This page is part of the PACIO Personal Functioning and Engagement Implementation Guide (v2.0.0-ballot: STU 2 Ballot 1) based on FHIR (HL7® FHIR® Standard) R4. The current version which supersedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions
Active as of 2024-08-13 |
Definitions for the pfe-use-of-device resource profile.
Guidance on how to interpret the contents of this table can be found here
0. DeviceUseStatement | |
2. DeviceUseStatement.subject | |
Type | Reference(US Core Patient Profile) |
4. DeviceUseStatement.device | |
Short | The description of the device that the patient used. |
6. DeviceUseStatement.bodySite | |
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/R4/extension-bodysite. |
Guidance on how to interpret the contents of this table can be found here
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 DeviceUseStatementStatushttp://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 Core Patient Profile, 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.device | |
Definition | The details of the device used. |
Short | The description of the device that the patient used.Reference to device used |
Control | 1..1 |
Type | Reference(Device) |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
12. 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 | For example codes, see SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-site (example 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/R4/extension-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 found here
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 )A human language.
| ||||
Type | code | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | false | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
10. 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 Core Patient Profile) | ||||
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 | The description of the device that the patient used. | ||||
Control | 1..1 | ||||
Type | Reference(Device) | ||||
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 | For example codes, see SNOMEDCTBodyStructures (example 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/R4/extension-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()) ) |