R6 Ballot (1st Draft)

This page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions

Biomedical Research and Regulation icon Work GroupMaturity Level: 2 Trial UseSecurity Category: Anonymous Compartments: No 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.

Short DisplayA 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.

Short DisplayBusiness 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.

Short Displayindication | contraindication | interaction | undesirable-effect | warning
Cardinality1..1
Terminology BindingClinical Use Definition Type (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".

Short DisplayA categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose"
Cardinality0..*
Terminology BindingClinical Use Definition Category (Preferred)
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.subject
Element IdClinicalUseDefinition.subject
Definition

The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning.

Short DisplayThe medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning
Cardinality0..*
TypeReference(MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | Substance | NutritionProduct | BiologicallyDerivedProduct)
Summarytrue
ClinicalUseDefinition.status
Element IdClinicalUseDefinition.status
Definition

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

Short DisplayWhether this is a current issue or one that has been retired etc
Cardinality0..1
Terminology BindingPublicationStatus (Preferred)
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.contraindication
Element IdClinicalUseDefinition.contraindication
Definition

Specifics for when this is a contraindication.

Short DisplaySpecifics for when this is a contraindication
Cardinality0..1
Summarytrue
Invariants
Affect 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.contraindication.diseaseSymptomProcedure
Element IdClinicalUseDefinition.contraindication.diseaseSymptomProcedure
Definition

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

Short DisplayThe situation that is being documented as contraindicating against this item
Cardinality0..1
Terminology BindingDisease Symptom Procedure (Example)
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.contraindication.diseaseStatus
Element IdClinicalUseDefinition.contraindication.diseaseStatus
Definition

The status of the disease or symptom for the contraindication, for example "chronic" or "metastatic".

Short DisplayThe status of the disease or symptom for the contraindication
Cardinality0..1
Terminology BindingDisease Status (Example)
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.contraindication.comorbidity
Element IdClinicalUseDefinition.contraindication.comorbidity
Definition

A comorbidity (concurrent condition) or coinfection.

Short DisplayA comorbidity (concurrent condition) or coinfection
Cardinality0..*
Terminology BindingDisease Symptom Procedure (Example)
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.contraindication.indication
Element IdClinicalUseDefinition.contraindication.indication
Definition

The indication which this is a contraidication for.

Short DisplayThe indication which this is a contraidication for
Cardinality0..*
TypeReference(ClinicalUseDefinition)
Summarytrue
ClinicalUseDefinition.contraindication.applicability
Element IdClinicalUseDefinition.contraindication.applicability
Definition

An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements.

Short DisplayAn expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
Cardinality0..1
TypeExpression
Summaryfalse
Comments

The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element.

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.

Short DisplayInformation about use of the 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.

Short DisplayThe type of relationship between the product indication/contraindication and another therapy
Cardinality1..1
Terminology BindingTherapy Relationship Type (Preferred)
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.contraindication.otherTherapy.treatment
Element IdClinicalUseDefinition.contraindication.otherTherapy.treatment
Definition

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

Short DisplayReference to a specific medication, substance etc. as part of an indication or contraindication
Cardinality1..1
Terminology BindingTherapy (Example)
TypeCodeableReference(MedicinalProductDefinition | Medication | Substance | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition)
Summarytrue
ClinicalUseDefinition.indication
Element IdClinicalUseDefinition.indication
Definition

Specifics for when this is an indication.

Short DisplaySpecifics for when this is an indication
Cardinality0..1
Summarytrue
Invariants
Affect 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.indication.diseaseSymptomProcedure
Element IdClinicalUseDefinition.indication.diseaseSymptomProcedure
Definition

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

Short DisplayThe situation that is being documented as an indicaton for this item
Cardinality0..1
Terminology BindingDisease Symptom Procedure (Example)
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.indication.diseaseStatus
Element IdClinicalUseDefinition.indication.diseaseStatus
Definition

The status of the disease or symptom for the indication, for example "chronic" or "metastatic".

Short DisplayThe status of the disease or symptom for the indication
Cardinality0..1
Terminology BindingDisease Status (Example)
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.indication.comorbidity
Element IdClinicalUseDefinition.indication.comorbidity
Definition

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

Short DisplayA comorbidity or coinfection as part of the indication
Cardinality0..*
Terminology BindingDisease Symptom Procedure (Example)
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.indication.intendedEffect
Element IdClinicalUseDefinition.indication.intendedEffect
Definition

The intended effect, aim or strategy to be achieved.

