The following page is to capture the discussion about the "Association" element for Device (and Device Definition).
Current JIRA Tickets
FHIR-39048 - Relationship between Device and Patient
FHIR-39009 - Device subject Jiras stomped on each other (related to changes from FHIR-30243, FHIR-34135, FHIR-32570
FHIR-38904 - Move patient association out of Device
- FHIR-39226 - Move patient association out of Device. See FHIR-38904 for more detail.
- FHIR-39243 - Move patient association out of Device. See ticket FHIR-38904.
FHIR-38637 - Add period to Device.association
Recommendation
Option #1 - Merge Operation and Association
- New Resource proposed
Discussion
Device (current)
Current State (in Device)
| Σ | 0..* | BackboneElement | Current association of the device | |
| Σ | 1..1 | CodeableConcept | Device usage state FHIRDeviceAssociationStatus (Example) | |
| 0..* | CodeableConcept | The reasons given for the current association status | ||
| 0..1 | Reference(Patient) | The individual associated with the device | ||
| Σ | 0..1 | CodeableReference(BodyStructure) | Current anatomical location of device in/on humanSubject |
New Resource (proposed)
Option #1 - Merge Operation and Association
| Σ | 0..* | |||
| 0..1 | CodeableConcept | (the nature of the association; is this code, type, or category) | |
| Σ | 1..1 | CodeableConcept | Describes the relationship with the subject or operator | |
| 0..* | CodeableConcept | The reasons given for the association status | ||
| 0..1 | Period | The start and end times when the device is associated with the subject or operator | |
| 0..1 | CodeableConcept | The designated condition for performing a task FHIRDeviceOperationMode (Example) | |
| 0..1 | Count | The series of occurrences that repeats during the operation of the device | |
| 0..1 | Duration | A measurement of time during the device's operation (e.g., days, hours, mins, etc) | |
| 0..1 | Reference (Patient, RelatedPerson, Practitioner, PractitionerRole, Organization) | The entity referenced in the association | ||
| 0..* | Reference(Patient | Practitioner | RelatedPerson) | The individual performing the action enabled by the entity (e.g., device) | |
| Σ | 0..1 | CodeableReference(BodyStructure) | Current anatomical location of entity (e.g., device) |
Option #2 - New Association Resource
| Σ | 0..1 | ||
| 1..1 | Reference(Patient) | The entity referenced in the association (e.g. device) | ||
| Σ | 0..1 | CodeableReference(BodyStructure) | Current anatomical location of entity (e.g., device) | |
| 1..1 | Reference (Device) | ||
| 1..1 | CodeableConcept | Describes the connection between the subject and focal entity (the nature of the association; is this code, type, or category)??? | |
| Σ | 1..1 | CodeableConcept | Describes the relationship with the subject or operator FHIRDeviceAssociationStatus (Example) | |
| 0..* | CodeableConcept | The reasons given for the association status | ||
| 1..1 | Period | The start and end times when the device is associated with the subject or operator |
Association (one association instance per association)
- subject(Patient | 1..1
- bodystructure 0..1
- device 1..1
- code 1..1 or role?
- status 1..1
- statuReason 0..1
- period 1..1
When do we use association vs. the relationship is by way of e.g., Procedure?
Look at operation whether they need to be understood in context of the linkage/association/dispense.
Summary Table
We may want to align with the following requirements:
- Association should be considered for use on devices, biologically derived products, and medicines
- The association should have a time Period
- Protect PHI with query
- Association with a patient, group, practitioner
- Does the association need to incorporate "Operation"?
- This new resource is referenced by other resources
Need to differentiate DeviceDispense from any new Resource.
Option--> | Options #1: Create new "Association+" Resource | Option #2: Create new "Association" Resource |
|---|---|---|
| Description | Merge the concepts currently under operation and association | Only move association |
| Discussion |
|
|
| Proposed changes | Association+
| Association
|
Options excluded:
- Linkage Resource
- Proposed by Jose Costa-Teixeira on chat.fhir.com
- Determined that Linkage is not appropriate for this use; used to indicate two FHIR resources are the same real-world object
- DeviceDispense is not for this use
- No all "associated" devices are "dispensed"
- Doesn't record end of association - would need to add (or extend) or use another resource (potentially List, suggested by David Pyke )
- DeviceUsage
- Intended for patient reported usage
- Associations do not involve the transport of the product
2 Comments
Elliot Silver
If we include operator information in this resource, should we remove it from Procedure?
Grant Forrest
Regarding the valueset https://build.fhir.org/valueset-device-association-status.html
implanted
explanted
attached
unknown
I'm struggling to come up with a value that would capture the lifecycle of a device such as a needle or catheter which is inserted, perhaps with a target body site, and remains in position for the duration of a procedure. In these cases, the Device has a temporary association, but isn't 'implanted' as such, but the device has an association, with a target body structure?