US Quality Core Implementation Guide
0.1.0 - cibuild

US Quality Core Implementation Guide, published by ASTP. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/FHIR/us-quality-core/ and changes regularly. See the Directory of published versions

## Resource Profile: USQualityCoreDeviceUseStatement - Detailed Descriptions

Active as of 2026-03-31

Definitions for the us-quality-core-deviceusestatement resource profile.

- Key Elements Table
- Differential Elements Table
- Snapshot Elements Table

Guidance on how to interpret the contents of this table can be foundhere

0. DeviceUseStatement
Definition | A record of a device being used by a patient where the record is the result of a report from the patient or another clinician.
Short | Record of use of a device
Control | 0..*
Is Modifier | false
Summary | false
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. DeviceUseStatement.implicitRules
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Short | A set of rules under which this content was created
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
Control | 0..1
Type | uri
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. DeviceUseStatement.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summary | false
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. DeviceUseStatement.status
Definition | A code representing the patient or other source's judgment about the state of the device used that this statement is about. Generally this will be active or completed.
Short | active | completed | entered-in-error +
Comments | DeviceUseStatment is a statement at a point in time. The status is only representative at the point when it was asserted. The value set for contains codes that assert the status of the use by the patient (for example, stopped or on hold) as well as codes that assert the status of the resource itself (for example, entered in error). This element is labeled as a modifier because the status contains the codes that mark the statement as not currently valid.
Control | 1..1
Binding | The codes SHALL be taken from DeviceUseStatementStatus http://hl7.org/fhir/ValueSet/device-statement-status|4.0.1 (required to `http://hl7.org/fhir/ValueSet/device-statement-status|4.0.1` ) A coded concept indicating the current status of the Device Usage.
Type | code
Is Modifier | true because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. DeviceUseStatement.subject
Definition | The patient who used the device.
Short | Patient using device
Control | 1..1
Type | Reference(US Quality Core Patient, Patient, Group)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. DeviceUseStatement.timing[x]
Definition | How often the device was used.
Short | How often the device was usedHow often the device was used
Control | 0..1
Type | Choice of: Timing, Period, dateTime
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. DeviceUseStatement.recordedOn
Definition | The time at which the statement was made/recorded.
Short | When statement was recorded
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. DeviceUseStatement.device
Definition | The details of the device used.
Short | Reference to device used
Control | 1..1
Type | Reference(US Quality Core Device, US Core Implantable Device Profile, Device)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. DeviceUseStatement.bodySite
Definition | Indicates the anotomic location on the subject's body where the device was used ( i.e. the target).
Short | Target body site
Control | 0..1
Binding | The codes SHOULD be taken from For example codes, see SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site|4.0.1 (preferred to `http://hl7.org/fhir/ValueSet/body-site` ) Codes describing anatomical locations. May include laterality.
Type | CodeableConcept
Is Modifier | false
Summary | true
Requirements | Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/bodySite. Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/bodySite.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be foundhere

0. DeviceUseStatement
2. DeviceUseStatement.status
Short | active | completed | entered-in-error +
4. DeviceUseStatement.subject
Short | Patient using device
Type | Reference(US Quality Core Patient)
6. DeviceUseStatement.timing[x]
Short | How often the device was used
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
8. DeviceUseStatement.recordedOn
Short | When statement was recorded
10. DeviceUseStatement.device
Short | Reference to device used
Type | Reference(US Quality Core Device, US Core Implantable Device Profile)
12. DeviceUseStatement.bodySite
Short | Target body site
Binding | The codes SHOULD be taken from SNOMEDCTBodyStructures (preferred to `http://hl7.org/fhir/ValueSet/body-site` ) Codes describing anatomical locations. May include laterality.
Requirements | Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/bodySite.

