Expanded Examples (relevant for FHIRSTACK Facade)

CGM Sensor - expanded FHIR

Sample Scenario

Data Point Value unit Comments
SessionId AAAA
Type CapillaryWholeblood string Possible values are CapillaryWholeBlood; CapillaryPlasma; VenousWholeBlood; VenousPlasma; ArterialWholeBlood; ArterialPlasma; UndeterminedWholeBlood; UndeterminedPlasma; InterstitialFluid_ISF; ControlSolution
Sample Location Finger string Possible values are Finger; AlternateSiteTest; Earlobe; ControlSolution; SubcutaneousTissue; SampleLocationValueNotAvailable
Sample Interval 5 min
Lot Number 12345 string
SystemID ABCD-1234 string
Manufacturer Name Roche string
Model Number 56789 string
Serial Number ABCD123467878767 string
HW Revision 1.0.0 string
FW Revision 2.0.0 string
SW Revision 3.0.0 string
Model Name Aero string
Appearance 0x0D00 (Generic Continuous Glucose Monitor) string
Mac address (from sessionInfoDBItem) 00:1B:44:11:3A:B7 string

Note: Comments are provided in green in the JSON below

DevceComponent resource for CGM Sensor

A reduced format of this resource will be sent from Confidence. See the section CGM sensor - reduced FHIR. The facade needs to further expand that resource by adding the other relelavnt fields as per our implementation guide. Details are provided in the comments below. Additionally a DeviceMetric resourec has to be created for each CGM Sensor DeviceComponent.

Note: Please see the section Detailed modelling for possible values for how the resource needs to be built for different values of sample type and sample location.


{
	"resourceType": "DeviceComponent",
	"id": "1e6f0b94-1519-4f95-b50c-758fa3d4ad11", //To be managed by FHIRSTACK 
      "meta": {  //To be updated by facade - FHIR profile for device component for FHIR internal storage
        "profile":  [
            "http://roche.com/fhir/rdc/StructureDefinition/phd-devicecomponent"  
           ]
        },
	"identifier": {   //retain value from the reduced FHIR
		"system": "http://roche.com/fhir/rdc/sid/device-identifier",
		"value": "confidence/701750003/<serial-number>" 
	},
	"type": {
		 "coding":  [ //To be added by facade - system, code and display for CGM sensor
                 {
                   "system": "http://snomed.info/sct",
                   "code": "701750003",
                   "display": "Subcutaneous glucose sensor"
                 }
               ],
		"text": "CGMSensor"   //static text describing that this resource is for the details of a CGM Sensor
	},
	"source": { //To be added by facade - link to the Device resource of Confidence app
                    "reference": "Device/1e6f0b94-1519-4f95-b50c-758fa3d4ad10"
                },
	"parent": { //To be added by facade - link to the DeviceComponent resource of  the dummy smartphone created for the patient
                    "reference": "DeviceComponent/1e6f0b94-1519-4f95-b50c-758fa3d4ad12"
                },
	"measurementPrinciple": "other", //To be added by the facade - always "other"
	"productionSpecification": [
		{
			"specType": {
					"coding":  [  //To be added by the facade - system, code and display for the relevant text from reduced FHIR
                                {
                                    "system": "http://ncimeta.nci.nih.gov",
                                    "code": "C1115660",
                                    "display": "Lot Number"
                                }
                            ],
					"text": "LotNumber"  //retain in case of restore
			},
			"productionSpec": "12345" 
		},
		{
			"specType": {
					"coding":  [  //To be added by the facade - system, code and display for the relevant text from reduced FHIR
                                {
                                    "system": "http://ncimeta.nci.nih.gov",
                                    "code": "C3272556",
                                    "display": "Product Identifier"
                                }
                            ],
					"text": "SystemId"  //retain in case of restore
			},
			"productionSpec": "ABCD-1234" 
		},
		{
			"specType": {
					"coding":  [   //To be added by the facade - system, code and display for the relevant text from reduced FHIR
                                {
                                    "system": "http://ncimeta.nci.nih.gov",
                                    "code": "C0947322",
                                    "display": "Manufacturer"
                                }
                            ],
					"text": "ManufacturerName" //retain in case of restore
			},
			"productionSpec": "Roche"
		},
		{
			"specType": {
					"coding":  [ //To be added by the facade - system, code and display for the relevant text from reduced FHIR
                                {
                                    "system": "http://hl7.org/fhir/specification-type",
                                    "code": "part-number",
                                    "display": "Part Number"
                                }
                            ],
					"text": "ModelNumber" //retain in case of restore
			},
			"productionSpec": "56789"
		},
		{
			"specType": {
					"coding":  [ //To be added by the facade - system, code and display for the relevant text from reduced FHIR
                                {
                                    "system": "http://hl7.org/fhir/specification-type",
                                    "code": "serial-number",
                                    "display": "Serial Number"
                                }
                            ],
					"text": "SerialNumber" //retain in case of restore
			},
			"productionSpec": "ABCD123467878767"
		},
		{
			"specType": {
					"coding":  [ //To be added by the facade - system, code and display for the relevant text from reduced FHIR
                                {
                                    "system": "http://hl7.org/fhir/specification-type",
                                    "code": "hardware-revision",
                                    "display": "Hardware Revision"
                                }
                            ],
					"text": "HWRevision" //retain in case of restore
			},
			"productionSpec": "1.0.0"
		},
		{
			"specType": {
					"coding":  [ //To be added by the facade - system, code and display for the relevant text from reduced FHIR
                                {
                                    "system": "http://hl7.org/fhir/specification-type",
                                    "code": "firmware-revision",
                                    "display": "Firmware Revision"
                                }
                            ],
					"text": "FWRevision"
			},
			"productionSpec": "2.0.0"
		},
		{
			"specType": {
					"coding":  [ //To be added by the facade - system, code and display for the relevant text from reduced FHIR
                                {
                                    "system": "http://hl7.org/fhir/specification-type",
                                    "code": "software-revision",
                                    "display": "Software Revision"
                                }
                            ],
					"text": "SWRevision" //retain in case of restore
			},
			"productionSpec": "3.0.0"
		},
		{
			"specType": {
					"coding":  [ //To be added by the facade - system, code and display for the relevant text from reduced FHIR
                                {
                                    "system": "http://hl7.org/fhir/specification-type",
                                    "code": "unspecified",
                                    "display": "Unspecified Production Specification"
                                }
                            ],
					"text": "ModelName" //retain in case of restore
			},
			"productionSpec": "Aero"
		},
		{
			"specType": {
					"coding":  [ //To be added by the facade - system, code and display for the relevant text from reduced FHIR
                                {
                                    "system": "http://ncimeta.nci.nih.gov",
                                    "code": "C0700364",
                                    "display": "Appearance"
                                }
                            ],
					"text": "Appearance" //retain in case of restore
			},
			"productionSpec": "0x0D00 (Generic Continuous Glucose Monitor)"
		},
		{
			"specType": {
					"coding":  [ //To be added by the facade - system, code and display for the relevant text from reduced FHIR
                                {
                                    "system": "http://roche.com/fhir/rdc/cs",
                                    "code": "mac-address",
                                    "display": "Mac address"
                                }
                            ],
					"text": "MacAddress" //retain in case of restore
			},
			"productionSpec": "00:1B:44:11:3A:B7"
		}
	],
	 "extension":  [
	{
		"url": "http://roche.com/fhir/rdc/StructureDefinition/cgm-session-id",  
		"valueString": "AAAA"   //retain session id from the reduced FHIR. No need to linkto the session resource because there is already a link from the session resource to the deviceComponent. This is retained for restore purpose
	},
	{
		"url": "http://roche.com/fhir/rdc/StructureDefinition/sample-type",  
		"valueCodeableConcept": {
			"coding":  [ //To be added by the facade - system, code and display for the relevant text from reduced FHIR
                     {
                     "system": "http://ncimeta.nci.nih.gov",
                      "code": "C0162367",
                      "display": "Interstitial Fluid"
                      }
                     ],
			"text": "InterstitialFluid_ISF"   //retain in case of restore
			}
	},
	{
		"url": "http://roche.com/fhir/rdc/StructureDefinition/sample-location",  
		"valueCodeableConcept": {
			"coding":  [ //To be added by the facade - system, code and display for the relevant text from reduced FHIR
                 {
                     "system": "http://ncimeta.nci.nih.gov",
                     "code": "C0278403",
                     "display": "Subcutis"
                    }
                 ],
			"text": "SubcutaneousTissue"   //retain in case of restore
			}
	},
	{
		"url": "http://roche.com/fhir/rdc/StructureDefinition/sample-interval",  
		"valueQuantity": {
				"value": 5, //retain value from reduced FHIR
				"unit": "min",  
				"system": "http://unitsofmeasure.org", //To be added by facade - system and code for the unit                           
				"code": "min"
			}
	},
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "<channel-name>" //To be added by facade - fill channel data
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "<source-name>" //To be added by facade - fill source data
        }
]
}

