R4 Draft for Comment
Clinical SummaryThis page is part of the FHIR Specification (v3.2.0: R4 Ballot 1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
. Page versions: R5 R4B R4 R3
| Patient Care Work Group | Maturity Level: N/A | Ballot Status: Informative | Compartments: Patient, Practitioner, RelatedPerson |
StructureDefinition for adverseevent
{
"resourceType": "StructureDefinition",
"id": "AdverseEvent",
"meta": {
"lastUpdated": "2017-12-20T15:52:34.818+11:00"
},
"text": {
"status": "generated",
"div": "<div>!-- Snipped for Brevity --></div>"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 0
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "pc"
}
],
"url": "http://hl7.org/fhir/StructureDefinition/AdverseEvent",
"name": "AdverseEvent",
"status": "draft",
"date": "2017-12-20T15:52:34+11:00",
"publisher": "Health Level Seven International (Patient Care)",
"contact": [
{
"telecom": [
{
"system": "url",
"value": "http://hl7.org/fhir"
}
]
},
{
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org/Special/committees/patientcare/index.cfm"
}
]
}
],
"description": "Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.",
"fhirVersion": "3.2.0",
"mapping": [
{
"identity": "w5",
"uri": "http://hl7.org/fhir/w5",
"name": "W5 Mapping"
},
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
}
],
"kind": "resource",
"abstract": false,
"type": "AdverseEvent",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"derivation": "specialization",
"snapshot": {
"element": [
{
"id": "AdverseEvent",
"path": "AdverseEvent",
"short": "Medical care, research study or other healthcare event causing physical injury",
"definition": "Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.",
"alias": [
"AE"
],
"min": 0,
"max": "*",
"constraint": [
{
"key": "dom-2",
"severity": "error",
"human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression": "contained.contained.empty()",
"xpath": "not(parent::f:contained and f:contained)",
"source": "DomainResource"
},
{
"key": "dom-1",
"severity": "error",
"human": "If the resource is contained in another resource, it SHALL NOT contain any narrative",
"expression": "contained.text.empty()",
"xpath": "not(parent::f:contained and f:text)",
"source": "DomainResource"
},
{
"key": "dom-4",
"severity": "error",
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"xpath": "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
"source": "DomainResource"
},
{
"key": "dom-3",
"severity": "error",
"human": "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": "contained.all(('#'+id in %resource.descendants().reference) or descendants().where(reference = '#').exists())",
"xpath": "not(exists(for $contained in f:contained return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::reference[@value='#'])]))",
"source": "DomainResource"
}
],
"mapping": [
{
"identity": "rim",
"map": "Entity. Role, or Act"
},
{
"identity": "w5",
"map": "clinical.general"
}
]
},
{
"id": "AdverseEvent.id",
"path": "AdverseEvent.id",
"short": "Logical id of this artifact",
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.id",
"min": 0,
"max": "1"
},
"type": [
{
"code": "id"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.meta",
"path": "AdverseEvent.meta",
"short": "Metadata about the resource",
"definition": "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.meta",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Meta"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.implicitRules",
"path": "AdverseEvent.implicitRules",
"short": "A set of rules under which this content was created",
"definition": "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.",
"comment": "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. \n\nThis element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.implicitRules",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"isModifier": true,
"isSummary": true
},
{
"id": "AdverseEvent.language",
"path": "AdverseEvent.language",
"short": "Language of the resource content",
"definition": "The base language in which the resource is written.",
"comment": "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": 0,
"max": "1",
"base": {
"path": "Resource.language",
"min": 0,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueReference": {
"reference": "http://hl7.org/fhir/ValueSet/all-languages"
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean": true
}
],
"strength": "extensible",
"description": "A human language.",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/languages"
}
}
},
{
"id": "AdverseEvent.text",
"path": "AdverseEvent.text",
"short": "Text summary of the resource, for human interpretation",
"definition": "A human-readable narrative that contains a summary of the resource, and may 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": "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded in formation is added later.",
"alias": [
"narrative",
"html",
"xhtml",
"display"
],
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.text",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Narrative"
}
],
"condition": [
"dom-1"
],
"mapping": [
{
"identity": "rim",
"map": "Act.text?"
