Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 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
| Active as of 2026-01-02 |
Definitions for the clinical-use-definition-undesirable-effect-uv-epi resource profile
Guidance on how to interpret the contents of this table can be foundhere
| 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 | 10..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 | 10..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.meta.profile | |
| Definition | A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url. A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url. |
| Short | Profiles this resource claims to conform to |
| Comments | It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set. |
| Control | 10..* |
| Type | canonical(StructureDefinition) |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 8. 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())) |
| 10. 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 |
| 12. 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()) |
| 14. ClinicalUseDefinition.identifier | |
| Definition | Business identifier for this issue. |
| Short | Business identifier for this issue |
| Note | This is a business identifier, not a resource identifier (see discussion) |
| Control | 10..* |
| 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())) |
| 16. ClinicalUseDefinition.identifier.use | |
| Definition | The purpose of this identifier. |
| Short | usual | official | temp | secondary | old (If known) |
| Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
| Control | 0..1 |
| Binding | The codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)Identifies the purpose for this identifier, if known . |
| Type | code |
| Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 18. ClinicalUseDefinition.identifier.system | |
| Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
| Short | The namespace for the identifier value |
| Comments | Identifier.system is always case sensitive. |
| Control | 10..1 |
| Type | uri |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| Requirements | There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. |
| Example | General: http://www.acme.com/identifiers/patient |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 20. ClinicalUseDefinition.identifier.value | |
| Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system. |
| Short | The value that is unique |
| Comments | If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. |
| Control | 10..1 This element is affected by the following invariants: ident-1 |
| Type | string |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| Example | General: 123456 |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 22. 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 |
| Fixed Value | undesirable-effect |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 24. 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 | 10..* |
| Binding | The codes SHOULD be taken from ClinicalUseDefinitionCategoryhttp://hl7.org/fhir/ValueSet/clinical-use-definition-category|5.0.0 (preferred to http://hl7.org/fhir/ValueSet/clinical-use-definition-category|5.0.0)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())) |
| 26. 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())) |
| 28. ClinicalUseDefinition.status | |
| Definition | Whether this is a current issue or one that has been retired etc. |
| Short | Whether this is a current issue or one that has been retired etc |
| Control | 10..1 |
| Binding | The codes SHOULD be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0 (preferred to http://hl7.org/fhir/ValueSet/publication-status|5.0.0)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())) |
| 30. ClinicalUseDefinition.population | |
| Definition | The population group to which this applies. |
| Short | The population group to which this applies |
| Control | 10..* |
| 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())) |
| 32. 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 | 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())) |
| 34. ClinicalUseDefinition.undesirableEffect.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()) |
| 36. ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | |
| Definition | The situation in which the undesirable effect may manifest. |
| Short | The situation in which the undesirable effect may manifest |
| Control | 0..1 |
| Binding | For example codes, see UndesirableEffectSymptomhttp://hl7.org/fhir/ValueSet/undesirable-effect-symptom|5.0.0 (example to http://hl7.org/fhir/ValueSet/undesirable-effect-symptom|5.0.0)An undesirable effect of clinical use. |
| 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())) |
| 38. ClinicalUseDefinition.undesirableEffect.classification | |
| Definition | High level classification of the effect. |
| Short | High level classification of the effect |
| Control | 0..1 |
| Binding | For example codes, see UndesirableEffectClassificationhttp://hl7.org/fhir/ValueSet/undesirable-effect-classification|5.0.0 (example to http://hl7.org/fhir/ValueSet/undesirable-effect-classification|5.0.0)A categorisation for an undesirable effect. |
| 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())) |
| 40. ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | |
| Definition | How often the effect is seen. |
| Short | How often the effect is seen |
| Control | 0..1 |