DeviceMetric resource for each CGM sensor

This resource has to be created by the facade for each CGM Sensor DeviceComponent




{
                "resourceType": "DeviceMetric",
                "meta": {
                    "profile":  [
                        "http://roche.com/fhir/rdc/StructureDefinition/dm-device-metric"
                    ]
                },
                "id": "0053cfd5-a427-4691-8690-b4d956c6e658",
                "identifier":  {  //build based on the deviceComponent identifier
                        "system": "http://roche.com/fhir/rdc/sid/devicemetric-identifier",
                        "value": "<deviceComponent.identifier.value>/2344-0"
                    },
                "type": {   //always same for CGM
                    "coding":  [
                        {
                            "system": "http://loinc.org",
                            "code": "2344-0",
                            "display": "Glucose [Mass/volume] in Body fluid"
                        }
                    ]
                },
                "unit": {   //always same for CGM
                    "coding":  [
                        {
                            "system": "http://unitsofmeasure.org",
                            "code": "mg/dL",
                            "display": "milligram per deciliter"
                        }
                    ]
                },
                "source": {
                    "reference": "Device/1e6f0b94-1519-4f95-b50c-758fa3d4ad10" //link to the device resource of Confidence app
                },
                "parent": {
                    "reference": "DeviceComponent/1e6f0b94-1519-4f95-b50c-758fa3d4ad11" //link to the CGM sensor deviceComponent
                },
                "operationalStatus": "on",
                "category": "measurement",
                "measurementPeriod": {   // based on the sample interval from Confidence which is also stored in the DeviceComponent ext sample-interval
                    "repeat": {
                        "frequency": 1,
                        "period": 5,     
                        "periodUnit": "min"
                    }
                },
                "extension":  [
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "<channel-name>" //To be added by facade - fill channel data
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "<source-name>" //To be added by facade - fill source data
        }
    ]
            }

Device resource for CGM sensor

This resource has to be created by the facade for CGM Sensor Device

{
	"resourceType": "Device",
	"id": "06e0de19-bef7-4c51-b34e-2ebc5f757432",
	"meta": {
		"profile": [
			"http://roche.com/fhir/rdc/StructureDefinition/phg-device"
		]
	},
	"identifier": [
		{
			"system": "http://roche.com/fhir/rdc/sid/device-identifier",
			"value": "confidence/<serial-number>"
		}
	],
	"status": "active",
	"type": {
		"coding": [
			{
				"system": "http://snomed.info/sct",
				"code": "701750003",
				"display": "Subcutaneous glucose sensor"
			}
		]
	},
	"lotNumber": "12345",
	"manufacturer": "Roche",
	"model": "Aero",
	"version": "3.0.0",
	"patient": {
		"reference": "Patient/2P0tI8p-SF9-6850"
	}
}

CGM Session - expanded FHIR

Sample Scenario

Data Point Value unit
SessionId AAAA
SessionStatus Started possible values: NotConfigured, Started, Stopped, WarmingUp, UnPaired
MacAddress Note: See the section CGM Sensor. As it is relevant to the sensor it is included in the DeviceComponent resource. There is an extension in the DeviceComponent resource that holds the Session ID.
Calculated Session start time 2020-08-03T05:05:00Z UTC
SessionStartTime (Paring Date) 2020-08-03T05:00:00Z UTC
CGM Session Run Time 5 hours
CGM session end time 2020-08-03T10:00:00Z UTC
NotificationAlreadyScheduled true bool

Note: Comments are provided in green in the JSON below
Paring Date will be same as the session start time

Observation resource for CGM Session

A reduced format of this resource will be sent from Confidence. See the section CGM Session - reduced FHIR. The facade needs to further expand that resource by adding the other relelavnt fields as per our implementation guide. Details are provided in the comments below.

{
		"resourceType": "Observation",    //FHIR resource type
		"id": "1e6f0b94-1519-4f95-b50c-758fa3d4ac4b", //To be managed by FHIRSTACK 
		"meta": {
			"profile": [
				"http://roche.com/fhir/rdc/StructureDefinition/miscellaneous-observation"  //To be added by facade - FHIR profile for CGM
			]
		},
		"identifier": [
			{
				"system": "http://roche.com/fhir/rdc/sid/observation/confidence",
				"value": "AAAA"   //retain same identifier received from Confidence reduced FHIR
			}
		],
		"status": "final",     //retain same status received from confidence reduced FHIR
		"code": {
			"coding": [ //To be added by facade - system, code and display when code.text "CGMSession" is received in the reduced FHIR
				{
					"system": "http://roche.com/fhir/rdc/cs",
					"code": "CGM-session",
					"display": "CGM Session" 
				}
				],
			
					"text": "CGMSession"   //To be retained as is from the reduced format so that on restore it can be sent back
			
		},
		"subject": {
			"reference": "Patient/2P0tI8p-SF9-6850" //To be added by facade -  - patient link
		},
		"performer": [
			{
				"reference": "Patient/2P0tI8p-SF9-6850"  //To be added by facade - Patient link
			}
		],
		 "effectivePeriod": {
						"start": "2020-08-03T05:00:00Z",    //To be retained as is from the reduced format
						"end": "2020-08-03T10:00:00Z"       //To be retained as is from the reduced format
					},
		"dataAbsentReason": {  //To be adedd by the facade - Reduced FHIR will not have any value for this Observation
			"coding": [
				{
					"system": "http://hl7.org/fhir/data-absent-reason",
					"code": "unknown",
					"display": "Unknown"  
				}
			]
		},
		"device": { //To be added by facade - link to deviceMetric of relevant CGM sensor deviceComponent
		"reference": "DeviceMetric/0053cfd5-a427-4691-8690-b4d956c6e658"
	},
		 "extension":  [
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/session-run-time",  
			"valueQuantity": {
					"value": 5,       //To be retained as is from the reduced format
					"unit": "h",      
					"system": "http://unitsofmeasure.org", //To be added by facade system and code for the units
					"code": "h"
				}
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/calculated-session-start-time",
			"valueDateTime": "2020-08-03T05:05:00Z"         //To be retained as is from the reduced format
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/session-status",
			"valueString": "Started"          //To be retained as is from the reduced format
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/notification-scheduled-status",
			"valueBoolean": true              //To be retained as is from the reduced format
		},
		{
		"url": "http://roche.com/fhir/rdc/StructureDefinition/patient-timezone",
		"valueString": "+02:00"   //to be retained as is from the reduced FHIR format **
	},
		{
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "<channel-name>" //To be added by facade - fill channel data
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "<source-name>" //To be added by facade - fill source data
        }
	]
	}

** Refer timezone extension page for possible combination of timezone captured HERE

BG data - expanded FHIR

Sample Scenario

Data Point Value unit
Blood Glucose Value 118 mg/dL
Notes Blood Glucose Observation string
Time Stamp 2020-08-04T15:00:16Z UTC

Observation resource for BG measurement

A reduced format of this resource will be sent from Confidence. See the section BG data - reduced FHIR. The facade needs to further expand that resource by adding the other relavent fields as per our implementation guide. Details are provided in the comments below in green.