Guidance on how to interpret the contents of this table can be foundhere

0. DeviceUseStatement
Definition | A record of a device being used by a patient where the record is the result of a report from the patient or another clinician.
Short | Record of use of a device
Control | 0..*
Is Modifier | false
Summary | false
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (`contained.contained.empty()`) dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (`contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (`contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (`contained.meta.security.empty()`) dom-6: A resource should have narrative for robust management (`text.`div`.exists()`)
2. DeviceUseStatement.id
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Short | Logical id of this artifact
Comments | The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
Control | 0..1
Type | id
Is Modifier | false
Summary | true
4. DeviceUseStatement.meta
Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
Short | Metadata about the resource
Control | 0..1
Type | Meta
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
6. DeviceUseStatement.implicitRules
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Short | A set of rules under which this content was created
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
Control | 0..1
Type | uri
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
8. DeviceUseStatement.language
Definition | The base language in which the resource is written.
Short | Language of the resource content
Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Control | 0..1
Binding | The codes SHOULD be taken from CommonLanguages (preferred to `http://hl7.org/fhir/ValueSet/languages|4.0.1` ) A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
10. DeviceUseStatement.text
Definition | A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Short | Text summary of the resource, for human interpretation
Comments | Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
Control | 0..1
Type | Narrative
Is Modifier | false
Summary | false
Alternate Names | narrative, html, xhtml, display
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
12. DeviceUseStatement.contained
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
Short | Contained, inline Resources
Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
Control | 0..*
Type | Resource
Is Modifier | false
Summary | false
Alternate Names | inline resources, anonymous resources, contained resources
14. DeviceUseStatement.extension
Definition | May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
16. DeviceUseStatement.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summary | false
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
18. DeviceUseStatement.identifier
Definition | An external identifier for this statement such as an IRI.
Short | External identifier for this record
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
Type | Identifier
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
20. DeviceUseStatement.basedOn
Definition | A plan, proposal or order that is fulfilled in whole or in part by this DeviceUseStatement.
Short | Fulfills plan, proposal or order
Control | 0..*
Type | Reference(ServiceRequest)
Is Modifier | false
Summary | true
Requirements | Allows tracing of authorization for the DeviceUseStatement and tracking whether proposals/recommendations were acted upon.
Alternate Names | fulfills
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
22. DeviceUseStatement.status
Definition | A code representing the patient or other source's judgment about the state of the device used that this statement is about. Generally this will be active or completed.
Short | active | completed | entered-in-error +
Comments | DeviceUseStatment is a statement at a point in time. The status is only representative at the point when it was asserted. The value set for contains codes that assert the status of the use by the patient (for example, stopped or on hold) as well as codes that assert the status of the resource itself (for example, entered in error). This element is labeled as a modifier because the status contains the codes that mark the statement as not currently valid.
Control | 1..1
Binding | The codes SHALL be taken from DeviceUseStatementStatus (required to `http://hl7.org/fhir/ValueSet/device-statement-status|4.0.1` ) A coded concept indicating the current status of the Device Usage.
Type | code
Is Modifier | true because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
24. DeviceUseStatement.subject
Definition | The patient who used the device.
Short | Patient using device
Control | 1..1
Type | Reference(US Quality Core Patient)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
26. DeviceUseStatement.derivedFrom
Definition | Allows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement.
Short | Supporting information
Comments | The most common use cases for deriving a DeviceUseStatement comes from creating it from a request or from an observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the DeviceUseStatement from.
Control | 0..*
Type | Reference(ServiceRequest, Procedure, Claim, Observation, QuestionnaireResponse, DocumentReference)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
28. DeviceUseStatement.timing[x]
Definition | How often the device was used.
Short | How often the device was used
Control | 0..1
Type | Choice of: Timing, Period, dateTime
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
30. DeviceUseStatement.recordedOn
Definition | The time at which the statement was made/recorded.
Short | When statement was recorded
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
32. DeviceUseStatement.source
Definition | Who reported the device was being used by the patient.
Short | Who made the statement
Control | 0..1
Type | Reference(Patient, Practitioner, PractitionerRole, RelatedPerson)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
34. DeviceUseStatement.device
Definition | The details of the device used.
Short | Reference to device used
Control | 1..1
Type | Reference(US Quality Core Device, US Core Implantable Device Profile)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. DeviceUseStatement.reasonCode
Definition | Reason or justification for the use of the device.
Short | Why device was used
Control | 0..*
Type | CodeableConcept
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
38. DeviceUseStatement.reasonReference
Definition | Indicates another resource whose existence justifies this DeviceUseStatement.
Short | Why was DeviceUseStatement performed?
Control | 0..*
Type | Reference(Condition, Observation, DiagnosticReport, DocumentReference, Media)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
40. DeviceUseStatement.bodySite
Definition | Indicates the anotomic location on the subject's body where the device was used ( i.e. the target).
Short | Target body site
Control | 0..1
Binding | The codes SHOULD be taken from SNOMEDCTBodyStructures (preferred to `http://hl7.org/fhir/ValueSet/body-site` ) Codes describing anatomical locations. May include laterality.
Type | CodeableConcept
Is Modifier | false
Summary | true
Requirements | Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/bodySite.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
42. DeviceUseStatement.note
Definition | Details about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement.
Short | Addition details (comments, instructions)
Control | 0..*
Type | Annotation
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)