| Binding | For example codes, see UndesirablEffectFrequencyhttp://hl7.org/fhir/ValueSet/undesirable-effect-frequency|5.0.0 (example to http://hl7.org/fhir/ValueSet/undesirable-effect-frequency|5.0.0)A categorisation for a frequency of occurence of an undesirable effect. |
| 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())) |
Guidance on how to interpret the contents of this table can be foundhere
| 0. ClinicalUseDefinition | |
| 2. ClinicalUseDefinition.id | |
| Control | 1..? |
| 4. ClinicalUseDefinition.meta | |
| Control | 1..? |
| 6. ClinicalUseDefinition.meta.profile | |
| Control | 1..? |
| 8. ClinicalUseDefinition.identifier | |
| Note | This is a business identifier, not a resource identifier (see discussion) |
| Control | 1..? |
| 10. ClinicalUseDefinition.identifier.system | |
| Control | 1..? |
| 12. ClinicalUseDefinition.identifier.value | |
| Control | 1..? |
| 14. ClinicalUseDefinition.type | |
| Control | 1..? |
| Fixed Value | undesirable-effect |
| 16. ClinicalUseDefinition.category | |
| Control | 1..? |
| 18. ClinicalUseDefinition.subject | |
| Control | 1..? |
| Type | Reference(MedicinalProductDefinition (ePI)) |
| 20. ClinicalUseDefinition.status | |
| Control | 1..? |
| 22. ClinicalUseDefinition.population | |
| Control | 1..? |
| 24. ClinicalUseDefinition.undesirableEffect | |
| Control | 1..? |
| 26. ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | |
| 28. ClinicalUseDefinition.undesirableEffect.classification | |
| 30. ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | |
Guidance on how to interpret the contents of this table can be foundhere
| 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 | 1..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 | 1..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.meta.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 | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 8. ClinicalUseDefinition.meta.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()) |
| Slicing | This element introduces a set of slices on ClinicalUseDefinition.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 10. ClinicalUseDefinition.meta.versionId | |
| Definition | The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted. |
| Short | Version specific identifier |
| Comments | The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes. |
| Control | 0..1 |
| Type | id |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 12. ClinicalUseDefinition.meta.lastUpdated | |
| Definition | When the resource last changed - e.g. when the version changed. |
| Short | When the resource version last changed |
| Comments | This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction. |
| Control | 0..1 |
| Type | instant |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 14. ClinicalUseDefinition.meta.source | |
| Definition | A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc. |
| Short | Identifies where the resource comes from |
| Comments | The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL. |
| Control | 0..1 |
| Type | uri |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 16. ClinicalUseDefinition.meta.profile | |
| Definition | A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url. |
| Short | Profiles this resource claims to conform to |
| Comments | It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set. |
| Control | 1..* |
| Type | canonical(StructureDefinition) |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 18. ClinicalUseDefinition.meta.security | |
| Definition | Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure. |
| Short | Security Labels applied to this resource |
| Comments | The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored. |
| Control | 0..* |
| Binding | Unless not suitable, these codes SHALL be taken from AllSecurityLabels (extensible to http://hl7.org/fhir/ValueSet/security-labels|5.0.0)Security Labels from the Healthcare Privacy and Security Classification System. |
| Type | Coding |
| Is Modifier | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 20. ClinicalUseDefinition.meta.tag | |
| Definition | Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource. |
| Short | Tags applied to this resource |
| Comments | The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored. |
| Control | 0..* |
| Binding | For example codes, see CommonTags (example to http://hl7.org/fhir/ValueSet/common-tags|5.0.0)Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". |
| Type | Coding |
| Is Modifier | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 22. 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())) |
| 24. 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())) |
| 26. 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())) |
| 28. 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 |
| 30. 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()) |
| 32. 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()) |
| 34. ClinicalUseDefinition.identifier | |
| Definition | Business identifier for this issue. |
| Short | Business identifier for this issue |
| Note | This is a business identifier, not a resource identifier (see discussion) |
| Control | 1..* |
| 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())) |
| 36. ClinicalUseDefinition.identifier.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 | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 38. ClinicalUseDefinition.identifier.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()) |
| Slicing | This element introduces a set of slices on ClinicalUseDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 40. ClinicalUseDefinition.identifier.use | |
| Definition | The purpose of this identifier. |
| Short | usual | official | temp | secondary | old (If known) |
| Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
| Control | 0..1 |
| Binding | The codes SHALL be taken from IdentifierUse (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)Identifies the purpose for this identifier, if known . |
| Type | code |
| Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 42. ClinicalUseDefinition.identifier.type | |
| Definition | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. |
| Short | Description of identifier |
| Comments | This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. |
| Control | 0..1 |
| Binding | Unless not suitable, these codes SHALL be taken from IdentifierTypeCodes (extensible to http://hl7.org/fhir/ValueSet/identifier-type|5.0.0)A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
| Type | CodeableConcept |
| Is Modifier | false |
| Summary | true |
| Requirements | Allows users to make use of identifiers when the identifier system is not known. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 44. ClinicalUseDefinition.identifier.system | |
| Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
| Short | The namespace for the identifier value |
| Comments | Identifier.system is always case sensitive. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| Requirements | There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. |
| Example | General: http://www.acme.com/identifiers/patient |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 46. ClinicalUseDefinition.identifier.value | |
| Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system. |
| Short | The value that is unique |
| Comments | If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. |
| Control | 1..1 This element is affected by the following invariants: ident-1 |
| Type | string |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| Example | General: 123456 |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 48. ClinicalUseDefinition.identifier.period | |
| Definition | Time period during which identifier is/was valid for use. |
| Short | Time period when id is/was valid for use |
| Control | 0..1 |
| Type | Period |
| Is Modifier | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 50. ClinicalUseDefinition.identifier.assigner | |
| Definition | Organization that issued/manages the identifier. |
| Short | Organization that issued id (may be just text) |
| Comments | The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. |
| Control | 0..1 |
| Type | Reference(Organization) |
| Is Modifier | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 52. 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 |
| Fixed Value | undesirable-effect |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 54. 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 | 1..* |
| Binding | The codes SHOULD be taken from ClinicalUseDefinitionCategory (preferred to http://hl7.org/fhir/ValueSet/clinical-use-definition-category|5.0.0)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())) |
| 56. 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())) |
| 58. ClinicalUseDefinition.status | |
| Definition | Whether this is a current issue or one that has been retired etc. |
| Short | Whether this is a current issue or one that has been retired etc |
| Control | 1..1 |
| Binding | The codes SHOULD be taken from PublicationStatus (preferred to http://hl7.org/fhir/ValueSet/publication-status|5.0.0)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())) |
| 60. ClinicalUseDefinition.contraindication | |
| Definition | Specifics for when this is a contraindication. |
| Short | Specifics for when this is a contraindication |
| Control | 0..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())) |
| 62. ClinicalUseDefinition.contraindication.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 |
| 64. ClinicalUseDefinition.contraindication.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()) |
| 66. ClinicalUseDefinition.contraindication.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()) |
| 68. ClinicalUseDefinition.contraindication.diseaseSymptomProcedure | |
| Definition | The situation that is being documented as contraindicating against this item. |
| Short | The situation that is being documented as contraindicating against this item |
| Control | 0..1 |
| Binding | For example codes, see DiseaseSymptomProcedure (example to http://hl7.org/fhir/ValueSet/disease-symptom-procedure|5.0.0)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())) |
| 70. ClinicalUseDefinition.contraindication.diseaseStatus | |
| Definition | The status of the disease or symptom for the contraindication, for example "chronic" or "metastatic". |
| Short | The status of the disease or symptom for the contraindication |
| Control | 0..1 |
| Binding | For example codes, see DiseaseStatus (example to http://hl7.org/fhir/ValueSet/disease-status|5.0.0)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())) |
| 72. ClinicalUseDefinition.contraindication.comorbidity | |
| Definition | A comorbidity (concurrent condition) or coinfection. |
| Short | A comorbidity (concurrent condition) or coinfection |
| Control | 0..* |
