StructureDefinition
for
adverseevent
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AdverseEvent : Actual or potential/avoided event causing unintended physical injury resulting
from or contributed to by medical care, a research study or other healthcare setting factors
that requires additional monitoring, treatment, or hospitalization, or that results in
death.
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padding:0px 4px 0px 4px
padding-left: 3px; padding-right: 3px; border: 1px grey solid; font-weight: bold; color:
black; background-color: #fff5e6
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padding:0px 4px 0px 4pxMedical care, research study or other healthcare event causing physical injury
Elements defined in Ancestors:
The logical id of the resource, as used in the URL for the resource. Once assigned, this
value never changes.,
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.,
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.,
,
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.,
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.,
May be used to represent additional information that is not part of the basic definition
of the resource. To make the use of extensions safe and manageable, there is a strict
set of governance applied to the definition and use of extensions. Though any implementer
can define an extension, there is a set of requirements that SHALL be met as part of the
definition of the extension.,
May be used to represent additional information that is not part of the basic definition
of the resource and that modifies the understanding of the element that contains it and/or
the understanding of the containing element's descendants. Usually modifier elements provide
negation or qualification. To make the use of extensions safe and manageable, there is
a strict set of governance applied to the definition and use of extensions. Though any
implementer is allowed to define an extension, there is a set of requirements that SHALL
be met as part of the definition of the extension. Applications processing a resource
are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource
(including cannot change the meaning of modifierExtension itself).
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AdverseEvent.identifier : 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.
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AdverseEvent.actuality : 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.
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padding:0px 4px 0px 4pxactual | potential
(
)
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solid; padding:0px 4px 0px 4pxproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-informati
on | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time
| expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environ
ment
(
To be conformant, the concept in this element SHALL be from the specified value set if
any of the codes within the value set can apply to the concept being communicated. If
the value set does not cover the concept (based on human review), alternate codings (or,
data type allowing, text) may be included instead.)
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AdverseEvent.event : This element defines the specific type of event that occurred or
that was prevented from occurring.
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padding:0px 4px 0px 4pxType of the event itself in relation to the subject
(
Instances are not expected or even encouraged to draw from the specified value set. The
value set merely provides examples of the types of concepts intended to be included.)
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(
|
|
|
)
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AdverseEvent.encounter : The Encounter during which AdverseEvent was created or to which
the creation of this record is tightly associated.
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AdverseEvent.detected : Estimated or actual date the AdverseEvent began, in the opinion
of the reporter.
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AdverseEvent.recordedDate : The date on which the existence of the AdverseEvent was first
recorded.
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AdverseEvent.resultingCondition : Includes information about the reaction that occurred
as a result of exposure to a substance (for example, a drug or a chemical).
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(
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(
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padding:0px 4px 0px 4pxSeriousness of the event
(
Instances are not expected or even encouraged to draw from the specified value set. The
value set merely provides examples of the types of concepts intended to be included.)
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AdverseEvent.severity : 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.
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solid; padding:0px 4px 0px 4pxmild | moderate | severe
(
)
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padding:0px 4px 0px 4px
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padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
padding:0px 4px 0px 4pxresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
(
)
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AdverseEvent.recorder : Information on who recorded the adverse event. May be the patient
or a practitioner.
vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px
(
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)
vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGg
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AdverseEvent.contributor : 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).
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padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
padding:0px 4px 0px 4px
(
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vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
padding:0px 4px 0px 4pxWho was involved in the adverse event or the potential adverse event
vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB
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EQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=)
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AdverseEvent.suspectEntity : Describes the entity that is suspected to have caused the
adverse event.
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solid; padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4pxThe suspected agent causing the adverse event
vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGg
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AdverseEvent.suspectEntity.instance : Identifies the actual instance of what caused the
adverse event. May be a substance, medication, medication administration, medication
statement or a device.
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padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
padding:0px 4px 0px 4px
(
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vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB
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exg8Shl1ckRUQVaMVkQ2kCstKCEAOw==
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solid; padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4pxInformation on the possible cause of the event
vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGg
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dCABMPwMo2ctnoQAAAABJRU5ErkJggg==
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CMGrAqAGjBowaMGoAAgAALL0DKYQ0DPIAAAAASUVORK5CYII=
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AdverseEvent.suspectEntity.causality.assessment : Assessment of if the entity caused the
event.
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padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
padding:0px 4px 0px 4px
vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
padding:0px 4px 0px 4pxAssessment of if the entity caused the event
(
Instances are not expected or even encouraged to draw from the specified value set. The
value set merely provides examples of the types of concepts intended to be included.)
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AdverseEvent.suspectEntity.causality.productRelatedness : AdverseEvent.suspectEntity.causalityProduc
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solid; padding:0px 4px 0px 4pxProbabilityScale | Bayesian | Checklist
(
Instances are not expected or even encouraged to draw from the specified value set. The
value set merely provides examples of the types of concepts intended to be included.)
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padding:0px 4px 0px 4pxAdverseEvent.subjectMedicalHistory
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(
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(
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padding:0px 4px 0px 4pxAdverseEvent.study
Documentation for this format
Actual or potential/avoided event causing unintended physical injury resulting from or
contributed to by medical care, a research study or other healthcare setting factors that
requires additional monitoring, treatment, or hospitalization, or that results in death.
Actual or potential/avoided event causing unintended physical injury resulting from or
contributed to by medical care, a research study or other healthcare setting factors that
requires additional monitoring, treatment, or hospitalization, or that results in death.
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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descenda
nts().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))))
or descendants().where(reference = '#').exists() or descendants().where(as(canonical)
= '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched',
id).empty()
not(exists(for $contained in f:contained return $contained[not(exists(parent::*/descendant::f:refere
nce/@value=concat('#', $contained/*/f:id/@value)) or exists(descendant::f:reference[@value='#']))]))
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or
a meta.lastUpdated
When a resource has no narrative, only systems that fully understand the data can display
the resource to a human safely. Including a human readable representation in the resource
makes for a much more robust eco-system and cheaper handling of resources by intermediary
systems. Some ecosystems restrict distribution of resources to only those systems that
do fully understand the resources, and as a consequence implementers may believe that
the narrative is superfluous. However experience shows that such eco-systems often open
up to new participants over time.
The logical id of the resource, as used in the URL for the resource. Once assigned, this
value never changes.
The only time that a resource does not have an id is when it is being submitted to the
server using a create operation.
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.
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.
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.
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
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).
A human-readable narrative that contains a summary of the resource and can be used to
represent the content of the resource to a human. The narrative need not encode all the
structured data, but is required to contain sufficient detail to make it "clinically
safe" for a human to just read the narrative. Resource definitions may define what
content should be represented in the narrative to ensure clinical safety.
Contained resources do not have narrative. Resources that are not contained SHOULD have
a narrative. In some cases, a resource may only have text with little or no additional
discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary
for data from legacy systems where information is captured as a "text blob"
or where text is additionally entered raw or narrated and encoded information is added
later.
These resources do not have an independent existence apart from the resource that contains
them - they cannot be identified independently, and nor can they have their own independent
transaction scope.
This should never be done when the content can be identified properly, as once identification
is lost, it is extremely difficult (and context dependent) to restore it again. Contained
resources may have profiles and tags In their meta elements, but SHALL NOT have security
labels.
Containing new R4B resources within R4 resources may cause interoperability issues if
instances are shared with R4 systems
($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable
or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this
is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition
or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus
or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence
or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefi
nition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition
or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorizat
ion or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource
is SubscriptionTopic)
not(f:Citation|f:Evidence|f:EvidenceReport|f:EvidenceVariable|f:MedicinalProductDefinition|f:Package
dProductDefinition|f:AdministrableProductDefinition|f:Ingredient|f:ClinicalUseDefinition|f:RegulatedA
uthorization|f:SubstanceDefinition|f:SubscriptionStatus|f:SubscriptionTopic) or not(parent::f:Citatio
n|parent::f:Evidence|parent::f:EvidenceReport|parent::f:EvidenceVariable|parent::f:MedicinalProductDe
finition|parent::f:PackagedProductDefinition|parent::f:AdministrableProductDefinition|parent::f:Ingre
dient|parent::f:ClinicalUseDefinition|parent::f:RegulatedAuthorization|parent::f:SubstanceDefinition|
f:SubscriptionStatus|f:SubscriptionTopic)
May be used to represent additional information that is not part of the basic definition
of the resource. To make the use of extensions safe and manageable, there is a strict
set of governance applied to the definition and use of extensions. Though any implementer
can define an extension, there is a set of requirements that SHALL be met as part of the
definition of the extension.
