11.3 Resource DeviceAssociation - Content

Note to Balloters: To ensure the DeviceAssociation resource is ready for Normative status, we are seeking ballot comments on the substantive content. The key changes made since R5 include:

• Collapsed the DeviceAssociation.operation backbone into the other elements (e.g., DeviceAssociation.relationship now describes the relationship between the device and subject).
• DeviceAssociation.category was renamed DeviceAssociation.relationship and given an extensible value set.
• Added DeviceAssociation.associationStatus.
• Updated search parameters to address the changes.

Release Notes (pending alternative process review with FMG):

• FHIR-53677
• FHIR-54843

11.3.1 Scope and Usage

DeviceAssociation captures the statement "[device] is [relationship] [subject] in the context of [focus]", for example "Breast pump is leased-by Patient/mother in the context of Patient/twin-1 and Patient/twin-2".

The scope covers all devices including, but not limited to: implantables, wheelchairs, RTLS, personal health and point of care devices, diagnostic, imaging, and durable medical equipment. This resource is intended to apply to any delivery environment and discipline where a device association is useful to record.

DeviceAssociation represents a relationship between a device and the entity to which it is directly associated (subject) for a period of time. The resource is used when the association itself is important for traceability, assignment, location, responsibility, monitoring, control, or operational context.

The subject identifies the direct target of the relationship and is not necessarily a patient. The nature of the association is described by the relationship element, which may represent concepts such as assignment, usage, custody, installation, maintenance, monitoring, control, or other forms of association.

Optionally, a focus may identify a different entity, product, process, or context that is the reason for, beneficiary of, or target affected by the association. This is most useful when the direct association target differs from the entity that benefits from or is impacted by the association. Examples include a device assigned to a caregiver on behalf of a patient, a device associated with another device for the benefit of a patient, or a device associated with a location for monitoring purposes.

The focus element is intended to provide care, organizational, or operational context for the association and is not intended to identify the primary patient, location, or device that is the direct target of the association. Those entities should be represented using subject.

Actors performing installation, calibration, maintenance, or operation are not considered the focus solely because they performed those activities. Such actors are only represented in DeviceAssociation when they are themselves the direct subject of the association, for example a device assigned to a practitioner or organization.

The associationStatus describes the state of the relationship, not the operational state or condition of the device.

When multiple relationships exist between the same device and subject, they may be represented either as multiple codings within relationship or as separate DeviceAssociation instances. A single DeviceAssociation is generally appropriate when the relationships share the same subject, focus, status, associationStatus, and period. Separate DeviceAssociation instances are appropriate when these attributes differ, when the relationships have different periods or lifecycle states, or when separate traceability is required.

Example scenarios describing the usage of relationship, subject, and focus:

11.3.2 Boundaries and Relationships

• DeviceAssociation (this resource) - To clarify when tracking the lifecycle and traceability of a device, including assignment or dissociation with a patient, practitioner, location, or another device.
• Device - The device that is, e.g., used, placed in or on, or owned by the subject referenced in the DeviceAssociation.
• DeviceUsage when documenting a patient's use of a device, typically clinical history or their ongoing reliance on the device.
• Procedure when the device is involved in a clinical action, such as implantation, removal, or adjustment, where details of that intervention need to be recorded.

These resources may be used together, for example, a procedure may establish or end an association, while DeviceUsage captures continued patient use.

To track changes in settings, the Observation resource can be used, where Observation.subject references the Device that the settings apply to. If, e.g., the patient that the Device is associated with needs to be identified, then the DeviceAssociation where DeviceAssociation.period includes the Observation.effective[x] would have that patient in DeviceAssociation.subject.

DeviceAssociation represents the relationship established, modified, suspended, or ended by an activity, rather than the activity itself. For example, calibration may establish a relationship between a calibration device and the device being calibrated; however, the calibration activity, result, performer, and associated workflow are more appropriately represented using resources such as Procedure, Observation, Task, or other workflow and event resources.

DeviceAssociation is intended to support longer-term tracking, traceability, assignment, responsibility, location, monitoring, control, and operational context for devices. It is not intended to replace event resources that record clinical or operational actions involving a device.

DeviceAssociation is not intended to record all clinical use of a device. Use appropriate event or workflow resources to record the activity itself. For example, DeviceUsage should be used when documenting a patient's use of, or dependence on, a device. Procedure should be used when recording clinical actions involving a device, such as implantation, removal, adjustment, maintenance, or other interventions. Observation should be used when recording measurements, settings, calibration results, environmental readings, or other observations about the device or the entity being monitored.

DeviceAssociation may be used in conjunction with these resources when the existence of the association provides context necessary to understand the event or activity being recorded.

• Structure
• UML
• XML
• JSON
• Turtle
• Version Diff
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Structure

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceAssociation	ΣD		DomainResource	A record of association of a device with a subject Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Instance identifier
device	Σ	1..1	Reference(Device)	Reference to the device that is being associated
relationship	Σ	0..*	CodeableConcept	Describes the relationship between the device and subject Binding: DeviceAssociation Relationship Codes (Example)
status	Σ	1..1	code	active | inactive | entered-in-error | unknown Binding: DeviceAssociation Status Codes (Required)
statusReason	Σ	0..*	CodeableConcept	Administrative or record-management reason for the record status Binding: DeviceAssociation Status Reason Codes (Preferred)
associationStatus	Σ	0..1	CodeableConcept	State of the device association relationship Binding: DeviceAssociation Association Status (Preferred)
subject	Σ	0..1	Reference(BiologicallyDerivedProduct | CareTeam | Device | Group | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)	The direct target of the device association
focus	Σ	0..*	Reference(CareTeam | Device | Group | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)	Context for interpreting the device association
bodyStructure	Σ	0..*	CodeableReference(BodyStructure)	Current anatomical location(s) of the device in/on subject Binding: SNOMED CT Body Structures (Example)
period	Σ	0..1	Period	Begin and end dates and times for the device association
Documentation for this format

See the Extensions for this resource

<DeviceAssociation xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <device><!-- 1..1 Reference(Device) Reference to the device that is being associated --></device>
 <relationship><!-- 0..* CodeableConcept Describes the relationship between the device and subject --></relationship>
 <status value="[code]"/><!-- 1..1 active | inactive | entered-in-error | unknown -->
 <statusReason><!-- 0..* CodeableConcept Administrative or record-management reason for the record status --></statusReason>
 <associationStatus><!-- 0..1 CodeableConcept State of the device association relationship --></associationStatus>
 <subject><!-- 0..1 Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|
   Location|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson) The direct target of the device association --></subject>
 <focus><!-- 0..* Reference(CareTeam|Device|Group|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) Context for interpreting the device association --></focus>
 <bodyStructure><!-- 0..* CodeableReference(BodyStructure) Current anatomical location(s) of the device in/on subject --></bodyStructure>
 <period><!-- 0..1 Period Begin and end dates and times for the device association --></period>
</DeviceAssociation>

{
  "resourceType" : "DeviceAssociation",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Instance identifier
  "device" : { Reference(Device) }, // R!  Reference to the device that is being associated
  "relationship" : [{ CodeableConcept }], // Describes the relationship between the device and subject
  "status" : "<code>", // R!  active | inactive | entered-in-error | unknown
  "statusReason" : [{ CodeableConcept }], // Administrative or record-management reason for the record status
  "associationStatus" : { CodeableConcept }, // State of the device association relationship
  "subject" : { Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|
   Location|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson) }, // The direct target of the device association
  "focus" : [{ Reference(CareTeam|Device|Group|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) }], // Context for interpreting the device association
  "bodyStructure" : [{ CodeableReference(BodyStructure) }], // Current anatomical location(s) of the device in/on subject
  "period" : { Period } // Begin and end dates and times for the device association
}

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:DeviceAssociation;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language
  # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir:modifierExtension
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Instance identifier
  fhir:device [ Reference(Device) ] ; # 1..1 Reference to the device that is being associated
  fhir:relationship  ( [ CodeableConcept ] ... ) ; # 0..* Describes the relationship between the device and subject
  fhir:status [ code ] ; # 1..1 active | inactive | entered-in-error | unknown
  fhir:statusReason  ( [ CodeableConcept ] ... ) ; # 0..* Administrative or record-management reason for the record status
  fhir:associationStatus [ CodeableConcept ] ; # 0..1 State of the device association relationship
  fhir:subject [ Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|Location|Organization|Patient|
  Practitioner|PractitionerRole|RelatedPerson) ] ; # 0..1 The direct target of the device association
  fhir:focus  ( [ Reference(CareTeam|Device|Group|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ] ... ) ; # 0..* Context for interpreting the device association
  fhir:bodyStructure  ( [ CodeableReference(BodyStructure) ] ... ) ; # 0..* Current anatomical location(s) of the device in/on subject
  fhir:period [ Period ] ; # 0..1 Begin and end dates and times for the device association
]

