflow.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. AdverseEvent.subject
Definition

This subject or group impacted by the event.

Control1..1
TypeReference(Patient|Group|Practitioner|RelatedPerson|ResearchSubject)
Summarytrue
Requirements

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

Alternate Namespatient
Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
8. AdverseEvent.seriousness
Definition

Assessment whether this event, or averted event, was of clinical importance.

Control0..01
BindingFor example codes, see AdverseEventSeriousness

Overall seriousness of this event for the patient.

TypeCodeableConcept
Summarytrue
Comments

Using an example, a rash can have an AdverseEvent.resultingEffect.severity = severe, yet an AdverseEvent.seriousness = non-serious. Alternatively, a medication given with the wrong dose (chemotherapy given with too low of a dose) can have an AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious. Another example would be a beta blocker clinical trial where patients with asthma should be excluded, yet a patient with asthma was included and had an asthmatic episode where AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
9. AdverseEvent.recorder
Definition

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

Control0..1
TypeReference(Patient|PractitionerRole|Practitioner|RelatedPerson|ResearchSubject)
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
10. AdverseEvent.study
Definition

The research study that the subject is enrolled in.

Control0..0*
TypeReference(ResearchStudy)
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
11. AdverseEvent.expectedInResearchStudy
Definition

Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.

Control0..01
Typeboolean
Summaryfalse
InvariantsDefined on this element
ele-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.

1. AdverseEvent
Definition

An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.

Control0..*
Summaryfalse
Alternate NamesAE
2. AdverseEvent.id
Definition

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

Control0..1
Typeid
Summarytrue
Comments

Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

3. 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.

Control0..1
TypeMeta
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
4. 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.

Control0..1
Typeuri
Is Modifiertrue
Summarytrue
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 its narrative along with other profiles, value sets, etc.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. AdverseEvent.language
Definition

The base language in which the resource is written.

Control0..1
BindingThe codes SHALL be taken from AllLanguages IETF language tag for a human languag
Typecode
Summaryfalse
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).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. 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.

Control0..1 This element is affected by the following invariants: dom-6
TypeNarrative
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Comments

Contained resources do not have a 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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. AdverseEvent.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

Control0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained 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.

8. 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 managable, 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.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
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())
9. 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 managable, 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
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())
10. 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.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
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.

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
11. AdverseEvent.status
Definition

The current state of the adverse event or potential adverse event.

Control1..1
BindingThe codes SHALL be taken from AdverseEventStatus Codes identifying the lifecycle stage of an event
Typecode
Is Modifiertrue
Summarytrue
Comments

This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
12. AdverseEvent.actuality
Definition

Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely.

Control1..1
BindingThe codes SHALL be taken from AdverseEventActuality Overall nature of the adverse event, e.g. real or potential
Typecode
Is Modifiertrue
Summarytrue
Comments

AllergyIntolerance should be used for the initial capture or recording of the individual's propensity to an adverse reaction to a substance. If an AllergyIntolerance does not exist, then an adverse reaction should be recorded as an AllergyIntolerance. If an AllergyIntolerance does exist and the substance was given, then an adverse reaction should be recorded as an AdverseEvent due to the aberrant workflow.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
13. AdverseEvent.category
Definition

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

Control0..*
BindingFor example codes, see AdverseEventCategory Overall categorization of the event, e.g. product-related or situational
TypeCodeableConcept
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
14. AdverseEvent.code
Definition

Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused.

Control0..1
BindingFor example codes, see AdverseEventType Detailed type of event
TypeCodeableConcept
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
15. AdverseEvent.subject
Definition

This subject or group impacted by the event.

Control1..1
TypeReference(Patient|Group|Practitioner|RelatedPerson)
Summarytrue
Requirements

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

Alternate Namespatient
Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
16. AdverseEvent.encounter
Definition

The Encounter associated with the start of the AdverseEvent.

Control0..1
TypeReference(Encounter)
Summarytrue
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 associated encounter. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the associated encounter.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
17. AdverseEvent.occurrence[x]
Definition

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

Control0..1
TypeChoice of: dateTime, Period, Timing
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
Alternate Namestiming
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
18. AdverseEvent.detected
Definition

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

Control0..1
TypedateTime
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
19. AdverseEvent.recordedDate
Definition

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

Control0..1
TypedateTime
Summarytrue
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. AdverseEvent.resultingEffect
Definition

Information about the condition that occurred as a result of the adverse event, such as hives due to the exposure to a substance (for example, a drug or a chemical) or a broken leg as a result of the fall.

Control0..*
TypeReference(Condition|Observation)
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
21. AdverseEvent.location
Definition

The information about where the adverse event occurred.

Control0..1
TypeReference(Location)
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
22. AdverseEvent.seriousness
Definition

Assessment whether this event, or averted event, was of clinical importance.

Control0..0
BindingFor example codes, see AdverseEventSeriousness Overall seriousness of this event for the patient
TypeCodeableConcept
Summarytrue
Comments

Using an example, a rash can have an AdverseEvent.resultingEffect.severity = severe, yet an AdverseEvent.seriousness = non-serious. Alternatively, a medication given with the wrong dose (chemotherapy given with too low of a dose) can have an AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious. Another example would be a beta blocker clinical trial where patients with asthma should be excluded, yet a patient with asthma was included and had an asthmatic episode where AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
23. AdverseEvent.outcome
Definition

Describes the type of outcome from the adverse event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal.

Control0..*
BindingFor example codes, see AdverseEventOutcome Codes describing the type of outcome from the adverse event
TypeCodeableConcept
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
24. AdverseEvent.recorder
Definition

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

Control0..1
TypeReference(Patient|PractitionerRole|Practitioner|RelatedPerson)
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
25. AdverseEvent.participant
Definition

Indicates who or what participated in the adverse event and how they were involved.