Below is an example JSON for the observation resource having bg information in expanded FHIR format

{
	"resourceType": "Observation", 
	"id": "905f85cd-5c11-47a8-8325-f7a176f434b5", //To be managed by FHIRSTACK 
	"meta": {
        "profile":  [  //To be updated by facade - FHIR profile for bg  observation for FHIR internal storage
            "http://roche.com/fhir/rdc/StructureDefinition/bg-observation"
        ]
    },
	"identifier": [ 
		{
			"system": "http://roche.com/fhir/rdc/sid/observation/confidence",
			"value": "<confidence unique identifier>" //retain same identifier received from Confidence reduced FHIR
		}
	],
	"status": "final", //retain same status received from confidence
	"category": [ //To be added by facade - category for bg will always be Clinical Observation
		{
			"coding": [
				{
					"system": "http://roche.com/fhir/rdc/cs",
					"code": "clinical-observation",
					"display": "Clinical Observation"
				}
			]
		}
	],
	"code": {
		"coding": [ //To be added by facade - system, code and display when code.text "BloodGlucoseValue" is received in the reduced FHIR
			{
				"system": "http://snomed.info/sct",
				"code": "362943005",
				"display": "Manual method (qualifier value)"
			}
		],
		"text": "BloodGlucoseValue" //To be retained as is from the reduced format so that on restore it can be sent back
	},
	"subject": {
		"reference": "Patient/2P0tI8p-SF9-6850" //To be added by facade - patient link
	},
	"effectiveDateTime": "2020-08-04T15:00:16Z", //Retain same value from Confidence reduced FHIR
	"performer": [
		{
			"reference": "Patient/2P0tI8p-SF9-6850" //To be added by facade - patient link
		}
	],
	"comment": "Blood Glucose Observation", //Retain same value from Confidence reduced FHIR
	"valueQuantity": {
		"value": "102", //retain value from reduced FHIR
		"unit": "mg/dL", //retain value from reduced FHIR
		"system": "http://unitsofmeasure.org", //To be added by facade - the system and code details for bg
		"code": "mg/dL"
	},
	"device": {
		"reference": "DeviceMetric/id-deviceMetric-smartPhone-bg" //To be added by facade - link to deviceMetric of smart phone capturing bg value .
	},
	"extension": [
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/patient-timezone",
			"valueString": "+02:00" //retain same data from Confidence reduced FHIR
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
			"valueString": "<channel-name>" //To be added by facade - fill channel data
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
			"valueString": "<source-name>" //To be added by facade - fill source data
		}
	]
}

carbs data - expanded FHIR

Sample Scenario

Data Point Value unit
Carbs 10 grams
Time Stamp 2020-08-04T15:00:16Z UTC

Observation resource for carbs measurement

A reduced format of this resource will be sent from Confidence. See the section Carbs data - reduced FHIR. The facade needs to further expand that resource by adding the other relavent fields as per our implementation guide. Details are provided in the comments below in green.

Below is an example JSON for the observation resource having Nutritional value of Carbohydrate intake information in expanded FHIR format


{
    "resourceType": "Observation",
    "id": "805f85cd-8c10-47a8-8325-f7a176f444b4", To be managed by FHIRSTACK 
    "meta": {
        "profile":  [  //To be updated by facade - FHIR profile for carbs observation for FHIR internal storage
            "http://roche.com/fhir/rdc/StructureDefinition/nutritional-value-observation"
        ]
    },
    "status": "final",  //retain same status received from confidence 
    "identifier":  [
        {
            "system": "http://roche.com/fhir/rdc/sid/observation/confidence",
            "value": "<confidence unique identifier>" //retain same identifier received from Confidence reduced FHIR
        }
    ],
    "category":  [ //To be added by facade - category for Carbs will always be Nutritional value, function (observable entity).
        {
            "coding":  [
                {
                    "system": "http://snomed.info/sct",
                    "code": "84626001",
                    "display": "Nutritional value, function (observable entity)"
                }
            ]
        }
    ],
    "code": {
        "coding":  [ //To be added by facade - system, code and display when code.text "Carbs" is received in the reduced FHIR
            {
                "system": "http://loinc.org",
                "code": "9060-5",
                "display": "Carbohydrate intake Measured"
            }
        ],
        "text": "Carbs"      //To be retained as is from the reduced format so that on restore it can be sent back
    },
    "subject": {
        "reference": "Patient/2P0tI8p-SF9-6850" //To be added by facade - patient link
    },
    "effectiveDateTime": "2020-08-04T15:00:16Z", //Retain same value from Confidence reduced FHIR
    "performer":  [
        {
            "reference": "Patient/2P0tI8p-SF9-6850" //To be added by facade - patient link
        }
    ],
    "valueQuantity": {
        "value": "10", //retain value from reduced FHIR
        "unit": "g", //retain value from reduced FHIR
        "system": "http://unitsofmeasure.org", //To be added by facade - the system and code details for Carbs
        "code": "g"
    },
    "device": {
        "reference": "DeviceMetric/id-deviceMetric-smartPhone-carb" //To be added by facade - link to deviceMetric of smart phone capturing carbs value .
    },
    "extension":  [
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/patient-timezone",
            "valueString": "+02:00" //retain same data from Confidence reduced FHIR
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "<channel-name>" //To be added by facade - fill channel data
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "<source-name>" //To be added by facade - fill source data
        }
    ]
}

Insulin data - expanded FHIR

Sample Scenario

Data Point Value unit
Bolus Insulin 3 iU
Basal Insulin 5 iU
Time Stamp 2020-08-04T15:00:16Z UTC

Medication Adminstration resource for Insulin value

A reduced format of this resource will be sent from Confidence. See the section Insulin data - reduced FHIR. The facade needs to further expand that resource by adding the other relavent fields as per our implementation guide. Details are provided in the comments below in green.

Below are examples of Medication adminstration resource having Insulin information in expanded FHIR format

Sample basal (long-acting)

{
	"resourceType": "MedicationAdministration",
	"id": "a4815578-c404-42a6-91a5-bd0c0439789b", To be managed by FHIRSTACK 
	"meta": {
		"profile": [ //To be updated by facade - FHIR profile for medication adminstration for FHIR internal storage
			"http://roche.com/fhir/rdc/StructureDefinition/medication-administration"
		]
	},
	"identifier": [
		{
			"system": "http://roche.com/fhir/rdc/sid/medication-administration/confidence",
			"value": "<confidence unique identifier>" //retain same identifier received from Confidence reduced FHIR
		}
	],
	"status": "completed", //retain same status received from confidence 
	"medicationCodeableConcept": {
		"coding": [  To be added by facade - system, code and display when medicationCodeableConcept.text "BolusInsulin" is received in the reduced FHIR
			{
				"system": "http://snomed.info/sct",
				"code": "25305005",
				"display": "Long-acting insulin (substance)"
			}
		],
		"text": "BasalInsulin"  //To be retained as is from the reduced format so that on restore it can be sent back
	},
	"subject": {
		"reference": "Patient/2P0tI8p-SF9-6850" //To be added by facade - patient link
	},
	"effectiveDateTime": "2020-08-04T15:00:16Z", //Retain same value from Confidence reduced FHIR
	"performer": [
		{
			"actor": {
				"reference": "Patient/2P0tI8p-SF9-6850" //To be added by facade - patient link
			}
		}
	],
	"dosage": {
		"dose": {
			"value": "5", //retain value from reduced FHIR
			"unit": "[iU]", //retain value from reduced FHIR
			"system": "http://unitsofmeasure.org", //To be added by facade - the system and code details for Insulin
			"code": "[iU]" 
		}
	},
	"extension": [
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/parent-device-metric",
			"valueReference": {
				"reference": "DeviceMetric/id-deviceMetric-smartPhone-insulin" //To be added by facade - link to deviceMetric of smart phone capturing insulin value 
			}
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/patient-timezone",
			"valueString": "+02:00" //retain same data from Confidence reduced FHIR
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
			"valueString": "<channel-name>" //To be added by facade - fill channel data
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
			"valueString": "<source-name>" //To be added by facade - fill source data
		}
	]
}

Sample bolus (short-acting)