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.
May be used to represent additional information that is not part of the basic definition
of the resource and that modifies the understanding of the element that contains it and/or
the understanding of the containing element's descendants. Usually modifier elements provide
negation or qualification. To make the use of extensions safe and manageable, there is
a strict set of governance applied to the definition and use of extensions. Though any
implementer is allowed to define an extension, there is a set of requirements that SHALL
be met as part of the definition of the extension. Applications processing a resource
are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource
(including cannot change the meaning of modifierExtension itself).
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.
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](extensibility.ht
ml#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource
that contains them
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.
This is a business identifier, not a resource identifier (see [discussion](resource.html#identifiers
)). 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.
Allows identification of the adverse event as it is known by various participating systems
and in a way that remains consistent across servers.
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.
This element is labeled as a modifier because it has a potential code that indicates the
adverse event did not actually happen.
product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-informati
on | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time
| expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environ
ment
This element defines the specific type of event that occurred or that was prevented from
occurring.
If AdverseEvent.resultingCondition differs among members of the group, then use Patient
as the subject.
The Encounter during which AdverseEvent was created or to which the creation of this record
is tightly associated.
This will typically be the encounter the event occurred within, but some activities may
be initiated prior to or after the official completion of an encounter but still be tied
to the context of the encounter. 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.
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.
Includes information about the reaction that occurred as a result of exposure to a substance
(for example, a drug or a chemical).
Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.se
riousness - a severe rash might not be serious, but a mild heart problem is.
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).
Unique id for the element within a resource (for internal references). This may be any
string value that does not contain spaces.
May be used to represent additional information that is not part of the basic definition
of the element. To make the use of extensions safe and manageable, there is a strict set
of governance applied to the definition and use of extensions. Though any implementer
can define an extension, there is a set of requirements that SHALL be met as part of the
definition of the extension.
There can be no stigma associated with the use of extensions by any application, project,
or standard - regardless of the institution or jurisdiction that uses or defines the extensions.
The use of extensions is what allows the FHIR specification to retain a core level of
simplicity for everyone.
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).
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.
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](extensibility.ht
ml#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the element
that contains them
Identifies the actual instance of what caused the adverse event. May be a substance,
medication, medication administration, medication statement or a device.
Unique id for the element within a resource (for internal references). This may be any
string value that does not contain spaces.
May be used to represent additional information that is not part of the basic definition
of the element. To make the use of extensions safe and manageable, there is a strict set
of governance applied to the definition and use of extensions. Though any implementer
can define an extension, there is a set of requirements that SHALL be met as part of the
definition of the extension.
There can be no stigma associated with the use of extensions by any application, project,
or standard - regardless of the institution or jurisdiction that uses or defines the extensions.
The use of extensions is what allows the FHIR specification to retain a core level of
simplicity for everyone.
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).
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.
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](extensibility.ht
ml#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the element
that contains them
Actual or potential/avoided event causing unintended physical injury resulting from or
contributed to by medical care, a research study or other healthcare setting factors that
requires additional monitoring, treatment, or hospitalization, or that results in death.
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.
This is a business identifier, not a resource identifier (see [discussion](resource.html#identifiers
)). 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.
Allows identification of the adverse event as it is known by various participating systems
and in a way that remains consistent across servers.
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.
This element is labeled as a modifier because it has a potential code that indicates the
adverse event did not actually happen.
product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-informati
on | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time
| expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environ
ment
This element defines the specific type of event that occurred or that was prevented from
occurring.
If AdverseEvent.resultingCondition differs among members of the group, then use Patient
as the subject.
The Encounter during which AdverseEvent was created or to which the creation of this record
is tightly associated.
This will typically be the encounter the event occurred within, but some activities may
be initiated prior to or after the official completion of an encounter but still be tied
to the context of the encounter. 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.
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.
Includes information about the reaction that occurred as a result of exposure to a substance
(for example, a drug or a chemical).
Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.se
riousness - a severe rash might not be serious, but a mild heart problem is.
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).
Identifies the actual instance of what caused the adverse event. May be a substance,
medication, medication administration, medication statement or a device.
<?xml version="1.0" encoding="UTF-8"?>
<StructureDefinition xmlns="http://hl7.org/fhir"> <id value="AdverseEvent"/> <meta> <lastUpdated value="2023-03-01T23:03:57.298+11:00"/> </meta> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"> <table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align:
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<a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a> </th> <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a> </th> <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description & Constraints</a> <span style="float: right"> <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"> <img alt="doco" src="help16.png" style="background-color: inherit"/> </a> </span> </th> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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<span title="AdverseEvent : 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.">AdverseEvent</span>
<a name="AdverseEvent"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="versions.html#std-process" style="padding-left: 3px; padding-right: 3px; border: 1px grey solid; font-weight: bold;
color: black; background-color: #fff5e6" title="Standards Status = Trial Use">TU</a>
</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px"/>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="domainresource.html">DomainResource</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">An event that may be related to unintended effects on a patient or research participant
<br/> <br/> Elements defined in Ancestors: <a href="resource.html#Resource" title="The logical id of the resource, as used in the URL for the resource. Once assigned,
this value never changes.">id</a> ,
<a href="resource.html#Resource" title="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.">meta</a> ,
<a href="resource.html#Resource" title="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.">implicitRules</a> ,
<a href="resource.html#Resource" title="The base language in which the resource is written.">language</a> , <a href="domainresource.html#DomainResource" title="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.">text</a> ,
<a href="domainresource.html#DomainResource" title="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.">contained</a> ,
<a href="domainresource.html#DomainResource" title="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.">extension</a> ,
<a href="domainresource.html#DomainResource" title="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).">modifierExtension</a>
</td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw
EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
jY/DQkad4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF
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PbPgrqZW+/QlPz48K2EMv36866OUPvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/L
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5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSFVResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuq
oTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/>
<span title="AdverseEvent.identifier : 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.">identifier</span>
<a name="AdverseEvent.identifier"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#Identifier">Identifier</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">Business identifier for the event
<br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj
9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
YAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI1
2P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/>
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
YAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpw
YAAAARklEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyj
uYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==" style="background-color: white; background-color: inherit" title="Primitive Data Type"/>
<span title="AdverseEvent.status : The current state of the adverse event or potential adverse
event.">status</span>
<a name="AdverseEvent.status"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="conformance-rules.html#isModifier" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is a modifier element">?!</a> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">1..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#code">code</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">in-progress | completed | entered-in-error | unknown
<br/> Binding: <a href="valueset-adverse-event-status.html">Adverse Event Status</a> ( <a href="terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value
set.">Required</a> )
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw
EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
YAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI1
2P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/>
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
YAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y
+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/>
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpw
YAAAARklEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyj
uYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type"/>
<span title="AdverseEvent.actuality : 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.">actuality</span>
<a name="AdverseEvent.actuality"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="conformance-rules.html#isModifier" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is a modifier element">?!</a> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#code">code</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">actual | potential
<br/> Binding: <a href="valueset-adverse-event-actuality.html">Adverse Event Actuality</a> ( <a href="terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value
set.">Required</a> )
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj
9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
YAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI1
2P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/>
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
YAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y
+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/>
<img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
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/369M2vdaqHRPz58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfX
Ri+bFhLWUVv379/rnwPvszv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjt
PbPgrqZW+/QlPz48K2EMv36866OUPvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/L
Slfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8AL
AAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYwbdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY
5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSFVResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuq
oTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: white; background-color: inherit" title="Data Type"/>
<span title="AdverseEvent.category : The overall type of event, intended for search and filtering
purposes.">category</span>
<a name="AdverseEvent.category"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">0..*</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment
| hospital-aquired-infection | wrong-body-site
<br/> Binding: <a href="valueset-adverse-event-category.html">Adverse Event Category</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
set. The value set merely provides examples of the types of concepts intended
to be included.">Example</a> )
<br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw
EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
YAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI1
2P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/>
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
YAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y
+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/>
<img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
jY/DQkad4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF
/369M2vdaqHRPz58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfX
Ri+bFhLWUVv379/rnwPvszv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjt
PbPgrqZW+/QlPz48K2EMv36866OUPvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/L
Slfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8AL
AAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYwbdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY
5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSFVResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuq
oTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/>
<span title="AdverseEvent.code : Specific event that occurred or that was averted, such as patient
fall, wrong organ removed, or wrong blood transfused.">code</span>
<a name="AdverseEvent.code"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">Event or incident that occurred or was averted
<br/> Binding: <a href="valueset-adverse-event-type.html">AdverseEvent Type</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
set. The value set merely provides examples of the types of concepts intended
to be included.">Example</a> )
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj
9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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2P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/>
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
YAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y
+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/>
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1
BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAA
FxJREFUOE/NjEEOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG
6TFi6cHULyz8KOjC7OIQKlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Reference to another Resource"/>
<span title="AdverseEvent.subject : This subject or group impacted by the event.">subject</span> <a name="AdverseEvent.subject"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">1..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="references.html#Reference">Reference</a> ( <a href="patient.html">Patient</a> | <a href="group.html">Group</a> | <a href="practitioner.html">Practitioner</a> | <a href="relatedperson.html">RelatedPerson</a> | <a href="researchsubject.html">ResearchSubject</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">Subject impacted by event
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw
EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1
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<span title="AdverseEvent.encounter : The Encounter associated with the start of the AdverseEvent.">encounter</span> <a name="AdverseEvent.encounter"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<a href="references.html#Reference">Reference</a> ( <a href="encounter.html">Encounter</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">The Encounter associated with the start of the AdverseEvent
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<span title="AdverseEvent.occurrence[x] : The date (and perhaps time) when the adverse event
occurred.">occurrence[x]</span>
<a name="AdverseEvent.occurrence_x_"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px"/>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">When the event occurred
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<span title="A date, date-time or partial date (e.g. just year or year + month). If hours and
minutes are specified, a UTC offset SHALL be populated. The format is a union of
the schema types gYear, gYearMonth, date and dateTime. Seconds must be provided
due to schema type constraints but may be zero-filled and may be ignored.
