HL7 Czech Shared Health Record Implementation Guide
0.0.1 - ci-build

HL7 Czech Shared Health Record Implementation Guide, published by HL7 Czech Republic. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7-cz/szz/ and changes regularly. See the Directory of published versions

## Resource Profile: Adverse event (SZZ CZ)

Official URL: https://hl7.cz/fhir/szz/StructureDefinition/cz-adverse-event | Version: 0.0.1
Draft as of 2025-12-22 | Computable Name: CZ_AdverseEvent

Czech profile for adverse event.

Usages:

- Use this Profile: Bundle (SZZ CZ)
- Refer to this Profile: Composition (SZZ CZ)
- Examples for this Profile: AdverseEvent/74d87d39-d681-4df4-80a5-975b359e6210

You can also check for usages in the FHIR IG Statistics

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
actuality | ?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
event | Σ | 0..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: Type of adverse event Value Set (required)
subject | Σ | 1..1 | Reference(Patient (CZ core) | Practitioner (CZ core) | Group | Related Person (CZ core)) | Subject impacted by event
location | Σ | 0..1 | Reference(Location (CZ core)) | Location where adverse event occurred
recorder | Σ | 0..1 | Reference(Practitioner (CZ core) | Practitioner Role (CZ core) | Patient (CZ core) | Related Person (CZ core)) | Who recorded the adverse event
Slices for suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
instance | Σ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event
suspectEntity:medication | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
instance | Σ | 1..1 | Reference(Medication (CZ) | Substance) | Refers to the specific entity that caused the adverse event
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
AdverseEvent.actuality | Base | required | AdverseEventActuality | 📍4.0.1 | FHIR Std.
AdverseEvent.event | Base | required | Type of adverse event Value Set | 📦0.0.1 | This IG

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | AdverseEvent | 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 | error | AdverseEvent | 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 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

This structure is derived from AdverseEvent

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
event |  | 0..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: Type of adverse event Value Set (required)
subject |  | 1..1 | Reference(Patient (CZ core) | Practitioner (CZ core) | Group | Related Person (CZ core)) | Subject impacted by event
location |  | 0..1 | Reference(Location (CZ core)) | Location where adverse event occurred
recorder |  | 0..1 | Reference(Practitioner (CZ core) | Practitioner Role (CZ core) | Patient (CZ core) | Related Person (CZ core)) | Who recorded the adverse event
Slices for suspectEntity |  | 0..* | BackboneElement | The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:medication |  | 0..* | BackboneElement | The suspected agent causing the adverse event
instance |  | 1..1 | Reference(Medication (CZ) | Substance) | Refers to the specific entity that caused the adverse event
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
AdverseEvent.event | Base | required | Type of adverse event Value Set | 📦0.0.1 | This IG