{
	"resourceType": "MedicationAdministration",
	"id": "50e98533-db88-43d5-8db2-e224148e93f4",
	"meta": {
		"profile": [ //To be retained as is from the reduced format  - FHIR profile for Insulin
			"http://roche.com/fhir/rdc/StructureDefinition/medication-administration"
		]
	},
	"identifier": [
		{
			"system": "http://roche.com/fhir/rdc/sid/medication-administration/confidence",
			"value": "<confidence unique identifier>" //retain same identifier received from Confidence reduced FHIR
		}
	],
	"status": "completed", //retain same status received from confidence 
	"medicationCodeableConcept": {
		"coding": [ To be added by facade - system, code and display when medicationCodeableConcept.text "BolusInsulin" is received in the reduced FHIR
			{
				"system": "http://snomed.info/sct",
				"code": "411531001",
				"display": "Short-acting insulin (substance)"
			}
		],
		"text": "BolusInsulin"  //To be retained as is from the reduced format so that on restore it can be sent back
	},
	"subject": {
		"reference": "Patient/2P0tI8p-SF9-6850" //To be added by facade - patient link
	},
	"effectiveDateTime": "2020-04-28T09:20:00Z", //Retain same value from Confidence reduced FHIR
	"performer": [
		{
			"actor": {
				"reference": "Patient/2P0tI8p-SF9-6850" //To be added by facade - patient link
			}
		}
	],
	"dosage": {
		"dose": {
			"value": "2", //retain value from reduced FHIR
			"unit": "[iU]", //retain value from reduced FHIR
			"system": "http://unitsofmeasure.org", //To be added by facade - the system and code details for Insulin
			"code": "[iU]"
		}
	},
	"extension": [
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/parent-device-metric", 
			"valueReference": {
				"reference": "DeviceMetric/id-deviceMetric-smartPhone-insulin" //To be added by facade - link to deviceMetric of smart phone capturing insulin value .
			}
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/patient-timezone", 
			"valueString": "+02:00" //retain same data from Confidence reduced FHIR
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
			"valueString": "<channel-name>" //To be added by facade - fill channel data
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
			"valueString": "<source-name>" //To be added by facade - fill source data
		} 
	]
}

Calibration BG - expanded FHIR

Sample Scenario

Data Point Value unit comment
SessionId AAAA
GlucoseConcentration (BG) 104 mg/dL
CalibrationTime 2020-08-04T15:00:16Z UTC
CalibrationType CapillaryWholeBlood String Possible values are CapillaryWholeBlood; CapillaryPlasma; VenousWholeBlood; VenousPlasma; ArterialWholeBlood; ArterialPlasma; UndeterminedWholeBlood; UndeterminedPlasma; InterstitialFluid_ISF; ControlSolution
CalibrationSampleLocation Finger String Possible values are Finger; AlternateSiteTest; Earlobe; ControlSolution; SubcutaneousTissue; SampleLocationValueNotAvailable
NextCalibrationTime 360 min
CalibrationDataRecordNumber 3
CalibrationStatus CalibrationProcessPending String Possible values are CalibrationDatarejected; CalibrationDataoutofrange; CalibrationProcessPending

Observation resource for Calibration BG measurement

A reduced format of this resource will be sent from Confidence. See the section Calibration BG - reduced FHIR. The facade needs to further expand that resource by adding the other relavent fields as per our implementation guide. Details are provided in the comments below in green.

Note: Please see the section Detailed modelling for possible values for how the resource needs to be built for different values of Calibration Type and Calibration Sample Location.

Below is an example JSON for the Calibration observation resource having bg information in expanded FHIR format


{
	"resourceType": "Observation",
	"id": "1e6f0b94-1519-4f95-b50c-758fa3d4ac4b", //To be managed by FHIRSTACK 
	"meta": {
		"profile": [ //To be updated by facade - FHIR profile for Calibration observation for FHIR internal storage
			"http://roche.com/fhir/rdc/StructureDefinition/observation-calibration" 
		]
	},
	"identifier": [
		{
			"system": "http://roche.com/fhir/rdc/sid/observation/confidence",
			"value": "<confidence unique identifier>"   //retain same identifier received from Confidence reduced FHIR
		}
	],
	"related": [
		{
			"type": "derived-from",
			"target": {
				"reference": "Observation/0053cfd5-a427-4691-8690-b4d956c6e690", //To be added by facade based on the SessionID (target.display) in the reduced FHIR.  Link to the relevant CGM session observation
				"display": "AAAA" //To be retained as is from the reduced format so that on restore it can be sent back
			}
		}
	],
	"status": "final", //retain same status received from confidence reduced FHIR
	"category": [ //To be added by facade - category for Calibration observation will always be Calibration
		{
			"coding": [
				{
					"system": "http://ncimeta.nci.nih.gov",
					"code": "C0006751",
					"display": "Calibration"
				}
			]
		}
	],
	"code": { 
		"coding": [ //To be added by facade - system, code and display when code.text "GlucoseConcentration(BG)" is received in the reduced FHIR
			{
				"system": "http://ncimeta.nci.nih.gov",
				"code": "C0337438",
				"display": "Glucose Measurement"
			}
		],
		"text": "GlucoseConcentration(Calibration)" //To be retained as is from the reduced format so that on restore it can be sent back
	},
	"subject": {
		"reference": "Patient/2P0tI8p-SF9-6850" //To be added by facade - patient link
	},
	"effectiveDateTime": "2020-08-04T15:00:16Z", //Retain same value from Confidence reduced FHIR
	"performer": [
		{
			"reference": "Patient/2P0tI8p-SF9-6850" //To be added by facade - patient link
		}
	],
	"valueQuantity": {
		"value": "104", //retain value from reduced FHIR
		"unit": "mg/dL", //retain value from reduced FHIR
		"system": "http://unitsofmeasure.org", //To be added by facade - the system and code details.
		"code": "mg/dL"
	},
	"bodySite": {
		"coding": [  //To be added by facade - system, code and display when bodysite.text "Finger" is received in the reduced FHIR
			{
				"system": "http://ncimeta.nci.nih.gov",
				"code": "C0016129",
				"display": "Finger"
			}
		],
		"text": "Finger" //To be retained as is from the reduced format so that on restore it can be sent back
	},
	"device": { //To be added by facade - link to deviceMetric of smart phone capturing bg value .
		"reference": "DeviceMetric/id-deviceMetric-smartPhone-bg"
	},
	"extension": [
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/patient-timezone",
			"valueString": "+02:00" //To be retained as is from the reduced format
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/sample-type",
			"valueCodeableConcept": {
				"coding": [ //To be added by facade - system, code and display when valueCodeableConcept.text "CapillaryWholeBlood" is received in the reduced FHIR
					{
						"system": "http://ncimeta.nci.nih.gov",
						"code": "C0229666",
						"display": "Capillary Blood"
					}
				],
				"text": "CapillaryWholeBlood"  //To be retained as is from the reduced format so that on restore it can be sent back
			}
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/next-calibration-time",
			"valueQuantity": {
				"value": 360, //To be retained as is from the reduced format
				"unit": "min", //To be retained as is from the reduced format
				"system": "http://unitsofmeasure.org",      //To be added by facade system and code for the units
				"code": "min"
			}
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/calibration-count",
			"valueInteger": 3 //To be retained as is from the reduced format
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/calibration-action",
			"valueString": "CalibrationProcessPending" //To be retained as is from the reduced format
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
			"valueString": "<channel-name>" //To be added by facade - fill channel data
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
			"valueString": "<source-name>" //To be added by facade - fill source data
		}
	]
}

EMWR - expanded FHIR

Sample Scenario

Data Point Value unit Comment
SessionId CGMSesssion AAAA
InstanceId EEMMWW mg/dL
MessageSource 2 Possible values are 0 = None, 1 = Application, 2 = CGM
EventName M_CALIBRATION_REQUIRED String Possible values are M_CALIBRATION_REQUIRED; M_CGM_BATTERY_LOW; M_CGM_SENSOR_MALFUNCTION_WITH_SESSION_STOP; W_CGM_SENSOR_MALFUNCTION_WITHOUT_SESSION_STOP; R_CGM_SESSION_END; M_END_OF_OPERATION; M_CGM_CONNECTION_LOST; M_SENSOR_TEMP_LOW; M_SENSOR_TEMP_HIGH; M_RC_COMM_FAILED; W_CGM_CALIBRATION_OUT_OF_RANGE; M_HYPO_MESSAGE; W_HYPER_MESSAGE; E_DATA_INTEGRITY_ERROR; M_RC_COMM_FAILED; W_HYPO_PREDICTION_MESSAGE; W_LENGTH_OF_STAY_MESSAGE; M_CALIBRATION_CRITICAL
TimeOffsetOccurance 200 min
State Snoozed String Possible values are NotProcessed, Processed, Snoozed, Dismissed
SnoozeWakeupTime 2020-08-05T15:10:16Z UTC
TimeWhenProcessed 2020-08-05T15:15:16Z UTC
Type Warning String Possible values are Error; Maintenance; Warning; Reminder; Message
Time Stamp 2020-08-04T15:00:16Z UTC

EWM Observation resource for Calibration BG measurement

A reduced format of this resource will be sent from Confidence. See the section EMWR - reduced FHIR. The facade needs to further expand that resource by adding the other relavent fields as per our implementation guide. Details are provided in the comments below in green.

Note: Please see the section Detailed modelling for possible values for how the resource needs to be built for different values of EMWR Type, EMWR Event Name and Message Source

Below is an example JSON for the EWM observation resource in expanded FHIR format

{
	"resourceType": "Observation",
    "id": "qe6f0b94-1519-4f95-b50c-758fa3d4ac55", //To be managed by FHIRSTACK 
	"meta": {
		"profile": [ //To be updated by facade - FHIR profile for Calibration observation for FHIR internal 
			"http://roche.com/fhir/rdc/StructureDefinition/observation-EWM"
		]
	},
	"identifier": [
		{
			"system": "http://roche.com/fhir/rdc/sid/observation/confidence",
			"value": "EEMMWW"  //retain same identifier received from Confidence reduced FHIR
		}
	],
	"status": "final", //retain same status received from confidence reduced FHIR
	"category": [ //To be added by facade - category for Calibration observation will always be "Error, Warning, Maintenance, Status"
		{
			"coding": [
				{
					"system": "http://roche.com/fhir/rdc/cs",
					"code": "EWM",
					"display": "Error, Warning, Maintenance, Status"
				}
			]
		}
	],
	"code": {
		"coding": [  //To be added by facade - system, code and display when code.text "Warning" is received in the reduced FHIR.
			{
				"system": "http://roche.com/fhir/rdc/cs",
				"code": "WARNING",
				"display": "Warning"
			}
		],
		"text": "Warning" //To be retained as is from the reduced format so that on restore it can be sent back
	},
	"subject": {
		"reference": "Device/0053cfd5-a427-4691-8690-b4d956c6e698" //To be added by facade - Device link
	},
	"effectiveDateTime": "2020-08-04T15:00:16Z", //Retain same value from Confidence reduced FHIR
	"performer": [
		{
			"reference": "Patient/2P0tI8p-SF9-6850" //To be added by facade - patient link
		}
	],
	"valueCodeableConcept": { //To be added by facade - system, code and display when code.text "M_CALIBRATION_REQUIRED" is received in the reduced FHIR.
		"coding": [
			{
				"system": "http://roche.com/fhir/rdc/cs",
				"code": "WARNING_49",
				"display": "Calibration Required"
			}
		],
		"text": "M_CALIBRATION_REQUIRED"  //To be retained as is from the reduced format so that on restore it can be sent back
	},
	"related": [
		{
			"type": "derived-from",
			"target": {
				"reference": "Observation/0053cfd5-a427-4691-8690-b4d956c6e690", //To be added by facade based on the SessionID (target.display) in the reduced FHIR.  Link to the relevant session observation
				"display": "AAAA" //To be retained as is from the reduced format so that on restore it can be sent back
			}
		}
	],
	"device": {
		"reference": "DeviceMetric/id-deviceMetric-CGM", //To be added by facade based on the device.display in the reduced FHIR. link to relavent device metric.
		"display": "2" //To be retained as is from the reduced format so that on restore it can be sent back
	},
	"extension": [
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/time-offset",
			"valueQuantity": {
				"value": 200, //retain value from reduced FHIR
				"unit": "min", //retain value from reduced FHIR
				"system": "http://unitsofmeasure.org", //To be added by facade - the system and code 
				"code": "min"
			}
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/ewm-state",
			"valueString": "Snoozed" //retain value from reduced FHIR
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/snooze-wakeup-time",
			"valueDateTime": "2020-08-05T15:10:16Z" //retain value from reduced FHIR
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/time-when-processed",
			"valueDateTime": "2020-08-05T15:15:16Z" //retain value from reduced FHIR
		},
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/patient-timezone",
			"valueString": "+02:00" //retain value from reduced FHIR
		},
		{
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "<channel-name>" //To be added by facade - fill channel data
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "<source-name>" //To be added by facade - fill source data
        }
	]
}

Notes - Expanded FHIR

Sample Scenario

Data Point Value unit Comment
Notes sample note entered along with log entry String The note field is where a patient can store additional information along with the log entry

Note: Comments are provided in green in the JSON below

Observation resource for Notes

A reduced format of this resource will be sent from Confidence. See the section Notes - reduced FHIR. The facade needs to further expand that resource by adding the other relavent fields as per our implementation guide. Details are provided in the comments below in green.

Below is an example JSON for the EWM observation resource in expanded FHIR format


{
	"resourceType": "Observation", //FHIR resource type
	"id": "ae6f0b94-1519-4f95-b50c-758fa3d4ac4d", //To be managed by FHIRSTACK 
	"meta": {
		"profile": [
			"http://roche.com/fhir/rdc/StructureDefinition/miscellaneous-observation" //To be added by facade - FHIR profile for CGM
		]
	},
	"identifier": [
		{
			"system": "http://roche.com/fhir/rdc/sid/observation/confidence",
			"value": "<confidence unique identifier>" //retain same identifier received from Confidence reduced FHIR
		}
	],
	"status": "final", //retain same status received from confidence reduced FHIR
	"code": {
		"coding": [ //To be added by facade - system, code and display when code.text "Notes" is received in the reduced FHIR
			{
				"system": "http://ncimeta.nci.nih.gov",
				"code": "C1317574",
                "display": "Note"
			}
		],
		"text": "Notes" //To be retained as is from the reduced format so that on restore it can be sent back
	},
	"valueString": "sample note entered along with log entry", //To be retained as is from the reduced format
	"subject": { //To be added by facade -  - patient link
		"reference": "Patient/2P0tI8p-SF9-6850"
	},
	"performer": [ //To be added by facade -  - patient link
		{
			"reference": "Patient/2P0tI8p-SF9-6850" 
		}
	],
	"effectiveDateTime": "2020-08-03T05:00:00Z", //To be retained as is from the reduced format
	"device": {
        "reference": "DeviceMetric/0053cfd5-a427-4691-8690-b4d956c6e658" //To be added by facade - link to dummy deviceMetric because Notes coming from an application do not have a specific deviceMetric
    },
	"extension": [
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/patient-timezone",
			"valueString": "+02:00" //to be retained as is from the reduced FHIR format
		},
		{
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "<channel-name>" //To be added by facade - fill channel data
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "<source-name>" //To be added by facade - fill source data
        }
	]
}

Default resources to be created

The following resources have to be created by the facade additionally in order to comply with RDC Implementation guide.

