Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
Page standards status: Trial-use | Maturity Level: 2 |
Definitions for the ClinicalUseDefinition-indication-uv-epi resource profile.
Guidance on how to interpret the contents of this table can be found here
0. ClinicalUseDefinition | |
2. ClinicalUseDefinition.identifier | |
Short | Business identifier for this clinical use. |
Note | This is a business identifier, not a resource identifier (see discussion) |
4. ClinicalUseDefinition.type | |
Pattern Value | indication |
6. ClinicalUseDefinition.subject | |
Control | 1..? |
Type | Reference(MedicinalProductDefinition (ePI)) |
8. ClinicalUseDefinition.status | |
Short | Defines whether this clinical use is draft, active or retired |
10. ClinicalUseDefinition.contraindication | |
Control | 0..0 |
12. ClinicalUseDefinition.indication | |
Control | 1..? |
14. ClinicalUseDefinition.indication.diseaseSymptomProcedure | |
Binding | The codes SHOULD be taken from MedDRA Terms for clinical diseases and symptoms (preferred to http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/meddra ) |
16. ClinicalUseDefinition.interaction | |
Control | 0..0 |
18. ClinicalUseDefinition.undesirableEffect | |
Control | 0..0 |
20. ClinicalUseDefinition.warning | |
Control | 0..0 |
Guidance on how to interpret the contents of this table can be found here
0. ClinicalUseDefinition | |
Definition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure. |
Short | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure |
Control | 0..* |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | cud-1: 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) dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) dom-3: 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 (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists()) |
2. ClinicalUseDefinition.implicitRules | |
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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. |
Short | A set of rules under which this content was created |
Comments | 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. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc. |
Control | 0..1 |
Type | uri |
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
4. ClinicalUseDefinition.contained | |
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
Short | Contained, inline Resources |
Comments | 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. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained resources |
6. ClinicalUseDefinition.modifierExtension | |
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 and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
Must Support | false |
Summary | true |
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
8. ClinicalUseDefinition.identifier | |
Definition | Business identifier for this issue. |
Short | Business identifier for this clinical use.Business identifier for this issue |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
10. ClinicalUseDefinition.type | |
Definition | indication | contraindication | interaction | undesirable-effect | warning. |
Short | indication | contraindication | interaction | undesirable-effect | warning |
Control | 1..1 |
Binding | The codes SHALL be taken from ClinicalUseDefinitionTypehttp://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0 (required to http://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0 )Overall defining type of this clinical use definition. |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Pattern Value | indication |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
12. ClinicalUseDefinition.subject | |
Definition | The medication, product, substance, device, procedure etc. for which this is an indication. |
Short | The medication, product, substance, device, procedure etc. for which this is an indication |
Control | 10..* |
Type | Reference(MedicinalProductDefinition (ePI), MedicinalProductDefinition, Medication, ActivityDefinition, PlanDefinition, Device, DeviceDefinition, Substance, NutritionProduct, BiologicallyDerivedProduct) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
14. ClinicalUseDefinition.status | |
Definition | Whether this is a current issue or one that has been retired etc. |
Short | Defines whether this clinical use is draft, active or retiredWhether this is a current issue or one that has been retired etc |
Control | 0..1 |
Binding | The codes SHOULD be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status (preferred to http://hl7.org/fhir/ValueSet/publication-status )The lifecycle status of an artifact. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
16. ClinicalUseDefinition.contraindication | |
Definition | Specifics for when this is a contraindication. |
Short | Specifics for when this is a contraindication |
Control | 0..01 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
19. ClinicalUseDefinition.indication | |
Definition | Specifics for when this is an indication. |
Short | Specifics for when this is an indication |
Control | 10..1 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
21. ClinicalUseDefinition.indication.modifierExtension | |
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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
23. ClinicalUseDefinition.indication.diseaseSymptomProcedure | |
Definition | The situation that is being documented as an indicaton for this item. |
Short | The situation that is being documented as an indicaton for this item |
Control | 0..1 |
Binding | The codes SHOULD be taken from For example codes, see MedDRA Terms for clinical diseases and symptomshttp://hl7.org/fhir/ValueSet/disease-symptom-procedure (preferred to http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/meddra ) |
