Order Catalog Implementation Guide, published by HL7 International - Orders and Observations Work Group. This is not an authorized publication; it is the continuous build for version current). This version is based on the current content of https://github.com/HL7/fhir-order-catalog/ and changes regularly. See the Directory of published versions
Draft as of 2023-07-08 |
Definitions for the UndesirableEffectDefinition resource profile.
Guidance on how to interpret the contents of this table can be found here.
1. ClinicalUseDefinition | |
2. ClinicalUseDefinition.type | |
Fixed Value | undesirable-effect |
3. ClinicalUseDefinition.contraindication | |
Control | 0..01 |
4. ClinicalUseDefinition.indication | |
Control | 0..01 |
5. ClinicalUseDefinition.interaction | |
Control | 0..01 |
6. ClinicalUseDefinition.undesirableEffect | |
Control | 10..1 |
7. ClinicalUseDefinition.warning | |
Control | 0..01 |
Guidance on how to interpret the contents of this table can be found here.
1. ClinicalUseDefinition | |
Definition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure. |
Control | 0..* |
Summary | false |
Invariants | Defined on this element cud-1: Indication, Contraindication, Interaction, UndesirableEffect and Warning cannot be used in the same instance (: (ClinicalUseDefinition.indication.count() + ClinicalUseDefinition.contraindication.count() + ClinicalUseDefinition.interaction.count() + ClinicalUseDefinition.undesirableEffect.count() + ClinicalUseDefinition.warning.count()) < 2) dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (: contained.contained.empty()) dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (: contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (: text.`div`.exists()) |
2. ClinicalUseDefinition.implicitRules | |
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. |
Control | 0..1 |
Type | uri |
Is Modifier | true |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
3. 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. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained 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. |
4. 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
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 |
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. |
Invariants | Defined on this element 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()) |
5. ClinicalUseDefinition.type | |
Definition | indication | contraindication | interaction | undesirable-effect | warning. |
Control | 1..1 |
Binding | The codes SHALL be taken from ClinicalUseDefinitionType Overall defining type of this clinical use definition. |
Type | code |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Fixed Value | undesirable-effect |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
6. ClinicalUseDefinition.contraindication | |
Definition | Specifics for when this is a contraindication. |
Control | 0..01 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
7. ClinicalUseDefinition.indication | |
Definition | Specifics for when this is an indication. |
Control | 0..01 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
8. ClinicalUseDefinition.interaction | |
Definition | Specifics for when this is an interaction. |
Control | 0..01 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
9. ClinicalUseDefinition.undesirableEffect | |
Definition | Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment. |
Control | 10..1 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
10. 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
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 |
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. |
Invariants | Defined on this element 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()) |
11. 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'. |
Control | 0..01 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be found here.
1. ClinicalUseDefinition | |
Definition | A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure. |
Control | 0..* |
Summary | false |
2. ClinicalUseDefinition.id | |
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. |
Control | 0..1 |
Type | id |
Summary | true |
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. |
3. 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. |
Control | 0..1 |
Type | Meta |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
4. 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. |
Control | 0..1 |
Type | uri |
Is Modifier | true |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
5. ClinicalUseDefinition.language | |
Definition | The base language in which the resource is written. |
Control | 0..1 |
Binding | The codes SHALL be taken from AllLanguages IETF language tag for a human languag |
Type | code |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | false |
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). |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
6. 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. |
Control | 0..1 This element is affected by the following invariants: dom-6 |
Type | Narrative |
Summary | false |
Alternate Names | narrative, html, xhtml, display |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
7. 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. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained 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. |
8. 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. |
Control | 0..* |
Type | Extension |
Summary | false |
Alternate Names | extensions, user content |
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. |
Invariants | Defined on this element 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()) |
9. 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
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 |
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. |
Invariants | Defined on this element 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()) |
10. ClinicalUseDefinition.identifier | |
Definition | Business identifier for this issue. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
11. ClinicalUseDefinition.type | |
Definition | indication | contraindication | interaction | undesirable-effect | warning. |
Control | 1..1 |
Binding | The codes SHALL be taken from ClinicalUseDefinitionType Overall defining type of this clinical use definition |
Type | code |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Fixed Value | undesirable-effect |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
12. 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". |
Control | 0..* |
Binding | The codes SHOULD be taken from ClinicalUseDefinitionCategory A categorisation for a clinical use information item |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
13. ClinicalUseDefinition.subject | |
Definition | The medication, product, substance, device, procedure etc. for which this is an indication. |
Control | 0..* |
Type | Reference(MedicinalProductDefinition|Medication|ActivityDefinition|PlanDefinition|Device|DeviceDefinition|Substance|NutritionProduct|BiologicallyDerivedProduct) |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
14. ClinicalUseDefinition.status | |
Definition | Whether this is a current issue or one that has been retired etc. |
Control | 0..1 |
Binding | The codes SHOULD be taken from PublicationStatus The lifecycle status of an artifact |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
15. ClinicalUseDefinition.contraindication | |
Definition | Specifics for when this is a contraindication. |
Control | 0..0 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
16. ClinicalUseDefinition.indication | |
Definition | Specifics for when this is an indication. |
Control | 0..0 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
17. ClinicalUseDefinition.interaction | |
Definition | Specifics for when this is an interaction. |
Control | 0..0 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
18. ClinicalUseDefinition.population | |
Definition | The population group to which this applies. |
Control | 0..* |
Type | Reference(Group) |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
19. ClinicalUseDefinition.library | |
Definition | Logic used by the clinical use definition. |
Control | 0..* |
Type | canonical(Library) |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
20. ClinicalUseDefinition.undesirableEffect | |
Definition | Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment. |
Control | 1..1 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
21. 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. |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
XML Representation | In the XML format, this property is represented as an attribute. |
Summary | false |
22. 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. |
Control | 0..* |
Type | Extension |
Summary | false |
Alternate Names | extensions, user content |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
23. ClinicalUseDefinition.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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
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 |
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. |
Invariants | Defined on this element 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()) |
24. ClinicalUseDefinition.undesirableEffect.symptomConditionEffect | |
Definition | The situation in which the undesirable effect may manifest. |
Control | 0..1 |
Binding | For example codes, see UndesirableEffectSymptom An undesirable effect of clinical use |
Type | CodeableReference(ObservationDefinition) |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
25. ClinicalUseDefinition.undesirableEffect.classification | |
Definition | High level classification of the effect. |
Control | 0..1 |
Binding | For example codes, see UndesirableEffectClassification A categorisation for an undesirable effect |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
26. ClinicalUseDefinition.undesirableEffect.frequencyOfOccurrence | |
Definition | How often the effect is seen. |
Control | 0..1 |
Binding | For example codes, see UndesirablEffectFrequency A categorisation for a frequency of occurence of an undesirable effect |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
27. 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'. |
Control | 0..0 This element is affected by the following invariants: cud-1 |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |