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11.3 Resource DeviceAssociation - Content

Responsible Owner: Orders and Observations icon Work Group DraftSecurity Category: Patient Compartments: Device, Group, Patient, Practitioner, RelatedPerson

A record of association or dissociation of a device with a subject (e.g. patient) and/or operator.

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 includes the operator role).
  • DeviceAssociation.category was renamed DeviceAssociation.relationship and given an extensible value set.
  • Added DeviceAssociation.relationshipStatus.
  • Updated search parameters to address the changes.

Release Notes (pending alternative process review with FMG):

DeviceAssociation records a relationship between a device and a subject (or alternatively a focus entity). The relationship might be as an owner, user, maintainer, etc. of the device. 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.

The subjects may include:

  • Patient - the following are often associated with a specific patient: implantables, prosthetics, activity trackers, mobility assistance, care monitoring, etc.
  • Group - some devices may be associated with a family group or treatment group: a weight scale or blood pressure cuff.
  • Practitioner - a device that is associated with the practitioner: pager, alert monitor, cell phone, laptop/tablet
  • Device - a device may be associated with another device when it is independent of the focal device. Note: this is different than the containment tree with parent element in the Device resource. For example a RFID tag used to track the location of a wheelchair.
  • BiologicallyDerivedProduct - a device may be associated with a biologically derived product for traceability purposes: bioreactors, incubators, storage systems, environmental monitoring devices.
  • Substance - some devices may be associated with a substance: storage systems, transport systems, environmental monitoring devices.
  • Specimen - some devices may be associated with a specimen: collection devices, storage systems, transport systems, laboratory monitoring devices.

In some cases a focus may be specified in addition to the subject, such as:

  • RelatedPerson - a device that is associated with another person related to the patient. For example, an alerting device given to a spouse while their partner (the subject patient) is in surgery.

DeviceAssociation can be thought of as expressing the statement "[ device ] [ relationship ] with [ subject ]" or "[ device ] [ relationship ] with [ focus ] for [ subject ]." For example:

Summary Device Relationship Subject Focus
An endoscope is used by a surgeon on a patient Endoscope used-by Patient/patient Practitioner/surgeon
A continuous glucose monitor is worn by a patient Continuous glucose monitor worn-by Patient/patient
A crib is leased by a parent for an infant Crib leased-by Patient/infant RelatedPerson/parent
A pager is assigned to the lead nurse of the on-call care team Pager assigned-to CareTeam/care-team PractitionerRole/nurse
An RFID tag tracks a wheelchair RFID tag attached-to Device/wheelchair
A temperature sensor is installed in a clean room Temperature sensor installed-at Location/clean-room
A ventilator is maintained by a biomed engineering department Ventilator maintained-by Organization/biomed-engineering
A battery backup unit powers a freezer monitor Battery backup unit powers Device/freezer-monitor
A bioreactor maintains a biologically derived product culture Bioreactor maintains BiologicallyDerivedProduct/culture1
A mixing system maintains a substance during processing Mixing system maintains Substance/substance1
  • 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 icon 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.

Events involving devices are primarily recorded using clinical or workflow resources ([Encounter], [Procedure], [Observation], [Task]). Those resource connect the device with the event. DeviceAssociation primarily records the association with the device for administrative or traceability purposes, or for longer term relationships outside a specific event. There may be some overlap between these records to support specific traceability needs for a device, particularly when there are patient safety or contamination concerns present.

To track changes in settings, the Observation resource can be used, where Observation.subject references the Device that the settings apply to. The patient associated with the device at that time can be determined by searching for DeviceAssociations where DeviceAssociation.period includes the Observation.effective[x].

No references for this Resource.

Structure

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceAssociation D DomainResource A record of association or dissociation of a device with a subject (e.g. patient) and/or operator

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 1..1 CodeableConcept Describes the relationship between the device and subject
Binding: DeviceAssociation Relationship Codes (Example)
... statusReason 0..1 CodeableConcept The reasons given for the current Device Association status
Binding: DeviceAssociation Status Reason Codes (Preferred)
... relationshipStatus Σ 0..1 CodeableConcept State of the device association's relationship
Binding: DeviceAssociation Relationship Status (Preferred)
... subject Σ 1..1 Reference(BiologicallyDerivedProduct | CareTeam | Device | Group | Location | Medication | NutritionProduct | Organization | Patient | Practitioner | PractitionerRole | Specimen | Substance) The entity or group that, nominally, the association is with
... focus Σ 0..1 Reference(BiologicallyDerivedProduct | CareTeam | Device | Group | Location | Medication | NutritionProduct | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson | Specimen | Substance) The entity or group that the association is with, if not the subject
... bodyStructure 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

doco Documentation for this format icon

See the Extensions for this resource

UML Diagram (Legend)