}
]
},
{
"id": "AdverseEvent.contained",
"path": "AdverseEvent.contained",
"short": "Contained, inline Resources",
"definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.",
"comment": "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.",
"alias": [
"inline resources",
"anonymous resources",
"contained resources"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.contained",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Resource"
}
],
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "AdverseEvent.extension",
"path": "AdverseEvent.extension",
"short": "Additional Content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "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": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "AdverseEvent.modifierExtension",
"path": "AdverseEvent.modifierExtension",
"short": "Extensions that cannot be ignored",
"definition": "May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.",
"comment": "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": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "AdverseEvent.identifier",
"path": "AdverseEvent.identifier",
"short": "Business identifier for the event",
"definition": "The identifier(s) of this adverse event that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate.",
"min": 0,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.actuality",
"path": "AdverseEvent.actuality",
"short": "actual | potential",
"definition": "Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.",
"min": 1,
"max": "1",
"type": [
{
"code": "code"
}
],
"isModifier": true,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventActuality"
}
],
"strength": "required",
"description": "Overall nature of the event, e.g. real or potential",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-actuality"
}
},
"mapping": [
{
"identity": "w5",
"map": "FiveWs.class"
},
{
"identity": "w5",
"map": "class"
}
]
},
{
"id": "AdverseEvent.category",
"path": "AdverseEvent.category",
"short": "ProductProblem | ProductQuality | ProductUseError | WrongDose | IncorrectPrescribingInformation | WrongTechnique | WrongRouteOfAdministration | WrongRate | WrongDuration | WrongTime | ExpiredDrug | MedicalDeviceUseError | ProblemDifferentManufacturer | UnsafePhysicalEnvironment",
"definition": "The overall type of event, intended for search and filtering purposes.",
"min": 0,
"max": "*",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventCategory"
}
],
"strength": "extensible",
"description": "Overall categorization of the event, e.g. product related or situational",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-category"
}
},
"mapping": [
{
"identity": "w5",
"map": "FiveWs.class"
},
{
"identity": "w5",
"map": "class"
}
]
},
{
"id": "AdverseEvent.event",
"path": "AdverseEvent.event",
"short": "Type of the event itself in relation to the subject",
"definition": "This element defines the specific type of event that occurred or that was prevented from occurring.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventType"
}
],
"strength": "example",
"description": "Detailed type of event",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-type"
}
},
"mapping": [
{
"identity": "w5",
"map": "FiveWs.what[x]"
},
{
"identity": "w5",
"map": "what"
}
]
},
{
"id": "AdverseEvent.subject",
"path": "AdverseEvent.subject",
"short": "Subject impacted by event",
"definition": "This subject or group impacted by the event. With a prospective adverse event, there will be no subject as the adverse event was prevented.",
"comment": "If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.",
"alias": [
"patient"
],
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Patient"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Group"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Practitioner"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/RelatedPerson"
}
],
"isSummary": true,
"mapping": [
{
"identity": "w5",
"map": "FiveWs.who"
},
{
"identity": "w5",
"map": "who"
}
]
},
{
"id": "AdverseEvent.date",
"path": "AdverseEvent.date",
"short": "When the event occurred",
"definition": "The date (and perhaps time) when the adverse event occurred.",
"min": 0,
"max": "1",
"type": [
{
"code": "dateTime"
}
],
"isSummary": true,
"mapping": [
{
"identity": "w5",
"map": "FiveWs.init"
},
{
"identity": "w5",
"map": "when.init"
}
]
},
{
"id": "AdverseEvent.resultingCondition",
"path": "AdverseEvent.resultingCondition",
"short": "Effect on the subject due to this event",
"definition": "Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Condition"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.location",
"path": "AdverseEvent.location",
"short": "Location where adverse event occurred",
"definition": "The information about where the adverse event occurred.",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Location"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.seriousness",
"path": "AdverseEvent.seriousness",
"short": "Seriousness of the event",
"definition": "Assessment whether this event was of real importance.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventSeriousness"
}
],
"strength": "example",
"description": "Overall seriousness of this event for the patient",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-seriousness"
}
}
},
{
"id": "AdverseEvent.severity",
"path": "AdverseEvent.severity",
"short": "Mild | Moderate | Severe",
"definition": "Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.serious - a severe rash might not be serious, but a mild heart problem is.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventSeverity"
}
],
"strength": "required",
"description": "The severity of the adverse event itself, in direct relation to the subject",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-severity"
}
}
},
{
"id": "AdverseEvent.outcome",
"path": "AdverseEvent.outcome",
"short": "resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown",
"definition": "Describes the type of outcome from the adverse event.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventOutcome"
}
],
"strength": "required",
"description": "TODO (and should this be required?)",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-outcome"