Type | CodeableReference(ObservationDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
25. ClinicalUseDefinition.interaction | |
Definition | Specifics for when this is an interaction. |
Short | Specifics for when this is an interaction |
Control | 0..01 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
28. ClinicalUseDefinition.undesirableEffect | |
Definition | Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment. |
Short | A possible negative outcome from the use of this treatment |
Control | 0..01 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
31. 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 | Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness' |
Control | 0..01 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be found here
0. ClinicalUseDefinition | |
Definition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure. |
Short | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure |
Control | 0..* |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | cud-1: 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 )dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources ( contained.contained.empty() )dom-3: 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 ( contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() )dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated ( contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() )dom-5: If a resource is contained in another resource, it SHALL NOT have a security label ( contained.meta.security.empty() )dom-6: A resource should have narrative for robust management ( text.`div`.exists() ) |
2. ClinicalUseDefinition.id | |
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. |
Short | Logical id of this artifact |
Comments | Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case. |
Control | 0..1 |
Type | id |
Is Modifier | false |
Must Support | false |
Summary | true |
4. ClinicalUseDefinition.meta | |
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. |
Short | Metadata about the resource |
Control | 0..1 |
Type | Meta |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
6. ClinicalUseDefinition.implicitRules | |
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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. |
Short | A set of rules under which this content was created |
Comments | 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. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc. |
Control | 0..1 |
Type | uri |
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
8. ClinicalUseDefinition.language | |
Definition | The base language in which the resource is written. |
Short | Language of the resource content |
Comments | 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). |
Control | 0..1 |
Binding | The codes SHALL be taken from AllLanguages (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0 )IETF language tag for a human language |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
10. ClinicalUseDefinition.text | |
Definition | A human-readable narrative that contains a summary of the resource and can 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. |
Short | Text summary of the resource, for human interpretation |
Comments | Contained resources do not have a 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 information is added later. |
Control | 0..1 This element is affected by the following invariants: dom-6 |
Type | Narrative |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | narrative, html, xhtml, display |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
12. ClinicalUseDefinition.contained | |
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
Short | Contained, inline Resources |
Comments | 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. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained resources |
14. ClinicalUseDefinition.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
16. ClinicalUseDefinition.modifierExtension | |
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 and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
Must Support | false |
Summary | true |
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
18. ClinicalUseDefinition.identifier | |
Definition | Business identifier for this issue. |
Short | Business identifier for this clinical use. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
20. ClinicalUseDefinition.type | |
Definition | indication | contraindication | interaction | undesirable-effect | warning. |
Short | indication | contraindication | interaction | undesirable-effect | warning |
Control | 1..1 |
Binding | The codes SHALL be taken from ClinicalUseDefinitionType (required to http://hl7.org/fhir/ValueSet/clinical-use-definition-type|5.0.0 )Overall defining type of this clinical use definition. |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Pattern Value | indication |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
22. 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 | A categorisation of the issue, primarily for dividing warnings into subject heading areas such as "Pregnancy", "Overdose" |
Control | 0..* |
Binding | The codes SHOULD be taken from ClinicalUseDefinitionCategory (preferred to http://hl7.org/fhir/ValueSet/clinical-use-definition-category )A categorisation for a clinical use information item. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
24. ClinicalUseDefinition.subject | |
Definition | The medication, product, substance, device, procedure etc. for which this is an indication. |
Short | The medication, product, substance, device, procedure etc. for which this is an indication |
Control | 1..* |
Type | Reference(MedicinalProductDefinition (ePI)) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
