HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting, published by Biomedical Research & Regulation WG. This is not an authorized publication; it is the continuous build for version 1.0.1). This version is based on the current content of https://github.com/HL7/fhir-icsr-ae-reporting/ and changes regularly. See the Directory of published versions
Draft as of 2023-08-30 |
Definitions for the icsr-adverseevent resource profile.
Guidance on how to interpret the contents of this table can be found here
0. AdverseEvent | |
2. AdverseEvent.extension | |
Slicing | This element introduces a set of slices on AdverseEvent.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
4. AdverseEvent.extension:ageAtTimeOfOnset | |
Slice Name | ageAtTimeOfOnset |
Control | 0..1 |
Type | Extension(AgeAtTimeOfOnset) (Extension Type: Age) |
6. AdverseEvent.identifier | |
Note | This is a business identifier, not a resource identifier (see discussion) |
Must Support | true |
8. AdverseEvent.actuality | |
Must Support | true |
Fixed Value | actual |
10. AdverseEvent.category | |
Must Support | true |
12. AdverseEvent.event | |
Control | 1..? |
Must Support | true |
14. AdverseEvent.event.coding | |
16. AdverseEvent.event.coding.system | |
Fixed Value | http://meddra.org |
18. AdverseEvent.subject | |
Type | Reference(ICSR Patient) |
Must Support | true |
20. AdverseEvent.encounter | |
Type | Reference(US Core Encounter Profile) |
Must Support | true |
22. AdverseEvent.date | |
Must Support | true |
24. AdverseEvent.date.extension | |
Slicing | This element introduces a set of slices on AdverseEvent.date.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
26. AdverseEvent.date.extension:eventDuration | |
Slice Name | eventDuration |
Control | 0..1 |
Type | Extension(EventDuration) (Extension Type: Duration) |
Must Support | true |
28. AdverseEvent.date.extension:endDate | |
Slice Name | endDate |
Control | 0..1 |
Type | Extension(EventEndDate) (Extension Type: dateTime) |
Must Support | true |
30. AdverseEvent.location | |
Type | Reference(US Core Location Profile) |
Must Support | true |
32. AdverseEvent.seriousness | |
Control | 1..? |
Binding | The codes SHALL be taken from ICSR Top-Level Seriousness |
Must Support | true |
34. AdverseEvent.seriousness.extension:seriousness | |
Slice Name | seriousness |
Control | 0..1 |
Type | Extension(EventSeriousness) (Extension Type: CodeableConcept) |
Must Support | true |
36. AdverseEvent.outcome | |
Must Support | true |
38. AdverseEvent.recorder | |
Type | Reference(Practitioner Author) |
Must Support | true |
40. AdverseEvent.suspectEntity | |
Control | 1..? |
Must Support | true |
42. AdverseEvent.suspectEntity.instance | |
Type | Reference(ICSR Immunization, ICSR MedicationAdministration, ICSR Transfusion) |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
44. AdverseEvent.suspectEntity.causality | |
Control | 1..1 |
Must Support | true |
46. AdverseEvent.suspectEntity.causality.productRelatedness | |
Control | 1..? |
Must Support | true |
Guidance on how to interpret the contents of this table can be found here
0. AdverseEvent | |
Definition | Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death. |
Short | Medical care, research study or other healthcare event causing physical injury |
Control | 0..* |
Is Modifier | false |
Summary | false |
Alternate Names | AE |
Invariants | 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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(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. AdverseEvent.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 it's 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 it's meaning or interpretation |
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())) |
4. AdverseEvent.extension | |
Definition | An Extension 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 manageable, 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 | ExtensionAdditional 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 AdverseEvent.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
6. AdverseEvent.extension:ageAtTimeOfOnset | |
Slice Name | ageAtTimeOfOnset |
Definition | The age of the patient when the event occurred. |
Short | Extension |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | Extension(AgeAtTimeOfOnset) (Extension Type: Age) |
Is Modifier | false |
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() )ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
8. AdverseEvent.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 manageable, 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 |
Summary | false |
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()) |
10. AdverseEvent.identifier | |
Definition | Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server. |
Short | Business identifier for the event |
Comments | This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
Type | Identifier |
Is Modifier | false |
Must Support | true |
Summary | true |
Requirements | Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
12. AdverseEvent.actuality | |
Definition | Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely. |
Short | actual | potential |
Control | 1..1 |
Binding | The codes SHALL be taken from AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 Overall nature of the adverse event, e.g. real or potential. |
Type | code |
Is Modifier | true because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen. |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Fixed Value | actual |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
14. AdverseEvent.category | |
Definition | The overall type of event, intended for search and filtering purposes. |
Short | product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment |
Control | 0..* |
Binding | Unless not suitable, these codes SHALL be taken from AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-category Overall categorization of the event, e.g. product-related or situational. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
16. AdverseEvent.event | |
Definition | This element defines the specific type of event that occurred or that was prevented from occurring. |
Short | Type of the event itself in relation to the subject |
Control | 10..1 |
Binding | For example codes, see SNOMEDCTClinicalFindingshttp://hl7.org/fhir/ValueSet/adverse-event-type Detailed type of event. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
18. AdverseEvent.subject | |
Definition | This subject or group impacted by the event. |
Short | Subject impacted by event |
Comments | If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject. |
Control | 1..1 |
Type | Reference(ICSR Patient, Patient, Group, Practitioner, RelatedPerson) |
Is Modifier | false |
Must Support | true |
Summary | true |
Requirements | Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital. |
Alternate Names | patient |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
20. AdverseEvent.encounter | |
Definition | The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated. |
Short | Encounter created as part of |
Comments | This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context. |
Control | 0..1 |
Type | Reference(US Core Encounter Profile, Encounter) |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
22. AdverseEvent.date | |
Definition | The date (and perhaps time) when the adverse event occurred. |
Short | When the event occurred |
Control | 0..1 |
Type | dateTime |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
24. AdverseEvent.date.extension | |
Definition | An Extension 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 manageable, 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 | ExtensionAdditional 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() )ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
Slicing | This element introduces a set of slices on AdverseEvent.date.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
26. AdverseEvent.date.extension:eventDuration | |
Slice Name | eventDuration |
Definition | The duration of the adverse event. |
Short | Extension |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | Extension(EventDuration) (Extension Type: Duration) |
Is Modifier | false |
Must Support | true |
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() )ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
28. AdverseEvent.date.extension:endDate | |
Slice Name | endDate |
Definition | When the event ended. |
Short | Extension |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | Extension(EventEndDate) (Extension Type: dateTime) |
Is Modifier | false |
Must Support | true |
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() )ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
30. AdverseEvent.location | |
Definition | The information about where the adverse event occurred. |
Short | Location where adverse event occurred |
Control | 0..1 |
Type | Reference(US Core Location Profile, Location) |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
32. AdverseEvent.seriousness | |
Definition | Assessment whether this event was of real importance. |
Short | Seriousness of the event |
Control | 10..1 |
Binding | The codes SHALL be taken from For example codes, see ICSR Top-Level Seriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousness |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
34. AdverseEvent.seriousness.extension:seriousness | |
Slice Name | seriousness |
Definition | Additional codes that give more detail around the adverse event seriousness. |
Short | Extension |
Control | 0..1 |
Type | Extension(EventSeriousness) (Extension Type: CodeableConcept) |
Is Modifier | false |
Must Support | true |
Summary | false |
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. AdverseEvent.outcome | |
Definition | Describes the type of outcome from the adverse event. |
Short | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown |
Control | 0..1 |
Binding | The codes SHALL be taken from AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 TODO (and should this be required?). |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
38. AdverseEvent.recorder | |
Definition | Information on who recorded the adverse event. May be the patient or a practitioner. |
Short | Who recorded the adverse event |
Control | 0..1 |
Type | Reference(Practitioner Author, Patient, Practitioner, PractitionerRole, RelatedPerson) |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
40. AdverseEvent.suspectEntity | |
Definition | Describes the entity that is suspected to have caused the adverse event. |
Short | The suspected agent causing the adverse event |
Control | 10..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
42. AdverseEvent.suspectEntity.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 manageable, 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()) |
44. AdverseEvent.suspectEntity.instance | |
Definition | Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device. |
Short | Refers to the specific entity that caused the adverse event |
Control | 1..1 |
Type | Reference(ICSR Immunization, ICSR MedicationAdministration, ICSR Transfusion, Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device) |
Is Modifier | false |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
Summary | true |
Alternate Names | Substance or Medication or Device |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
46. AdverseEvent.suspectEntity.causality | |
Definition | Information on the possible cause of the event. |
Short | Information on the possible cause of the event |
Control | 10..1* |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
48. AdverseEvent.suspectEntity.causality.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 manageable, 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()) |
50. AdverseEvent.suspectEntity.causality.productRelatedness | |
Definition | AdverseEvent.suspectEntity.causalityProductRelatedness. |
Short | AdverseEvent.suspectEntity.causalityProductRelatedness |
Control | 10..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be found here
0. AdverseEvent | |||||
Definition | Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death. | ||||
Short | Medical care, research study or other healthcare event causing physical injury | ||||
Control | 0..* | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | AE | ||||
Invariants | 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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(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. AdverseEvent.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 | The only time that a resource does not have an id is when it is being submitted to the server using a create operation. | ||||
Control | 0..1 | ||||
Type | id | ||||
Is Modifier | false | ||||
Summary | true | ||||
4. AdverseEvent.meta | |||||
Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. | ||||
Short | Metadata about the resource | ||||
Control | 0..1 | ||||
Type | Meta | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
6. AdverseEvent.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 it's 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 it's meaning or interpretation | ||||
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. AdverseEvent.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 SHOULD be taken from CommonLanguages: A human language.
| ||||
Type | code | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | false | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
10. AdverseEvent.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 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 | ||||
Type | Narrative | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | narrative, html, xhtml, display | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
12. AdverseEvent.contained | |||||
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. | ||||
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..* | ||||
Type | Resource | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | inline resources, anonymous resources, contained resources | ||||
14. AdverseEvent.extension | |||||
Definition | An Extension | ||||
Short | Extension | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
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 AdverseEvent.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: | ||||
16. AdverseEvent.extension:ageAtTimeOfOnset | |||||
Slice Name | ageAtTimeOfOnset | ||||
Definition | The age of the patient when the event occurred. | ||||
Short | Extension | ||||
Control | 0..1 This element is affected by the following invariants: ele-1 | ||||
Type | Extension(AgeAtTimeOfOnset) (Extension Type: Age) | ||||
Is Modifier | false | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) | ||||
18. AdverseEvent.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 manageable, 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. | ||||
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 | ||||
Summary | false | ||||
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() ) | ||||
20. AdverseEvent.identifier | |||||
Definition | Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server. | ||||
Short | Business identifier for the event | ||||
Comments | This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number. | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 0..1 | ||||
Type | Identifier | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Requirements | Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
22. AdverseEvent.actuality | |||||
Definition | Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely. | ||||
Short | actual | potential | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from AdverseEventActuality: Overall nature of the adverse event, e.g. real or potential. | ||||
Type | code | ||||
Is Modifier | true because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen. | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Fixed Value | actual | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
24. AdverseEvent.category | |||||
Definition | The overall type of event, intended for search and filtering purposes. | ||||
Short | product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment | ||||
Control | 0..* | ||||
Binding | Unless not suitable, these codes SHALL be taken from AdverseEventCategory: Overall categorization of the event, e.g. product-related or situational. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
26. AdverseEvent.event | |||||
Definition | This element defines the specific type of event that occurred or that was prevented from occurring. | ||||
Short | Type of the event itself in relation to the subject | ||||
Control | 1..1 | ||||
Binding | For example codes, see SNOMEDCTClinicalFindings: Detailed type of event. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
28. AdverseEvent.event.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 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
30. AdverseEvent.event.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 manageable, 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 AdverseEvent.event.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: | ||||
32. AdverseEvent.event.coding | |||||
Definition | A reference to a code defined by a terminology system. | ||||
Short | Code defined by a terminology system | ||||
Comments | Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. | ||||
Control | 0..* | ||||
Type | Coding | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
34. AdverseEvent.event.coding.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 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
36. AdverseEvent.event.coding.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 manageable, 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 AdverseEvent.event.coding.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: | ||||
38. AdverseEvent.event.coding.system | |||||
Definition | The identification of the code system that defines the meaning of the symbol in the code. | ||||
Short | Identity of the terminology system | ||||
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. | ||||
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 | ||||
Requirements | Need to be unambiguous about the source of the definition of the symbol. | ||||
Fixed Value | http://meddra.org | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
40. AdverseEvent.event.coding.version | |||||
Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. | ||||
Short | Version of the system - if relevant | ||||
Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. | ||||
Note | This is a business versionId, not a resource version id (see discussion) | ||||
Control | 0..1 | ||||
Type | string | ||||
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()) ) | ||||
42. AdverseEvent.event.coding.code | |||||
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). | ||||
Short | Symbol in syntax defined by the system | ||||
Control | 0..1 | ||||
Type | code | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Requirements | Need to refer to a particular code in the system. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
44. AdverseEvent.event.coding.display | |||||
Definition | A representation of the meaning of the code in the system, following the rules of the system. | ||||
Short | Representation defined by the system | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
46. AdverseEvent.event.coding.userSelected | |||||
Definition | Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). | ||||
Short | If this coding was chosen directly by the user | ||||
Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. | ||||
Control | 0..1 | ||||
Type | boolean | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
48. AdverseEvent.event.text | |||||
Definition | A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. | ||||
Short | Plain text representation of the concept | ||||
Comments | Very often the text is the same as a displayName of one of the codings. | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Requirements | The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
50. AdverseEvent.subject | |||||
Definition | This subject or group impacted by the event. | ||||
Short | Subject impacted by event | ||||
Comments | If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject. | ||||
Control | 1..1 | ||||
Type | Reference(ICSR Patient) | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Requirements | Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital. | ||||
Alternate Names | patient | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
52. AdverseEvent.encounter | |||||
Definition | The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated. | ||||
Short | Encounter created as part of | ||||
Comments | This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context. | ||||
Control | 0..1 | ||||
Type | Reference(US Core Encounter Profile) | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
54. AdverseEvent.date | |||||
Definition | The date (and perhaps time) when the adverse event occurred. | ||||
Short | When the event occurred | ||||
Control | 0..1 | ||||
Type | dateTime | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
56. AdverseEvent.date.id | |||||
Definition | unique id for the element within a resource (for internal references) | ||||
Short | xml:id (or equivalent in JSON) | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
58. AdverseEvent.date.extension | |||||
Definition | An Extension | ||||
Short | Extension | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
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 AdverseEvent.date.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: | ||||
60. AdverseEvent.date.extension:eventDuration | |||||
Slice Name | eventDuration | ||||
Definition | The duration of the adverse event. | ||||
Short | Extension | ||||
Control | 0..1 This element is affected by the following invariants: ele-1 | ||||
Type | Extension(EventDuration) (Extension Type: Duration) | ||||
Is Modifier | false | ||||
Must Support | true | ||||
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() ) | ||||
62. AdverseEvent.date.extension:endDate | |||||
Slice Name | endDate | ||||
Definition | When the event ended. | ||||
Short | Extension | ||||
Control | 0..1 This element is affected by the following invariants: ele-1 | ||||
Type | Extension(EventEndDate) (Extension Type: dateTime) | ||||
Is Modifier | false | ||||
Must Support | true | ||||
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() ) | ||||
64. AdverseEvent.date.value | |||||
Definition | The actual value | ||||
Short | Primitive value for dateTime | ||||
Control | 0..1 | ||||
Type | dateTime | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
66. AdverseEvent.detected | |||||
Definition | Estimated or actual date the AdverseEvent began, in the opinion of the reporter. | ||||
Short | When the event was detected | ||||
Control | 0..1 | ||||
Type | dateTime | ||||
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()) ) | ||||
68. AdverseEvent.recordedDate | |||||
Definition | The date on which the existence of the AdverseEvent was first recorded. | ||||
Short | When the event was recorded | ||||
Comments | The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata. | ||||
Control | 0..1 | ||||
Type | dateTime | ||||
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()) ) | ||||
70. AdverseEvent.resultingCondition | |||||
Definition | Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical). | ||||
Short | Effect on the subject due to this event | ||||
Control | 0..* | ||||
Type | Reference(Condition) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
72. AdverseEvent.location | |||||
Definition | The information about where the adverse event occurred. | ||||
Short | Location where adverse event occurred | ||||
Control | 0..1 | ||||
Type | Reference(US Core Location Profile) | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
74. AdverseEvent.seriousness | |||||
Definition | Assessment whether this event was of real importance. | ||||
Short | Seriousness of the event | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from ICSR Top-Level Seriousness | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
76. AdverseEvent.seriousness.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 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
78. AdverseEvent.seriousness.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 manageable, 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 AdverseEvent.seriousness.extension . The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: | ||||
80. AdverseEvent.seriousness.extension:seriousness | |||||
Slice Name | seriousness | ||||
Definition | Additional codes that give more detail around the adverse event seriousness. | ||||
Short | Extension | ||||
Control | 0..1 | ||||
Type | Extension(EventSeriousness) (Extension Type: CodeableConcept) | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | false | ||||
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() ) | ||||
82. AdverseEvent.seriousness.coding | |||||
Definition | A reference to a code defined by a terminology system. | ||||
Short | Code defined by a terminology system | ||||
Comments | Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. | ||||
Control | 0..* | ||||
Type | Coding | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