Patient

{
    "resourceType": "Patient",
    "id": "3f6AHVp-w86-1061",
    "meta": {
        "profile": [
            "http://roche.com/fhir/rdc/StructureDefinition/patient"
        ]
    },
    "identifier": [
        {
            "use": "official",
            "system": "http://roche.com/fhir/rdc/sid/pid/gigya",
            "value": "210527-confidence-dev"
        }
    ],
    "active": true
}

Device

There will be one Device resource for the ConfidenceApp integration

{
    "resourceType": "Device",
    "id": "confidence-1.0.0",
    "meta": {
        "profile": [
            "http://roche.com/fhir/rdc/StructureDefinition/phg-device"
        ]
    },
    "extension": [
            {
                "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
                "valueString": "confidence"
            },
            {
                "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
                "valueString": "confidence"
            }
    ],
    "status": "active",
    "type": {
        "coding": [
            {
                "system": "http://roche.com/fhir/rdc/cdf",
                "code": "cdf.dev.im",
                "display": "Manual interface"
            }
        ]
    },
    "manufacturer": "Roche",
    "model": "confidence",
    "version": "1.0.0"
}

DeviceComponent for a dummy SmartPhone

The ConfidenceApp does not share details of the smartphone on which the application is installed. However, we need a DeviceComponent for the smart phone to link the BG, Carb, Insulin etc. from the logbook.

{
    "resourceType": "DeviceComponent",
    "id": "cf.devicecomponent.3f6AHVp-w86-1061",
    "meta": {
        "profile": [
            "http://roche.com/fhir/rdc/StructureDefinition/phd-devicecomponent"
        ]
    },
    "extension": [
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "confidence"
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "confidence"
        }
    ],
    "identifier": {
        "system": "http://roche.com/fhir/rdc/sid/device-identifier",
        "value": "confidence/<patient-id>"
    },
    "type": {
        "coding": [
            {
                "system": "http://roche.com/fhir/rdc/cs",
                "code": "smartPhone",
                "display": "Smart Phone"
            }
        ]
    },
    "lastSystemChange": "2021-06-01T00:00:00.000Z",
    "source": {
        "reference": "Device/confidence-1.0.0"
    }
}

DeviceMetric for BG/Calibration

A DeviceMetric resource is needed to link an Observation to a DeviceComponent.

{
    "resourceType": "DeviceMetric",
    "meta": {
        "profile":  [
                        "http://roche.com/fhir/rdc/StructureDefinition/dm-device-metric"
        ]
        },
    "extension": [
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "confidence"
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "confidence"
        }
    ],
    "id": "cf.dmglucose.3f6AHVp-w86-1061",
    "identifier": {
        "system": "http://roche.com/fhir/rdc/sid/devicemetric-identifier",
        "value": "<deviceComponent.identifier.value>/2339-0"
    },
    "type": {
        "coding":  [
            {
                "system": "http://loinc.org",
                "code": "2339-0",
                "display": "Glucose [Mass/volume] in Blood"
            }
        ]
    },
    "unit": {
        "coding":  [
            {
                "system": "http://unitsofmeasure.org",
                "code": "mg/dL",
                "display": "milligram per deciliter"
            }
        ]
    },
    "source": {
        "reference": "Device/confidence-1.0.0"
    },
    "parent": {
        "reference": "DeviceComponent/cf.devicecomponent.3f6AHVp-w86-1061" //link to the dummy smartphone devicecomponent resource
    },
    "operationalStatus": "on",
        "category": "measurement"
}

DeviceMetric for Carb

A DeviceMetric resource is needed to link an Observation to a DeviceComponent.

{
    "resourceType": "DeviceMetric",
    "id": "cf.dmcarbs.3f6AHVp-w86-1061",
    "meta": {
        "profile":  [
            "http://roche.com/fhir/rdc/StructureDefinition/dm-device-metric"
        ]
    },
    "extension": [
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "confidence"
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "confidence"
        }
    ],
    "identifier": {
        "system": "http://roche.com/fhir/rdc/sid/devicemetric-identifier",
        "value": "<deviceComponent.identifier.value>/2331003"
    },
    "type": {
        "coding":  [
            {
                "system": "http://snomed.info/sct",
                "code": "2331003",
                "display": "Carbohydrate (substance)"
            }
        ]
    },
    "unit": {
        "coding":  [
            {
                "system": "http://unitsofmeasure.org",
                "code": "g",
                "display": "gram"
            }
        ]
    },
    "source": {
        "reference": "Device/confidence-1.0.0"
    },
    "parent": {
        "reference": "DeviceComponent/cf.devicecomponent.3f6AHVp-w86-1061" //link to the dummy smartphone devicecomponent resource
    },
    "operationalStatus": "on",
    "category": "measurement" 
}

DeviceMetric for Insulin

A DeviceMetric resource is needed to link a MedcationAdministration to a DeviceComponent.

 {
        "id": "cf.dmins.3f6AHVp-w86-1061",
        "meta": {
            "profile":  [
                        "http://roche.com/fhir/rdc/StructureDefinition/dm-device-metric"
            ]
         },
        "extension": [
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "confidence"
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "confidence"
        }
        ],
        "resourceType": "DeviceMetric",
        "identifier": {
            "system": "http://roche.com/fhir/rdc/sid/devicemetric-identifier",
            "value": "<deviceComponent.identifier.value>/67866001"
        },
        "type": {
            "coding":  [
                {
                    "system": "http://snomed.info/sct",
                    "code": "67866001",
                    "display": "Insulin (substance)"
                }
            ]
        },
        "unit": {
            "coding":  [
                {
                    "system": "http://unitsofmeasure.org",
                    "code": "[iU]",
                    "display": "international unit"
                }
            ]
        },
        "source": {
        "reference": "Device/confidence-1.0.0"
        },
        "parent": {
         "reference": "DeviceComponent/cf.devicecomponent.3f6AHVp-w86-1061" //link to the dummy smartphone devicecomponent resource
        },
        "operationalStatus": "on",
        "category": "measurement"
}

DeviceMetric for EMWR / Notes

A DeviceMetric resource is needed to link an Observation to a DeviceComponent. This is a dummy deviceMetric because errors/messages/Notes coming from an application do not have a specific deviceMetric

 {
        "id": "cf.dmemwr.3f6AHVp-w86-1061",
        "meta": {
            "profile":  [
                        "http://roche.com/fhir/rdc/StructureDefinition/dm-device-metric"
            ]
         },
        "extension": [
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "confidence"
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "confidence"
        }
        ],
        "resourceType": "DeviceMetric",
        "identifier": {
            "system": "http://roche.com/fhir/rdc/sid/devicemetric-identifier",
            "value": "<deviceComponent.identifier.value>/10003008"
        },
       "type": {  
            "coding":  [
                {
                    "system": "http://snomed.info/sct",
                    "code": "10003008",
                    "display": "Non-specific (qualifier value)"
                }
            ]
        },
        "unit": {   
            "coding":  [
                {
                    "system": "http://ncimeta.nci.nih.gov",
                    "code": "C1272460",
                    "display": "Not Applicable"
                }
            ]
        },
        "source": {
        "reference": "Device/confidence-1.0.0"
        },
        "parent": {
         "reference": "DeviceComponent/cf.devicecomponent.3f6AHVp-w86-1061" //link to the dummy smartphone devicecomponent resource
        },
        "operationalStatus": "on",
        "category": "measurement"
}

Dummy DeviceComponent and DevceMetric for a Sensor if the Session data is shared before the Sensor data

If the session is shared before the sensor, the facade creates temporarily a dummy DeviceComponent and DeviceMetric until the actual sensor details is received. This is because the session Observation needs to be linked to the sensor deviceComponent. Once the sensor details are received the DeviceComponent and DeviceMetric are updated as per Sensor


{
	"resourceType": "DeviceComponent",
	"id": "cf.dccgm.xaHovTo-GZa-9.ZZZZ",
	"meta": {
		"profile": ["http://roche.com/fhir/rdc/StructureDefinition/phd-devicecomponent"]
	},
	"extension": [{
		"url": "http://roche.com/fhir/rdc/StructureDefinition/cgm-session-id",
		"valueString": "ZZZZ"
	}, {
		"url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
		"valueString": "confidence"
	}, {
		"url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
		"valueString": "confidence"
	}],
	"identifier": {
		"system": "http://roche.com/fhir/rdc/sid/device-identifier",
		"value": "default-sensor/0130a615-4687-4e8f-ab6c-8df7e5fb48c6"
	},
	"type": {
		"coding": [{
			"system": "http://snomed.info/sct",
			"code": "701750003",
			"display": "Subcutaneous glucose sensor"
		}],
		"text": "CGMSensor"
	},
	"source": {
		"reference": "Device/confidence-1.0.0"
	},
	"parent": {
		"reference": "DeviceComponent/cf.globaldc.xaHovTo-GZa-9"
	}
}


