See also: DoF: Alerting 

Name

datatype

cardinality

definition

DeviceAlert

DomainResource



identifier

Identifier

0..*

Brief: Instance identifier

Detailed:

Comments:

statuscode1..1

Brief: Instance resource status

Detailed:

Comments:

code

CodeableConcept

1..1

Brief: Identifies the specific meaning of the alert

Detailed:

Comments:

priority

code

0..1

Brief: Severity of the alert

Detailed:

Comments:

type

code

1..1

Brief: Whether the alert is physiological (about the patient) or technical (about the device)

Detailed:

Comments:

subject

Reference(Patient|Device)

1..1

  1. Brief: Patient or device that the alert is about

Detailed:

Comments: How does this relate with DeviceAssociation? How about reference to a Device Metric? Where should it point in the DeviceHierarchy?

condition[x]
with choices
conditionDateTime
conditionPeriod

dateTime|PeriodOfTime0..1

Brief: Time when condition started if not complete, period of time after condition ended

Detailed:

Comments:

conditionAbsenceReasoncode0..1

Brief: Reason for absence of condition[x] (time of alert)

Detailed:

ValueSet: 

Comments: Improve the name?

deviceReference(Device|DeviceMetric)1..1

Brief: Device Reference for MDS, VMD, Channel and DeviceMetric for individual Metric (e.g. HR in a HR HIGH Alarm).

Detailed:

Comments: In smart alarming, one device is calling the alert, though multiple devices may be providing inputs

derivedFromReference(Observation|Device|DeviceMetric)0..1

Brief: Evidentiary data that is needed to interpret the condition or that is the reason why the condition is present

Detailed: 

Comments: Does it really need to reference a Device or DeviceMetric rather than the Observation actually containing the evidence. Future possible elaboration: Normally just one, but allowing for multiple sources to derive from (problem: what is the role of each, how do they relate to one another). 

alarmText

  type

  string

BackboneElement0..*

Brief: Short but informative description of the alert for limited-space presentation

Detailed:

Comments: Highly recommended to have what is displayed on the device, and a descriptive text. Should this be a BackboneElement to include an indication of what the meaning of the different instances of alarmText are (for short descriptor, longer descriptor, alternate languages etc.)

safetyClasscode0..1

Brief

Detailed: 

Very Detailed: Documentation SafetyClassification allows POC MEDICAL DEVICE manufacturers to limit their responsibility for the provided objects that allow informational use or use in clinical functions. It reflects the quality of the respective data from the risk management perspective of the data provider.
Enumeration values prefixed with "Med" indicate that the manufacturer has considered a clinical function related to the object in its development process, particularly the risk management, software development, usability, and verification process. (BICEPS B.449 SafetyClassification)

ValueSet: Inf, MedA, MedB, MedC

Comments:  






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






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.



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. (Indicate reason for absence, cf. DeviceAlert) 

    activationState
0..1codeon | off | paused ("latched" question applies here as well)
    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 issues

Handling of latching state as opposed to a signal not being active because it is actively switched off by a user



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