84. AdverseEvent.seriousness.text | |||||
Definition | A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. | ||||
Short | Plain text representation of the concept | ||||
Comments | Very often the text is the same as a displayName of one of the codings. | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Requirements | The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
86. AdverseEvent.severity | |||||
Definition | Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is. | ||||
Short | mild | moderate | severe | ||||
Control | 0..1 | ||||
Binding | The codes SHALL be taken from AdverseEventSeverity: The severity of the adverse event itself, in direct relation to the subject. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
88. AdverseEvent.outcome | |||||
Definition | Describes the type of outcome from the adverse event. | ||||
Short | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown | ||||
Control | 0..1 | ||||
Binding | The codes SHALL be taken from AdverseEventOutcome: TODO (and should this be required?). | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
90. AdverseEvent.recorder | |||||
Definition | Information on who recorded the adverse event. May be the patient or a practitioner. | ||||
Short | Who recorded the adverse event | ||||
Control | 0..1 | ||||
Type | Reference(Practitioner Author) | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
92. AdverseEvent.contributor | |||||
Definition | Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness). | ||||
Short | Who was involved in the adverse event or the potential adverse event | ||||
Control | 0..* | ||||
Type | Reference(Practitioner, PractitionerRole, Device) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
94. AdverseEvent.suspectEntity | |||||
Definition | Describes the entity that is suspected to have caused the adverse event. | ||||
Short | The suspected agent causing the adverse event | ||||
Control | 1..* | ||||
Type | BackboneElement | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
96. AdverseEvent.suspectEntity.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 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
98. AdverseEvent.suspectEntity.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 manageable, 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() ) | ||||
100. AdverseEvent.suspectEntity.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 manageable, 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. | ||||
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() ) | ||||
102. AdverseEvent.suspectEntity.instance | |||||
Definition | Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device. | ||||
Short | Refers to the specific entity that caused the adverse event | ||||
Control | 1..1 | ||||
Type | Reference(ICSR Immunization, ICSR MedicationAdministration, ICSR Transfusion) | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Must Support Types | No must-support rules about the choice of types/profiles | ||||
Summary | true | ||||
Alternate Names | Substance or Medication or Device | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
104. AdverseEvent.suspectEntity.causality | |||||
Definition | Information on the possible cause of the event. | ||||
Short | Information on the possible cause of the event | ||||
Control | 1..1 | ||||
Type | BackboneElement | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
106. AdverseEvent.suspectEntity.causality.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 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
108. AdverseEvent.suspectEntity.causality.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 manageable, 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() ) | ||||
110. AdverseEvent.suspectEntity.causality.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 manageable, 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. | ||||
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() ) | ||||
112. AdverseEvent.suspectEntity.causality.assessment | |||||
Definition | Assessment of if the entity caused the event. | ||||
Short | Assessment of if the entity caused the event | ||||
Control | 0..1 | ||||
Binding | For example codes, see AdverseEventCausalityAssessment: Codes for the assessment of whether the entity caused the event. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
114. AdverseEvent.suspectEntity.causality.productRelatedness | |||||
Definition | AdverseEvent.suspectEntity.causalityProductRelatedness. | ||||
Short | AdverseEvent.suspectEntity.causalityProductRelatedness | ||||
Control | 1..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
116. AdverseEvent.suspectEntity.causality.author | |||||
Definition | AdverseEvent.suspectEntity.causalityAuthor. | ||||
Short | AdverseEvent.suspectEntity.causalityAuthor | ||||
Control | 0..1 | ||||
Type | Reference(Practitioner, PractitionerRole) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
118. AdverseEvent.suspectEntity.causality.method | |||||
Definition | ProbabilityScale | Bayesian | Checklist. | ||||
Short | ProbabilityScale | Bayesian | Checklist | ||||
Control | 0..1 | ||||
Binding | For example codes, see AdverseEventCausalityMethod: TODO. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
120. AdverseEvent.subjectMedicalHistory | |||||
Definition | AdverseEvent.subjectMedicalHistory. | ||||
Short | AdverseEvent.subjectMedicalHistory | ||||
Control | 0..* | ||||
Type | Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Media, DocumentReference) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
122. AdverseEvent.referenceDocument | |||||
Definition | AdverseEvent.referenceDocument. | ||||
Short | AdverseEvent.referenceDocument | ||||
Control | 0..* | ||||
Type | Reference(DocumentReference) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
124. AdverseEvent.study | |||||
Definition | AdverseEvent.study. | ||||
Short | AdverseEvent.study | ||||
Control | 0..* | ||||
Type | Reference(ResearchStudy) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |