Introduction

This profile is used to represent de-identified AdverseEvent information. The de-identification process has to remove all data elements not explicitly identified as "SUPPORTED" in the profile.

The HHS De-identification Guidance is to be followed to ensure appropriate level of de-identification is performed.

According to the HHS guidance, dates should not have a precision of more than the year. This means month and day cannot be included. This includes AdverseEvent.recorded and date elements.

In FHIR Resources, text elements and reference.display elements which provide human readable information to the providers may be generated using programs and tools from the data present within the resource. For e.g a AdverseEvent resource text element may contain information such as the AdverseEvent dates, patient information. This type of information will enable identification of the individuals. In order to avoid inadvertent revealing of PII/PHI, text elements cannot be included in the De-identified FHIR resource and the submission will be rejected when text elements are present by the validation process.

Ids and References

The original AdverseEvent resource id should not be included in the De-identified AdverseEvent instance. Instead a new id should be created and provided as part of the FHIR resource. The Data Submitter should be capable of using the generated id to relink the data to the original AdverseEvent. All resource references to the AdverseEvent submitted as part of the UDS+ report should refer to newly generated id.

Resource references cannot contain text element as it may contain PHI/PII. The text element for following references are not allowed

• subject

Date Truncation

The Data Submitter has to truncate the following dates to only have a precision of year