Dates SHALL be valid dates.">occurrenceDateTime</span>
</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<a href="datatypes.html#dateTime">dateTime</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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</tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<span title="A time period defined by a start and end date and optionally time.">occurrencePeriod</span> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px"/>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px"/>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#Period">Period</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px"/>
</tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<span title="Specifies an event that may occur multiple times. Timing schedules are used to
record when things are planned, expected or requested to occur. The most common
usage is in dosage instructions for medications. They are also used when planning
care of various kinds, and may be used for reporting the schedule to which past
regular activities were carried out.">occurrenceTiming</span>
</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<a href="datatypes.html#Timing">Timing</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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</tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpw
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<span title="AdverseEvent.detected : Estimated or actual date the AdverseEvent began, in the
opinion of the reporter.">detected</span>
<a name="AdverseEvent.detected"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">0..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#dateTime">dateTime</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">When the event was detected
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpw
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<span title="AdverseEvent.recordedDate : The date on which the existence of the AdverseEvent
was first recorded.">recordedDate</span>
<a name="AdverseEvent.recordedDate"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#dateTime">dateTime</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">When the event was recorded
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1
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<span title="AdverseEvent.resultingEffect : 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.">resultingEffect</span>
<a name="AdverseEvent.resultingEffect"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">0..*</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="references.html#Reference">Reference</a> ( <a href="condition.html">Condition</a> | <a href="observation.html">Observation</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">Effect on the subject due to this event
<br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw
EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1
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<span title="AdverseEvent.location : The information about where the adverse event occurred.">location</span> <a name="AdverseEvent.location"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="references.html#Reference">Reference</a> ( <a href="location.html">Location</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">Location where adverse event occurred
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
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oTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: white; background-color: inherit" title="Data Type"/>
<span title="AdverseEvent.seriousness : Assessment whether this event, or averted event, was
of clinical importance.">seriousness</span>
<a name="AdverseEvent.seriousness"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">0..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">Seriousness or gravity of the event
<br/> Binding: <a href="valueset-adverse-event-seriousness.html">Adverse Event Seriousness</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
set. The value set merely provides examples of the types of concepts intended
to be included.">Example</a> )
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw
EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
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Slfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8AL
AAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYwbdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY
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oTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/>
<span title="AdverseEvent.outcome : Describes the type of outcome from the adverse event, such
as resolved, recovering, ongoing, resolved-with-sequelae, or fatal.">outcome</span>
<a name="AdverseEvent.outcome"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">Type of outcome from the adverse event
<br/> Binding: <a href="valueset-adverse-event-outcome.html">AdverseEvent Outcome</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
set. The value set merely provides examples of the types of concepts intended
to be included.">Example</a> )
<br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj
9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1
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6TFi6cHULyz8KOjC7OIQKlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Reference to another Resource"/>
<span title="AdverseEvent.recorder : Information on who recorded the adverse event. May be
the patient or a practitioner.">recorder</span>
<a name="AdverseEvent.recorder"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">0..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="references.html#Reference">Reference</a> ( <a href="patient.html">Patient</a> | <a href="practitioner.html">Practitioner</a> | <a href="practitionerrole.html">PractitionerRole</a> | <a href="relatedperson.html">RelatedPerson</a> | <a href="researchsubject.html">ResearchSubject</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">Who recorded the adverse event
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
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<img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPQfAOvGUf7ztuvPMf/78/fkl/Pbg+u8Rvjqteu2Pf3zxPz36Pz0z+vTmPz
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<span title="AdverseEvent.participant : Indicates who or what participated in the adverse event
and how they were involved.">participant</span>
<a name="AdverseEvent.participant"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="types.html#BackBoneElement">BackboneElement</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">Who was involved in the adverse event or the potential adverse event and what they
did
<br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<span title="AdverseEvent.participant.function : Distinguishes the type of involvement of the
actor in the adverse event, such as contributor or informant.">function</span>
<a name="AdverseEvent.participant.function"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">0..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">Type of involvement
<br/> Binding: <a href="valueset-adverse-event-participant-function.html">AdverseEvent Participant Function</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
set. The value set merely provides examples of the types of concepts intended
to be included.">Example</a> )
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1
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<span title="AdverseEvent.participant.actor : Indicates who or what participated in the event.">actor</span> <a name="AdverseEvent.participant.actor"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="references.html#Reference">Reference</a> ( <a href="practitioner.html">Practitioner</a> | <a href="practitionerrole.html">PractitionerRole</a> | <a href="organization.html">Organization</a> | <a href="careteam.html">CareTeam</a> | <a href="patient.html">Patient</a> | <a href="device.html">Device</a> | <a href="relatedperson.html">RelatedPerson</a> | <a href="researchsubject.html">ResearchSubject</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">Who was involved in the adverse event or the potential adverse event
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
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9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1
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<span title="AdverseEvent.study : The research study that the subject is enrolled in.">study</span> <a name="AdverseEvent.study"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">0..*</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="references.html#Reference">Reference</a> ( <a href="researchstudy.html">ResearchStudy</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">Research study that the subject is enrolled in
<br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpw
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<span title="AdverseEvent.expectedInResearchStudy : 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.">expectedInResearchStudy</span>
<a name="AdverseEvent.expectedInResearchStudy"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px"/>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#boolean">boolean</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">Considered likely or probable or anticipated in the research study
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
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9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPQfAOvGUf7ztuvPMf/78/fkl/Pbg+u8Rvjqteu2Pf3zxPz36Pz0z+vTmPz
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<span title="AdverseEvent.suspectEntity : Describes the entity that is suspected to have caused
the adverse event.">suspectEntity</span>
<a name="AdverseEvent.suspectEntity"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">0..*</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="types.html#BackBoneElement">BackboneElement</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">The suspected agent causing the adverse event
<br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<span title="AdverseEvent.suspectEntity.instance[x] : Identifies the actual instance of what
caused the adverse event. May be a substance, medication, medication administration,
medication statement or a device.">instance[x]</span>
<a name="AdverseEvent.suspectEntity.instance_x_"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">Refers to the specific entity that caused the adverse event
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<span title="A concept that may be defined by a formal reference to a terminology or ontology
or may be provided by text.">instanceCodeableConcept</span>
</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px"/>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px"/>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px"/>
</tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1
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</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<a href="references.html#Reference">Reference</a> ( <a href="immunization.html">Immunization</a> | <a href="procedure.html">Procedure</a> | <a href="substance.html">Substance</a> | <a href="medication.html">Medication</a> | <a href="medicationadministration.html">MedicationAdministration</a> | <a href="medicationstatement.html">MedicationStatement</a> | <a href="device.html">Device</a> | <a href="biologicallyderivedproduct.html">BiologicallyDerivedProduct</a> | <a href="researchstudy.html">ResearchStudy</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px"/>
</tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPQfAOvGUf7ztuvPMf/78/fkl/Pbg+u8Rvjqteu2Pf3zxPz36Pz0z+vTmPz
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<span title="AdverseEvent.suspectEntity.causality : Information on the possible cause of the
event.">causality</span>
<a name="AdverseEvent.suspectEntity.causality"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">0..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="types.html#BackBoneElement">BackboneElement</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">Information on the possible cause of the event
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
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<span title="AdverseEvent.suspectEntity.causality.assessmentMethod : The method of evaluating
the relatedness of the suspected entity to the event.">assessmentMethod</span>
<a name="AdverseEvent.suspectEntity.causality.assessmentMethod"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">Method of evaluating the relatedness of the suspected entity to the event
<br/> Binding: <a href="valueset-adverse-event-causality-method.html">Adverse Event Causality Method</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
set. The value set merely provides examples of the types of concepts intended
to be included.">Example</a> )
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3NoQ0AIBRDwb9r958B0KAgAcw1OfNMK0