Structure

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceAssociation	ΣD		DomainResource	A record of association of a device with a subject Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Instance identifier
device	Σ	1..1	Reference(Device)	Reference to the device that is being associated
relationship	Σ	0..*	CodeableConcept	Describes the relationship between the device and subject Binding: DeviceAssociation Relationship Codes (Example)
status	Σ	1..1	code	active | inactive | entered-in-error | unknown Binding: DeviceAssociation Status Codes (Required)
statusReason	Σ	0..*	CodeableConcept	Administrative or record-management reason for the record status Binding: DeviceAssociation Status Reason Codes (Preferred)
associationStatus	Σ	0..1	CodeableConcept	State of the device association relationship Binding: DeviceAssociation Association Status (Preferred)
subject	Σ	0..1	Reference(BiologicallyDerivedProduct | CareTeam | Device | Group | Location | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)	The direct target of the device association
focus	Σ	0..*	Reference(CareTeam | Device | Group | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson)	Context for interpreting the device association
bodyStructure	Σ	0..*	CodeableReference(BodyStructure)	Current anatomical location(s) of the device in/on subject Binding: SNOMED CT Body Structures (Example)
period	Σ	0..1	Period	Begin and end dates and times for the device association
Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

XML Template

<DeviceAssociation xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <device><!-- 1..1 Reference(Device) Reference to the device that is being associated --></device>
 <relationship><!-- 0..* CodeableConcept Describes the relationship between the device and subject --></relationship>
 <status value="[code]"/><!-- 1..1 active | inactive | entered-in-error | unknown -->
 <statusReason><!-- 0..* CodeableConcept Administrative or record-management reason for the record status --></statusReason>
 <associationStatus><!-- 0..1 CodeableConcept State of the device association relationship --></associationStatus>
 <subject><!-- 0..1 Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|
   Location|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson) The direct target of the device association --></subject>
 <focus><!-- 0..* Reference(CareTeam|Device|Group|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) Context for interpreting the device association --></focus>
 <bodyStructure><!-- 0..* CodeableReference(BodyStructure) Current anatomical location(s) of the device in/on subject --></bodyStructure>
 <period><!-- 0..1 Period Begin and end dates and times for the device association --></period>
</DeviceAssociation>

JSON Template

{
  "resourceType" : "DeviceAssociation",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Instance identifier
  "device" : { Reference(Device) }, // R!  Reference to the device that is being associated
  "relationship" : [{ CodeableConcept }], // Describes the relationship between the device and subject
  "status" : "<code>", // R!  active | inactive | entered-in-error | unknown
  "statusReason" : [{ CodeableConcept }], // Administrative or record-management reason for the record status
  "associationStatus" : { CodeableConcept }, // State of the device association relationship
  "subject" : { Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|
   Location|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson) }, // The direct target of the device association
  "focus" : [{ Reference(CareTeam|Device|Group|Organization|Patient|
   Practitioner|PractitionerRole|RelatedPerson) }], // Context for interpreting the device association
  "bodyStructure" : [{ CodeableReference(BodyStructure) }], // Current anatomical location(s) of the device in/on subject
  "period" : { Period } // Begin and end dates and times for the device association
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:DeviceAssociation;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language
  # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir:modifierExtension
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Instance identifier
  fhir:device [ Reference(Device) ] ; # 1..1 Reference to the device that is being associated
  fhir:relationship  ( [ CodeableConcept ] ... ) ; # 0..* Describes the relationship between the device and subject
  fhir:status [ code ] ; # 1..1 active | inactive | entered-in-error | unknown
  fhir:statusReason  ( [ CodeableConcept ] ... ) ; # 0..* Administrative or record-management reason for the record status
  fhir:associationStatus [ CodeableConcept ] ; # 0..1 State of the device association relationship
  fhir:subject [ Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|Location|Organization|Patient|
  Practitioner|PractitionerRole|RelatedPerson) ] ; # 0..1 The direct target of the device association
  fhir:focus  ( [ Reference(CareTeam|Device|Group|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ] ... ) ; # 0..* Context for interpreting the device association
  fhir:bodyStructure  ( [ CodeableReference(BodyStructure) ] ... ) ; # 0..* Current anatomical location(s) of the device in/on subject
  fhir:period [ Period ] ; # 0..1 Begin and end dates and times for the device association
]

Changes from R5 to R6

DeviceAssociation
DeviceAssociation.relationship	Added Element
DeviceAssociation.status	Type changed from CodeableConcept to code Remove codes implanted, explanted, attached Add codes active, inactive
DeviceAssociation.statusReason	Remove Binding `http://hl7.org/fhir/ValueSet/deviceassociation-status-reason|5.0.0` (required)
DeviceAssociation.associationStatus	Added Element
DeviceAssociation.subject	Type Reference: Added Target Types BiologicallyDerivedProduct, CareTeam, Location, Organization, PractitionerRole
DeviceAssociation.focus	Added Element
DeviceAssociation.bodyStructure	Max Cardinality changed from 1 to * Type changed from Reference(BodyStructure) to CodeableReference
DeviceAssociation.category	Deleted
DeviceAssociation.operation	Deleted

Changes from R4B to R6

This resource did not exist in Release R4B

Changes from R4 to R6

This resource did not exist in Release R4

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.