Observations


Blood Glucose Observation

Profile (bg-observation)

Measurement informing about a patient’s glucose level. These are clinical observations that can be measured by the patient or the device.

Below is the category used for this Observation:

System Code Display
http://roche.com/fhir/rdc/cs clinical-observation Clinical Observation

The code of blood glucose observations is mentioned below:

System Code Display
http://loinc.org 41653-7 Glucose [Mass/volume] in Capillary blood by Glucometer
http://snomed.info/sct 362943005 Manual method (qualifier value)

BG observation resource subject element will be mapped to Patient because this observation is about and into who record the observation is placed.

device element will be mapped to DeviceMetric resource.

Blood glucose measurements are captured in the valueQuantity element. effectiveDateTime element shows the time the observation has been taken place, at the current time zone.

The related element is used to capture related Observations, such as Carbs Intake Observations, Carbs Advice Observations, Health Events Observations, EWM Observations. It has defined the relation type, with value has-member, and also has a reference to the related Observation.

Note : For edited use case, If there is any update on any entry, application shall send the updated resource. use shall see the updated details through history. In case of deleted use case the status shall be updated from 'final' to 'cancelled'


Carbohydrate Observation

Carbs associated to the observation; Carbohydrate measurements are represented by the Related Observation pattern, related to the coincident blood glucose reading, and also linked to a Device as the capture source. This observation could be related with a Carbohydrate Advice Observation (if exists).

Carbohydrate measurements are represented by the Related Observation pattern, related to the coincident blood glucose reading, and also linked to a Device as the capture source. This observation could be related with a Carbohydrate Advice Observation (if exists).

  • Below is the category used for this Observation

    System Code Display
    http://roche.com/fhir/rdc/cs carb-observation Carbohydrate intake Observation

  • Below is a list of possible values of code for this Observation (The valueset ObservationCodes has all the Observation codes, the below list only shows the codes that are relevant to this profile)

    System Code Display
    http://loinc.org 9059-7 Carbohydrate intake Estimated

  • Below code is used for new Implementations like confidence for modelling carbs data point. More details about this code is available in nutritional value Observation

    System Code Display
    http://loinc.org 9060-5 Carbohydrate intake Measured

  • This observation can be performed by a Patient so subject element will be mapped to Patient resource.

  • device element will be mapped to Device resource. A diagram that depicts Carbohydrate Observation structure and relationships is showed below:

Carbohydrate Observation

Note : For edited use case, If there is any update on any entry, application shall send the updated resource. use shall see the updated details through history. In case of deleted use case the status shall be updated from 'final' to 'cancelled'

Carbohydrate Advice Observation

Advised carbs may occur as a result of an advising application, indicating the patient should ingest carbohydrates.

Advised carbs may occur as a result of an advising application, indicating the patient should ingest carbohydrates. This is provided in the PHD/PHG by a related result to a BG result and estimates the carbohydrates (in Grams) that should be ingested. The actual patient estimate of Carbs ingested as a result is represented as an additional related result for carbohydrates.

Carbohydrate advice is represented as an observation with adviced value of carbohydrates by using valueQuantity and the profile used for this is "observation-carb-advice"

  • Below is the category used for this Observation

    System Code Display
    http://roche.com/fhir/rdc/cs carb-advice Carbohydrate advice observation

  • Below is a list of possible values of code for this Observation (The valueset ObservationCodes has all the Observation codes, the below list only shows the codes that are relevant to this profile)

    System Code Display
    http://snomed.info/sct 285390004 Recommendation to change carbohydrate intake (procedure)

  • This observation is generated based on the adviced carbs suggested from device so subject and device element will be mapped to Device resource.

  • BG-Observation should be related with Carbs Intake Observation

  • BG-Observation should be related with Carbs Advice Observation

  • Carbs Intake Observation should to be related with Carbs Advice Observation if exists.