ntGGtze+n3PwAAcG4JAAAAt3RWK0BWYk6o4QAAAABJRU5ErkJggg==)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
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<span title="AdverseEvent.suspectEntity.causality.entityRelatedness : The result of the assessment
regarding the relatedness of the suspected entity to the event.">entityRelatedness</span>
<a name="AdverseEvent.suspectEntity.causality.entityRelatedness"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">0..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">Result of the assessment regarding the relatedness of the suspected entity to the
event
<br/> Binding: <a href="valueset-adverse-event-causality-assess.html">Adverse Event Causality Assessment</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
set. The value set merely provides examples of the types of concepts intended
to be included.">Example</a> )
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw
EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
YAAAAB3RJTUUH3wYeFzME+lXFigAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1
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<span title="AdverseEvent.suspectEntity.causality.author : The author of the information on
the possible cause of the event.">author</span>
<a name="AdverseEvent.suspectEntity.causality.author"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="references.html#Reference">Reference</a> ( <a href="practitioner.html">Practitioner</a> | <a href="practitionerrole.html">PractitionerRole</a> | <a href="patient.html">Patient</a> | <a href="relatedperson.html">RelatedPerson</a> | <a href="researchsubject.html">ResearchSubject</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">Author of the information on the possible cause of the event
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj
9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPQfAOvGUf7ztuvPMf/78/fkl/Pbg+u8Rvjqteu2Pf3zxPz36Pz0z+vTmPz
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slgxaLR4/3rMAWoBp32V5exg8Shl1ckRUQVaMVkQ2kCstKCEAOw==" style="background-color: white; background-color: inherit" title="Element"/>
<span title="AdverseEvent.contributingFactor : The contributing factors suspected to have increased
the probability or severity of the adverse event.">contributingFactor</span>
<a name="AdverseEvent.contributingFactor"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">0..*</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">
<a href="types.html#BackBoneElement">BackboneElement</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">Contributing factors suspected to have increased the probability or severity of
the adverse event
<br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
#F7F7F7">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw
EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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<img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAMQfAGm6/idTd4yTmF+v8Xa37KvW+lyh3KHJ62aq41ee2bXZ98nm/2mt5W2
Ck5XN/C1chEZieho8WXXA/2Gn4P39/W+y6V+l3qjP8Njt/lx2izxPYGyv51Oa1EJWZ////////yH5BAEAAB8ALAAAAAAQA
BAAAAWH4Cd+Xml6Y0pCQts0EKp6GbYshaM/skhjhCChUmFIeL4OsHIxXRAISQTl6SgIG8+FgfBMoh2qtbLZQr0TQJhk3TC
4pYPBApiyFVDEwSOf18UFXxMWBoUJBn9sDgmDewcJCRyJJBoEkRyYmAABPZQEAAOhA5seFDMaDw8BAQ9TpiokJyWwtLUhA
Ds=" style="background-color: #F7F7F7; background-color: inherit" title="Choice of Types"/>
<span title="AdverseEvent.contributingFactor.item[x] : The item that is suspected to have increased
the probability or severity of the adverse event.">item[x]</span>
<a name="AdverseEvent.contributingFactor.item_x_"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px"/>
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
#F0F0F0 solid; padding:0px 4px 0px 4px">Item suspected to have increased the probability or severity of the adverse event
<br/> Binding: <a href="valueset-adverse-event-contributing-factor.html">AdverseEvent Contributing Factor</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
set. The value set merely provides examples of the types of concepts intended
to be included.">Example</a> )
<br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
white">
<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<a href="references.html#Reference">Reference</a> ( <a href="condition.html">Condition</a> | <a href="observation.html">Observation</a> | <a href="allergyintolerance.html">AllergyIntolerance</a> | <a href="familymemberhistory.html">FamilyMemberHistory</a> | <a href="immunization.html">Immunization</a> | <a href="procedure.html">Procedure</a> | <a href="device.html">Device</a> | <a href="deviceusage.html">DeviceUsage</a> | <a href="documentreference.html">DocumentReference</a> | <a href="medicationadministration.html">MedicationAdministration</a> | <a href="medicationstatement.html">MedicationStatement</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<span title="AdverseEvent.preventiveAction : Preventive actions that contributed to avoiding
the adverse event.">preventiveAction</span>
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<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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<span title="AdverseEvent.preventiveAction.item[x] : The action that contributed to avoiding
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<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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set. The value set merely provides examples of the types of concepts intended
to be included.">Example</a> )
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<span title="AdverseEvent.mitigatingAction : The ameliorating action taken after the adverse
event occured in order to reduce the extent of harm.">mitigatingAction</span>
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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<span title="AdverseEvent.mitigatingAction.item[x] : The ameliorating action taken after the
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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set. The value set merely provides examples of the types of concepts intended
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<a href="references.html#Reference">Reference</a> ( <a href="procedure.html">Procedure</a> | <a href="documentreference.html">DocumentReference</a> | <a href="medicationadministration.html">MedicationAdministration</a> | <a href="medicationrequest.html">MedicationRequest</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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<span title="AdverseEvent.supportingInfo.item[x] : 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.">item[x]</span>
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<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<br/> Binding: <a href="valueset-adverse-event-supporting-info.html">AdverseEvent Supporting Information</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
set. The value set merely provides examples of the types of concepts intended
to be included.">Example</a> )
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<a href="references.html#Reference">Reference</a> ( <a href="condition.html">Condition</a> | <a href="observation.html">Observation</a> | <a href="allergyintolerance.html">AllergyIntolerance</a> | <a href="familymemberhistory.html">FamilyMemberHistory</a> | <a href="immunization.html">Immunization</a> | <a href="procedure.html">Procedure</a> | <a href="documentreference.html">DocumentReference</a> | <a href="medicationadministration.html">MedicationAdministration</a> | <a href="medicationstatement.html">MedicationStatement</a> | <a href="questionnaireresponse.html">QuestionnaireResponse</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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<span title="AdverseEvent.note : Comments made about the adverse event by the performer, subject
or other participants.">note</span>
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solid; padding:0px 4px 0px 4px">
<a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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<a href="datatypes.html#Annotation">Annotation</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
solid; padding:0px 4px 0px 4px">Comment on adverse event
<br/> <br/> </td> </tr> <tr> <td class="hierarchy" colspan="5"> <br/> <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"> <img alt="doco" src="help16.png" style="background-color: inherit"/> Documentation for this format </a> </td> </tr> </table> </div> </text> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-category"> <valueString value="Clinical.Summary"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="trial-use"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"> <valueInteger value="0"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category"> <valueCode value="patient"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"> <valueCode value="pc"/> </extension> <url value="http://hl7.org/fhir/StructureDefinition/AdverseEvent"/> <version value="5.0.0-draft-final"/> <name value="AdverseEvent"/> <status value="draft"/> <experimental value="true"/> <date value="2023-03-01T23:03:57+11:00"/> <publisher value="Health Level Seven International (Patient Care)"/> <contact> <telecom> <system value="url"/> <value value="http://hl7.org/fhir"/> </telecom> </contact> <contact> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/patientcare/index.cfm"/> </telecom> </contact> <description value="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."/>
<jurisdiction> <coding> <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/> <code value="001"/> <display value="World"/> </coding> </jurisdiction> <fhirVersion value="5.0.0-draft-final"/> <mapping> <identity value="workflow"/> <uri value="http://hl7.org/fhir/workflow"/> <name value="Workflow Pattern"/> </mapping> <mapping> <identity value="rim"/> <uri value="http://hl7.org/v3"/> <name value="RIM Mapping"/> </mapping> <mapping> <identity value="w5"/> <uri value="http://hl7.org/fhir/fivews"/> <name value="FiveWs Pattern Mapping"/> </mapping> <kind value="resource"/> <abstract value="false"/> <type value="AdverseEvent"/> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> <derivation value="specialization"/> <snapshot> <element id="AdverseEvent"> <path value="AdverseEvent"/> <short value="An event that may be related to unintended effects on a patient or research participant"/> <definition value="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."/>
<alias value="AE"/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent"/> <min value="0"/> <max value="*"/> </base> <constraint> <key value="dom-2"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/> <expression value="contained.contained.empty()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-3"/> <severity value="error"/> <human value="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"/>
<expression value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofTy
pe(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('unmat
ched', id).empty()"/>
<source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-4"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId
or a meta.lastUpdated"/>
<expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-5"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a security label"/> <expression value="contained.meta.security.empty()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice"> <valueBoolean value="true"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation"> <valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can
display the resource to a human safely. Including a human readable representation
in the resource makes for a much more robust eco-system and cheaper handling of
resources by intermediary systems. Some ecosystems restrict distribution of resources
to only those systems that do fully understand the resources, and as a consequence
implementers may believe that the narrative is superfluous. However experience
shows that such eco-systems often open up to new participants over time."/>
</extension> <key value="dom-6"/> <severity value="warning"/> <human value="A resource should have narrative for robust management"/> <expression value="text.`div`.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Entity. Role, or Act"/> </mapping> <mapping> <identity value="workflow"/> <map value="Event"/> </mapping> <mapping> <identity value="rim"/> <map value="Act"/> </mapping> <mapping> <identity value="w5"/> <map value="clinical.general"/> </mapping> </element> <element id="AdverseEvent.id"> <path value="AdverseEvent.id"/> <short value="Logical id of this artifact"/> <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned,
this value never changes."/>
<comment value="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."/>
<min value="0"/> <max value="1"/> <base> <path value="Resource.id"/> <min value="0"/> <max value="1"/> </base>
<type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.meta"> <path value="AdverseEvent.meta"/> <short value="Metadata about the resource"/> <definition value="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."/>