| Binding | For example codes, see DiseaseSymptomProcedure (example to http://hl7.org/fhir/ValueSet/disease-symptom-procedure|5.0.0)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())) |
| 74. ClinicalUseDefinition.contraindication.indication | |
| Definition | The indication which this is a contraidication for. |
| Short | The indication which this is a contraidication for |
| 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())) |
| 76. ClinicalUseDefinition.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 | 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())) |
| 78. ClinicalUseDefinition.contraindication.otherTherapy | |
| Definition | Information about the use of the medicinal product in relation to other therapies described as part of the contraindication. |
| Short | Information about use of the product in relation to other therapies described as part of the contraindication |
| Control | 0..* |
| 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())) |
| 80. ClinicalUseDefinition.contraindication.otherTherapy.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 |
| 82. ClinicalUseDefinition.contraindication.otherTherapy.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()) |
| 84. ClinicalUseDefinition.contraindication.otherTherapy.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()) |
| 86. ClinicalUseDefinition.contraindication.otherTherapy.relationshipType | |
| Definition | The type of relationship between the medicinal product indication or contraindication and another therapy. |
| Short | The type of relationship between the product indication/contraindication and another therapy |
| Control | 1..1 |
| Binding | The codes SHOULD be taken from TherapyRelationshipType (preferred to http://hl7.org/fhir/ValueSet/therapy-relationship-type|5.0.0)Classification of relationship between a therapy and a contraindication or an indication. |
| 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())) |
| 88. ClinicalUseDefinition.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 | Reference to a specific medication, substance etc. as part of an indication or contraindication |
| Control | 1..1 |
| Binding | For example codes, see Therapy (example to http://hl7.org/fhir/ValueSet/therapy|5.0.0)A therapy. |
| Type | CodeableReference(MedicinalProductDefinition, Medication, Substance, SubstanceDefinition, NutritionProduct, BiologicallyDerivedProduct, ActivityDefinition) |
| 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())) |
| 90. ClinicalUseDefinition.indication | |
| Definition | Specifics for when this is an indication. |
| Short | Specifics for when this is an indication |
| Control | 0..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())) |
| 92. 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 |
| 94. 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()) |
| 96. 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()) |
| 98. 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 | For example codes, see DiseaseSymptomProcedure (example to http://hl7.org/fhir/ValueSet/disease-symptom-procedure|5.0.0)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())) |
| 100. 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|5.0.0)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())) |
| 102. 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|5.0.0)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())) |
| 104. 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|5.0.0)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())) |
| 106. 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())) |
| 108. 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())) |
| 110. 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())) |
| 112. 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())) |
| 114. ClinicalUseDefinition.interaction | |
| Definition | Specifics for when this is an interaction. |
| Short | Specifics for when this is an interaction |
| Control | 0..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())) |
| 116. ClinicalUseDefinition.interaction.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 |
| 118. ClinicalUseDefinition.interaction.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()) |
| 120. ClinicalUseDefinition.interaction.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()) |
| 122. ClinicalUseDefinition.interaction.interactant | |
| Definition | The specific medication, product, food, substance etc. or laboratory test that interacts. |
| Short | The specific medication, product, food etc. or laboratory test that interacts |
| Control | 0..* |
| 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())) |
| 124. ClinicalUseDefinition.interaction.interactant.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 |
| 126. ClinicalUseDefinition.interaction.interactant.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()) |
| 128. ClinicalUseDefinition.interaction.interactant.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()) |
| 130. ClinicalUseDefinition.interaction.interactant.item[x] | |
| Definition | The specific medication, product, food, substance etc. or laboratory test that interacts. |
| Short | The specific medication, product, food etc. or laboratory test that interacts |
| Control | 1..1 |
| Binding | For example codes, see Interactant (example to http://hl7.org/fhir/ValueSet/interactant|5.0.0)An interactant - a substance that may have a clinically significant effect on another. |