DeviceAssociation (DomainResource)Instance identifieridentifier : Identifier [0..*]Reference to the device that is being associateddevice : Reference [1..1] « Device »Describes the relationship between the device and subject (or focus). The codes in this list may vary depending on their context of use, or the kind of subject being described in the relationshiprelationship : CodeableConcept [1..1] « A coded concept specifying the type of association. (Strength=Example) DeviceAssociationRelationship...?? »Indicates the state of the Device Association. The status describes the status of the DeviceAssociation record itself (e.g., administrative or lifecycle reasons for the record state), not the state of the underlying device relationship (this element modifies the meaning of other elements)status : code [1..1] « A coded concept specifying the state of the device association. (Strength=Required)DeviceAssociationStatusCodes! »The reasons given for the current Device Association statusstatusReason : CodeableConcept [0..1] « null (Strength=Preferred) DeviceAssociationStatusReason...? »State of the device association's relationshiprelationshipStatus : CodeableConcept [0..1] « States that characterize the lifecycle of the relationship between the device and the associated subject. (Strength=Preferred) DeviceAssociationRelationship...? »The individual, group of individuals, entity, or device that the target device is nominally associated with (i.e. subject of record). Where a patient is involved, they are usually the subjectsubject : Reference [1..1] « BiologicallyDerivedProduct|CareTeam| Device|Group|Location|Medication|NutritionProduct|Organization| Patient|Practitioner|PractitionerRole|Specimen|Substance »The individual, group of individuals, or entity that the target device is actually associated with, if they are not the subject of record. This may be a RelatedPerson when a device is rented to a patient's parent, or a Practitioner when a device is operated by a surgeon during a procedure on a patientfocus : Reference [0..1] « BiologicallyDerivedProduct|CareTeam| Device|Group|Location|Medication|NutritionProduct|Organization| Patient|Practitioner|PractitionerRole|RelatedPerson|Specimen| Substance »Current anatomical location(s) of the device in/on subjectbodyStructure : CodeableReference [0..*] « BodyStructure; Codes describing anatomical body structures. May include laterality. (Strength=Example) SNOMEDCTBodyStructures?? »Begin and end dates and times for the device associationperiod : Period [0..1]

XML Template

<DeviceAssociation xmlns="http://hl7.org/fhir"> doco
 <!-- 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><!-- 1..1 CodeableConcept Describes the relationship between the device and subject --></relationship>
 <status value="[code]"/><!-- 1..1 active | inactive | entered-in-error | unknown -->
 <statusReason><!-- 0..1 CodeableConcept The reasons given for the current Device Association status --></statusReason>
 <relationshipStatus><!-- 0..1 CodeableConcept State of the device association's relationship --></relationshipStatus>
 <subject><!-- 1..1 Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|
   Location|Medication|NutritionProduct|Organization|Patient|Practitioner|
   PractitionerRole|Specimen|Substance) The entity or group that, nominally, the association is with --></subject>
 <focus><!-- 0..1 Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|
   Location|Medication|NutritionProduct|Organization|Patient|Practitioner|
   PractitionerRole|RelatedPerson|Specimen|Substance) The entity or group that the association is with, if not the subject --></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>

Turtle Template

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


[ 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 ] ; # 1..1 Describes the relationship between the device and subject
  fhir:status [ code ] ; # 1..1 active | inactive | entered-in-error | unknown
  fhir:statusReason [ CodeableConcept ] ; # 0..1 The reasons given for the current Device Association status
  fhir:relationshipStatus [ CodeableConcept ] ; # 0..1 State of the device association's relationship
  fhir:subject [ Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|Location|Medication|
  NutritionProduct|Organization|Patient|Practitioner|PractitionerRole|Specimen|
  Substance) ] ; # 1..1 The entity or group that, nominally, the association is with
  fhir:focus [ Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|Location|Medication|
  NutritionProduct|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson|Specimen|Substance) ] ; # 0..1 The entity or group that the association is with, if not the subject
  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
  • Renamed from category to relationship
  • Min Cardinality changed from 0 to 1
  • Max Cardinality changed from * to 1
DeviceAssociation.status
  • Type changed from CodeableConcept to code
  • Remove codes implanted, explanted, attached
  • Add codes active, inactive
  • Now marked as Modifier
DeviceAssociation.statusReason
  • Max Cardinality changed from * to 1
  • Remove Binding `http://hl7.org/fhir/ValueSet/deviceassociation-status-reason|5.0.0` (required)
DeviceAssociation.relationshipStatus
  • Added Element
DeviceAssociation.subject
  • Min Cardinality changed from 0 to 1
  • Type Reference: Added Target Types BiologicallyDerivedProduct, CareTeam, Location, Medication, NutritionProduct, Organization, PractitionerRole, Specimen, Substance
  • Type Reference: Removed Target Type RelatedPerson
DeviceAssociation.focus
  • Moved from DeviceAssociation.operation.operator to focus
  • Max Cardinality changed from * to 1
  • Type Reference: Added Target Types BiologicallyDerivedProduct, CareTeam, Device, Group, Location, Medication, NutritionProduct, Organization, PractitionerRole, Specimen, Substance
DeviceAssociation.bodyStructure
  • Max Cardinality changed from 1 to *
  • Type changed from Reference(BodyStructure) to CodeableReference
DeviceAssociation.period
  • Moved from DeviceAssociation.operation to DeviceAssociation
DeviceAssociation.period
  • Deleted
DeviceAssociation.operation
  • Deleted (Backbone collapsed into other elements; operator role is expressed with relationship/focus/subject)

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.

Structure

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceAssociation D DomainResource A record of association or dissociation of a device with a subject (e.g. patient) and/or operator

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 1..1 CodeableConcept Describes the relationship between the device and subject
Binding: DeviceAssociation Relationship Codes (Example)
... statusReason 0..1 CodeableConcept The reasons given for the current Device Association status
Binding: DeviceAssociation Status Reason Codes (Preferred)
... relationshipStatus Σ 0..1 CodeableConcept State of the device association's relationship
Binding: DeviceAssociation Relationship Status (Preferred)
... subject Σ 1..1 Reference(BiologicallyDerivedProduct | CareTeam | Device | Group | Location | Medication | NutritionProduct | Organization | Patient | Practitioner | PractitionerRole | Specimen | Substance) The entity or group that, nominally, the association is with
... focus Σ 0..1 Reference(BiologicallyDerivedProduct | CareTeam | Device | Group | Location | Medication | NutritionProduct | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson | Specimen | Substance) The entity or group that the association is with, if not the subject
... bodyStructure 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

doco Documentation for this format icon

See the Extensions for this resource

UML Diagram (Legend)

DeviceAssociation (DomainResource)Instance identifieridentifier : Identifier [0..*]Reference to the device that is being associateddevice : Reference [1..1] « Device »Describes the relationship between the device and subject (or focus). The codes in this list may vary depending on their context of use, or the kind of subject being described in the relationshiprelationship : CodeableConcept [1..1] « A coded concept specifying the type of association. (Strength=Example) DeviceAssociationRelationship...?? »Indicates the state of the Device Association. The status describes the status of the DeviceAssociation record itself (e.g., administrative or lifecycle reasons for the record state), not the state of the underlying device relationship (this element modifies the meaning of other elements)status : code [1..1] « A coded concept specifying the state of the device association. (Strength=Required)DeviceAssociationStatusCodes! »The reasons given for the current Device Association statusstatusReason : CodeableConcept [0..1] « null (Strength=Preferred) DeviceAssociationStatusReason...? »State of the device association's relationshiprelationshipStatus : CodeableConcept [0..1] « States that characterize the lifecycle of the relationship between the device and the associated subject. (Strength=Preferred) DeviceAssociationRelationship...? »The individual, group of individuals, entity, or device that the target device is nominally associated with (i.e. subject of record). Where a patient is involved, they are usually the subjectsubject : Reference [1..1] « BiologicallyDerivedProduct|CareTeam| Device|Group|Location|Medication|NutritionProduct|Organization| Patient|Practitioner|PractitionerRole|Specimen|Substance »The individual, group of individuals, or entity that the target device is actually associated with, if they are not the subject of record. This may be a RelatedPerson when a device is rented to a patient's parent, or a Practitioner when a device is operated by a surgeon during a procedure on a patientfocus : Reference [0..1] « BiologicallyDerivedProduct|CareTeam| Device|Group|Location|Medication|NutritionProduct|Organization| Patient|Practitioner|PractitionerRole|RelatedPerson|Specimen| Substance »Current anatomical location(s) of the device in/on subjectbodyStructure : CodeableReference [0..*] « BodyStructure; Codes describing anatomical body structures. May include laterality. (Strength=Example) SNOMEDCTBodyStructures?? »Begin and end dates and times for the device associationperiod : Period [0..1]

XML Template

<DeviceAssociation xmlns="http://hl7.org/fhir"> doco
 <!-- 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><!-- 1..1 CodeableConcept Describes the relationship between the device and subject --></relationship>
 <status value="[code]"/><!-- 1..1 active | inactive | entered-in-error | unknown -->
 <statusReason><!-- 0..1 CodeableConcept The reasons given for the current Device Association status --></statusReason>
 <relationshipStatus><!-- 0..1 CodeableConcept State of the device association's relationship --></relationshipStatus>
 <subject><!-- 1..1 Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|
   Location|Medication|NutritionProduct|Organization|Patient|Practitioner|
   PractitionerRole|Specimen|Substance) The entity or group that, nominally, the association is with --></subject>
 <focus><!-- 0..1 Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|
   Location|Medication|NutritionProduct|Organization|Patient|Practitioner|
   PractitionerRole|RelatedPerson|Specimen|Substance) The entity or group that the association is with, if not the subject --></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>

Turtle Template

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


[ 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 ] ; # 1..1 Describes the relationship between the device and subject
  fhir:status [ code ] ; # 1..1 active | inactive | entered-in-error | unknown
  fhir:statusReason [ CodeableConcept ] ; # 0..1 The reasons given for the current Device Association status
  fhir:relationshipStatus [ CodeableConcept ] ; # 0..1 State of the device association's relationship
  fhir:subject [ Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|Location|Medication|
  NutritionProduct|Organization|Patient|Practitioner|PractitionerRole|Specimen|
  Substance) ] ; # 1..1 The entity or group that, nominally, the association is with
  fhir:focus [ Reference(BiologicallyDerivedProduct|CareTeam|Device|Group|Location|Medication|
  NutritionProduct|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson|Specimen|Substance) ] ; # 0..1 The entity or group that the association is with, if not the subject
  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
  • Renamed from category to relationship
  • Min Cardinality changed from 0 to 1
  • Max Cardinality changed from * to 1
DeviceAssociation.status
  • Type changed from CodeableConcept to code
  • Remove codes implanted, explanted, attached
  • Add codes active, inactive
  • Now marked as Modifier
DeviceAssociation.statusReason
  • Max Cardinality changed from * to 1
  • Remove Binding `http://hl7.org/fhir/ValueSet/deviceassociation-status-reason|5.0.0` (required)
DeviceAssociation.relationshipStatus
  • Added Element
DeviceAssociation.subject
  • Min Cardinality changed from 0 to 1
  • Type Reference: Added Target Types BiologicallyDerivedProduct, CareTeam, Location, Medication, NutritionProduct, Organization, PractitionerRole, Specimen, Substance
  • Type Reference: Removed Target Type RelatedPerson
DeviceAssociation.focus
  • Moved from DeviceAssociation.operation.operator to focus
  • Max Cardinality changed from * to 1
  • Type Reference: Added Target Types BiologicallyDerivedProduct, CareTeam, Device, Group, Location, Medication, NutritionProduct, Organization, PractitionerRole, Specimen, Substance
DeviceAssociation.bodyStructure
  • Max Cardinality changed from 1 to *
  • Type changed from Reference(BodyStructure) to CodeableReference
DeviceAssociation.period
  • Moved from DeviceAssociation.operation to DeviceAssociation
DeviceAssociation.period
  • Deleted
DeviceAssociation.operation
  • Deleted (Backbone collapsed into other elements; operator role is expressed with relationship/focus/subject)

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.

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

Path ValueSet Type Documentation
DeviceAssociation.relationship DeviceAssociationRelationshipCodes Example

DeviceAssociation Relationship Codes

DeviceAssociation.status DeviceAssociationStatusCodes Required

DeviceAssociation Status Codes

DeviceAssociation.statusReason DeviceAssociationStatusReasonCodes Preferred

DeviceAssociation Status Reason Codes

DeviceAssociation.relationshipStatus DeviceAssociationRelationshipStatus (a valid code from DeviceAssociation Relationship Status Codes) Preferred

Codes that describe the lifecycle state of a DeviceAssociation relationship.

DeviceAssociation.bodyStructure SNOMEDCTBodyStructures Example

This value set includes all codes from SNOMED CT icon where concept is-a 442083009 (Anatomical or acquired body site (body structure)).

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
date date Search for associations at or within specific times DeviceAssociation.period
device reference Search for products that match this code DeviceAssociation.device
(Device)
focus reference The focus of an association. DeviceAssociation.focus
(Group, Organization, CareTeam, BiologicallyDerivedProduct, Device, Patient, PractitionerRole, RelatedPerson, Practitioner, Specimen, NutritionProduct, Medication, Substance, Location)
identifier token The identifier of the device association DeviceAssociation.identifier
patient reference The patient associated with the device DeviceAssociation.subject.where(resolve() is Patient)
(Patient)
57 Resources
relationship token Search for specific device association relationships DeviceAssociation.relationship
status token The status of the device associations DeviceAssociation.status
subject reference The identity of the individual(s) or entity for whom to list associations DeviceAssociation.subject
(Group, Organization, CareTeam, BiologicallyDerivedProduct, Device, Patient, PractitionerRole, Practitioner, Specimen, NutritionProduct, Medication, Substance, Location)