<min value="0"/> <max value="1"/> <base> <path value="Resource.meta"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Meta"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.implicitRules"> <path value="AdverseEvent.implicitRules"/> <short value="A set of rules under which this content was created"/> <definition value="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."/>
<comment value="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."/>
<min value="0"/> <max value="1"/> <base> <path value="Resource.implicitRules"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional
knowledge about the resource that modifies its meaning or interpretation"/>
<isSummary value="true"/> </element> <element id="AdverseEvent.language"> <path value="AdverseEvent.language"/> <short value="Language of the resource content"/> <definition value="The base language in which the resource is written."/> <comment value="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)."/>
<min value="0"/> <max value="1"/> <base> <path value="Resource.language"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Language"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="required"/> <description value="IETF language tag for a human language"/> <valueSet value="http://hl7.org/fhir/ValueSet/all-languages|5.0.0-draft-final"/> <additional> <purpose value="starter"/> <valueSet value="http://hl7.org/fhir/ValueSet/languages"/> </additional> </binding> </element> <element id="AdverseEvent.text"> <path value="AdverseEvent.text"/> <short value="Text summary of the resource, for human interpretation"/> <definition value="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."/>
<comment value="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."/>
<alias value="narrative"/> <alias value="html"/> <alias value="xhtml"/> <alias value="display"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.text"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Narrative"/> </type> <condition value="dom-6"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Act.text?"/> </mapping> </element> <element id="AdverseEvent.contained"> <path value="AdverseEvent.contained"/> <short value="Contained, inline Resources"/> <definition value="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."/>
<comment value="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."/>
<alias value="inline resources"/> <alias value="anonymous resources"/> <alias value="contained resources"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.contained"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Resource"/> </type> <condition value="dom-2"/> <condition value="dom-4"/> <condition value="dom-3"/> <condition value="dom-5"/> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.extension"> <path value="AdverseEvent.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/>
<comment value="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."/>
<alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.modifierExtension"> <path value="AdverseEvent.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="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)."/>
<comment value="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."/>
<requirements value="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](extensibility.html#modifierExtension)."/>
<alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the
resource that contains them"/>
<isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.identifier"> <path value="AdverseEvent.identifier"/> <short value="Business identifier for the event"/> <definition value="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."/>
<comment value="This is a business identifier, not a resource identifier (see [discussion](resource.html#iden
tifiers)). 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."/>
<requirements value="Allows identification of the adverse event as it is known by various participating
systems and in a way that remains consistent across servers."/>
<min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.identifier"/> </mapping> </element> <element id="AdverseEvent.status"> <path value="AdverseEvent.status"/> <short value="in-progress | completed | entered-in-error | unknown"/> <definition value="The current state of the adverse event or potential adverse event."/> <comment value="This is not the reporting of the event to any regulatory or quality organization.
This is not the outcome of the patient's condition."/>
<min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.status"/> <min value="1"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="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"/>
<isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventStatus"/> </extension> <strength value="required"/> <description value="Codes identifying the lifecycle stage of an event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0-draft-final"/> </binding> <mapping> <identity value="workflow"/> <map value="Event.status"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.status"/> </mapping> </element> <element id="AdverseEvent.actuality"> <path value="AdverseEvent.actuality"/> <short value="actual | potential"/> <definition value="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."/>
<comment value="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."/>
<min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.actuality"/> <min value="1"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because it has a potential code that indicates
the adverse event did not actually happen."/>
<isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventActuality"/> </extension> <strength value="required"/> <description value="Overall nature of the adverse event, e.g. real or potential."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0-draft-final"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.class"/> </mapping> </element> <element id="AdverseEvent.category"> <path value="AdverseEvent.category"/> <short value="wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment
| hospital-aquired-infection | wrong-body-site"/>
<definition value="The overall type of event, intended for search and filtering purposes."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.category"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCategory"/> </extension> <strength value="example"/> <description value="Overall categorization of the event, e.g. product-related or situational."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-category"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.class"/> </mapping> </element> <element id="AdverseEvent.code"> <path value="AdverseEvent.code"/> <short value="Event or incident that occurred or was averted"/> <definition value="Specific event that occurred or that was averted, such as patient fall, wrong organ
removed, or wrong blood transfused."/>
<min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.code"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventType"/> </extension> <strength value="example"/> <description value="Detailed type of event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-type"/> </binding> <mapping> <identity value="workflow"/> <map value="Event.code"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> </element> <element id="AdverseEvent.subject"> <path value="AdverseEvent.subject"/> <short value="Subject impacted by event"/> <definition value="This subject or group impacted by the event."/> <comment value="If AdverseEvent.resultingEffect differs among members of the group, then use Patient
as the subject."/>
<requirements value="Allows for exposure of biohazard (such as legionella) to a group of individuals
in a hospital."/>
<alias value="patient"/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.subject"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.subject"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.subject[x]"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.subject"/> </mapping> </element> <element id="AdverseEvent.encounter"> <path value="AdverseEvent.encounter"/> <short value="The Encounter associated with the start of the AdverseEvent"/> <definition value="The Encounter associated with the start of the AdverseEvent."/> <comment value="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."/>
<min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.encounter"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Encounter"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.encounter"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.context"/> </mapping> </element> <element id="AdverseEvent.occurrence[x]"> <path value="AdverseEvent.occurrence[x]"/> <short value="When the event occurred"/> <definition value="The date (and perhaps time) when the adverse event occurred."/> <alias value="timing"/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.occurrence[x]"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <type> <code value="Period"/> </type> <type> <code value="Timing"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.occurrence"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.done[x]"/> </mapping> </element> <element id="AdverseEvent.detected"> <path value="AdverseEvent.detected"/> <short value="When the event was detected"/> <definition value="Estimated or actual date the AdverseEvent began, in the opinion of the reporter."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.detected"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.recordedDate"> <path value="AdverseEvent.recordedDate"/> <short value="When the event was recorded"/> <definition value="The date on which the existence of the AdverseEvent was first recorded."/> <comment value="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."/>
<min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.recordedDate"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.recorded"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.recorded"/> </mapping> </element> <element id="AdverseEvent.resultingEffect"> <path value="AdverseEvent.resultingEffect"/> <short value="Effect on the subject due to this event"/> <definition value="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."/>
<min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.resultingEffect"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Condition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Observation"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.location"> <path value="AdverseEvent.location"/> <short value="Location where adverse event occurred"/> <definition value="The information about where the adverse event occurred."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.location"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.location"/> </mapping> </element> <element id="AdverseEvent.seriousness"> <path value="AdverseEvent.seriousness"/> <short value="Seriousness or gravity of the event"/> <definition value="Assessment whether this event, or averted event, was of clinical importance."/> <comment value="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.resu
ltingEffect.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."/>
<min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.seriousness"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventSeriousness"/> </extension> <strength value="example"/> <description value="Overall seriousness of this event for the patient."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-seriousness"/> </binding> </element> <element id="AdverseEvent.outcome"> <path value="AdverseEvent.outcome"/> <short value="Type of outcome from the adverse event"/> <definition value="Describes the type of outcome from the adverse event, such as resolved, recovering,
ongoing, resolved-with-sequelae, or fatal."/>
<min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.outcome"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventOutcome"/> </extension> <strength value="example"/> <description value="Codes describing the type of outcome from the adverse event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-outcome"/> </binding> </element> <element id="AdverseEvent.recorder"> <path value="AdverseEvent.recorder"/> <short value="Who recorded the adverse event"/> <definition value="Information on who recorded the adverse event. May be the patient or a practitioner."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.recorder"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.author"/> </mapping> </element> <element id="AdverseEvent.participant"> <path value="AdverseEvent.participant"/> <short value="Who was involved in the adverse event or the potential adverse event and what they
did"/>
<definition value="Indicates who or what participated in the adverse event and how they were involved."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.participant"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.performer"/> </mapping> </element> <element id="AdverseEvent.participant.id"> <path value="AdverseEvent.participant.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may