| Type | Choice of: Reference(MedicinalProductDefinition, Medication, Substance, NutritionProduct, BiologicallyDerivedProduct, ObservationDefinition), CodeableConcept |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| 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())) |
| 132. ClinicalUseDefinition.interaction.type | |
| Definition | The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction. |
| Short | The type of the interaction e.g. drug-drug interaction, drug-lab test interaction |
| Control | 0..1 |
| Binding | For example codes, see InteractionType (example to http://hl7.org/fhir/ValueSet/interaction-type|5.0.0)A categorisation for an interaction between two substances. |
| 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())) |
| 134. ClinicalUseDefinition.interaction.effect | |
| Definition | The effect of the interaction, for example "reduced gastric absorption of primary medication". |
| Short | The effect of the interaction, for example "reduced gastric absorption of primary medication" |
| Control | 0..1 |
| Binding | For example codes, see InteractionEffect (example to http://hl7.org/fhir/ValueSet/interaction-effect|5.0.0)A interaction effect of clinical use of a medication or other substance. |
| 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())) |
| 136. ClinicalUseDefinition.interaction.incidence | |
| Definition | The incidence of the interaction, e.g. theoretical, observed. |
| Short | The incidence of the interaction, e.g. theoretical, observed |
| Control | 0..1 |
| Binding | For example codes, see InteractionIncidence (example to http://hl7.org/fhir/ValueSet/interaction-incidence|5.0.0)A categorisation for incidence of occurence of an interaction. |
| 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())) |
| 138. ClinicalUseDefinition.interaction.management | |
| Definition | Actions for managing the interaction. |
| Short | Actions for managing the interaction |
| Control | 0..* |
| Binding | For example codes, see InteractionManagement (example to http://hl7.org/fhir/ValueSet/interaction-management|5.0.0)A type of management for an interaction of a medication or other substance. |
| 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())) |
| 140. ClinicalUseDefinition.population | |
| Definition | The population group to which this applies. |
| Short | The population group to which this applies |
| Control | 1..* |
| 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())) |
| 142. 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())) |
| 144. 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 | 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())) |
| 146. ClinicalUseDefinition.undesirableEffect.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 |
| 148. ClinicalUseDefinition.undesirableEffect.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()) |
| 150. ClinicalUseDefinition.undesirableEffect.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()) |
| 152. ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | |
| Definition | The situation in which the undesirable effect may manifest. |
| Short | The situation in which the undesirable effect may manifest |
| Control | 0..1 |
| Binding | For example codes, see UndesirableEffectSymptom (example to http://hl7.org/fhir/ValueSet/undesirable-effect-symptom|5.0.0)An undesirable effect of clinical use. |
| 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())) |
| 154. ClinicalUseDefinition.undesirableEffect.classification | |
| Definition | High level classification of the effect. |
| Short | High level classification of the effect |
| Control | 0..1 |
| Binding | For example codes, see UndesirableEffectClassification (example to http://hl7.org/fhir/ValueSet/undesirable-effect-classification|5.0.0)A categorisation for an undesirable effect. |
| 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())) |
| 156. ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | |
| Definition | How often the effect is seen. |
| Short | How often the effect is seen |
| Control | 0..1 |
| Binding | For example codes, see UndesirablEffectFrequency (example to http://hl7.org/fhir/ValueSet/undesirable-effect-frequency|5.0.0)A categorisation for a frequency of occurence of an undesirable effect. |
| 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())) |
| 158. 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..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())) |
| 160. ClinicalUseDefinition.warning.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 |
| 162. ClinicalUseDefinition.warning.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()) |
| 164. ClinicalUseDefinition.warning.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()) |
| 166. ClinicalUseDefinition.warning.description | |
| Definition | A textual definition of this warning, with formatting. |
| Short | A textual definition of this warning, with formatting |
| Control | 0..1 |
| Type | markdown |
| 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())) |
| 168. ClinicalUseDefinition.warning.code | |
| Definition | A coded or unformatted textual definition of this warning. |
| Short | A coded or unformatted textual definition of this warning |
| Control | 0..1 |
| Binding | For example codes, see WarningType (example to http://hl7.org/fhir/ValueSet/warning-type|5.0.0)Classification of warning type. |
| 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())) |