R6 Ballot (3rd Draft) FHIR CI-Build

This page is part of the FHIR Specification v6.0.0-ballot3: Release 6 Ballot (3rd Draft) (see Ballot Notes ). The current version is 5.0.0 . For a full list Continuous Integration Build of available versions, see FHIR (will be incorrect/inconsistent at times).
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Responsible Owner: Biomedical Research and Regulation icon Work Group Maturity Level : 2   Trial Use Normative Security Category : Anonymous Compartments : No defined compartments

Detailed Descriptions for the elements in the ClinicalUseDefinition resource.

Element Id ClinicalUseDefinition.undesirableEffect Definition Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment. Short Display 0..1 Constraints Affect this element cud-1 Rule 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
Element Id ClinicalUseDefinition
Definition

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

Short Display A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure
Cardinality 0..*
Type DomainResource
Summary false
Constraints
Defined on this element
cud-1 Rule 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
cud-2 Rule ClinicalUseDefinition.contraindication can only be used when type is 'contraindication' ClinicalUseDefinition.contraindication.empty() or ClinicalUseDefinition.type='contraindication'
cud-3 Rule ClinicalUseDefinition.indication can only be used when type is 'indication' ClinicalUseDefinition.indication.empty() or ClinicalUseDefinition.type='indication'
cud-4 Rule ClinicalUseDefinition.undesirableEffect can only be used when type is 'undesirable-effect' ClinicalUseDefinition.undesirableEffect.empty() or ClinicalUseDefinition.type='undesirable-effect'
cud-5 Rule ClinicalUseDefinition.interaction can only be used when type is 'interaction' ClinicalUseDefinition.interaction.empty() or ClinicalUseDefinition.type='interaction'
cud-6 Rule ClinicalUseDefinition.warning can only be used when type is 'warning' ClinicalUseDefinition.warning.empty() or ClinicalUseDefinition.type='warning'
Element Id ClinicalUseDefinition.identifier
Definition

Business identifier for this issue.

Short Display Business identifier for this issue
Note This is a business identifier, not a resource identifier (see discussion )
Cardinality 0..*
Type Identifier
Summary true
Element Id ClinicalUseDefinition.type
Definition

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

Short Display indication | contraindication | interaction | undesirable-effect | warning
Cardinality 1..1
Terminology Binding Clinical Use Definition Type ( Required )
Type code
Summary true
Element Id ClinicalUseDefinition.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 Display A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose"
Cardinality 0..*
Terminology Binding Clinical Use Definition Category ( Preferred )
Type CodeableConcept
Summary true
Element Id ClinicalUseDefinition.subject
Definition

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

Short Display The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning
Cardinality 0..* 1..*
Terminology Binding SNOMED CT Medication Codes ( Example )
Type Reference CodeableReference ( MedicinalProductDefinition | Medication | ActivityDefinition | PlanDefinition | Device | DeviceDefinition | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct )
Summary true
Element Id ClinicalUseDefinition.status
Definition

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

Short Display Whether this is a current issue or one that has been retired etc
Cardinality 0..1
Terminology Binding PublicationStatus ( Preferred )
Type CodeableConcept
Is Modifier true (Reason: This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid)
Summary true
Element Id ClinicalUseDefinition.contraindication ClinicalUseDefinition.undesirableEffect
Definition

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

Short Display A possible negative outcome from the use of this treatment
Cardinality 0..1
Summary true
Constraints
Affect this element
cud-1 Rule 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
Element Id ClinicalUseDefinition.undesirableEffect.symptomConditionEffect
Definition

The situation in which the undesirable effect may manifest.

Short Display The situation in which the undesirable effect may manifest
Cardinality 0..1
Terminology Binding Undesirable Effect Symptom ( Example )
Type CodeableReference ( ObservationDefinition )
Summary true
Element Id ClinicalUseDefinition.undesirableEffect.classification
Definition

High level classification of the effect.

Short Display High level classification of the effect
Cardinality 0..1
Terminology Binding Undesirable Effect Classification ( Example )
Type CodeableConcept
Summary true
Element Id ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence
Definition

How often the effect is seen.