Source ACSPIX tag example:

<BG Val="111" Dt="2005-04-27" Tm="12:04" Carb="37" D="1">

<ADVICED_CARBS Carb="42"/>

A diagram that depicts Carbohydrate Advice Observation structure and relationships is showed below:

Could not find subject. File not found for 'subject=CarbohydrateAdvice-Observation'

Note : For edited use case, If there is any update on any entry, application shall send the updated resource. use shall see the updated details through history. In case of deleted use case the status shall be updated from 'final' to 'cancelled'

EWM Observation

Data related to the operation and behavior of the device itself rather than containing measurements against the patient. Personal Health Devices emit operational data such as Events, Warnings, and Status (sometimes referred to as "maintenance") (EWS) information during uploads of measurements.

Since this data is related to the operation and behavior of the device itself rather than containing measurements against the patient, it is necessary to represent the data differently.

Main extensions used in this profile are:

A diagram that depicts EWM Observation structure and relationships is showed below:

EWM-Observation

Control Solution Observation

Control Observation is a type of observation to indicate this one is like a calibration measurement.

Control Observation is a type of observation to indicate this one is like a calibration measurement. BG elements that include a Ctrl attribute behave differently than other BG elements, in that the presence of a Ctrl attribute indicates that the BG @Val attribute provides the measurement value of Control Solution "n", where "n" is provided by @Ctrl="n". (possible values: 1, 2, 3 and ?)

  • Below is the category used for this Observation

    System Code Display
    http://roche.com/fhir/rdc/cs control-solution Control solution observation

  • Below is a list of possible values of code for this Observation (The valueset ObservationCodes has all the Observation codes, the below list only shows the codes that are relevant to this profile)

    System Code Display
    http://roche.com/fhir/rdc/cdf cdf.resq.control.L Control solution generic
    http://roche.com/fhir/rdc/cdf cdf.resq.control.1 Control solution 1
    http://roche.com/fhir/rdc/cdf cdf.resq.control.2 Control solution 2
    http://roche.com/fhir/rdc/cdf cdf.resq.control.3 Control solution 3

  • subject element will be mapped to Device also device element will be mapped to Device resource.

A diagram that depicts Control Solution Observation structure and relationships is showed below:

Could not find subject. File not found for 'subject=ControlObservation'

Health Events Observation

Observation that is used to stores information about activities of the patient, exercise, Illness, stress levels, and other information (Premenstrual, etc…) which is self reported via device. A blood glucose reading could occur in the context of exercise, where the observation of “exercise", it’s duration, intensity, etc. are modeled as a related observation to the primary glucose observation.

  • Below is the category used for this Observation

    System Code Display
    http://roche.com/fhir/rdc/cs observation-health-event Health Event Observation

  • Below is a list of possible values of code for this Observation (The valueset ObservationCodes has all the Observation codes, the below list only shows the codes that are relevant to this profile)

    System Code Display
    http://snomed.info/sct 405157008 Personal health status (observable entity)

  • Health events are captured in the valueCodeableConcept element (ValueSet -HealthEventCodes).

  • subject element will be mapped to Patient resource and device element will be mapped to Device resource.

Main extensions used in this profile are:

  • EventTiming - Event of the day that observation has been taken place.
  • RegisteredTimestamp - Timestamp when the observation was registered on the device/application

A diagram that depicts Health Events Observation structure and relationships is showed below:

Could not find subject. File not found for 'subject=Health-EventObservation'

Insulin TDD Observation

Report of 24-hour summaries of insulin delivered provided by some Insulin Pumps.

Some IPs report 24-hour summaries of insulin delivered. There are two different summary types:

  1. Total amount of insulin delivered by bolus in 24 hours (sum of bolus deliveries for the day)
  2. Total amount of insulin delivered by bolus and basal in 24 hours (sum of basal hourly rates of the day plus the sum of the bolus amount).

From ACSPix, the first summary daily insulin record (Bolus only) type is: <BOLUS dt="yyyy-mm-dd" tm="" type="" amount="" remark="Bolus Total"/>

And the second summary daily insulin record (Bolus+Basal) type is: <BOLUS dt="yyyy-mm-dd" tm="" type="" amount="" remark="Bolus+Basal Total"/>

  • subject element will be mapped to Patient resource and device element will be mapped to Device resource.