}
}
},
{
"id": "AdverseEvent.recorder",
"path": "AdverseEvent.recorder",
"short": "Who recorded the adverse event",
"definition": "Information on who recorded the adverse event. May be the patient or a practitioner.",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Patient"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Practitioner"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/RelatedPerson"
}
],
"isSummary": true,
"mapping": [
{
"identity": "w5",
"map": "FiveWs.author"
},
{
"identity": "w5",
"map": "who.author"
}
]
},
{
"id": "AdverseEvent.eventParticipant",
"path": "AdverseEvent.eventParticipant",
"short": "Who was involved in the adverse event or the potential adverse event",
"definition": "Parties that may or should contribute or have contributed information to the Act. Such information includes information leading to the decision to perform the Act and how to perform the Act (e.g. consultant), information that the Act itself seeks to reveal (e.g. informant of clinical history), or information about what Act was performed (e.g. informant witness).",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Practitioner"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Device"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.description",
"path": "AdverseEvent.description",
"short": "Description of the adverse event",
"definition": "Describes the adverse event in text.",
"min": 0,
"max": "1",
"type": [
{
"code": "string"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.suspectEntity",
"path": "AdverseEvent.suspectEntity",
"short": "The suspected agent causing the adverse event",
"definition": "Describes the entity that is suspected to have caused the adverse event.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() | (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "Element"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.suspectEntity.id",
"path": "AdverseEvent.suspectEntity.id",
"representation": [
"xmlAttr"
],
"short": "xml:id (or equivalent in JSON)",
"definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "AdverseEvent.suspectEntity.extension",
"path": "AdverseEvent.suspectEntity.extension",
"short": "Additional Content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "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": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "AdverseEvent.suspectEntity.modifierExtension",
"path": "AdverseEvent.suspectEntity.modifierExtension",
"short": "Extensions that cannot be ignored",
"definition": "May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.",
"comment": "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": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": true,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "AdverseEvent.suspectEntity.instance",
"path": "AdverseEvent.suspectEntity.instance",
"short": "Refers to the specific entity that caused the adverse event",
"definition": "Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.",
"alias": [
"Substance or Medication or Device"
],
"min": 1,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Substance"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Medication"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/MedicationAdministration"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/MedicationStatement"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Device"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.suspectEntity.causality",
"path": "AdverseEvent.suspectEntity.causality",
"short": "Information on the possible cause of the event",
"definition": "Information on the possible cause of the event.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() | (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "Element"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.suspectEntity.causality.id",
"path": "AdverseEvent.suspectEntity.causality.id",
"representation": [
"xmlAttr"
],
"short": "xml:id (or equivalent in JSON)",
"definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "AdverseEvent.suspectEntity.causality.extension",
"path": "AdverseEvent.suspectEntity.causality.extension",
"short": "Additional Content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "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": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "AdverseEvent.suspectEntity.causality.modifierExtension",
"path": "AdverseEvent.suspectEntity.causality.modifierExtension",
"short": "Extensions that cannot be ignored",
"definition": "May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.",
"comment": "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": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": true,
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "AdverseEvent.suspectEntity.causality.assessment",
"path": "AdverseEvent.suspectEntity.causality.assessment",
"short": "Assessment of if the entity caused the event",
"definition": "Assessment of if the entity caused the event.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventCausalityAssessment"
}
],
"strength": "example",
"description": "TODO",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-causality-assess"
}
}
},
{
"id": "AdverseEvent.suspectEntity.causality.productRelatedness",
"path": "AdverseEvent.suspectEntity.causality.productRelatedness",
"short": "AdverseEvent.suspectEntity.causalityProductRelatedness",
"definition": "AdverseEvent.suspectEntity.causalityProductRelatedness.",
"min": 0,
"max": "1",
"type": [
{
"code": "string"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.suspectEntity.causality.author",
"path": "AdverseEvent.suspectEntity.causality.author",
"short": "AdverseEvent.suspectEntity.causalityAuthor",
"definition": "AdverseEvent.suspectEntity.causalityAuthor.",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Practitioner"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/PractitionerRole"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.suspectEntity.causality.method",
"path": "AdverseEvent.suspectEntity.causality.method",
"short": "ProbabilityScale | Bayesian | Checklist",