Short Display How often the effect is seen
Cardinality 0..1
Terminology Binding Undesirabl Effect Frequency ( Example )
Type CodeableConcept
Summary true
Element Id ClinicalUseDefinition.undesirableEffect.management
Definition

Actions for managing the undesirable effect.

Short Display Actions for managing the undesirable effect
Cardinality 0..*
Terminology Binding Interaction Management ( Example )
Type CodeableConcept
Summary true
Element Id ClinicalUseDefinition.indication
Definition

Specifics for when this is a contraindication. an indication.

Short Display Specifics for when this is a contraindication an indication
Cardinality 0..1
Summary true
Constraints
Affect this element
cud-1 Rule 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
Element Id ClinicalUseDefinition.contraindication.diseaseSymptomProcedure ClinicalUseDefinition.indication.diseaseSymptomProcedure
Definition

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

Short Display The situation that is being documented as contraindicating against an indication for this item
Cardinality 0..1
Terminology Binding Disease Symptom Procedure ( Example )
Type CodeableReference ( ObservationDefinition )
Summary true
Element Id ClinicalUseDefinition.contraindication.diseaseStatus ClinicalUseDefinition.indication.diseaseStatus
Definition

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

Short Display The status of the disease or symptom for the contraindication indication
Cardinality 0..1
Terminology Binding Disease Status ( Example )
Type CodeableReference ( ObservationDefinition )
Summary true
Element Id ClinicalUseDefinition.contraindication.comorbidity ClinicalUseDefinition.indication.comorbidity
Definition

A comorbidity (concurrent condition) or coinfection. coinfection as part of the indication. Where this repeats it means that any one of these is relevant, rather than all of them needing to be present.

Short Display A comorbidity (concurrent condition) or coinfection as part of the indication
Cardinality 0..*
Terminology Binding Disease Symptom Procedure ( Example )
Type CodeableReference ( ObservationDefinition )
Summary true
Element Id ClinicalUseDefinition.contraindication.indication ClinicalUseDefinition.indication.intendedEffect
Definition

The indication which this is a contraindication for. intended effect, aim or strategy to be achieved.

Short Display The indication which this is a contraindication for intended effect, aim or strategy to be achieved
Cardinality 0..*
Terminology Binding Product Intended Use ( Preferred )
Type Reference CodeableReference ( ClinicalUseDefinition ObservationDefinition )
Summary true
Element Id ClinicalUseDefinition.contraindication.applicability ClinicalUseDefinition.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 Display Timing or duration information
Cardinality 0..1
Type Range | string
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
Element Id ClinicalUseDefinition.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 Display An unwanted side effect or negative outcome of the subject of this resource when being used for this indication
Cardinality 0..*
Type See ClinicalUseDefinition.undesirableEffect
Summary true
Element Id ClinicalUseDefinition.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 Display An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements
Cardinality 0..1
Type Expression
Summary false
Comments

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

Element Id ClinicalUseDefinition.contraindication.otherTherapy ClinicalUseDefinition.indication.otherTherapy
Definition

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

Short Display Information about use of the product in relation to other therapies described as part of the contraindication
Cardinality 0..*
Summary true
Element Id ClinicalUseDefinition.contraindication.otherTherapy.relationshipType ClinicalUseDefinition.indication.otherTherapy.relationshipType
Definition

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

Short Display The type of relationship between the product indication/contraindication and another therapy
Cardinality 1..1
Terminology Binding Therapy Relationship Type ( Preferred )
Type CodeableConcept
Summary true
Element Id ClinicalUseDefinition.contraindication.otherTherapy.treatment ClinicalUseDefinition.indication.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 Display Reference to a specific medication, substance etc. as part of an indication or contraindication
Cardinality 1..1
Terminology Binding Therapy ( Example )
Type CodeableReference ( MedicinalProductDefinition | Medication | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ActivityDefinition )
Summary true
Element Id ClinicalUseDefinition.indication ClinicalUseDefinition.contraindication
Definition

Specifics for when this is an indication. a contraindication.