{
    "resourceType": "DeviceMetric",
    "id": "cf.dmcgm.xaHovTo-GZa-9.ZZZZ",
    "meta": {
        "profile": [
            "http://roche.com/fhir/rdc/StructureDefinition/dm-device-metric"
        ]
    },
    "extension": [{
        "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
        "valueString": "confidence"
    }, {
        "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
        "valueString": "confidence"
    }],
    "identifier": {
        "system": "http://roche.com/fhir/rdc/sid/devicemetric-identifier",
        "value": "default-sensor/0130a615-4687-4e8f-ab6c-8df7e5fb48c6/2344-0"
    },
    "type": {
        "coding": [{
            "system": "http://loinc.org",
            "code": "2344-0",
            "display": "Glucose [Mass/volume] in Body fluid"
        }]
    },
    "unit": {
        "coding": [{
            "system": "http://unitsofmeasure.org",
            "code": "mg/dL",
            "display": "milligram per deciliter"
        }]
    },
    "source": {
        "reference": "Device/confidence-1.0.0"
    },
    "parent": {
        "reference": "DeviceComponent/cf.dccgm.xaHovTo-GZa-9.ZZZZ"
    },
    "operationalStatus": "on",
    "category": "measurement"
}

DM careplan - expanded FHIR

This is example of expanded format for Diabetes Management careplan which is a Master careplan associated to a patient, which holds all other careplans as a Master (parent) careplan.

{
	"resourceType": "CarePlan",
    "id": "93034f38-6c66-4297-af64-e0088eaa4ff0", //To be managed by FHIRSTACK 
	"meta": {
		"profile": [ //To be updated by facade - FHIR profile for dm-careplan for FHIR internal storage
			"http://roche.com/fhir/rdc/StructureDefinition/dm-careplan"
		]
	},
	"identifier": [
		{
			"system": "http://roche.com/fhir/rdc/sid/careplan/confidence",
			"value": "cf-dmcp-001" //retain same identifier received from Confidence reduced FHIR
		}
	],
	 "category": [  //To be added by facade - category for dm-careplan will always be "Diabetes clinical management plan"
          {
            "coding": [
              {
                "system": "http://snomed.info/sct",
                "code": "412777005",
                "display": "Diabetes clinical management plan"
              }
            ]
          }
        ],
	"status": "active",  //retain same status received from confidence
	"intent": "plan",  //retain same intent received from confidence
	"title": "Diabetes Management Plan", //retain same title received from confidence
	"subject": {
          "reference": "Patient/14435e70-25d8-4db4-8941-9a191735b31e"
        },
                "extension":  [
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "<channel-name>" //To be added by facade - fill channel data
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "<source-name>" //To be added by facade - fill source data
        }
    ]			
}

Target settings - expanded FHIR

sample scenario :

Data Point Value unit
Lower target 70 mg/dL
Upper target 180 mg/dL

Note: Comments are provided in green in the JSON below

Below is an example JSON for the Therapy Time block settings (Target ranges) in careplan and goal resource in expanded FHIR format. TherapyTimeBlock currently spans for one whole day and it is captured in Target ranges careplan- scheduledTiming.

Target ranges - Careplan :

{
	"resourceType": "CarePlan",
	"id": "941f886d-bfb8-43c6-a979-54d582a4a88f", //To be managed by FHIRSTACK 
	"meta": { //To be updated by facade - FHIR profile for careplan target ranges for FHIR internal storage
		"profile": [
			"http://roche.com/fhir/rdc/StructureDefinition/careplan-target-ranges"
		]
	},
	"identifier": [
		{
			"system": "http://roche.com/fhir/rdc/sid/careplan/confidence", 
			"value": "cf-tgcp-001" //retain same identifier received from Confidence reduced FHIR
		}
	],
	"partOf": [
		{
			"reference": "CarePlan/93034f38-6c66-4297-af64-e0088eaa4ff0" //To be added by facade - based on identifier value of careplan resource 
			"identifier": {
				"value": "cf-dmcp-001" //retain same identifier received from Confidence reduced FHIR
			}
		}
	],
	"status": "active", //retain same status received from confidence
	"intent": "plan", //retain same intent received from confidence
	 "category": [ //To be added by facade - category will be Target ranges plan
	 {
            "coding": [
              {
                "system": "http://roche.com/fhir/rdc/cs",
                "code": "target-ranges-careplan",
                "display": "Target ranges plan"
              }
            ]
          }
        ],
	"title": "Target ranges plan", //retain same title received from confidence
	"subject": { //To be added by facade - patient link
		"reference": "Patient/14435e70-25d8-4db4-8941-9a191735b31e"
	},
	"activity": [
		{
			"detail": {
				"category": {
					"coding": [  //To be added by facade - system, code and display when category.text "Observation" is received in the reduced FHIR
                  {
                    "system": "http://hl7.org/fhir/care-plan-activity-category",
                    "code": "observation",
                    "display": "Observation"
                  }
                ],
					"text": "Observation" //To be retained as is from the reduced format so that on restore it can be sent back
				},
				"code": {
					"coding": [ //To be added by facade - system, code and display when code.text "Identified target range activity" is received in the reduced FHIR
                  {
                    "system": "http://roche.com/fhir/rdc/cs",
                    "code": "identified-target-range-activity",
                    "display": "Identified target range activity"
                  }
                ],
					"text": "Identified target range activity" //To be retained as is from the reduced format so that on restore it can be sent back
				},
				"goal": [
					{
						"reference": "Goal/c882e4c5-91b9-4b4e-86b2-bc42fa6119ed",//To be added by facade - based on identifier value of goal resource
						"identifier": {
							"value": "cf-goal-001" //retain value from reduced FHIR
						}
					},
					{
						"reference": "Goal/8fc3a008-0dfa-4d41-991c-21dbe3fdac35",//To be added by facade - based on identifier value of goal resource
						"identifier": {
							"value": "cf-goal-002" //retain value from reduced FHIR
						}
					}
				],
				"status": "unknown",
				"scheduledTiming": {
					"repeat": {
						"duration": 1440,
						"durationUnit": "min",
						"timeOfDay": [
							"00:00:00"
						]
					}
				}
			}
		}
	],
                "extension":  [
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "<channel-name>" //To be added by facade - fill channel data
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "<source-name>" //To be added by facade - fill source data
        }
    ]
}

Goal resources

Lower - Hypoglycemia

{
	"id": "c882e4c5-91b9-4b4e-86b2-bc42fa6119ed", //To be managed by FHIRSTACK
	"resourceType": "Goal",
	"status": "planned", //retain value from reduced FHIR
	"meta": { //To be updated by facade - FHIR profile for goal for FHIR internal storage
		"profile": [
			"http://roche.com/fhir/rdc/StructureDefinition/goal"
		]
	},
	"identifier": [
		{
			"system": "http://roche.com/fhir/rdc/sid/goal/confidence",
			"value": "cf-goal-001" //retain same identifier received from Confidence reduced FHIR
		}
	],
	"description": {
		"coding": [ //To be added by facade - coding will be Hypoglycemia based on description.text = Lower target
            {
              "system": "http://snomed.info/sct",
              "code": "302866003",
              "display": "Hypoglycemia (disorder)"
            }
          ],
		"text": "Hypoglycemia"//To be retained as is from the reduced format so that on restore it can be sent back
	},
	"subject": { //To be added by facade - patient link
          "reference": "Patient/14435e70-25d8-4db4-8941-9a191735b31e"
        },
	"target": {
		"measure": {
			"coding": [  //To be added by facade - system, code and display when measure.text "mg/dL" is received in the reduced FHIR
              {
                "system": "http://loinc.org",
                "code": "32016-8",
                "display": "Glucose [Mass/volume] in Capillary blood"
              }
            ],
			"text": "mg/dL"//To be retained as is from the reduced format so that on restore it can be sent back
		},
		"detailQuantity": {
			"value": 70, //retain value from reduced FHIR
			"comparator": "<=", // To be added by facade - the comparator, system and code details for goal
			"unit": "mg/dL", //retain value from reduced FHIR
			"system": "http://unitsofmeasure.org",
            "code": "mg/dL"
		}
	},
                "extension":  [
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "<channel-name>" //To be added by facade - fill channel data
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "<source-name>" //To be added by facade - fill source data
        }
    ]
}