• date
• recordedDate

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	De-Identified UDS Plus AdverseEvent
AdverseEvent.id	S This element must be supported. Σ This element is included in summaries.	0..1	id	The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
AdverseEvent.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
AdverseEvent.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
AdverseEvent.actuality	?! This element is a modifier element. S This element must be supported. Σ This element is included in summaries.	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
AdverseEvent.category	S This element must be supported. Σ This element is included in summaries.	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.
AdverseEvent.event	S This element must be supported. Σ This element is included in summaries.	1..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
AdverseEvent.subject	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(De-Identified UDS Plus Patient)	Subject impacted by event
AdverseEvent.date	S This element must be supported. Σ This element is included in summaries. C	0..1	dateTime	When the event occurred Constraints: uds-plus-advevent-1, uds-plus-advevent-1a, uds-plus-advevent-1b
AdverseEvent.detected	Σ This element is included in summaries. C	0..1	dateTime	When the event was detected Constraints: uds-plus-advevent-2, uds-plus-advevent-2a, uds-plus-advevent-2b
AdverseEvent.recordedDate	S This element must be supported. Σ This element is included in summaries. C	0..1	dateTime	When the event was recorded Constraints: uds-plus-advevent-3, uds-plus-advevent-3a, uds-plus-advevent-3b
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
AdverseEvent.actuality	Base	required	AdverseEventActuality	📍4.0.1	FHIR Std.
AdverseEvent.category	Base	extensible	AdverseEventCategory	📍4.0.1	FHIR Std.
AdverseEvent.event	Base	example	SNOMED CT Clinical Findings	📍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()
uds-plus-advevent-1	error	AdverseEvent.date	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-1a	error	AdverseEvent.date	All dateTime data elements should have valid year >= 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-1b	error	AdverseEvent.date	All dateTime data elements should have valid year <= 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-advevent-2	error	AdverseEvent.detected	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-2a	error	AdverseEvent.detected	All dateTime data elements should have valid year >= 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-2b	error	AdverseEvent.detected	All dateTime data elements should have valid year <= 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-advevent-3	error	AdverseEvent.recordedDate	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-3a	error	AdverseEvent.recordedDate	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-3b	error	AdverseEvent.recordedDate	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	De-Identified UDS Plus AdverseEvent
AdverseEvent.id	S This element must be supported.	0..1	id	The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
AdverseEvent.text		0..0		Cannot include any text in the resource as part of the de-identified data.
AdverseEvent.contained		0..0		Cannot include any contained resources in the resource as part of the de-identified data.
AdverseEvent.actuality	S This element must be supported.	1..1	code	actual | potential
AdverseEvent.category	S This element must be supported.	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
AdverseEvent.event	S This element must be supported.	1..1	CodeableConcept	Type of the event itself in relation to the subject
AdverseEvent.subject	S This element must be supported.	1..1	Reference(De-Identified UDS Plus Patient)	Subject impacted by event
AdverseEvent.subject.display		0..0		Text alternative for the resource
AdverseEvent.encounter
AdverseEvent.encounter.display		0..0		Text alternative for the resource
AdverseEvent.date	S This element must be supported. C	0..1	dateTime	When the event occurred Constraints: uds-plus-advevent-1, uds-plus-advevent-1a, uds-plus-advevent-1b
AdverseEvent.detected	C	0..1	dateTime	When the event was detected Constraints: uds-plus-advevent-2, uds-plus-advevent-2a, uds-plus-advevent-2b
AdverseEvent.recordedDate	S This element must be supported. C	0..1	dateTime	When the event was recorded Constraints: uds-plus-advevent-3, uds-plus-advevent-3a, uds-plus-advevent-3b
AdverseEvent.recorder
AdverseEvent.recorder.display		0..0		Text alternative for the resource
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
uds-plus-advevent-1	error	AdverseEvent.date	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-1a	error	AdverseEvent.date	All dateTime data elements should have valid year >= 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-1b	error	AdverseEvent.date	All dateTime data elements should have valid year <= 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-advevent-2	error	AdverseEvent.detected	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-2a	error	AdverseEvent.detected	All dateTime data elements should have valid year >= 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-2b	error	AdverseEvent.detected	All dateTime data elements should have valid year <= 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-advevent-3	error	AdverseEvent.recordedDate	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-3a	error	AdverseEvent.recordedDate	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-3b	error	AdverseEvent.recordedDate	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	De-Identified UDS Plus AdverseEvent
AdverseEvent.id	S This element must be supported. Σ This element is included in summaries.	0..1	id	The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
AdverseEvent.meta	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource
AdverseEvent.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
AdverseEvent.language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
AdverseEvent.extension		0..*	Extension	Additional content defined by implementations
AdverseEvent.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
AdverseEvent.identifier	Σ This element is included in summaries.	0..1	Identifier	Business identifier for the event
AdverseEvent.actuality	?! This element is a modifier element. S This element must be supported. Σ This element is included in summaries.	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