Short Display Specifics for when this is an indication a contraindication
Cardinality 0..1
Summary true
Constraints
Affect this element
cud-1 Rule 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
Element Id ClinicalUseDefinition.indication.diseaseSymptomProcedure ClinicalUseDefinition.contraindication.diseaseSymptomProcedure
Definition

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

Short Display The situation that is being documented as an indication for contraindicating against this item
Cardinality 0..1
Terminology Binding Disease Symptom Procedure ( Example )
Type CodeableReference ( ObservationDefinition )
Summary true
Element Id ClinicalUseDefinition.indication.diseaseStatus ClinicalUseDefinition.contraindication.diseaseStatus
Definition

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

Short Display The status of the disease or symptom for the indication contraindication
Cardinality 0..1
Terminology Binding Disease Status ( Example )
Type CodeableReference ( ObservationDefinition )
Summary true
Element Id ClinicalUseDefinition.indication.comorbidity ClinicalUseDefinition.contraindication.comorbidity
Definition

A comorbidity (concurrent condition) or coinfection as part coinfection. Where this repeats it means that any one of the indication. these is relevant, rather than all of them needing to be present.

Short Display A comorbidity (concurrent condition) or coinfection as part of the indication
Cardinality 0..*
Terminology Binding Disease Symptom Procedure ( Example )
Type CodeableReference ( ObservationDefinition )
Summary true
Element Id ClinicalUseDefinition.indication.intendedEffect ClinicalUseDefinition.contraindication.indication
Definition

The intended effect, aim or strategy to be achieved. indication which this is a contraindication for.

Short Display The intended effect, aim or strategy to be achieved indication which this is a contraindication for
Cardinality 0..1 Terminology Binding Product Intended Use ( Preferred ) 0..*
Type CodeableReference ( ObservationDefinition See ClinicalUseDefinition.indication )
Summary true
Element Id ClinicalUseDefinition.indication.duration[x] ClinicalUseDefinition.contraindication.applicability
Definition

Timing or duration information, An expression that may be associated with use with returns true or false, indicating whether 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). indication is applicable or not, after having applied its other elements.

Short Display Timing An expression that returns true or duration information false, indicating whether the indication is applicable or not, after having applied its other elements
Cardinality 0..1
Type Range | string Expression
[x] Note Summary See Choice of Datatypes for further information about how to use [x] false
Summary Comments true

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

Element Id ClinicalUseDefinition.indication.undesirableEffect ClinicalUseDefinition.contraindication.management
Definition

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

Short Display An unwanted side effect or negative outcome of the subject of this resource when being used Actions for this indication managing the contraindication
Cardinality 0..*
Type Terminology Binding Reference Interaction Management ( ClinicalUseDefinition Example )
Summary true ClinicalUseDefinition.indication.applicability Element Id ClinicalUseDefinition.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 Display An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements Cardinality 0..1 Type Expression CodeableConcept
Summary false Comments The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element. true
Element Id ClinicalUseDefinition.indication.otherTherapy ClinicalUseDefinition.contraindication.otherTherapy
Definition

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

Short Display The Information about use of the medicinal product in relation to other therapies described as part of the indication contraindication
Cardinality 0..*
Type See ClinicalUseDefinition.contraindication.otherTherapy ClinicalUseDefinition.indication.otherTherapy
Summary true
Element Id ClinicalUseDefinition.interaction
Definition

Specifics for when this is an interaction.

Short Display Specifics for when this is an interaction
Cardinality 0..1
Summary true
Constraints
Affect this element
cud-1 Rule 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
Element Id ClinicalUseDefinition.interaction.interactant
Definition

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

Short Display The specific medication, product, food etc. or laboratory test that interacts
Cardinality 0..*
Summary true
Element Id ClinicalUseDefinition.interaction.interactant.item[x]
Definition

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

Short Display The specific medication, product, food etc. or laboratory test that interacts
Cardinality 1..1
Terminology Binding Interactant ( Example )
Type Reference ( MedicinalProductDefinition | Medication | SubstanceDefinition | NutritionProduct | BiologicallyDerivedProduct | ObservationDefinition )| CodeableConcept
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
Element Id ClinicalUseDefinition.interaction.type ClinicalUseDefinition.interaction.interactant.route
Definition

The type of route by which the item is administered to cause the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction.