  • Below is the category used for this Observation

    System Code Display
    http://roche.com/fhir/rdc/cs observation-tdd-insulin TDD Insulin Observation

  • Below is a list of possible values of code for this Observation (The valueset ObservationCodes has all the Observation codes, the below list only shows the codes that are relevant to this profile)

    System Code Display
    http://roche.com/fhir/rdc/cs TDD-Bolus-Only Bolus TDD
    http://roche.com/fhir/rdc/cdf cdf.dat.insulin.tdd Basal and Bolus TDD

A diagram that depicts Insulin TDD Observation structure and relationships is showed below:

Could not find subject. File not found for 'subject=InsulinTDDObservation-diagram'

Vital Signs Observation

Vital Signs observations measure the body's basic functions such as blood pressure, heart rate, respiratory rate, height, weight, body mass index, head circumference, pulse oximetry, temperature, and body surface area.

  • Below is the category used for this Observation

    System Code Display
    http://hl7.org/fhir/observation-category vital-signs Vital Signs

  • Below is a list of possible values of code for this Observation (The valueset ObservationCodes has all the Observation codes, the below list only shows the codes that are relevant to this profile)

    System Code Display
    http://loinc.org 29463-7 Body weight
    http://loinc.org 39156-5 Body mass index (BMI) [Ratio]
    http://loinc.org 8302-2 Body height
    http://snomed.info/sct 434910001 Interstitial fluid glucose concentration (observable entity)
    http://snomed.info/sct 75367002 Blood pressure (observable entity)

  • Below are list of possible optional values of code for this Observation (The below codes are used by Projects which are in development)

    System Code Display
    http://loinc.org 8867-4 Heart rate
    http://loinc.org 41924-2 Heart rate 24 hour mean
    http://snomed.info/sct 248300009 Body fat observable (observable entity)

  • subject SHALL be referenced only to patient profile.

  • performer SHALL be referenced only to patient profile.

  • device SHALL be referenced to DeviceMetric profile.

  • component may be included if an observation has multiple related values like Systolic and Diastolic blood pressure. Below list contains the possible component.code

    System Code Display
    http://snomed.info/sct 271649006 Systolic blood pressure (observable entity)
    http://snomed.info/sct 271650006 Diastolic blood pressure (observable entity)
    http://roche.com/fhir/rdc/cs CGM-rate-of-change CGM rate of change
    http://roche.com/fhir/rdc/cs CGM-quality CGM quality

Extensions used in this profile are:

Main extensions used in this profile are:

  • EventTiming - Event of the day that observation has been taken place.
  • RegisteredTimestamp - Timestamp when the observation was registered on the device/application

Vital Signs Observation

Laboratory Observation

The results of observations generated by laboratories. Laboratory results are typically generated by laboratories providing analytic services in areas such as chemistry, hematology, serology, histology, cytology, anatomic pathology (including digital pathology), microbiology, and/or virology. These observations are based on analysis of specimens obtained from the patient and submitted to the laboratory.

  • Below is the category used for this Observation

    System Code Display
    http://hl7.org/fhir/observation-category laboratory Laboratory

  • Below is a list of possible values of code for this Observation (The valueset ObservationCodes has all the Observation codes, the below list only shows the codes that are relevant to this profile)

    System Code Display
    http://loinc.org 4548-4 Hemoglobin A1c/​Hemoglobin.total in Blood
    http://loinc.org 59261-8 Hemoglobin A1c/Hemoglobin.total in Blood by IFCC protocol
    http://snomed.info/sct 59431004 Ketone (substance)

  • subject SHALL be referenced only to patient profile.

  • performer SHALL be referenced to patient profile \ practitioner profile.

  • device SHALL be referenced to DeviceMetric profile.

Main extensions used in this profile are:

  • EventTiming - Event of the day that observation has been taken place.
  • RegisteredTimestamp - Timestamp when the observation was registered on the device/application

Could not find subject. File not found for 'subject=Laboratory-Observation-image'

Activity Metric Observation

Activity metric observation profile is used to record data related to activities like exercises, sleep etc. Some example metrics are active duration, steps, caloroes burned, sleep duration etc.