"definition": "ProbabilityScale | Bayesian | Checklist.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventCausalityMethod"
}
],
"strength": "example",
"description": "TODO",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-causality-method"
}
}
},
{
"id": "AdverseEvent.subjectMedicalHistory",
"path": "AdverseEvent.subjectMedicalHistory",
"short": "AdverseEvent.subjectMedicalHistory",
"definition": "AdverseEvent.subjectMedicalHistory.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Condition"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Observation"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/AllergyIntolerance"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Immunization"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Procedure"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.referenceDocument",
"path": "AdverseEvent.referenceDocument",
"short": "AdverseEvent.referenceDocument",
"definition": "AdverseEvent.referenceDocument.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/DocumentReference"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.study",
"path": "AdverseEvent.study",
"short": "AdverseEvent.study",
"definition": "AdverseEvent.study.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/ResearchStudy"
}
],
"isSummary": true
}
]
},
"differential": {
"element": [
{
"id": "AdverseEvent",
"path": "AdverseEvent",
"short": "Medical care, research study or other healthcare event causing physical injury",
"definition": "Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.",
"alias": [
"AE"
],
"min": 0,
"max": "*",
"mapping": [
{
"identity": "w5",
"map": "clinical.general"
}
]
},
{
"id": "AdverseEvent.identifier",
"path": "AdverseEvent.identifier",
"short": "Business identifier for the event",
"definition": "The identifier(s) of this adverse event that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate.",
"min": 0,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.actuality",
"path": "AdverseEvent.actuality",
"short": "actual | potential",
"definition": "Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.",
"min": 1,
"max": "1",
"type": [
{
"code": "code"
}
],
"isModifier": true,
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventActuality"
}
],
"strength": "required",
"description": "Overall nature of the event, e.g. real or potential",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-actuality"
}
},
"mapping": [
{
"identity": "w5",
"map": "FiveWs.class"
},
{
"identity": "w5",
"map": "class"
}
]
},
{
"id": "AdverseEvent.category",
"path": "AdverseEvent.category",
"short": "ProductProblem | ProductQuality | ProductUseError | WrongDose | IncorrectPrescribingInformation | WrongTechnique | WrongRouteOfAdministration | WrongRate | WrongDuration | WrongTime | ExpiredDrug | MedicalDeviceUseError | ProblemDifferentManufacturer | UnsafePhysicalEnvironment",
"definition": "The overall type of event, intended for search and filtering purposes.",
"min": 0,
"max": "*",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventCategory"
}
],
"strength": "extensible",
"description": "Overall categorization of the event, e.g. product related or situational",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-category"
}
},
"mapping": [
{
"identity": "w5",
"map": "FiveWs.class"
},
{
"identity": "w5",
"map": "class"
}
]
},
{
"id": "AdverseEvent.event",
"path": "AdverseEvent.event",
"short": "Type of the event itself in relation to the subject",
"definition": "This element defines the specific type of event that occurred or that was prevented from occurring.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventType"
}
],
"strength": "example",
"description": "Detailed type of event",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-type"
}
},
"mapping": [
{
"identity": "w5",
"map": "FiveWs.what[x]"
},
{
"identity": "w5",
"map": "what"
}
]
},
{
"id": "AdverseEvent.subject",
"path": "AdverseEvent.subject",
"short": "Subject impacted by event",
"definition": "This subject or group impacted by the event. With a prospective adverse event, there will be no subject as the adverse event was prevented.",
"comment": "If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.",
"alias": [
"patient"
],
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Patient"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Group"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Practitioner"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/RelatedPerson"
}
],
"isSummary": true,
"mapping": [
{
"identity": "w5",
"map": "FiveWs.who"
},
{
"identity": "w5",
"map": "who"
}
]
},
{
"id": "AdverseEvent.date",
"path": "AdverseEvent.date",
"short": "When the event occurred",
"definition": "The date (and perhaps time) when the adverse event occurred.",
"min": 0,
"max": "1",
"type": [
{
"code": "dateTime"
}
],
"isSummary": true,
"mapping": [
{
"identity": "w5",
"map": "FiveWs.init"
},
{
"identity": "w5",
"map": "when.init"
}
]
},
{
"id": "AdverseEvent.resultingCondition",
"path": "AdverseEvent.resultingCondition",
"short": "Effect on the subject due to this event",
"definition": "Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Condition"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.location",
"path": "AdverseEvent.location",
"short": "Location where adverse event occurred",
"definition": "The information about where the adverse event occurred.",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Location"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.seriousness",
"path": "AdverseEvent.seriousness",
"short": "Seriousness of the event",
"definition": "Assessment whether this event was of real importance.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventSeriousness"
}
],
"strength": "example",
"description": "Overall seriousness of this event for the patient",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-seriousness"
}
}
},
{
"id": "AdverseEvent.severity",
"path": "AdverseEvent.severity",
"short": "Mild | Moderate | Severe",
"definition": "Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.serious - a severe rash might not be serious, but a mild heart problem is.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventSeverity"
}
],
"strength": "required",