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | Σ | 0..1 | Identifier | Business identifier for the event
actuality | ?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category | Σ | 0..* | CodeableConcept | 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 Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
event | Σ | 0..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: Type of adverse event Value Set (required)
subject | Σ | 1..1 | Reference(Patient (CZ core) | Practitioner (CZ core) | Group | Related Person (CZ core)) | Subject impacted by event
encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of
date | Σ | 0..1 | dateTime | When the event occurred
detected | Σ | 0..1 | dateTime | When the event was detected
recordedDate | Σ | 0..1 | dateTime | When the event was recorded
resultingCondition | Σ | 0..* | Reference(Condition) | Effect on the subject due to this event
location | Σ | 0..1 | Reference(Location (CZ core)) | Location where adverse event occurred
seriousness | Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
outcome | Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?).
recorder | Σ | 0..1 | Reference(Practitioner (CZ core) | Practitioner Role (CZ core) | Patient (CZ core) | Related Person (CZ core)) | Who recorded the adverse event
contributor | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event
Slices for suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:All Slices |  |  |  | Content/Rules for all slices
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
instance | Σ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event
causality | Σ | 0..* | BackboneElement | Information on the possible cause of the event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
assessment | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
productRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness
author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor
method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO.
suspectEntity:medication | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
instance | Σ | 1..1 | Reference(Medication (CZ) | Substance) | Refers to the specific entity that caused the adverse event
causality | Σ | 0..* | BackboneElement | Information on the possible cause of the event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
assessment | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
productRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness
author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor
method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO.
subjectMedicalHistory | Σ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory
referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument
study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
AdverseEvent.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std.
AdverseEvent.actuality | Base | required | AdverseEventActuality | 📍4.0.1 | FHIR Std.
AdverseEvent.category | Base | extensible | AdverseEventCategory | 📍4.0.1 | FHIR Std.
AdverseEvent.event | Base | required | Type of adverse event Value Set | 📦0.0.1 | This IG
AdverseEvent.seriousness | Base | example | AdverseEventSeriousness | 📍4.0.1 | FHIR Std.
AdverseEvent.severity | Base | required | AdverseEventSeverity | 📍4.0.1 | FHIR Std.
AdverseEvent.outcome | Base | required | AdverseEventOutcome | 📍4.0.1 | FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment | Base | example | AdverseEventCausalityAssessment | 📍4.0.1 | FHIR Std.
AdverseEvent.suspectEntity.​causality.method | Base | example | AdverseEventCausalityMethod | 📍4.0.1 | FHIR Std.
AdverseEvent.suspectEntity:medication.​causality.assessment | Base | example | AdverseEventCausalityAssessment | 📍4.0.1 | FHIR Std.
AdverseEvent.suspectEntity:medication.​causality.method | Base | example | AdverseEventCausalityMethod | 📍4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | AdverseEvent | 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 | error | AdverseEvent | 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 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

This structure is derived from AdverseEvent

Summary

Structures

This structure refers to these other structures:

- Patient (CZ core) (https://hl7.cz/fhir/core/StructureDefinition/cz-patient-core)
- Practitioner (CZ core) (https://hl7.cz/fhir/core/StructureDefinition/cz-practitioner-core)
- Related Person (CZ core) (https://hl7.cz/fhir/core/StructureDefinition/cz-relatedPerson-core)
- Location (CZ core) (https://hl7.cz/fhir/core/StructureDefinition/cz-location-core)
- Practitioner Role (CZ core) (https://hl7.cz/fhir/core/StructureDefinition/cz-practitionerrole-core)
- Medication (CZ) (https://hl7.cz/fhir/core/StructureDefinition/cz-Medication)

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of AdverseEvent.suspectEntity

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
actuality | ?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
event | Σ | 0..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: Type of adverse event Value Set (required)
subject | Σ | 1..1 | Reference(Patient (CZ core) | Practitioner (CZ core) | Group | Related Person (CZ core)) | Subject impacted by event
location | Σ | 0..1 | Reference(Location (CZ core)) | Location where adverse event occurred
recorder | Σ | 0..1 | Reference(Practitioner (CZ core) | Practitioner Role (CZ core) | Patient (CZ core) | Related Person (CZ core)) | Who recorded the adverse event
Slices for suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
instance | Σ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event
suspectEntity:medication | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
instance | Σ | 1..1 | Reference(Medication (CZ) | Substance) | Refers to the specific entity that caused the adverse event
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
AdverseEvent.actuality | Base | required | AdverseEventActuality | 📍4.0.1 | FHIR Std.
AdverseEvent.event | Base | required | Type of adverse event Value Set | 📦0.0.1 | This IG

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | AdverseEvent | 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 | error | AdverseEvent | 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 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

Differential View

This structure is derived from AdverseEvent

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
event |  | 0..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: Type of adverse event Value Set (required)
subject |  | 1..1 | Reference(Patient (CZ core) | Practitioner (CZ core) | Group | Related Person (CZ core)) | Subject impacted by event
location |  | 0..1 | Reference(Location (CZ core)) | Location where adverse event occurred
recorder |  | 0..1 | Reference(Practitioner (CZ core) | Practitioner Role (CZ core) | Patient (CZ core) | Related Person (CZ core)) | Who recorded the adverse event
Slices for suspectEntity |  | 0..* | BackboneElement | The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:medication |  | 0..* | BackboneElement | The suspected agent causing the adverse event
instance |  | 1..1 | Reference(Medication (CZ) | Substance) | Refers to the specific entity that caused the adverse event
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
AdverseEvent.event | Base | required | Type of adverse event Value Set | 📦0.0.1 | This IG

