Release 5 Draft Ballot

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions

Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the ClinicalUseDefinition resource.

ClinicalUseDefinition
Element IdClinicalUseDefinition
Definition

A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.

Cardinality0..*
TypeDomainResource
Summaryfalse
Invariants
Defined on this element
cud-1Rule Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance(ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraIndication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2
ClinicalUseDefinition.identifier
Element IdClinicalUseDefinition.identifier
Definition

Business identifier for this issue.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
ClinicalUseDefinition.type
Element IdClinicalUseDefinition.type
Definition

indication | contraindication | interaction | undesirable-effect | warning.

Cardinality1..1
Terminology BindingClinicalUseIssueType (Required)
Typecode
Summarytrue
ClinicalUseDefinition.category
Element IdClinicalUseDefinition.category
Definition

A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy and Lactation", "Overdose", "Effects on Ability to Drive and Use Machines".

Cardinality0..*
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.subject
Element IdClinicalUseDefinition.subject
Definition

The medication or procedure for which this is an indication.

Cardinality0..*
TypeReference(MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance)
PatternsReference(MedicinalProductDefinition,Medication,ActivityDefinition,PlanDefinition,Device,DeviceDefinition,Substance): No common pattern
Summarytrue
ClinicalUseDefinition.status
Element IdClinicalUseDefinition.status
Definition

Whether this is a current issue or one that has been retired etc.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.contraindication
Element IdClinicalUseDefinition.contraindication
Definition

Specifics for when this is a contraindication.

Cardinality0..1
Summarytrue
ClinicalUseDefinition.contraindication.diseaseSymptomProcedure
Element IdClinicalUseDefinition.contraindication.diseaseSymptomProcedure
Definition

The situation that is being documented as contraindicating against this item.

Cardinality0..1
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.contraindication.diseaseStatus
Element IdClinicalUseDefinition.contraindication.diseaseStatus
Definition

The status of the disease or symptom for the contraindication.

Cardinality0..1
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.contraindication.comorbidity
Element IdClinicalUseDefinition.contraindication.comorbidity
Definition

A comorbidity (concurrent condition) or coinfection.

Cardinality0..*
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.contraindication.indication
Element IdClinicalUseDefinition.contraindication.indication
Definition

The indication which this is a contraidication for.

Cardinality0..*
TypeReference(ClinicalUseDefinition)
Summarytrue
ClinicalUseDefinition.contraindication.otherTherapy
Element IdClinicalUseDefinition.contraindication.otherTherapy
Definition

Information about the use of the medicinal product in relation to other therapies described as part of the contraindication.

Cardinality0..*
Summarytrue
ClinicalUseDefinition.contraindication.otherTherapy.relationshipType
Element IdClinicalUseDefinition.contraindication.otherTherapy.relationshipType
Definition

The type of relationship between the medicinal product indication or contraindication and another therapy.

Cardinality1..1
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.contraindication.otherTherapy.therapy
Element IdClinicalUseDefinition.contraindication.otherTherapy.therapy
Definition

Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication.

Cardinality1..1
TypeCodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | ActivityDefinition)
PatternsCodeableReference(MedicinalProductDefinition,Medication,Substance,SubstanceDefinition,ActivityDefinition): No common pattern
Summarytrue
ClinicalUseDefinition.indication
Element IdClinicalUseDefinition.indication
Definition

Specifics for when this is an indication.

Cardinality0..1
Summarytrue
ClinicalUseDefinition.indication.diseaseSymptomProcedure
Element IdClinicalUseDefinition.indication.diseaseSymptomProcedure
Definition

The situation that is being documented as an indicaton for this item.

Cardinality0..1
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.indication.diseaseStatus
Element IdClinicalUseDefinition.indication.diseaseStatus
Definition

The status of the disease or symptom for the indication.

Cardinality0..1
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.indication.comorbidity
Element IdClinicalUseDefinition.indication.comorbidity
Definition

A comorbidity (concurrent condition) or coinfection as part of the indication.

Cardinality0..*
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.indication.intendedEffect
Element IdClinicalUseDefinition.indication.intendedEffect
Definition

The intended effect, aim or strategy to be achieved.

Cardinality0..1
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.indication.duration
Element IdClinicalUseDefinition.indication.duration
Definition

Timing or duration information.

Cardinality0..1
TypeQuantity
Summarytrue
ClinicalUseDefinition.indication.undesirableEffect
Element IdClinicalUseDefinition.indication.undesirableEffect
Definition

The specific undesirable effects of the medicinal product.

Cardinality0..*
TypeReference(ClinicalUseDefinition)
Summarytrue
ClinicalUseDefinition.indication.otherTherapy
Element IdClinicalUseDefinition.indication.otherTherapy
Definition

Information about the use of the medicinal product in relation to other therapies described as part of the indication.

Cardinality0..*
TypeSee ClinicalUseDefinition.contraindication.otherTherapy
Summarytrue
ClinicalUseDefinition.interaction
Element IdClinicalUseDefinition.interaction
Definition

Specifics for when this is an interaction.

Cardinality0..1
Summarytrue
ClinicalUseDefinition.interaction.interactant
Element IdClinicalUseDefinition.interaction.interactant
Definition

The specific medication, food, substance or laboratory test that interacts.

Cardinality0..*
Summarytrue
ClinicalUseDefinition.interaction.interactant.item[x]
Element IdClinicalUseDefinition.interaction.interactant.item[x]
Definition

The specific medication, food or laboratory test that interacts.

Cardinality1..1
TypeReference(MedicinalProductDefinition | Medication | Substance | ObservationDefinition)|CodeableConcept
PatternsReference(MedicinalProductDefinition,Medication,Substance,ObservationDefinition): No common pattern
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
ClinicalUseDefinition.interaction.type
Element IdClinicalUseDefinition.interaction.type
Definition

The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.interaction.effect
Element IdClinicalUseDefinition.interaction.effect
Definition

The effect of the interaction, for example "reduced gastric absorption of primary medication".

Cardinality0..1
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.interaction.incidence
Element IdClinicalUseDefinition.interaction.incidence
Definition

The incidence of the interaction, e.g. theoretical, observed.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.interaction.management
Element IdClinicalUseDefinition.interaction.management
Definition

Actions for managing the interaction.

Cardinality0..*
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.population
Element IdClinicalUseDefinition.population
Definition

The population group to which this applies.

Cardinality0..*
TypeReference(Group)
Summarytrue
ClinicalUseDefinition.undesirableEffect
Element IdClinicalUseDefinition.undesirableEffect
Definition

Describe the undesirable effects of the medicinal product.

Cardinality0..1
Summarytrue
ClinicalUseDefinition.undesirableEffect.symptomConditionEffect
Element IdClinicalUseDefinition.undesirableEffect.symptomConditionEffect
Definition

The situation in which the undesirable effect may manifest.

Cardinality0..1
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.undesirableEffect.classification
Element IdClinicalUseDefinition.undesirableEffect.classification
Definition

High level classification of the effect.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence
Element IdClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence
Definition

How often the effect is seen.

Cardinality0..1
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.warning
Element IdClinicalUseDefinition.warning
Definition

A critical piece of information about environmental, health or physical risks or hazards that serve as caution to the user. For example 'Do not operate heavy machinery', 'May cause drowsiness', or 'Get medical advice/attention if you feel unwell'.

Cardinality0..1
Summarytrue
ClinicalUseDefinition.warning.description
Element IdClinicalUseDefinition.warning.description
Definition

A textual definition of this warning, with formatting.

Cardinality0..1
Typemarkdown
Summarytrue
ClinicalUseDefinition.warning.code
Element IdClinicalUseDefinition.warning.code
Definition

A coded or unformatted textual definition of this warning.

Cardinality0..1
Terminology BindingWarningType (Example)
TypeCodeableConcept
Summarytrue