Short Display The type of route by which the item is administered to cause the interaction e.g. drug-drug interaction, drug-lab test interaction
Cardinality 0..1
Terminology Binding Interaction Type SNOMED CT Route Codes ( Example )
Type CodeableConcept
Summary true false
Element Id ClinicalUseDefinition.interaction.effect ClinicalUseDefinition.interaction.type
Definition

The effect type of the interaction e.g. drug-drug interaction, for example "reduced gastric absorption of primary medication". drug-food interaction, drug-lab test interaction.

Short Display The effect type of the interaction e.g. drug-drug interaction, for example "reduced gastric absorption of primary medication" drug-lab test interaction
Cardinality 0..1
Terminology Binding Interaction Effect Type ( Example )
Type CodeableReference ( ObservationDefinition CodeableConcept )
Summary true
Element Id ClinicalUseDefinition.interaction.incidence ClinicalUseDefinition.interaction.effect
Definition

The incidence effect of the interaction, e.g. theoretical, observed. for example "reduced gastric absorption of primary medication".

Short Display The incidence effect of the interaction, e.g. theoretical, observed for example "reduced gastric absorption of primary medication"
Cardinality 0..1
Terminology Binding Interaction Incidence Effect ( Example )
Type CodeableConcept CodeableReference ( ObservationDefinition )
Summary true
Element Id ClinicalUseDefinition.interaction.management ClinicalUseDefinition.interaction.incidence
Definition

Actions for managing The incidence of the interaction. interaction, e.g. theoretical, observed.

Short Display Actions for managing The incidence of the interaction interaction, e.g. theoretical, observed
Cardinality 0..* 0..1
Terminology Binding Interaction Management Incidence ( Example )
Type CodeableConcept
Summary true
Element Id ClinicalUseDefinition.library ClinicalUseDefinition.interaction.management
Definition

Logic used by Actions for managing the clinical use definition. interaction.

Short Display Logic used by Actions for managing the clinical use definition interaction
Cardinality 0..*
Type Terminology Binding canonical Interaction Management ( Library Example )
Summary true ClinicalUseDefinition.undesirableEffect Type A possible negative outcome from the use of this treatment Cardinality CodeableConcept
Summary true
Element Id ClinicalUseDefinition.undesirableEffect.symptomConditionEffect ClinicalUseDefinition.interaction.severity
Definition

The situation in which severity of the undesirable effect may manifest. interaction.

Short Display The situation in which severity of the undesirable effect may manifest interaction
Cardinality 0..1
Terminology Binding Undesirable Effect Symptom Allergy Intolerance Severity ( Example )
Type CodeableReference ( ObservationDefinition CodeableConcept )
Summary true
Element Id ClinicalUseDefinition.undesirableEffect.classification ClinicalUseDefinition.population
Definition

High level classification of the effect. The population group to which this applies.

Short Display High level classification of the effect The population group to which this applies
Cardinality 0..1 0..*
Terminology Binding Type Undesirable Effect Classification Reference ( Example Group )
Type CodeableConcept Summary true
Element Id ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence ClinicalUseDefinition.library
Definition

How often Logic used by the effect is seen. clinical use definition.

Short Display How often Logic used by the effect is seen clinical use definition
Cardinality 0..1 0..*
Terminology Binding Type Undesirabl Effect Frequency canonical ( Example Library )
Type CodeableConcept Summary true
Element Id ClinicalUseDefinition.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 Display Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness'
Cardinality 0..1
Summary true
Constraints
Affect this element
cud-1 Rule 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
Element Id ClinicalUseDefinition.warning.description
Definition

A textual definition of this warning, with formatting.

Short Display A textual definition of this warning, with formatting
Cardinality 0..1
Type markdown
Summary true
Element Id ClinicalUseDefinition.warning.code
Definition

A coded or unformatted textual definition of this warning.

Short Display A coded or unformatted textual definition of this warning
Cardinality 0..1
Terminology Binding Warning Type ( Example )
Type CodeableConcept
Summary true