be any string value that does not contain spaces."/>
<min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base>
<type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.participant.extension"> <path value="AdverseEvent.participant.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/>
<comment value="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."/>
<alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.participant.modifierExtension"> <path value="AdverseEvent.participant.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="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)."/>
<comment value="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."/>
<requirements value="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](extensibility.html#modifierExtension)."/>
<alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the
element that contains them"/>
<isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.participant.function"> <path value="AdverseEvent.participant.function"/> <short value="Type of involvement"/> <definition value="Distinguishes the type of involvement of the actor in the adverse event, such as
contributor or informant."/>
<min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.participant.function"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventParticipantFunction"/> </extension> <strength value="example"/> <description value="Codes describing the type of involvement of the actor in the adverse event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-participant-function"/> </binding> <mapping> <identity value="workflow"/> <map value="Event.performer.function"/> </mapping> </element> <element id="AdverseEvent.participant.actor"> <path value="AdverseEvent.participant.actor"/> <short value="Who was involved in the adverse event or the potential adverse event"/> <definition value="Indicates who or what participated in the event."/> <comment value="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."/>
<min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.participant.actor"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/CareTeam"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.performer.actor"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.actor"/> </mapping> <mapping> <identity value="rim"/> <map value=".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]"/> </mapping> </element> <element id="AdverseEvent.study"> <path value="AdverseEvent.study"/> <short value="Research study that the subject is enrolled in"/> <definition value="The research study that the subject is enrolled in."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.study"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.expectedInResearchStudy"> <path value="AdverseEvent.expectedInResearchStudy"/> <short value="Considered likely or probable or anticipated in the research study"/> <definition value="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."/>
<min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.expectedInResearchStudy"/> <min value="0"/> <max value="1"/> </base> <type> <code value="boolean"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="AdverseEvent.suspectEntity"> <path value="AdverseEvent.suspectEntity"/> <short value="The suspected agent causing the adverse event"/> <definition value="Describes the entity that is suspected to have caused the adverse event."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.suspectEntity"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.id"> <path value="AdverseEvent.suspectEntity.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may
be any string value that does not contain spaces."/>
<min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base>
<type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.extension"> <path value="AdverseEvent.suspectEntity.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/>
<comment value="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."/>
<alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.modifierExtension"> <path value="AdverseEvent.suspectEntity.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="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)."/>
<comment value="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."/>
<requirements value="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](extensibility.html#modifierExtension)."/>
<alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the
element that contains them"/>
<isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.instance[x]"> <path value="AdverseEvent.suspectEntity.instance[x]"/> <short value="Refers to the specific entity that caused the adverse event"/> <definition value="Identifies the actual instance of what caused the adverse event. May be a substance,
medication, medication administration, medication statement or a device."/>
<alias value="Substance or Medication or Device"/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.instance[x]"/> <min value="1"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Immunization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Substance"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Medication"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationAdministration"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationStatement"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causality"> <path value="AdverseEvent.suspectEntity.causality"/> <short value="Information on the possible cause of the event"/> <definition value="Information on the possible cause of the event."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causality"/> <min value="0"/> <max value="1"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causality.id"> <path value="AdverseEvent.suspectEntity.causality.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may
be any string value that does not contain spaces."/>
<min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base>
<type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.causality.extension"> <path value="AdverseEvent.suspectEntity.causality.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/>
<comment value="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."/>
<alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.causality.modifierExtension"> <path value="AdverseEvent.suspectEntity.causality.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="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)."/>
<comment value="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."/>
<requirements value="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](extensibility.html#modifierExtension)."/>
<alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the
element that contains them"/>
<isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.causality.assessmentMethod"> <path value="AdverseEvent.suspectEntity.causality.assessmentMethod"/> <short value="Method of evaluating the relatedness of the suspected entity to the event"/> <definition value="The method of evaluating the relatedness of the suspected entity to the event."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causality.assessmentMethod"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCausalityMethod"/> </extension> <strength value="example"/> <description value="TODO."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-causality-method"/> </binding> </element> <element id="AdverseEvent.suspectEntity.causality.entityRelatedness"> <path value="AdverseEvent.suspectEntity.causality.entityRelatedness"/> <short value="Result of the assessment regarding the relatedness of the suspected entity to the
event"/>
<definition value="The result of the assessment regarding the relatedness of the suspected entity
to the event."/>
<min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causality.entityRelatedness"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCausalityAssessment"/> </extension> <strength value="example"/> <description value="Codes for the assessment of whether the entity caused the event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-causality-assess"/> </binding> </element> <element id="AdverseEvent.suspectEntity.causality.author"> <path value="AdverseEvent.suspectEntity.causality.author"/> <short value="Author of the information on the possible cause of the event"/> <definition value="The author of the information on the possible cause of the event."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causality.author"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.contributingFactor"> <path value="AdverseEvent.contributingFactor"/> <short value="Contributing factors suspected to have increased the probability or severity of
the adverse event"/>
<definition value="The contributing factors suspected to have increased the probability or severity
of the adverse event."/>
<min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.contributingFactor"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.contributingFactor.id"> <path value="AdverseEvent.contributingFactor.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may
be any string value that does not contain spaces."/>
<min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base>
<type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.contributingFactor.extension"> <path value="AdverseEvent.contributingFactor.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/>
<comment value="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."/>
<alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.contributingFactor.modifierExtension"> <path value="AdverseEvent.contributingFactor.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="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)."/>
<comment value="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."/>
<requirements value="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](extensibility.html#modifierExtension)."/>
<alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the
element that contains them"/>
<isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.contributingFactor.item[x]"> <path value="AdverseEvent.contributingFactor.item[x]"/> <short value="Item suspected to have increased the probability or severity of the adverse event"/> <definition value="The item that is suspected to have increased the probability or severity of the
adverse event."/>
<min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.contributingFactor.item[x]"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Condition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Observation"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/AllergyIntolerance"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Immunization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DeviceUsage"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationAdministration"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationStatement"/> </type> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventContributingFactor"/> </extension> <strength value="example"/> <description value="Codes describing the contributing factors suspected to have increased the probability
or severity of the adverse event."/>
<valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor"/> </binding> </element> <element id="AdverseEvent.preventiveAction"> <path value="AdverseEvent.preventiveAction"/> <short value="Preventive actions that contributed to avoiding the adverse event"/> <definition value="Preventive actions that contributed to avoiding the adverse event."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.preventiveAction"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.preventiveAction.id"> <path value="AdverseEvent.preventiveAction.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may
be any string value that does not contain spaces."/>
<min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base>
<type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.preventiveAction.extension"> <path value="AdverseEvent.preventiveAction.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/>
<comment value="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."/>
<alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.preventiveAction.modifierExtension"> <path value="AdverseEvent.preventiveAction.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="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)."/>
<comment value="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."/>
<requirements value="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](extensibility.html#modifierExtension)."/>
<alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the
element that contains them"/>
<isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.preventiveAction.item[x]"> <path value="AdverseEvent.preventiveAction.item[x]"/> <short value="Action that contributed to avoiding the adverse event"/> <definition value="The action that contributed to avoiding the adverse event."/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.preventiveAction.item[x]"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Immunization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationAdministration"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationRequest"/> </type> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventPreventiveAction"/> </extension> <strength value="example"/> <description value="Codes describing the preventive actions that contributed to avoiding the adverse