Control0..*
TypeBackboneElement
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
26. AdverseEvent.participant.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
27. AdverseEvent.participant.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 managable, 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.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
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())
28. AdverseEvent.participant.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 managable, 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
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())
29. AdverseEvent.participant.function
Definition

Distinguishes the type of involvement of the actor in the adverse event, such as contributor or informant.

Control0..1
BindingFor example codes, see AdverseEventParticipantFunction Codes describing the type of involvement of the actor in the adverse event
TypeCodeableConcept
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
30. AdverseEvent.participant.actor
Definition

Indicates who or what participated in the event.

Control1..1
TypeReference(Practitioner|PractitionerRole|Organization|CareTeam|Patient|Device|RelatedPerson)
Summarytrue
Comments

For example, the physician prescribing a drug, a nurse administering the drug, a device that administered the drug, a witness to the event, or an informant of clinical history.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
31. AdverseEvent.study
Definition

The research study that the subject is enrolled in.

Control0..0
TypeReference(ResearchStudy)
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
32. AdverseEvent.expectedInResearchStudy
Definition

Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.

Control0..0
Typeboolean
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
33. AdverseEvent.suspectEntity
Definition

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

Control0..*
TypeBackboneElement
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
34. 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.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
35. 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 managable, 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.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
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())
36. 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 managable, 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
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())
37. AdverseEvent.suspectEntity.instance[x]
Definition

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

Control1..1
TypeChoice of: CodeableConcept, Reference(Immunization|Procedure|Substance|Medication|MedicationAdministration|MedicationStatement|Device|BiologicallyDerivedProduct|ResearchStudy)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
Alternate NamesSubstance or Medication or Device
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
38. AdverseEvent.suspectEntity.causality
Definition

Information on the possible cause of the event.

Control0..1
TypeBackboneElement
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
39. 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.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
40. 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 managable, 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.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
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())
41. 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 managable, 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
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())
42. AdverseEvent.suspectEntity.causality.assessmentMethod
Definition

The method of evaluating the relatedness of the suspected entity to the event.

Control0..1
BindingFor example codes, see AdverseEventCausalityMethod TODO
TypeCodeableConcept
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
43. AdverseEvent.suspectEntity.causality.entityRelatedness
Definition

The result of the assessment regarding the relatedness of the suspected entity to the event.

Control0..1
BindingFor example codes, see AdverseEventCausalityAssessment Codes for the assessment of whether the entity caused the event
TypeCodeableConcept
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
44. AdverseEvent.suspectEntity.causality.author
Definition

The author of the information on the possible cause of the event.

Control0..1
TypeReference(Practitioner|PractitionerRole|Patient|RelatedPerson)
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
45. AdverseEvent.contributingFactor
Definition

The contributing factors suspected to have increased the probability or severity of the adverse event.

Control0..*
TypeBackboneElement
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
46. AdverseEvent.contributingFactor.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
47. AdverseEvent.contributingFactor.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 managable, 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.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
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())
48. AdverseEvent.contributingFactor.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 managable, 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
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())
49. AdverseEvent.contributingFactor.item[x]
Definition

The item that is suspected to have increased the probability or severity of the adverse event.

Control1..1
BindingFor example codes, see AdverseEventContributingFactor Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event
TypeChoice of: Reference(Condition|Observation|AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure|Device|DeviceUsage|DocumentReference|MedicationAdministration|MedicationStatement), CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
50. AdverseEvent.preventiveAction
Definition

Preventive actions that contributed to avoiding the adverse event.

Control0..*
TypeBackboneElement
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
51. AdverseEvent.preventiveAction.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
52. AdverseEvent.preventiveAction.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 managable, 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.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
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())
53. AdverseEvent.preventiveAction.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 managable, 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
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())
54. AdverseEvent.preventiveAction.item[x]
Definition

The action that contributed to avoiding the adverse event.

Control1..1
BindingFor example codes, see AdverseEventPreventiveAction Codes describing the preventive actions that contributed to avoiding the adverse event
TypeChoice of: Reference(Immunization|Procedure|DocumentReference|MedicationAdministration|MedicationRequest), CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
55. AdverseEvent.mitigatingAction
Definition

The ameliorating action taken after the adverse event occured in order to reduce the extent of harm.

Control0..*
TypeBackboneElement
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
56. AdverseEvent.mitigatingAction.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
57. AdverseEvent.mitigatingAction.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 managable, 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.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
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())
58. AdverseEvent.mitigatingAction.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 managable, 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
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())
59. AdverseEvent.mitigatingAction.item[x]
Definition

The ameliorating action taken after the adverse event occured in order to reduce the extent of harm.

Control1..1
BindingFor example codes, see AdverseEventMitigatingAction Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
TypeChoice of: Reference(Procedure|DocumentReference|MedicationAdministration|MedicationRequest), CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
60. AdverseEvent.supportingInfo
Definition

Supporting information relevant to the event.

Control0..*
TypeBackboneElement
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
61. AdverseEvent.supportingInfo.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
62. AdverseEvent.supportingInfo.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 managable, 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.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
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())
63. AdverseEvent.supportingInfo.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 managable, 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).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
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())
64. AdverseEvent.supportingInfo.item[x]
Definition

Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a pencillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.

Control1..1
BindingFor example codes, see AdverseEventSupportingInforation Codes describing the supporting information relevant to the event
TypeChoice of: Reference(Condition|Observation|AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure|DocumentReference|MedicationAdministration|MedicationStatement|QuestionnaireResponse), CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
65. AdverseEvent.note
Definition

Comments made about the adverse event by the performer, subject or other participants.

Control0..*
TypeAnnotation
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))