International Patient Summary Implementation Guide (Release 0.3.0 STU1 Ballot)

This page is part of the International Patient Summary Implementation Guide (v0.3.0: STU 1 (FHIR R4) Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.1.0. For a full list of available versions, see the Directory of published versions

Definitions for the StructureDefinition-DeviceUseStatement-uv-ips Profile.

1. 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.

Control0..*
Must Supporttrue
InvariantsDefined on this element
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.

Control0..1
Typeid
Must Supporttrue
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.

3. 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.

Control0..1
TypeMeta
Must Supporttrue
4. DeviceUseStatement.meta.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
5. DeviceUseStatement.meta.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
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.

SlicingThis element introduces a set of slices on DeviceUseStatement.meta.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
6. DeviceUseStatement.meta.versionId
Definition

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

Control0..1
Typeid
Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

7. DeviceUseStatement.meta.lastUpdated
Definition

When the resource last changed - e.g. when the version changed.

Control0..1
Typeinstant
Comments

This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

8. DeviceUseStatement.meta.source
Definition

A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

Control0..1
Typeuri
Comments

In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

9. DeviceUseStatement.meta.profile
Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

Control0..*
Typecanonical(StructureDefinition)
Must Supporttrue
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Fixed Valuehttp://hl7.org/fhir/uv/ips/StructureDefinition/DeviceUseStatement-uv-ips
10. DeviceUseStatement.meta.security
Definition

Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

Control0..*
BindingSecurity Labels from the Healthcare Privacy and Security Classification System.
The codes SHALL be taken from All Security Labels; other codes may be used where these codes are not suitable
TypeCoding
Comments

The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

11. DeviceUseStatement.meta.tag
Definition

Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

Control0..*
BindingCodes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
For example codes, see CommonTags
TypeCoding
Comments

The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

12. 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.

Control0..1
Typeuri
Is Modifiertrue
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.

13. DeviceUseStatement.language
Definition

The base language in which the resource is written.

Control0..1
BindingA human language.
The codes SHOULD be taken from CommonLanguages
Max Binding: AllLanguages
Typecode
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).

14. 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.

Control0..1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
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.

15. 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.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained 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.

16. 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
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.

17. 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).

Control0..*
TypeExtension
Is Modifiertrue
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 Namesextensions, user content
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.

18. DeviceUseStatement.identifier
Definition

An external identifier for this statement such as an IRI.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
19. DeviceUseStatement.basedOn
Definition

A plan, proposal or order that is fulfilled in whole or in part by this DeviceUseStatement.

Control0..*
TypeReference(ServiceRequest)
Requirements

Allows tracing of authorization for the DeviceUseStatement and tracking whether proposals/recommendations were acted upon.

Alternate Namesfulfills
20. 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.

Control1..1
BindingA coded concept indicating the current status of the Device Usage.
The codes SHALL be taken from DeviceUseStatementStatus
Typecode
Is Modifiertrue
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.

21. DeviceUseStatement.subject
Definition

The patient using the device.

Control1..1
TypeReference(PatientUvIps)
Must Supporttrue
22. DeviceUseStatement.subject.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
23. DeviceUseStatement.subject.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
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.

SlicingThis element introduces a set of slices on DeviceUseStatement.subject.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
24. DeviceUseStatement.subject.reference
Definition

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

Control1..1 This element is affected by the following invariants: ref-1
Typestring
Must Supporttrue
Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

25. DeviceUseStatement.subject.type
Definition

The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

Control0..1
BindingAa resource (or, for logical models, the URI of the logical model).
The codes SHALL be taken from ResourceType; other codes may be used where these codes are not suitable
Typeuri
Comments

This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

26. DeviceUseStatement.subject.identifier
Definition

An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Comments

When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

27. DeviceUseStatement.subject.display
Definition

Plain text narrative that identifies the resource in addition to the resource reference.

Control0..1
Typestring
Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

28. DeviceUseStatement.derivedFrom
Definition

Allows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement.

Control0..*
TypeReference(ServiceRequest | Procedure | Claim | Observation | QuestionnaireResponse | DocumentReference)
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.

29. DeviceUseStatement.timing[x]
Definition

How often the device was used.

Control1..1
TypeChoice of: Timing, Period, dateTime
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
30. DeviceUseStatement.timing[x].id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
31. DeviceUseStatement.timing[x].extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
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.

SlicingThis element introduces a set of slices on DeviceUseStatement.timing[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
32. DeviceUseStatement.timing[x].extension:data-absent-reason
SliceNamedata-absent-reason
Definition

Provides a reason why the timing is missing.

Control0..1
TypeExtension(Data Absent Reason) (Extension Type: code)
Must Supporttrue
33. DeviceUseStatement.timing[x].extension:data-absent-reason.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
34. DeviceUseStatement.timing[x].extension:data-absent-reason.extension
Definition

An Extension

Control0..0
TypeExtension
SlicingThis element introduces a set of slices on DeviceUseStatement.timing[x].extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
35. DeviceUseStatement.timing[x].extension:data-absent-reason.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuehttp://hl7.org/fhir/StructureDefinition/data-absent-reason
36. DeviceUseStatement.timing[x].extension:data-absent-reason.valueCode
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control0..1
BindingUsed to specify why the normally expected content of the data element is missing.
The codes SHALL be taken from DataAbsentReason
Typecode
37. DeviceUseStatement.recordedOn
Definition

The time at which the statement was made/recorded.

Control0..1
TypedateTime
38. DeviceUseStatement.source
Definition

Who reported the device was being used by the patient.

Control0..1
TypeReference(Patient | Practitioner | PractitionerRole | RelatedPerson)
Must Supporttrue
39. DeviceUseStatement.device
Definition

The details of the device used.

Control1..1
TypeReference(DeviceUvIps)
Must Supporttrue
40. DeviceUseStatement.reasonCode
Definition

Reason or justification for the use of the device.

Control0..*
TypeCodeableConcept
41. DeviceUseStatement.reasonReference
Definition

Indicates another resource whose existence justifies this DeviceUseStatement.

Control0..*
TypeReference(Condition | Observation | DiagnosticReport | DocumentReference | Media)
42. DeviceUseStatement.bodySite
Definition

A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.

Control0..1 This element is affected by the following invariants: ele-1
BindingFor example codes, see SNOMEDCTBodyStructures
TypeCodeableConcept(CodeableConceptIPS)
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 bodySite

Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
43. 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.

Control0..*
TypeAnnotation