Short DisplayThe intended effect, aim or strategy to be achieved
Cardinality0..1
Terminology BindingProduct Intended Use (Preferred)
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.indication.duration[x]
Element IdClinicalUseDefinition.indication.duration[x]
Definition

Timing or duration information, that may be associated with use with the indicated condition e.g. Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months).

Short DisplayTiming or duration information
Cardinality0..1
TypeRange|string
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
ClinicalUseDefinition.indication.undesirableEffect
Element IdClinicalUseDefinition.indication.undesirableEffect
Definition

An unwanted side effect or negative outcome that may happen if you use the drug (or other subject of this resource) for this indication.

Short DisplayAn unwanted side effect or negative outcome of the subject of this resource when being used for this indication
Cardinality0..*
TypeReference(ClinicalUseDefinition)
Summarytrue
ClinicalUseDefinition.indication.applicability
Element IdClinicalUseDefinition.indication.applicability
Definition

An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements.

Short DisplayAn expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
Cardinality0..1
TypeExpression
Summaryfalse
Comments

The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element.

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.

Short DisplayThe 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.

Short DisplaySpecifics for when this is an interaction
Cardinality0..1
Summarytrue
Invariants
Affect 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.interaction.interactant
Element IdClinicalUseDefinition.interaction.interactant
Definition

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

Short DisplayThe specific medication, product, food etc. or laboratory test that interacts
Cardinality0..*
Summarytrue
ClinicalUseDefinition.interaction.interactant.item[x]
Element IdClinicalUseDefinition.interaction.interactant.item[x]
Definition

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

Short DisplayThe specific medication, product, food etc. or laboratory test that interacts
Cardinality1..1
Terminology BindingInteractant (Example)
TypeReference(MedicinalProductDefinition | Medication | Substance | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition)|CodeableConcept
[x] NoteSee Choice of Datatypes 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.

Short DisplayThe type of the interaction e.g. drug-drug interaction, drug-lab test interaction
Cardinality0..1
Terminology BindingInteraction Type (Example)
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.interaction.effect
Element IdClinicalUseDefinition.interaction.effect
Definition

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

Short DisplayThe effect of the interaction, for example "reduced gastric absorption of primary medication"
Cardinality0..1
Terminology BindingInteraction Effect (Example)
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.interaction.incidence
Element IdClinicalUseDefinition.interaction.incidence
Definition

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

Short DisplayThe incidence of the interaction, e.g. theoretical, observed
Cardinality0..1
Terminology BindingInteraction Incidence (Example)
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.interaction.management
Element IdClinicalUseDefinition.interaction.management
Definition

Actions for managing the interaction.

Short DisplayActions for managing the interaction
Cardinality0..*
Terminology BindingInteraction Management (Example)
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.population
Element IdClinicalUseDefinition.population
Definition

The population group to which this applies.

Short DisplayThe population group to which this applies
Cardinality0..*
TypeReference(Group)
Summarytrue
ClinicalUseDefinition.library
Element IdClinicalUseDefinition.library
Definition

Logic used by the clinical use definition.

Short DisplayLogic used by the clinical use definition
Cardinality0..*
Typecanonical(Library)
Summarytrue
ClinicalUseDefinition.undesirableEffect
Element IdClinicalUseDefinition.undesirableEffect
Definition

Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment.

Short DisplayA possible negative outcome from the use of this treatment
Cardinality0..1
Summarytrue
Invariants
Affect 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.undesirableEffect.symptomConditionEffect
Element IdClinicalUseDefinition.undesirableEffect.symptomConditionEffect
Definition

The situation in which the undesirable effect may manifest.

Short DisplayThe situation in which the undesirable effect may manifest
Cardinality0..1
Terminology BindingUndesirable Effect Symptom (Example)
TypeCodeableReference(ObservationDefinition)
Summarytrue
ClinicalUseDefinition.undesirableEffect.classification
Element IdClinicalUseDefinition.undesirableEffect.classification
Definition

High level classification of the effect.

Short DisplayHigh level classification of the effect
Cardinality0..1
Terminology BindingUndesirable Effect Classification (Example)
TypeCodeableConcept
Summarytrue
ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence
Element IdClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence
Definition

How often the effect is seen.

Short DisplayHow often the effect is seen
Cardinality0..1
Terminology BindingUndesirabl Effect Frequency (Example)
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'.

Short DisplayCritical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
Cardinality0..1
Summarytrue
Invariants
Affect 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.warning.description
Element IdClinicalUseDefinition.warning.description
Definition

A textual definition of this warning, with formatting.

Short DisplayA 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.

Short DisplayA coded or unformatted textual definition of this warning
Cardinality0..1
Terminology BindingWarning Type (Example)
TypeCodeableConcept
Summarytrue