AdverseEvent.category	S This element must be supported. Σ This element is included in summaries.	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.
AdverseEvent.event	S This element must be supported. Σ This element is included in summaries.	1..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
AdverseEvent.subject	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(De-Identified UDS Plus Patient)	Subject impacted by event
AdverseEvent.subject.id		0..1	string	Unique id for inter-element referencing
AdverseEvent.subject.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
AdverseEvent.subject.reference	Σ This element is included in summaries. C	0..1	string	Literal reference, Relative, internal or absolute URL
AdverseEvent.subject.type	Σ This element is included in summaries.	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
AdverseEvent.subject.identifier	Σ This element is included in summaries.	0..1	Identifier	Logical reference, when literal reference is not known
AdverseEvent.encounter	Σ This element is included in summaries.	0..1	Reference(Encounter)	Encounter created as part of
AdverseEvent.encounter.id		0..1	string	Unique id for inter-element referencing
AdverseEvent.encounter.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
AdverseEvent.encounter.reference	Σ This element is included in summaries. C	0..1	string	Literal reference, Relative, internal or absolute URL
AdverseEvent.encounter.type	Σ This element is included in summaries.	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
AdverseEvent.encounter.identifier	Σ This element is included in summaries.	0..1	Identifier	Logical reference, when literal reference is not known
AdverseEvent.date	S This element must be supported. Σ This element is included in summaries. C	0..1	dateTime	When the event occurred Constraints: uds-plus-advevent-1, uds-plus-advevent-1a, uds-plus-advevent-1b
AdverseEvent.detected	Σ This element is included in summaries. C	0..1	dateTime	When the event was detected Constraints: uds-plus-advevent-2, uds-plus-advevent-2a, uds-plus-advevent-2b
AdverseEvent.recordedDate	S This element must be supported. Σ This element is included in summaries. C	0..1	dateTime	When the event was recorded Constraints: uds-plus-advevent-3, uds-plus-advevent-3a, uds-plus-advevent-3b
AdverseEvent.resultingCondition	Σ This element is included in summaries.	0..*	Reference(Condition)	Effect on the subject due to this event
AdverseEvent.location	Σ This element is included in summaries.	0..1	Reference(Location)	Location where adverse event occurred
AdverseEvent.seriousness	Σ This element is included in summaries.	0..1	CodeableConcept	Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
AdverseEvent.severity	Σ This element is included in summaries.	0..1	CodeableConcept	mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
AdverseEvent.outcome	Σ This element is included in summaries.	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?).
AdverseEvent.recorder	Σ This element is included in summaries.	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)	Who recorded the adverse event
AdverseEvent.recorder.id		0..1	string	Unique id for inter-element referencing
AdverseEvent.recorder.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
AdverseEvent.recorder.reference	Σ This element is included in summaries. C	0..1	string	Literal reference, Relative, internal or absolute URL
AdverseEvent.recorder.type	Σ This element is included in summaries.	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
AdverseEvent.recorder.identifier	Σ This element is included in summaries.	0..1	Identifier	Logical reference, when literal reference is not known
AdverseEvent.contributor	Σ This element is included in summaries.	0..*	Reference(Practitioner | PractitionerRole | Device)	Who was involved in the adverse event or the potential adverse event
AdverseEvent.suspectEntity	Σ This element is included in summaries.	0..*	BackboneElement	The suspected agent causing the adverse event
AdverseEvent.suspectEntity.id		0..1	string	Unique id for inter-element referencing
AdverseEvent.suspectEntity.extension		0..*	Extension	Additional content defined by implementations
AdverseEvent.suspectEntity.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
AdverseEvent.suspectEntity.instance	Σ This element is included in summaries.	1..1	Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)	Refers to the specific entity that caused the adverse event
AdverseEvent.suspectEntity.causality	Σ This element is included in summaries.	0..*	BackboneElement	Information on the possible cause of the event
AdverseEvent.suspectEntity.causality.id		0..1	string	Unique id for inter-element referencing
AdverseEvent.suspectEntity.causality.extension		0..*	Extension	Additional content defined by implementations
AdverseEvent.suspectEntity.causality.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
AdverseEvent.suspectEntity.causality.assessment	Σ This element is included in summaries.	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.
AdverseEvent.suspectEntity.causality.productRelatedness	Σ This element is included in summaries.	0..1	string	AdverseEvent.suspectEntity.causalityProductRelatedness
AdverseEvent.suspectEntity.causality.author	Σ This element is included in summaries.	0..1	Reference(Practitioner | PractitionerRole)	AdverseEvent.suspectEntity.causalityAuthor
AdverseEvent.suspectEntity.causality.method	Σ This element is included in summaries.	0..1	CodeableConcept	ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO.
AdverseEvent.subjectMedicalHistory	Σ This element is included in summaries.	0..*	Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)	AdverseEvent.subjectMedicalHistory
AdverseEvent.referenceDocument	Σ This element is included in summaries.	0..*	Reference(DocumentReference)	AdverseEvent.referenceDocument
AdverseEvent.study	Σ This element is included in summaries.	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	example	SNOMED CT Clinical Findings	📍4.0.1	FHIR Std.
AdverseEvent.subject.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
AdverseEvent.encounter.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
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.recorder.​type	Base	extensible	ResourceType	📍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.