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
AdverseEvent |  | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | Σ | 0..1 | Identifier | Business identifier for the event
actuality | ?!Σ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category | Σ | 0..* | CodeableConcept | 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 Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
event | Σ | 0..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: Type of adverse event Value Set (required)
subject | Σ | 1..1 | Reference(Patient (CZ core) | Practitioner (CZ core) | Group | Related Person (CZ core)) | Subject impacted by event
encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of
date | Σ | 0..1 | dateTime | When the event occurred
detected | Σ | 0..1 | dateTime | When the event was detected
recordedDate | Σ | 0..1 | dateTime | When the event was recorded
resultingCondition | Σ | 0..* | Reference(Condition) | Effect on the subject due to this event
location | Σ | 0..1 | Reference(Location (CZ core)) | Location where adverse event occurred
seriousness | Σ | 0..1 | CodeableConcept | Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
outcome | Σ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?).
recorder | Σ | 0..1 | Reference(Practitioner (CZ core) | Practitioner Role (CZ core) | Patient (CZ core) | Related Person (CZ core)) | Who recorded the adverse event
contributor | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event
Slices for suspectEntity | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event Slice: Unordered, Open by profile:instance
suspectEntity:All Slices |  |  |  | Content/Rules for all slices
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
instance | Σ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event
causality | Σ | 0..* | BackboneElement | Information on the possible cause of the event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
assessment | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
productRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness
author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor
method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO.
suspectEntity:medication | Σ | 0..* | BackboneElement | The suspected agent causing the adverse event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
instance | Σ | 1..1 | Reference(Medication (CZ) | Substance) | Refers to the specific entity that caused the adverse event
causality | Σ | 0..* | BackboneElement | Information on the possible cause of the event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
assessment | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
productRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness
author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor
method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO.
subjectMedicalHistory | Σ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory
referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument
study | Σ | 0..* | Reference(ResearchStudy) | AdverseEvent.study
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
AdverseEvent.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std.
AdverseEvent.actuality | Base | required | AdverseEventActuality | 📍4.0.1 | FHIR Std.
AdverseEvent.category | Base | extensible | AdverseEventCategory | 📍4.0.1 | FHIR Std.
AdverseEvent.event | Base | required | Type of adverse event Value Set | 📦0.0.1 | This IG
AdverseEvent.seriousness | Base | example | AdverseEventSeriousness | 📍4.0.1 | FHIR Std.
AdverseEvent.severity | Base | required | AdverseEventSeverity | 📍4.0.1 | FHIR Std.
AdverseEvent.outcome | Base | required | AdverseEventOutcome | 📍4.0.1 | FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment | Base | example | AdverseEventCausalityAssessment | 📍4.0.1 | FHIR Std.
AdverseEvent.suspectEntity.​causality.method | Base | example | AdverseEventCausalityMethod | 📍4.0.1 | FHIR Std.
AdverseEvent.suspectEntity:medication.​causality.assessment | Base | example | AdverseEventCausalityAssessment | 📍4.0.1 | FHIR Std.
AdverseEvent.suspectEntity:medication.​causality.method | Base | example | AdverseEventCausalityMethod | 📍4.0.1 | FHIR Std.

#### Constraints

Id | Grade | Path(s) | Description | Expression
dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | AdverseEvent | 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 | error | AdverseEvent | 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 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

This structure is derived from AdverseEvent

Summary

Structures

This structure refers to these other structures:

- Patient (CZ core) (https://hl7.cz/fhir/core/StructureDefinition/cz-patient-core)
- Practitioner (CZ core) (https://hl7.cz/fhir/core/StructureDefinition/cz-practitioner-core)
- Related Person (CZ core) (https://hl7.cz/fhir/core/StructureDefinition/cz-relatedPerson-core)
- Location (CZ core) (https://hl7.cz/fhir/core/StructureDefinition/cz-location-core)
- Practitioner Role (CZ core) (https://hl7.cz/fhir/core/StructureDefinition/cz-practitionerrole-core)
- Medication (CZ) (https://hl7.cz/fhir/core/StructureDefinition/cz-Medication)

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of AdverseEvent.suspectEntity

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