  • Below is the category used for this Observation

    System Code Display
    http://ncimeta.nci.nih.gov C4049938 Physical Activity Measurement

  • Below is a list of possible values of code for this Observation (The valueset ObservationCodes has all the Observation codes, the below list only shows the codes that are relevant to this profile)

    System Code Display
    http://loinc.org 55411-3 Exercise duration
    http://loinc.org 74008-4 Exercise intensity
    http://ncimeta.nci.nih.gov C3166374 Steps taken

  • Below is a list of optional possible values of code for this Observation (The below codes are used by Projects which are in development)

System Code Display
http://loinc.org 41950-7 Number of steps in 24 hour Measured
http://loinc.org 41979-6 Calories burned in 24 hour Calculated
http://loinc.org 41981-2 Calories burned
http://snomed.info/sct 444981005 Resting heart rate (observable entity)
http://snomed.info/sct 60984000 Non-rapid eye movement sleep, function (observable entity)
http://snomed.info/sct 89129007 Rapid eye movement sleep, function (observable entity)
http://snomed.info/sct 248263006 Duration of sleep (observable entity)
http://snomed.info/sct 252130009 Total exercise time (observable entity)
  • subject SHALL be referenced only to patient profile.
  • performer SHALL be referenced only to patient profile.
  • device SHALL be referenced to DeviceMetric profile.

Main extensions used in this profile are:

  • EventTiming - Event of the day that observation has been taken place.
  • RegisteredTimestamp - Timestamp when the observation was registered on the device/application

activity-metric-observation-image

Nutritional value Observation

Nutritional value observation profile is used to record data related to the nutritional value of a particular food or source of nutrition. For example - fat, carbohydrate etc.

  • Below is the category used for this Observation

    System Code Display
    http://snomed.info/sct 84626001 Nutritional value, function (observable entity)

  • Below is the possible value of code for this Observation (The valueset ObservationCodes has all the Observation codes, the below list only shows the codes that are relevant to this profile)

    System Code Display
    http://loinc.org 9060-5 Carbohydrate intake Measured

  • Below is a list of possible optional values of code for this Observation (The below codes are used by Projects which are in development)

    System Code Display
    http://loinc.org 9067-0 Fat intake Measured
    http://snomed.info/sct 787787004 Energy intake (observable entity)

  • subject SHALL be referenced only to patient profile.

  • performer SHALL be referenced only to patient profile.

  • device SHALL be referenced to DeviceMetric profile.

Main extensions used in this profile are:

  • EventTiming - Event of the day that observation has been taken place.
  • RegisteredTimestamp - Timestamp when the observation was registered on the device/application

nutritional-value-observation-image

Activity Observation

Activity observation profile is used to record an activity. For example - running, workout, sleep etc

  • Below is the category used for this Observation

    System Code Display
    http://snomed.info/sct 257733005 Activity (observable entity)

  • Below is the code used for this Observation (The valueset ObservationCodes has all the Observation codes, the below list only shows the codes that are relevant to this profile)

    System Code Display
    http://snomed.info/sct 280147009 Type of activity (attribute)

  • Below is the optional code for this Observation (The below codes are used by Projects which are in development)

    System Code Display
    http://roche.com/fhir/rdc/cs daily-activity-summary Daily activity summary

  • value(x):

    • codeableConcept - if the activity type is codes, like a mysugr tag related to activity (ValueSet - ActivityTypes)
    • string - if the activity type is a freetext description, like in mySugr logentry

  • subject SHALL be referenced only to patient profile.

  • performer SHALL be referenced only to patient profile.

  • device SHALL be referenced to Device/DeviceMetric profile.