event."/>
<valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-preventive-action"/> </binding> </element> <element id="AdverseEvent.mitigatingAction"> <path value="AdverseEvent.mitigatingAction"/> <short value="Ameliorating actions taken after the adverse event occured in order to reduce the
extent of harm"/>
<definition value="The ameliorating action taken after the adverse event occured in order to reduce
the extent of harm."/>
<min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.mitigatingAction"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.mitigatingAction.id"> <path value="AdverseEvent.mitigatingAction.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may
be any string value that does not contain spaces."/>
<min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base>
<type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.mitigatingAction.extension"> <path value="AdverseEvent.mitigatingAction.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/>
<comment value="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."/>
<alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.mitigatingAction.modifierExtension"> <path value="AdverseEvent.mitigatingAction.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="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)."/>
<comment value="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."/>
<requirements value="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](extensibility.html#modifierExtension)."/>
<alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the
element that contains them"/>
<isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.mitigatingAction.item[x]"> <path value="AdverseEvent.mitigatingAction.item[x]"/> <short value="Ameliorating action taken after the adverse event occured in order to reduce the
extent of harm"/>
<definition value="The ameliorating action taken after the adverse event occured in order to reduce
the extent of harm."/>
<min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.mitigatingAction.item[x]"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationAdministration"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationRequest"/> </type> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventMitigatingAction"/> </extension> <strength value="example"/> <description value="Codes describing the ameliorating actions taken after the adverse event occured
in order to reduce the extent of harm."/>
<valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action"/> </binding> </element> <element id="AdverseEvent.supportingInfo"> <path value="AdverseEvent.supportingInfo"/> <short value="Supporting information relevant to the event"/> <definition value="Supporting information relevant to the event."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.supportingInfo"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.supportingInfo.id"> <path value="AdverseEvent.supportingInfo.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may
be any string value that does not contain spaces."/>
<min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base>
<type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.supportingInfo.extension"> <path value="AdverseEvent.supportingInfo.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/>
<comment value="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."/>
<alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.supportingInfo.modifierExtension"> <path value="AdverseEvent.supportingInfo.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="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)."/>
<comment value="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."/>
<requirements value="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](extensibility.html#modifierExtension)."/>
<alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the
element that contains them"/>
<isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.supportingInfo.item[x]"> <path value="AdverseEvent.supportingInfo.item[x]"/> <short value="Subject medical history or document relevant to this adverse event"/> <definition value="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."/>
<min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.supportingInfo.item[x]"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Condition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Observation"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/AllergyIntolerance"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Immunization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationAdministration"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationStatement"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/QuestionnaireResponse"/> </type> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventSupportingInfo"/> </extension> <strength value="example"/> <description value="Codes describing the supporting information relevant to the event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-supporting-info"/> </binding> </element> <element id="AdverseEvent.note"> <path value="AdverseEvent.note"/> <short value="Comment on adverse event"/> <definition value="Comments made about the adverse event by the performer, subject or other participants."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.note"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Annotation"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> </snapshot> <differential> <element id="AdverseEvent"> <path value="AdverseEvent"/> <short value="An event that may be related to unintended effects on a patient or research participant"/> <definition value="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."/>
<alias value="AE"/> <min value="0"/> <max value="*"/> <mustSupport value="false"/> <isModifier value="false"/> <mapping> <identity value="workflow"/> <map value="Event"/> </mapping> <mapping> <identity value="rim"/> <map value="Act"/> </mapping> <mapping> <identity value="w5"/> <map value="clinical.general"/> </mapping> </element> <element id="AdverseEvent.identifier"> <path value="AdverseEvent.identifier"/> <short value="Business identifier for the event"/> <definition value="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."/>
<comment value="This is a business identifier, not a resource identifier (see [discussion](resource.html#iden
tifiers)). 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."/>
<requirements value="Allows identification of the adverse event as it is known by various participating
systems and in a way that remains consistent across servers."/>
<min value="0"/> <max value="*"/> <type> <code value="Identifier"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.identifier"/> </mapping> </element> <element id="AdverseEvent.status"> <path value="AdverseEvent.status"/> <short value="in-progress | completed | entered-in-error | unknown"/> <definition value="The current state of the adverse event or potential adverse event."/> <comment value="This is not the reporting of the event to any regulatory or quality organization.
This is not the outcome of the patient's condition."/>
<min value="1"/> <max value="1"/> <type> <code value="code"/> </type> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="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"/>
<isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventStatus"/> </extension> <strength value="required"/> <description value="Codes identifying the lifecycle stage of an event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0-draft-final"/> </binding> <mapping> <identity value="workflow"/> <map value="Event.status"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.status"/> </mapping> </element> <element id="AdverseEvent.actuality"> <path value="AdverseEvent.actuality"/> <short value="actual | potential"/> <definition value="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."/>
<comment value="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."/>
<min value="1"/> <max value="1"/> <type> <code value="code"/> </type> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because it has a potential code that indicates
the adverse event did not actually happen."/>
<isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventActuality"/> </extension> <strength value="required"/> <description value="Overall nature of the adverse event, e.g. real or potential."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0-draft-final"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.class"/> </mapping> </element> <element id="AdverseEvent.category"> <path value="AdverseEvent.category"/> <short value="wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment
| hospital-aquired-infection | wrong-body-site"/>
<definition value="The overall type of event, intended for search and filtering purposes."/> <min value="0"/> <max value="*"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCategory"/> </extension> <strength value="example"/> <description value="Overall categorization of the event, e.g. product-related or situational."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-category"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.class"/> </mapping> </element> <element id="AdverseEvent.code"> <path value="AdverseEvent.code"/> <short value="Event or incident that occurred or was averted"/> <definition value="Specific event that occurred or that was averted, such as patient fall, wrong organ
removed, or wrong blood transfused."/>
<min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventType"/> </extension> <strength value="example"/> <description value="Detailed type of event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-type"/> </binding> <mapping> <identity value="workflow"/> <map value="Event.code"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> </element> <element id="AdverseEvent.subject"> <path value="AdverseEvent.subject"/> <short value="Subject impacted by event"/> <definition value="This subject or group impacted by the event."/> <comment value="If AdverseEvent.resultingEffect differs among members of the group, then use Patient
as the subject."/>
<requirements value="Allows for exposure of biohazard (such as legionella) to a group of individuals
in a hospital."/>
<alias value="patient"/> <min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.subject"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.subject[x]"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.subject"/> </mapping> </element> <element id="AdverseEvent.encounter"> <path value="AdverseEvent.encounter"/> <short value="The Encounter associated with the start of the AdverseEvent"/> <definition value="The Encounter associated with the start of the AdverseEvent."/> <comment value="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."/>
<min value="0"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Encounter"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.encounter"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.context"/> </mapping> </element> <element id="AdverseEvent.occurrence[x]"> <path value="AdverseEvent.occurrence[x]"/> <short value="When the event occurred"/> <definition value="The date (and perhaps time) when the adverse event occurred."/> <alias value="timing"/> <min value="0"/> <max value="1"/> <type> <code value="dateTime"/> </type> <type> <code value="Period"/> </type> <type> <code value="Timing"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.occurrence"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.done[x]"/> </mapping> </element> <element id="AdverseEvent.detected"> <path value="AdverseEvent.detected"/> <short value="When the event was detected"/> <definition value="Estimated or actual date the AdverseEvent began, in the opinion of the reporter."/> <min value="0"/> <max value="1"/> <type> <code value="dateTime"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.recordedDate"> <path value="AdverseEvent.recordedDate"/> <short value="When the event was recorded"/> <definition value="The date on which the existence of the AdverseEvent was first recorded."/> <comment value="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."/>
<min value="0"/> <max value="1"/> <type> <code value="dateTime"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.recorded"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.recorded"/> </mapping> </element> <element id="AdverseEvent.resultingEffect"> <path value="AdverseEvent.resultingEffect"/> <short value="Effect on the subject due to this event"/> <definition value="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."/>
