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

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

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	De-Identified UDS Plus AdverseEvent
id	S	0..1	id	The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
text		0..0
contained		0..0
actuality	S	1..1	code	actual | potential
category	S	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
event	S	1..1	CodeableConcept	Type of the event itself in relation to the subject
subject	S	1..1	Reference(De-Identified UDS Plus Patient)	Subject impacted by event
display		0..0
date	S	0..1	dateTime	When the event occurred
recordedDate	S	0..1	dateTime	When the event was recorded
Documentation for this format

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

Terminology Bindings

Path	Conformance	ValueSet
AdverseEvent.actuality	required	AdverseEventActuality
AdverseEvent.category	extensible	AdverseEventCategory
AdverseEvent.event	example	SNOMEDCTClinicalFindings

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	De-Identified UDS Plus AdverseEvent
id	SΣ	0..1	id	The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
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
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	?!SΣ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category	SΣ	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	SΣ	1..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
subject	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Subject impacted by event
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	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).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
encounter	Σ	0..1	Reference(Encounter)	Encounter created as part of
date	SΣ	0..1	dateTime	When the event occurred
detected	Σ	0..1	dateTime	When the event was detected
recordedDate	SΣ	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)	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(Patient | Practitioner | PractitionerRole | RelatedPerson)	Who recorded the adverse event
contributor	Σ	0..*	Reference(Practitioner | PractitionerRole | Device)	Who was involved in the adverse event or the potential adverse event
suspectEntity	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(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.
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	Conformance	ValueSet
AdverseEvent.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
AdverseEvent.actuality	required	AdverseEventActuality
AdverseEvent.category	extensible	AdverseEventCategory
AdverseEvent.event	example	SNOMEDCTClinicalFindings
AdverseEvent.subject.type	extensible	ResourceType
AdverseEvent.seriousness	example	AdverseEventSeriousness
AdverseEvent.severity	required	AdverseEventSeverity
AdverseEvent.outcome	required	AdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessment	example	AdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.method	example	AdverseEventCausalityMethod

Constraints

Id	Grade	Path(s)	Details	Requirements
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
AdverseEvent		0..*	AdverseEvent	De-Identified UDS Plus AdverseEvent
id	S	0..1	id	The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
text		0..0
contained		0..0
actuality	S	1..1	code	actual | potential
category	S	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
event	S	1..1	CodeableConcept	Type of the event itself in relation to the subject
subject	S	1..1	Reference(De-Identified UDS Plus Patient)	Subject impacted by event
display		0..0
date	S	0..1	dateTime	When the event occurred
recordedDate	S	0..1	dateTime	When the event was recorded
Documentation for this format

Key Elements View

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

Terminology Bindings

Path	Conformance	ValueSet
AdverseEvent.actuality	required	AdverseEventActuality
AdverseEvent.category	extensible	AdverseEventCategory
AdverseEvent.event	example	SNOMEDCTClinicalFindings

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	De-Identified UDS Plus AdverseEvent
id	SΣ	0..1	id	The de-identified AdverseEvent identifier created by the health center to send data to UDS+ Data Receiver
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
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	?!SΣ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category	SΣ	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	SΣ	1..1	CodeableConcept	Type of the event itself in relation to the subject Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
subject	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Subject impacted by event
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	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).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
encounter	Σ	0..1	Reference(Encounter)	Encounter created as part of
date	SΣ	0..1	dateTime	When the event occurred
detected	Σ	0..1	dateTime	When the event was detected
recordedDate	SΣ	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)	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(Patient | Practitioner | PractitionerRole | RelatedPerson)	Who recorded the adverse event
contributor	Σ	0..*	Reference(Practitioner | PractitionerRole | Device)	Who was involved in the adverse event or the potential adverse event
suspectEntity	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(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.
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	Conformance	ValueSet
AdverseEvent.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
AdverseEvent.actuality	required	AdverseEventActuality
AdverseEvent.category	extensible	AdverseEventCategory
AdverseEvent.event	example	SNOMEDCTClinicalFindings
AdverseEvent.subject.type	extensible	ResourceType
AdverseEvent.seriousness	example	AdverseEventSeriousness
AdverseEvent.severity	required	AdverseEventSeverity
AdverseEvent.outcome	required	AdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessment	example	AdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.method	example	AdverseEventCausalityMethod

Constraints

Id	Grade	Path(s)	Details	Requirements
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

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