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()
uds-plus-advevent-1	error	AdverseEvent.date	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-1a	error	AdverseEvent.date	All dateTime data elements should have valid year >= 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-1b	error	AdverseEvent.date	All dateTime data elements should have valid year <= 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-advevent-2	error	AdverseEvent.detected	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-2a	error	AdverseEvent.detected	All dateTime data elements should have valid year >= 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-2b	error	AdverseEvent.detected	All dateTime data elements should have valid year <= 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-advevent-3	error	AdverseEvent.recordedDate	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-3a	error	AdverseEvent.recordedDate	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-3b	error	AdverseEvent.recordedDate	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	De-Identified UDS Plus AdverseEvent
AdverseEvent.id	S This element must be supported. Σ This element is included in summaries.	0..1	id	The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
AdverseEvent.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
AdverseEvent.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
AdverseEvent.actuality	?! This element is a modifier element. S This element must be supported. Σ This element is included in summaries.	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
AdverseEvent.category	S This element must be supported. Σ This element is included in summaries.	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.
AdverseEvent.event	S This element must be supported. Σ This element is included in summaries.	1..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
AdverseEvent.subject	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(De-Identified UDS Plus Patient)	Subject impacted by event
AdverseEvent.date	S This element must be supported. Σ This element is included in summaries. C	0..1	dateTime	When the event occurred Constraints: uds-plus-advevent-1, uds-plus-advevent-1a, uds-plus-advevent-1b
AdverseEvent.detected	Σ This element is included in summaries. C	0..1	dateTime	When the event was detected Constraints: uds-plus-advevent-2, uds-plus-advevent-2a, uds-plus-advevent-2b
AdverseEvent.recordedDate	S This element must be supported. Σ This element is included in summaries. C	0..1	dateTime	When the event was recorded Constraints: uds-plus-advevent-3, uds-plus-advevent-3a, uds-plus-advevent-3b
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
AdverseEvent.actuality	Base	required	AdverseEventActuality	📍4.0.1	FHIR Std.
AdverseEvent.category	Base	extensible	AdverseEventCategory	📍4.0.1	FHIR Std.
AdverseEvent.event	Base	example	SNOMED CT Clinical Findings	📍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()
uds-plus-advevent-1	error	AdverseEvent.date	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-1a	error	AdverseEvent.date	All dateTime data elements should have valid year >= 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-1b	error	AdverseEvent.date	All dateTime data elements should have valid year <= 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-advevent-2	error	AdverseEvent.detected	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-2a	error	AdverseEvent.detected	All dateTime data elements should have valid year >= 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-2b	error	AdverseEvent.detected	All dateTime data elements should have valid year <= 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-advevent-3	error	AdverseEvent.recordedDate	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-3a	error	AdverseEvent.recordedDate	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-3b	error	AdverseEvent.recordedDate	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'

Differential View

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	De-Identified UDS Plus AdverseEvent
AdverseEvent.id	S This element must be supported.	0..1	id	The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
AdverseEvent.text		0..0		Cannot include any text in the resource as part of the de-identified data.
AdverseEvent.contained		0..0		Cannot include any contained resources in the resource as part of the de-identified data.
AdverseEvent.actuality	S This element must be supported.	1..1	code	actual | potential
AdverseEvent.category	S This element must be supported.	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
AdverseEvent.event	S This element must be supported.	1..1	CodeableConcept	Type of the event itself in relation to the subject
AdverseEvent.subject	S This element must be supported.	1..1	Reference(De-Identified UDS Plus Patient)	Subject impacted by event
AdverseEvent.subject.display		0..0		Text alternative for the resource
AdverseEvent.encounter
AdverseEvent.encounter.display		0..0		Text alternative for the resource
AdverseEvent.date	S This element must be supported. C	0..1	dateTime	When the event occurred Constraints: uds-plus-advevent-1, uds-plus-advevent-1a, uds-plus-advevent-1b
AdverseEvent.detected	C	0..1	dateTime	When the event was detected Constraints: uds-plus-advevent-2, uds-plus-advevent-2a, uds-plus-advevent-2b
AdverseEvent.recordedDate	S This element must be supported. C	0..1	dateTime	When the event was recorded Constraints: uds-plus-advevent-3, uds-plus-advevent-3a, uds-plus-advevent-3b
AdverseEvent.recorder
AdverseEvent.recorder.display		0..0		Text alternative for the resource
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
uds-plus-advevent-1	error	AdverseEvent.date	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-1a	error	AdverseEvent.date	All dateTime data elements should have valid year >= 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-1b	error	AdverseEvent.date	All dateTime data elements should have valid year <= 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-advevent-2	error	AdverseEvent.detected	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-2a	error	AdverseEvent.detected	All dateTime data elements should have valid year >= 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-2b	error	AdverseEvent.detected	All dateTime data elements should have valid year <= 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-advevent-3	error	AdverseEvent.recordedDate	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-3a	error	AdverseEvent.recordedDate	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-3b	error	AdverseEvent.recordedDate	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent		0..*	AdverseEvent	De-Identified UDS Plus AdverseEvent
AdverseEvent.id	S This element must be supported. Σ This element is included in summaries.	0..1	id	The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
AdverseEvent.meta	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource
AdverseEvent.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
AdverseEvent.language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
AdverseEvent.extension		0..*	Extension	Additional content defined by implementations
AdverseEvent.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
AdverseEvent.identifier	Σ This element is included in summaries.	0..1	Identifier	Business identifier for the event
AdverseEvent.actuality	?! This element is a modifier element. S This element must be supported. Σ This element is included in summaries.	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
AdverseEvent.category	S This element must be supported. Σ This element is included in summaries.	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.
AdverseEvent.event	S This element must be supported. Σ This element is included in summaries.	1..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
AdverseEvent.subject	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(De-Identified UDS Plus Patient)	Subject impacted by event
AdverseEvent.subject.id		0..1	string	Unique id for inter-element referencing
AdverseEvent.subject.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
AdverseEvent.subject.reference	Σ This element is included in summaries. C	0..1	string	Literal reference, Relative, internal or absolute URL
AdverseEvent.subject.type	Σ This element is included in summaries.	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
AdverseEvent.subject.identifier	Σ This element is included in summaries.	0..1	Identifier	Logical reference, when literal reference is not known
AdverseEvent.encounter	Σ This element is included in summaries.	0..1	Reference(Encounter)	Encounter created as part of
AdverseEvent.encounter.id		0..1	string	Unique id for inter-element referencing
AdverseEvent.encounter.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
AdverseEvent.encounter.reference	Σ This element is included in summaries. C	0..1	string	Literal reference, Relative, internal or absolute URL
AdverseEvent.encounter.type	Σ This element is included in summaries.	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
AdverseEvent.encounter.identifier	Σ This element is included in summaries.	0..1	Identifier	Logical reference, when literal reference is not known
AdverseEvent.date	S This element must be supported. Σ This element is included in summaries. C	0..1	dateTime	When the event occurred Constraints: uds-plus-advevent-1, uds-plus-advevent-1a, uds-plus-advevent-1b
AdverseEvent.detected	Σ This element is included in summaries. C	0..1	dateTime	When the event was detected Constraints: uds-plus-advevent-2, uds-plus-advevent-2a, uds-plus-advevent-2b
AdverseEvent.recordedDate	S This element must be supported. Σ This element is included in summaries. C	0..1	dateTime	When the event was recorded Constraints: uds-plus-advevent-3, uds-plus-advevent-3a, uds-plus-advevent-3b
AdverseEvent.resultingCondition	Σ This element is included in summaries.	0..*	Reference(Condition)	Effect on the subject due to this event
AdverseEvent.location	Σ This element is included in summaries.	0..1	Reference(Location)	Location where adverse event occurred
AdverseEvent.seriousness	Σ This element is included in summaries.	0..1	CodeableConcept	Seriousness of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
AdverseEvent.severity	Σ This element is included in summaries.	0..1	CodeableConcept	mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
AdverseEvent.outcome	Σ This element is included in summaries.	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?).
AdverseEvent.recorder	Σ This element is included in summaries.	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)	Who recorded the adverse event
AdverseEvent.recorder.id		0..1	string	Unique id for inter-element referencing
AdverseEvent.recorder.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
AdverseEvent.recorder.reference	Σ This element is included in summaries. C	0..1	string	Literal reference, Relative, internal or absolute URL
AdverseEvent.recorder.type	Σ This element is included in summaries.	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
AdverseEvent.recorder.identifier	Σ This element is included in summaries.	0..1	Identifier	Logical reference, when literal reference is not known
AdverseEvent.contributor	Σ This element is included in summaries.	0..*	Reference(Practitioner | PractitionerRole | Device)	Who was involved in the adverse event or the potential adverse event
AdverseEvent.suspectEntity	Σ This element is included in summaries.	0..*	BackboneElement	The suspected agent causing the adverse event
AdverseEvent.suspectEntity.id		0..1	string	Unique id for inter-element referencing
AdverseEvent.suspectEntity.extension		0..*	Extension	Additional content defined by implementations
AdverseEvent.suspectEntity.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
AdverseEvent.suspectEntity.instance	Σ This element is included in summaries.	1..1	Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)	Refers to the specific entity that caused the adverse event
AdverseEvent.suspectEntity.causality	Σ This element is included in summaries.	0..*	BackboneElement	Information on the possible cause of the event
AdverseEvent.suspectEntity.causality.id		0..1	string	Unique id for inter-element referencing
AdverseEvent.suspectEntity.causality.extension		0..*	Extension	Additional content defined by implementations
AdverseEvent.suspectEntity.causality.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
AdverseEvent.suspectEntity.causality.assessment	Σ This element is included in summaries.	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.
AdverseEvent.suspectEntity.causality.productRelatedness	Σ This element is included in summaries.	0..1	string	AdverseEvent.suspectEntity.causalityProductRelatedness
AdverseEvent.suspectEntity.causality.author	Σ This element is included in summaries.	0..1	Reference(Practitioner | PractitionerRole)	AdverseEvent.suspectEntity.causalityAuthor
AdverseEvent.suspectEntity.causality.method	Σ This element is included in summaries.	0..1	CodeableConcept	ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO.
AdverseEvent.subjectMedicalHistory	Σ This element is included in summaries.	0..*	Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)	AdverseEvent.subjectMedicalHistory
AdverseEvent.referenceDocument	Σ This element is included in summaries.	0..*	Reference(DocumentReference)	AdverseEvent.referenceDocument
AdverseEvent.study	Σ This element is included in summaries.	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	example	SNOMED CT Clinical Findings	📍4.0.1	FHIR Std.
AdverseEvent.subject.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
AdverseEvent.encounter.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
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.recorder.​type	Base	extensible	ResourceType	📍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.

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()
uds-plus-advevent-1	error	AdverseEvent.date	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-1a	error	AdverseEvent.date	All dateTime data elements should have valid year >= 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-1b	error	AdverseEvent.date	All dateTime data elements should have valid year <= 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-advevent-2	error	AdverseEvent.detected	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-2a	error	AdverseEvent.detected	All dateTime data elements should have valid year >= 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-2b	error	AdverseEvent.detected	All dateTime data elements should have valid year <= 2030	$this is DateTime implies $this.toString() <= '2030'
uds-plus-advevent-3	error	AdverseEvent.recordedDate	All dateTime data elements should be truncated to a year only for de-identified resources.	$this is DateTime implies $this.toString().length() = 4
uds-plus-advevent-3a	error	AdverseEvent.recordedDate	All dateTime data elements should have valid year > 1900	$this is DateTime implies $this.toString() >= '1900'
uds-plus-advevent-3b	error	AdverseEvent.recordedDate	All dateTime data elements should have valid year < 2030	$this is DateTime implies $this.toString() <= '2030'

This structure is derived from AdverseEvent

Summary

Mandatory: 3 elements
Must-Support: 7 elements
Prohibited: 5 elements

Structures

This structure refers to these other structures:

• De-Identified UDS Plus Patient (http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/de-identified-uds-plus-patient)

Maturity: 2