R6 Ballot (2nd Draft)
Clinical SummaryPublish-box (todo)
| Patient Care Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Patient, Practitioner, RelatedPerson |
Raw XML (canonical form + also see XML Format Specification)
StructureDefinition for adverseevent
<?xml version="1.0" encoding="UTF-8"?> <StructureDefinition xmlns="http://hl7.org/fhir"> <id value="AdverseEvent"/> <meta> <lastUpdated value="2024-08-12T16:52:12.437+08:00"/> </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: top;"> <tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"> <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="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 solid; padding:0px 4px 0px 4px"> <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a> </th> <th class="hierarchy" style="width: 100px"> <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</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="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="data:(snipped in html view)" style="background-color: inherit"/> </a> </span> </th> </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/LjIAAAAJUlEQVR4Xu3IIQEAAAgDsHd9/w4EQIOamFnaBgAA4M MKAACAKwNp30CqZFfFmwAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Resource"/> <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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" 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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" 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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" 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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" 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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" 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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" 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> ) </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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource"/> <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 #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="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 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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Choice of Types"/> <span title="AdverseEvent.cause[x] : The date (and perhaps time) when the cause of the AdverseEvent occurred.">cause[x]</span> <a name="AdverseEvent.cause_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 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"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">When the cause of the AdverseEvent occurred <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/LjIAAAAMUlEQVR4Xu3LMQoAIBA Dwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type"/> <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.">causeDateTime</span> </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"/> <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"/> </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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="A time period defined by a start and end date and optionally time.">causePeriod</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: #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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Choice of Types"/> <span title="AdverseEvent.effect[x] : The date (and perhaps time) when the effect of the AdverseEvent occurred.">effect[x]</span> <a name="AdverseEvent.effect_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">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"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">When the effect of the AdverseEvent 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/LjIAAAAMUlEQVR4Xu3LMQoAIBADwftr/v8GtdbqEAthAtMspJ JUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Primitive Data Type"/> <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.">effectDateTime</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#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"/> </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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <span title="A time period defined by a start and end date and optionally time.">effectPeriod</span> </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"/> <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#Period">Period</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: 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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Primitive Data Type"/> <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 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#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: #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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type"/> <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 e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj 9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource"/> <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 9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" 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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" 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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" 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> ) </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: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Element"/> <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 e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBADwftr/v8GtdbqEAthAtMspJ JUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Data Type"/> <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: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource"/> <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> ) </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 e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj 9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <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 EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type"/> <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 e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj 9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Element"/> <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 #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBA Dwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource"/> <span title="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.">instance</span> <a name="AdverseEvent.suspectEntity.instance"> </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#CodeableReference">CodeableReference</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">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 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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Element"/> <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 #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3NoQ0AIBR Dwb9r958B0KAgAcw1OfNMK0ntGGtze+n3PwAAcG4JAAAAt3RWK0BWYk6o4QAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Data Type"/> <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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource"/> <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> ) </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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <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="references.html#CodeableReference">CodeableReference</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 solid; padding:0px 4px 0px 4px">Contributing factors 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/> <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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource"/> <span title="AdverseEvent.preventiveAction : Preventive actions that contributed to avoiding the adverse event.">preventiveAction</span> <a name="AdverseEvent.preventiveAction"> </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="references.html#CodeableReference">CodeableReference</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="medicationrequest.html">MedicationRequest</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Preventive actions that contributed to avoiding the adverse event <br/> Binding: <a href="valueset-adverse-event-preventive-action.html">AdverseEvent Preventive Action</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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="AdverseEvent.mitigatingAction : The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm.">mitigatingAction</span> <a name="AdverseEvent.mitigatingAction"> </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#CodeableReference">CodeableReference</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 solid; padding:0px 4px 0px 4px">Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm <br/> Binding: <a href="valueset-adverse-event-mitigating-action.html">AdverseEvent Mitigating Action</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:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource"/> <span title="AdverseEvent.supportingInfo : Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin 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.">supportingInfo</span> <a name="AdverseEvent.supportingInfo"> </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="references.html#CodeableReference">CodeableReference</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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Subject medical history or document relevant to this adverse event <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> ) <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/LjIAAAAJUlEQVR4Xu3IIQEAAAgDsHd9/w4EQIOamFnaBgAA4M MKAACAKwNp30CqZFfFmwAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="AdverseEvent.note : Comments made about the adverse event by the performer, subject or other participants.">note</span> <a name="AdverseEvent.note"> </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#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="data:(snipped in html view)" 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-wg"> <valueCode value="pc"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"> <valueInteger value="2"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category"> <valueCode value="patient"/> </extension> <url value="http://hl7.org/fhir/StructureDefinition/AdverseEvent"/> <version value="6.0.0-ballot2"/> <name value="AdverseEvent"/> <status value="draft"/> <experimental value="false"/> <date value="2024-08-12T16:52:12+08:00"/> <publisher value="HL7 International / Patient Care"/> <contact> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/fiwg"/> </telecom> </contact> <contact> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/patientcare"/> </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="6.0.0-ballot2"/> <mapping> <identity value="workflow"/> <uri value="http://hl7.org/fhir/workflow"/> <name value="Workflow Pattern"/> </mapping> <mapping> <identity value="w5"/> <uri value="http://hl7.org/fhir/fivews"/> <name value="FiveWs Pattern Mapping"/> </mapping> <mapping> <identity value="rim"/> <uri value="http://hl7.org/v3"/> <name value="RIM 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,Act"/> </mapping> <mapping> <identity value="workflow"/> <map value="Event"/> </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> <!-- Note: special primitive values have a FHIRPath system type. e.g. this is compiler magic (j) --> <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|6.0.0-ballot2"/> <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> <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> <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. The adverse event status may be determined by the timing of the clinical trial assessments and is not necessarily the same as the condition status."/> <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|6.0.0-ballot2"/> </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|6.0.0-ballot2"/> </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"/> </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> </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.cause[x]"> <path value="AdverseEvent.cause[x]"/> <short value="When the cause of the AdverseEvent occurred"/> <definition value="The date (and perhaps time) when the cause of the AdverseEvent occurred."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.cause[x]"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <type> <code value="Period"/> </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.effect[x]"> <path value="AdverseEvent.effect[x]"/> <short value="When the effect of the AdverseEvent occurred"/> <definition value="The date (and perhaps time) when the effect of the AdverseEvent occurred."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.effect[x]"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <type> <code value="Period"/> </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"/> </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."/> <comment value="The participant should not be used when there is another element to capture the participation, such as subject or recorder."/> <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> <!-- Note: special primitive values have a FHIRPath system type. e.g. this is compiler magic (j) --> <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> <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> <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. The subject can be a participant if the subject was involved in the adverse event in another capacity beyond just being the subject, such as when the subject is a contributor or informant."/> <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"/> </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> <!-- Note: special primitive values have a FHIRPath system type. e.g. this is compiler magic (j) --> <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> <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> <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"> <path value="AdverseEvent.suspectEntity.instance"/> <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."/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.instance"/> <min value="1"/> <max value="1"/> </base> <type> <code value="CodeableReference"/> <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> <!-- Note: special primitive values have a FHIRPath system type. e.g. this is compiler magic (j) --> <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> <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> <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"/> </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="CodeableReference"/> <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> <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="CodeableReference"/> <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> <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 occurred in order to reduce the extent of harm"/> <definition value="The ameliorating action taken after the adverse event occurred 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="CodeableReference"/> <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> <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="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 penicillin 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="0"/> <max value="*"/> <base> <path value="AdverseEvent.supportingInfo"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableReference"/> <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> <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="w5"/> <map value="clinical.general"/> </mapping> <mapping> <identity value="rim"/> <map value="Act"/> </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. The adverse event status may be determined by the timing of the clinical trial assessments and is not necessarily the same as the condition status."/> <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|6.0.0-ballot2"/> </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|6.0.0-ballot2"/> </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"/> </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> </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.cause[x]"> <path value="AdverseEvent.cause[x]"/> <short value="When the cause of the AdverseEvent occurred"/> <definition value="The date (and perhaps time) when the cause of the AdverseEvent occurred."/> <min value="0"/> <max value="1"/> <type> <code value="dateTime"/> </type> <type> <code value="Period"/> </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.effect[x]"> <path value="AdverseEvent.effect[x]"/> <short value="When the effect of the AdverseEvent occurred"/> <definition value="The date (and perhaps time) when the effect of the AdverseEvent occurred."/> <min value="0"/> <max value="1"/> <type> <code value="dateTime"/> </type> <type> <code value="Period"/> </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"/> </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."/> <comment value="The participant should not be used when there is another element to capture the participation, such as subject or recorder."/> <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. The subject can be a participant if the subject was involved in the adverse event in another capacity beyond just being the subject, such as when the subject is a contributor or informant."/> <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"/> </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"> <path value="AdverseEvent.suspectEntity.instance"/> <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."/> <min value="1"/> <max value="1"/> <type> <code value="CodeableReference"/> <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"/> </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="CodeableReference"/> <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> <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="CodeableReference"/> <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> <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 occurred in order to reduce the extent of harm"/> <definition value="The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm."/> <min value="0"/> <max value="*"/> <type> <code value="CodeableReference"/> <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> <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="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 penicillin 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="0"/> <max value="*"/> <type> <code value="CodeableReference"/> <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> <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.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot2 generated on Mon, Aug 12, 2024 16:57+0800.
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