"description": "The severity of the adverse event itself, in direct relation to the subject",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-severity"
}
}
},
{
"id": "AdverseEvent.outcome",
"path": "AdverseEvent.outcome",
"short": "resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown",
"definition": "Describes the type of outcome from the adverse event.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventOutcome"
}
],
"strength": "required",
"description": "TODO (and should this be required?)",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-outcome"
}
}
},
{
"id": "AdverseEvent.recorder",
"path": "AdverseEvent.recorder",
"short": "Who recorded the adverse event",
"definition": "Information on who recorded the adverse event. May be the patient or a practitioner.",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Patient"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Practitioner"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/RelatedPerson"
}
],
"isSummary": true,
"mapping": [
{
"identity": "w5",
"map": "FiveWs.author"
},
{
"identity": "w5",
"map": "who.author"
}
]
},
{
"id": "AdverseEvent.eventParticipant",
"path": "AdverseEvent.eventParticipant",
"short": "Who was involved in the adverse event or the potential adverse event",
"definition": "Parties that may or should contribute or have contributed information to the Act. Such information includes information leading to the decision to perform the Act and how to perform the Act (e.g. consultant), information that the Act itself seeks to reveal (e.g. informant of clinical history), or information about what Act was performed (e.g. informant witness).",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Practitioner"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Device"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.description",
"path": "AdverseEvent.description",
"short": "Description of the adverse event",
"definition": "Describes the adverse event in text.",
"min": 0,
"max": "1",
"type": [
{
"code": "string"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.suspectEntity",
"path": "AdverseEvent.suspectEntity",
"short": "The suspected agent causing the adverse event",
"definition": "Describes the entity that is suspected to have caused the adverse event.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.suspectEntity.instance",
"path": "AdverseEvent.suspectEntity.instance",
"short": "Refers to the specific entity that caused the adverse event",
"definition": "Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.",
"alias": [
"Substance or Medication or Device"
],
"min": 1,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Substance"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Medication"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/MedicationAdministration"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/MedicationStatement"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Device"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.suspectEntity.causality",
"path": "AdverseEvent.suspectEntity.causality",
"short": "Information on the possible cause of the event",
"definition": "Information on the possible cause of the event.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.suspectEntity.causality.assessment",
"path": "AdverseEvent.suspectEntity.causality.assessment",
"short": "Assessment of if the entity caused the event",
"definition": "Assessment of if the entity caused the event.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventCausalityAssessment"
}
],
"strength": "example",
"description": "TODO",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-causality-assess"
}
}
},
{
"id": "AdverseEvent.suspectEntity.causality.productRelatedness",
"path": "AdverseEvent.suspectEntity.causality.productRelatedness",
"short": "AdverseEvent.suspectEntity.causalityProductRelatedness",
"definition": "AdverseEvent.suspectEntity.causalityProductRelatedness.",
"min": 0,
"max": "1",
"type": [
{
"code": "string"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.suspectEntity.causality.author",
"path": "AdverseEvent.suspectEntity.causality.author",
"short": "AdverseEvent.suspectEntity.causalityAuthor",
"definition": "AdverseEvent.suspectEntity.causalityAuthor.",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Practitioner"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/PractitionerRole"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.suspectEntity.causality.method",
"path": "AdverseEvent.suspectEntity.causality.method",
"short": "ProbabilityScale | Bayesian | Checklist",
"definition": "ProbabilityScale | Bayesian | Checklist.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "AdverseEventCausalityMethod"
}
],
"strength": "example",
"description": "TODO",
"valueSetReference": {
"reference": "http://hl7.org/fhir/ValueSet/adverse-event-causality-method"
}
}
},
{
"id": "AdverseEvent.subjectMedicalHistory",
"path": "AdverseEvent.subjectMedicalHistory",
"short": "AdverseEvent.subjectMedicalHistory",
"definition": "AdverseEvent.subjectMedicalHistory.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Condition"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Observation"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/AllergyIntolerance"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Immunization"
},
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/Procedure"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.referenceDocument",
"path": "AdverseEvent.referenceDocument",
"short": "AdverseEvent.referenceDocument",
"definition": "AdverseEvent.referenceDocument.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/DocumentReference"
}
],
"isSummary": true
},
{
"id": "AdverseEvent.study",
"path": "AdverseEvent.study",
"short": "AdverseEvent.study",
"definition": "AdverseEvent.study.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": "http://hl7.org/fhir/StructureDefinition/ResearchStudy"
}
],
"isSummary": true
}
]
}
}
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.
®© HL7.org 2011+. FHIR Release 4 Draft for Comment (Jan-2018 v3.2.0-12885) generated on Wed, Dec 20, 2017 15:56+1100. QA Page
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