Higher - Hyperglycemia

{
	"id": "8fc3a008-0dfa-4d41-991c-21dbe3fdac35", //To be managed by FHIRSTACK
	"resourceType": "Goal",
	"status": "planned", //retain value from reduced FHIR
	"meta": { //To be updated by facade - FHIR profile for goal for FHIR internal storage
		"profile": [
			"http://roche.com/fhir/rdc/StructureDefinition/goal"
		]
	},
	"identifier": [
		{
			"system": "http://roche.com/fhir/rdc/sid/goal/confidence",
			"value": "cf-goal-002" //retain same identifier received from Confidence reduced FHIR
		}
	],
	"description": {
		"coding": [ //To be added by facade - coding will be Hyperglycemia based on description.text = Higher target
            {
              "system": "http://snomed.info/sct",
              "code": "80394007",
              "display": "Hyperglycemia (disorder)"
            }
          ],
		"text": "Hyperglycemia"
	},
	"subject": { //To be added by facade - patient link
          "reference": "Patient/14435e70-25d8-4db4-8941-9a191735b31e"
        },
	"target": {
		"measure": {
			"coding": [  //To be added by facade - system, code and display when measure.text "mg/dL" is received in the reduced FHIR
              {
                "system": "http://loinc.org",
                "code": "32016-8",
                "display": "Glucose [Mass/volume] in Capillary blood"
              }
            ],
			"text": "mg/dL"//To be retained as is from the reduced format so that on restore it can be sent back
		},
		"detailQuantity": {
			"value": 180, //retain value from reduced FHIR
			"comparator": ">=", // To be added by facade - the comparator, system and code details for goal
			"unit": "mg/dL", //retain value from reduced FHIR
			"system": "http://unitsofmeasure.org",
            "code": "mg/dL"
		}
	},
                "extension":  [
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "<channel-name>" //To be added by facade - fill channel data
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "<source-name>" //To be added by facade - fill source data
        }
    ]
}

Time block settings - expanded FHIR

sample scenario :

Data Point Value unit
Time Block status True Boolean
Time Block Start Time 08:00:00 HH:MM:SS
Time Block End Time 11:59:00 HH:MM:SS
Hypo Limit 80 mg/dL
Hyper Limit 130 mg/dL
Hypo Lower Limit 54 mg/dL
Hypo Alert True Boolean
Hyper Alert True Boolean
Urgent Hypo Alert false Boolean

Note: Comments are provided in green in the JSON below

Below is an example JSON for the Careplan resource having Timeblock information in reduced FHIR format

Bolus Advice careplan

{
    "resourceType": "CarePlan", //FHIR resource type
    "id": "7fa36838-6730-44ae-aaba-fffc4c5551f5",
    "meta": { //Should be sent by Confidence saying which profile the below resource conforms to. 
		"profile": [
			"http://roche.com/fhir/rdc/StructureDefinition/careplan-bolus-advice"
		]
	},
	"identifier": [
		{
			"system": "http://roche.com/fhir/rdc/sid/careplan/confidence", //always same for resourceType careplan
			"value": "cf-bol-adv-cp-001" // Unique identifier from confidence
		}
	],
	"basedOn":  [
        {
            "reference": "CarePlan/careplan-dm-careplan-example", //To be added by facade - based on identifier value of careplan resource 
            "identifier": {
				"value": "cf-dmcp-001" // Unique identifier for related dm-careplan
			}
        }
    ],
    "partOf":  [
        {
            "reference": "CarePlan/careplan-dm-careplan-example",
            "identifier": {
				"value": "cf-dmcp-001" // Unique identifier for related dm-careplan
			}
        }
    ],
    "status": "active", //Status will be 'active' for careplan
    "intent": "plan", //intent will be 'plan' for careplan
    "category":  [ // Category will be added by facade as Bolus management plan
        {
            "coding":  [
                {
                    "system": "http://roche.com/fhir/rdc/cs",
                    "code": "bolus-management-careplan",
                    "display": "Bolus management plan"
                }
            ]
        }
    ],
    "title": "Bolus Advice Careplan", //title will be 'Bolus Advice Careplan' for careplan-target-ranges
    "extension":  [
        {
            "extension":  [
                {
                    "url": "TimeblockStatus",
                    "valueBoolean": true
                },
                {
                    "url": "startTime",
                    "valueTime": "08:00:00"
                },
                {
                    "url": "endTime",
                    "valueTime": "11:59:00"
                },
                {
                    "url": "LowerLimit",
                    "valueQuantity": {
                        "value": 80,
                        "unit": "mg/dL",
                        "system": "https://unitsofmeasure.org",// To be added by facade
                        "code": "mg/dL"// To be added by facade
                    }
                },
                {
                    "url": "UpperLimit",
                    "valueQuantity": {
                        "value": 130,
                        "unit": "mg/dL",
                        "system": "https://unitsofmeasure.org",// To be added by facade
                        "code": "mg/dL"// To be added by facade
                    }
                },
                {
                    "url": "UrgentLowerLimit",
                    "valueQuantity": {
                        "value": 54,
                        "unit": "mg/dL",
                        "system": "https://unitsofmeasure.org",// To be added by facade
                        "code": "mg/dL"// To be added by facade
                    }
                },
                {
                    "url": "HypoAlert",
                    "valueBoolean": true
                },
                {
                    "url": "HyperAlert",
                    "valueBoolean": true
                },
                {
                    "url": "UrgentHypoAlert",
                    "valueBoolean": false
                }
            ],
            
            "url": "http://roche.com/fhir/rdc/StructureDefinition/careplan-timeblock-options"
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-channel",
            "valueString": "<channel-name>" //To be added by facade - fill channel data
        },
        {
            "url": "http://roche.com/fhir/rdc/StructureDefinition/provenance-source",
            "valueString": "<source-name>"  //To be added by facade - fill source data
        }
    ],
    "subject": {
        "reference": "Patient/<patient reference>" // This value will be overwritten by the FHIR Server to put the fhir id of the user sending data from auth header
    }
}

Mobile device - expanded FHIR (This modelling will be implemented by confidence in future)

Sample Scenario

Data Point Value unit Comments
Mobile Model Number 5.0 string This is Mobile model number
Mobile OS version 11.0 string This is Mobile OS version

Note: Comments are provided in green in the JSON below

Example :

{
	"resourceType": "DeviceComponent",
	"id": "cf.globaldc.3f6AHVp-w86-1061",
	"meta": {
		"profile": [
			"http://roche.com/fhir/rdc/StructureDefinition/phd-devicecomponent"
		]
	},
	"identifier": {
		"system": "http://roche.com/fhir/rdc/sid/device-identifier",
		"value": "<confidence unique identifier>"
	},
	"type": {
		"coding": [
			{
				"system": "http://roche.com/fhir/rdc/cs",
				"code": "smartPhone",
				"display": "Smart Phone"
			}
		],
		"text": "smartPhone"
	},
	"productionSpecification": [

		{
			"specType": {
				"coding": [
					{
						"system": "http://hl7.org/fhir/specification-type",
						"code": "part-number",
						"display": "Part Number"
					}
				],
				"text": "MobileModelNumber"
			},
			"productionSpec": "5.0"
		},
		{
			"specType": {
				"coding": [
					{
						"system": "http://hl7.org/fhir/specification-type",
						"code": "software-revision",
						"display": "Software Revision"
					}
				],
				"text": "MobileOSVersion"
			},
			"productionSpec": "11.0"
		}
	],
	"lastSystemChange": "2021-06-01T00:00:00.000Z",
    "source": {
        "reference": "Device/confidence-1.0.0"
    },
	"extension": [ 
		{
			"url": "http://roche.com/fhir/rdc/StructureDefinition/sample-interval",
			"valueQuantity": {
				"value": 0
			}
		}
	]
}