  • Can have child observations like activity metrics, vital signs etc using the related element

Main extensions used in this profile are:

  • EventTiming - Event of the day that observation has been taken place.
  • RegisteredTimestamp - Timestamp when the observation was registered on the device/application

activity-observation-image

Diet intake Observation

Diet intake observation profile is used to record any source of nutrition (food, meal etc) that is consumed

  • Below is the category used for this Observation

    System Code Display
    http://snomed.info/sct 364395008 Dietary intake (observable entity)

  • Below is a list of possible values of code for this Observation (The valueset ObservationCodes has all the Observation codes, the below list only shows the codes that are relevant to this profile)

    System Code Display
    http://snomed.info/sct 246251008 Type of meal (attribute)

  • value(x):

    • codeableConcept - if the meal type is codes, like a mysugr tag related to meal (ValueSet - MealTypes)
    • string - if the meal type is a freetext description, like in mySugr logentry

  • subject SHALL be referenced only to patient profile.

  • performer SHALL be referenced only to patient profile.

  • device SHALL be referenced to Device/DeviceMetric profile.

  • Can have child observations like nutritional values(carb, fat, energy intake etc) using the related element

  • component may include related data like type of foods part of that meal etc. Possible codes are below:

    System Code Display
    http://roche.com/fhir/rdc/cs carbs-complexity Carbs complexity
    http://snomed.info/sct 246250009 Type of food (attribute)
    http://snomed.info/sct 229957008 Food composition types (substance)

Main extensions used in this profile are:

diet-intake-observation-image

Risk assessment Observation

This resource captures insights algorithm outcomes for a patient on the basis of source information.

Insights algorithm are patterns run over a set of data stored by the app in mySugr backend. These patterns produce an output using the pattern algorithm. The output may then be provided as a report or as structured data to the user

  • Below is the category used for this Observation

    System Code Display
    http://snomed.info/sct 225338004 Risk assessment (procedure)

  • status - registered | preliminary | final | amended

  • method (binding valueset Algorithm-name

  • subject (reference to the Patient resource)

  • code (binding valueset Insights-outcome

  • effectivePeriod - Start and end time from which the log entry data was analyzed for the provided algorithm.

Extensions added in this profile for are:

Could not find subject. File not found for 'subject=risk-assessment-observation-image'

Miscellaneous Observation

This resource captures Observations that do not fall under any standard or clear category For instance - CGM Session

  • Below is a list of possible values of code for this Observation (The valueset ObservationCodes has all the Observation codes, the below list only shows the codes that are relevant to this profile)

    System Code Display
    http://roche.com/fhir/rdc/cs CGM-session CGM Session
    http://ncimeta.nci.nih.gov C1317574 Note

  • subject SHALL be referenced only to patient profile.

  • performer SHALL be referenced only to patient profile.

  • device SHALL be referenced to Device/DeviceMetric profile.

Main extensions (apart from the standard source/channel/gdpr etc) added in this profile for are:

Calibration Observation

Calibration BG value observation profile is used to record the BG data related to the CGM sensor, to verify the device is working as expected with the BG value calculated. The goal of calibration is to minimise any measurement uncertainty by ensuring the accuracy of test equipment.

  • Below is the category used for this Observation

    System Code Display
    http://ncimeta.nci.nih.gov C0006751 Calibration

  • Below is a list of possible values of code for this Observation (The valueset ObservationCodes has all the Observation codes, the below list only shows the codes that are relevant to this profile)

    System Code Display
    http://snomed.info/sct C0337438 Glucose Measurement

  • subject SHALL be referenced only to patient profile.

  • performer SHALL be referenced only to patient profile.

  • device SHALL be referenced to DeviceMetric profile.

Main extensions used in this profile are:

  • next-calibration-time - information about when the next calibration will be necessary
  • calibration-sample-type - Type of calibration sample taken, like Capillary Plasma, Venous Whole blood, Arterial Whole blood, Arterial Plasma and many others.
  • calibration-count - This holds the count of calibaration performed.

Could not find subject. File not found for 'subject=Calibration-Observation-image'

Device event observation

`The below overview shows the elements of the resource, data type and the cardinality of each. Further details like "Binding"/"Fixed values"/"contraints" etc can be found on clicking on each element.

Important - The binding in the profiles below show that from the FHR Standard. Please refer the values to send in the text fields of various elements in the Reduced examples section.

Canonical url - http://roche.com/fhir/rdc/StructureDefinition/device-event-observation-reduced

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