26. ClinicalUseDefinition.status | |
Definition | Whether this is a current issue or one that has been retired etc. |
Short | Defines whether this clinical use is draft, active or retired |
Control | 0..1 |
Binding | The codes SHOULD be taken from PublicationStatus (preferred to http://hl7.org/fhir/ValueSet/publication-status )The lifecycle status of an artifact. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
28. ClinicalUseDefinition.contraindication | |
Definition | Specifics for when this is a contraindication. |
Short | Specifics for when this is a contraindication |
Control | 0..0 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
44. ClinicalUseDefinition.indication | |
Definition | Specifics for when this is an indication. |
Short | Specifics for when this is an indication |
Control | 1..1 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
46. ClinicalUseDefinition.indication.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
48. ClinicalUseDefinition.indication.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
50. ClinicalUseDefinition.indication.modifierExtension | |
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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
52. ClinicalUseDefinition.indication.diseaseSymptomProcedure | |
Definition | The situation that is being documented as an indicaton for this item. |
Short | The situation that is being documented as an indicaton for this item |
Control | 0..1 |
Binding | The codes SHOULD be taken from MedDRA Terms for clinical diseases and symptoms (preferred to http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/meddra ) |
Type | CodeableReference(ObservationDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
54. ClinicalUseDefinition.indication.diseaseStatus | |
Definition | The status of the disease or symptom for the indication, for example "chronic" or "metastatic". |
Short | The status of the disease or symptom for the indication |
Control | 0..1 |
Binding | For example codes, see DiseaseStatus (example to http://hl7.org/fhir/ValueSet/disease-status )The status of a disease or symptom. |
Type | CodeableReference(ObservationDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
56. ClinicalUseDefinition.indication.comorbidity | |
Definition | A comorbidity (concurrent condition) or coinfection as part of the indication. |
Short | A comorbidity or coinfection as part of the indication |
Control | 0..* |
Binding | For example codes, see DiseaseSymptomProcedure (example to http://hl7.org/fhir/ValueSet/disease-symptom-procedure )A symptom, disease or procedure. |
Type | CodeableReference(ObservationDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
58. ClinicalUseDefinition.indication.intendedEffect | |
Definition | The intended effect, aim or strategy to be achieved. |
Short | The intended effect, aim or strategy to be achieved |
Control | 0..1 |
Binding | The codes SHOULD be taken from ProductIntendedUse (preferred to http://hl7.org/fhir/ValueSet/product-intended-use )The overall intended use of a product. |
Type | CodeableReference(ObservationDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
60. 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 | Timing or duration information |
Control | 0..1 |
Type | Choice of: Range, string |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
62. 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 | An unwanted side effect or negative outcome of the subject of this resource when being used for this indication |
Control | 0..* |
Type | Reference(ClinicalUseDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
64. 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 | An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements |
Comments | The expression may be inlined or may be a reference to a named expression within a logic library referenced by the library element. |
Control | 0..1 |
Type | Expression |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
66. ClinicalUseDefinition.indication.otherTherapy | |
Definition | Information about the use of the medicinal product in relation to other therapies described as part of the indication. |
Short | The use of the medicinal product in relation to other therapies described as part of the indication |
Control | 0..* |
Type | Seettp://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition#ClinicalUseDefinition.contraindication.otherTherapy |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
68. ClinicalUseDefinition.interaction | |
Definition | Specifics for when this is an interaction. |
Short | Specifics for when this is an interaction |
Control | 0..0 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
82. ClinicalUseDefinition.population | |
Definition | The population group to which this applies. |
Short | The population group to which this applies |
Control | 0..* |
Type | Reference(Group) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
84. ClinicalUseDefinition.library | |
Definition | Logic used by the clinical use definition. |
Short | Logic used by the clinical use definition |
Control | 0..* |
Type | canonical(Library) |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
86. ClinicalUseDefinition.undesirableEffect | |
Definition | Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment. |
Short | A possible negative outcome from the use of this treatment |
Control | 0..0 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
94. 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 | Critical environmental, health or physical risks or hazards. For example 'Do not operate heavy machinery', 'May cause drowsiness' |
Control | 0..0 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |