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"
	}
}