<min value="0"/> <max value="*"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Condition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Observation"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.location"> <path value="AdverseEvent.location"/> <short value="Location where adverse event occurred"/> <definition value="The information about where the adverse event occurred."/> <min value="0"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.location"/> </mapping> </element> <element id="AdverseEvent.seriousness"> <path value="AdverseEvent.seriousness"/> <short value="Seriousness or gravity of the event"/> <definition value="Assessment whether this event, or averted event, was of clinical importance."/> <comment value="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.resu
ltingEffect.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."/>
<min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventSeriousness"/> </extension> <strength value="example"/> <description value="Overall seriousness of this event for the patient."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-seriousness"/> </binding> </element> <element id="AdverseEvent.outcome"> <path value="AdverseEvent.outcome"/> <short value="Type of outcome from the adverse event"/> <definition value="Describes the type of outcome from the adverse event, such as resolved, recovering,
ongoing, resolved-with-sequelae, or fatal."/>
<min value="0"/> <max value="*"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventOutcome"/> </extension> <strength value="example"/> <description value="Codes describing the type of outcome from the adverse event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-outcome"/> </binding> </element> <element id="AdverseEvent.recorder"> <path value="AdverseEvent.recorder"/> <short value="Who recorded the adverse event"/> <definition value="Information on who recorded the adverse event. May be the patient or a practitioner."/> <min value="0"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.author"/> </mapping> </element> <element id="AdverseEvent.participant"> <path value="AdverseEvent.participant"/> <short value="Who was involved in the adverse event or the potential adverse event and what they
did"/>
<definition value="Indicates who or what participated in the adverse event and how they were involved."/> <min value="0"/> <max value="*"/> <type> <code value="BackboneElement"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.performer"/> </mapping> </element> <element id="AdverseEvent.participant.function"> <path value="AdverseEvent.participant.function"/> <short value="Type of involvement"/> <definition value="Distinguishes the type of involvement of the actor in the adverse event, such as
contributor or informant."/>
<min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventParticipantFunction"/> </extension> <strength value="example"/> <description value="Codes describing the type of involvement of the actor in the adverse event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-participant-function"/> </binding> <mapping> <identity value="workflow"/> <map value="Event.performer.function"/> </mapping> </element> <element id="AdverseEvent.participant.actor"> <path value="AdverseEvent.participant.actor"/> <short value="Who was involved in the adverse event or the potential adverse event"/> <definition value="Indicates who or what participated in the event."/> <comment value="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."/>
<min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/CareTeam"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="workflow"/> <map value="Event.performer.actor"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.actor"/> </mapping> <mapping> <identity value="rim"/> <map value=".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]"/> </mapping> </element> <element id="AdverseEvent.study"> <path value="AdverseEvent.study"/> <short value="Research study that the subject is enrolled in"/> <definition value="The research study that the subject is enrolled in."/> <min value="0"/> <max value="*"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.expectedInResearchStudy"> <path value="AdverseEvent.expectedInResearchStudy"/> <short value="Considered likely or probable or anticipated in the research study"/> <definition value="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."/>
<min value="0"/> <max value="1"/> <type> <code value="boolean"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="AdverseEvent.suspectEntity"> <path value="AdverseEvent.suspectEntity"/> <short value="The suspected agent causing the adverse event"/> <definition value="Describes the entity that is suspected to have caused the adverse event."/> <min value="0"/> <max value="*"/> <type> <code value="BackboneElement"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.instance[x]"> <path value="AdverseEvent.suspectEntity.instance[x]"/> <short value="Refers to the specific entity that caused the adverse event"/> <definition value="Identifies the actual instance of what caused the adverse event. May be a substance,
medication, medication administration, medication statement or a device."/>
<alias value="Substance or Medication or Device"/> <min value="1"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Immunization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Substance"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Medication"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationAdministration"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationStatement"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causality"> <path value="AdverseEvent.suspectEntity.causality"/> <short value="Information on the possible cause of the event"/> <definition value="Information on the possible cause of the event."/> <min value="0"/> <max value="1"/> <type> <code value="BackboneElement"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causality.assessmentMethod"> <path value="AdverseEvent.suspectEntity.causality.assessmentMethod"/> <short value="Method of evaluating the relatedness of the suspected entity to the event"/> <definition value="The method of evaluating the relatedness of the suspected entity to the event."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCausalityMethod"/> </extension> <strength value="example"/> <description value="TODO."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-causality-method"/> </binding> </element> <element id="AdverseEvent.suspectEntity.causality.entityRelatedness"> <path value="AdverseEvent.suspectEntity.causality.entityRelatedness"/> <short value="Result of the assessment regarding the relatedness of the suspected entity to the
event"/>
<definition value="The result of the assessment regarding the relatedness of the suspected entity
to the event."/>
<min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCausalityAssessment"/> </extension> <strength value="example"/> <description value="Codes for the assessment of whether the entity caused the event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-causality-assess"/> </binding> </element> <element id="AdverseEvent.suspectEntity.causality.author"> <path value="AdverseEvent.suspectEntity.causality.author"/> <short value="Author of the information on the possible cause of the event"/> <definition value="The author of the information on the possible cause of the event."/> <min value="0"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.contributingFactor"> <path value="AdverseEvent.contributingFactor"/> <short value="Contributing factors suspected to have increased the probability or severity of
the adverse event"/>
<definition value="The contributing factors suspected to have increased the probability or severity
of the adverse event."/>
<min value="0"/> <max value="*"/> <type> <code value="BackboneElement"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.contributingFactor.item[x]"> <path value="AdverseEvent.contributingFactor.item[x]"/> <short value="Item suspected to have increased the probability or severity of the adverse event"/> <definition value="The item that is suspected to have increased the probability or severity of the
adverse event."/>
<min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Condition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Observation"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/AllergyIntolerance"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Immunization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DeviceUsage"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationAdministration"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationStatement"/> </type> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventContributingFactor"/> </extension> <strength value="example"/> <description value="Codes describing the contributing factors suspected to have increased the probability
or severity of the adverse event."/>
<valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor"/> </binding> </element> <element id="AdverseEvent.preventiveAction"> <path value="AdverseEvent.preventiveAction"/> <short value="Preventive actions that contributed to avoiding the adverse event"/> <definition value="Preventive actions that contributed to avoiding the adverse event."/> <min value="0"/> <max value="*"/> <type> <code value="BackboneElement"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.preventiveAction.item[x]"> <path value="AdverseEvent.preventiveAction.item[x]"/> <short value="Action that contributed to avoiding the adverse event"/> <definition value="The action that contributed to avoiding the adverse event."/> <min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Immunization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationAdministration"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationRequest"/> </type> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventPreventiveAction"/> </extension> <strength value="example"/> <description value="Codes describing the preventive actions that contributed to avoiding the adverse
event."/>
<valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-preventive-action"/> </binding> </element> <element id="AdverseEvent.mitigatingAction"> <path value="AdverseEvent.mitigatingAction"/> <short value="Ameliorating actions taken after the adverse event occured in order to reduce the
extent of harm"/>
<definition value="The ameliorating action taken after the adverse event occured in order to reduce
the extent of harm."/>
<min value="0"/> <max value="*"/> <type> <code value="BackboneElement"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.mitigatingAction.item[x]"> <path value="AdverseEvent.mitigatingAction.item[x]"/> <short value="Ameliorating action taken after the adverse event occured in order to reduce the
extent of harm"/>
<definition value="The ameliorating action taken after the adverse event occured in order to reduce
the extent of harm."/>
<min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationAdministration"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationRequest"/> </type> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventMitigatingAction"/> </extension> <strength value="example"/> <description value="Codes describing the ameliorating actions taken after the adverse event occured
in order to reduce the extent of harm."/>
<valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action"/> </binding> </element> <element id="AdverseEvent.supportingInfo"> <path value="AdverseEvent.supportingInfo"/> <short value="Supporting information relevant to the event"/> <definition value="Supporting information relevant to the event."/> <min value="0"/> <max value="*"/> <type> <code value="BackboneElement"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.supportingInfo.item[x]"> <path value="AdverseEvent.supportingInfo.item[x]"/> <short value="Subject medical history or document relevant to this adverse event"/> <definition value="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."/>
<min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Condition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Observation"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/AllergyIntolerance"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Immunization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationAdministration"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationStatement"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/QuestionnaireResponse"/> </type> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventSupportingInfo"/> </extension> <strength value="example"/> <description value="Codes describing the supporting information relevant to the event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-supporting-info"/> </binding> </element> <element id="AdverseEvent.note"> <path value="AdverseEvent.note"/> <short value="Comment on adverse event"/> <definition value="Comments made about the adverse event by the performer, subject or other participants."/> <min value="0"/> <max value="*"/> <type> <code value="Annotation"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> </differential>
</
StructureDefinition
>
Usage
note:
every
effort
has
been
made
to
ensure
that
the
examples
are
correct
and
useful,
but
they
are
not
a
normative
part
of
the
specification.