R4 Draft for Comment

This 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 GroupMaturity Level: 0 Draft Compartments: Patient, Practitioner, RelatedPerson

Detailed Descriptions for the elements in the AdverseEvent resource.

AdverseEvent
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.

Control1..1
Alternate NamesAE
Summarytrue
AdverseEvent.identifier
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.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Summarytrue
AdverseEvent.actuality
Definition

Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.

Control1..1
Terminology BindingAdverseEventActuality (Required)
Typecode
Is Modifiertrue
Summarytrue
AdverseEvent.category
Definition

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

Control0..*
Terminology BindingAdverseEventCategory (Extensible)
TypeCodeableConcept
Summarytrue
AdverseEvent.event
Definition

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

Control0..1
Terminology BindingSNOMED CT Clinical Findings (Example)
TypeCodeableConcept
Summarytrue
AdverseEvent.subject
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.

Control0..1
TypeReference(Patient | Group | Practitioner | RelatedPerson)
Alternate Namespatient
Summarytrue
Comments

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

AdverseEvent.date
Definition

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

Control0..1
TypedateTime
Summarytrue
AdverseEvent.resultingCondition
Definition

Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).

Control0..*
TypeReference(Condition)
Summarytrue
AdverseEvent.location
Definition

The information about where the adverse event occurred.

Control0..1
TypeReference(Location)
Summarytrue
AdverseEvent.seriousness
Definition

Assessment whether this event was of real importance.

Control0..1
Terminology BindingAdverseEventSeriousness (Example)
TypeCodeableConcept
Summarytrue
AdverseEvent.severity
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.

Control0..1
Terminology BindingAdverseEventSeverity (Required)
TypeCodeableConcept
Summarytrue
AdverseEvent.outcome
Definition

Describes the type of outcome from the adverse event.

Control0..1
Terminology BindingAdverseEventOutcome (Required)
TypeCodeableConcept
Summarytrue
AdverseEvent.recorder
Definition

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

Control0..1
TypeReference(Patient | Practitioner | RelatedPerson)
Summarytrue
AdverseEvent.eventParticipant
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).

Control0..1
TypeReference(Practitioner | Device)
Summarytrue
AdverseEvent.description
Definition

Describes the adverse event in text.

Control0..1
Typestring
Summarytrue
AdverseEvent.suspectEntity
Definition

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

Control0..*
Summarytrue
AdverseEvent.suspectEntity.instance
Definition

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

Control1..1
TypeReference(Substance | Medication | MedicationAdministration | MedicationStatement | Device)
Alternate NamesSubstance or Medication or Device
Summarytrue
AdverseEvent.suspectEntity.causality
Definition

Information on the possible cause of the event.

Control0..*
Summarytrue
To Dois this meant to be a backbone element?
AdverseEvent.suspectEntity.causality.assessment
Definition

Assessment of if the entity caused the event.

Control0..1
Terminology BindingAdverseEventCausalityAssessment (Example)
TypeCodeableConcept
Summarytrue
To Dowhat is difference between assessment and result?
AdverseEvent.suspectEntity.causality.productRelatedness
Definition

AdverseEvent.suspectEntity.causalityProductRelatedness.

Control0..1
Typestring
Summarytrue
AdverseEvent.suspectEntity.causality.author
Definition

AdverseEvent.suspectEntity.causalityAuthor.

Control0..1
TypeReference(Practitioner | PractitionerRole)
Summarytrue
AdverseEvent.suspectEntity.causality.method
Definition

ProbabilityScale | Bayesian | Checklist.

Control0..1
Terminology BindingAdverseEventCausalityMethod (Example)
TypeCodeableConcept
Summarytrue
AdverseEvent.subjectMedicalHistory
Definition

AdverseEvent.subjectMedicalHistory.

Control0..*
TypeReference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure)
Summarytrue
AdverseEvent.referenceDocument
Definition

AdverseEvent.referenceDocument.

Control0..*
TypeReference(DocumentReference)
Summarytrue
AdverseEvent.study
Definition

AdverseEvent.study.

Control0..*
TypeReference(ResearchStudy)
Summarytrue