ss

Name

datatype

cardinality

definition

Value set

DeviceAlert

DomainResource




identifier

Identifier

0..*

Instance identifier

A business identifier for  a particular time-continuous or instantaneous occurrence  of a particular alert condition in a subject (patient or device) that can be used to track it over its life-cycle.
statuscode1..1Instance resource status

This as FHIR resource status rather than a device status (with codes derived from the Event pattern):

CodeDisplayDefinition
in-progressIn ProgressThe alert is currently occurring.
stoppedStoppedThis alert record was terminated prior to the full completion of the alert, e.g., by deactivation of alert detection.
completedCompletedThis alert record has now concluded, i.e., alert condition ceased and all derived signals off.
entered-in-errorEntered in ErrorThis electronic record should never have existed, though it is possible that real-world decisions were based on it.

code

CodeableConcept

1..1

Identifies the specific meaning of the alert

From IEEE-11072-10101 alert partition

priority

code

0..1


Low, Medium, High, or for information-only signals requiring no urgent action, None)

type

code

1..1

Whether the alert is physiological or technical

physiological | technical

subject

Reference(Patient|Device)

1..1

Patient or device that is the alert is about


condition[x]
with choices
conditionDateTime
conditionPeriod

dateTime|PeriodOfTime0..1Time when condition started if not complete, period of time after condition endedDo we have consensus that it can be either a dateTime or a period (an open-ended period if the alert condition still persists)
conditionAbsenceReason
?Reason for absence of condition[x] (time of alert)What should be in the valueSet?
deviceReference(Device|DeviceMetric)
Device Reference for MDS, VMD, Channel and DeviceMetric for indivual Metric (e.g. HR in a HR HIGH Alarm).
derivedFromReference(Observation|Device|DeviceMetric)
Evidentiary data that is needed to interpret the condition or that is the reason why the condition is present
alarmLabel
0..*
AlertString: Display Text that may combine the alarm  concept code as well as the measurement type and potentially also bodysites. (Can a severity code and metric value be included?)
safetyClass








Signal description. Backbone element describing an occurrence of an alert signal. This is not an attribute of the alert, but rather an attribute of the emitter of the signal, which can be multiple (a medical device, a mobile device, a specialized annunciator, ...). Where and how applied?

signal
0..*

Backbone element

AlertSignalState

    activationState


ON|OFF|PAUSED
    presence


ON|OFF|LATCHED|ACKNOWLEGDED
    manifestation


ManifestationAud|Tang|Vis|Oth
    location 


LOCAL|REMOTE|MOBILE

    indication[x]

    with choices

   indicationDateTime
   indicationPeriod





Related attributes that should be added to Device resource definition

Extension: device-alertDetection

NameFlagsCard.TypeDescription and Constraints
alertDetection
0..*Extension
    code
0..1CodeableConcept

Alert code for specific alert activation state

    activationState
1..1codeon | off | paused

Note:
If code is not present, activationState represents the overall state within the scope of the device or device component. Additional entries may provide deviating state for specific alerts.

Related attributes that should be added to DeviceMetric resource definition

Additions to FHIR Resource: DeviceMetric

NameFlagsCard.TypeDescription and Constraints
alertDetection
0..*BackboneElement
    code
0..1CodeableConcept

Either alert code for specific alert activationState or metric code for components 

    activationState
0..1codeon | off | paused
    limitRange
0..1BackboneElementAlarm limits that are applied in the determination of the alert condition
        low
0..1decimalLower limit. Unit is in DeviceMetric.unit.
        high
0..1decimalUpper limit. Unit is in DeviceMetric.unit.

Note:
If code is not present, activationState represents the overall state for the device metric. Additional entries may provide deviating state for specific alerts.
If code is not present, limitRange applies to DeviceMetric.type. For metrics with multiple components (e.g., blood pressure measurement) the code identifies the component.

Open Questions



Optionality of code?Is there a need to represent situations where the data are not available but it is known that there is an alert situation but details not yet available. What is the value of knowing just that "something is happening"?
Optionality of time?See optionality of code. Should the notion and the codes of conditionAbsenceReason attempt  to refine this?
safetyClass in Device resource sufficient?Also an attribute of the individual alert. What is the interpretation of the device's safetyClass value?
Collating multiple alerts in (say) a device?Multiple alerts can simultaneously exist in a particular scope (say, an MDS). Is it essential to our target use cases that the DeviceAlert resource tackle the issue (or at least form a part of the solution) of representing the prioritization of multiple alerts, something that MDSs typically are designed to do?
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