Phg Device Profile

The properties and specifications of the PHG are reported in a Device resource. A PHG does not have an MDS object, but for the purposes of reporting the PHG information, like its system identifier, time synchronization, and serial number, these values are treated as if they came from MDS-attributes in an MDS object. These 'mock' attributes and object are not required to exist on the PHG.

Unlike the PHD where one reports the information if delivered, in the PHG case far fewer fields are required to be reported. The following table summarizes the required 'MDS' fields and their mappings:

For Continua compliance, the values in the mock Reg-Cert-Data-List shall be included:

A transport address is not required. It is still strongly recommended that the transport address is reported as it is often beneficial to consumers. Most PHD-PHG transports provide a means of obtaining a transport address or an equivalent identifier such as a USB VID and PID. In addition, it may be beneficial to report the transport address of the H&FS interface as well, such as the MAC address.

Similar to the PHD case, when CodeableConcept data types are used it is recommended to put the MDC reference identifier as part of the display element when the system element indicates the MDC coding system "urn.iso.std.iso:11073:10101".

The structure definition for the Phg Device Profile is shown below:

DeviceComponent

DeviceComponent.meta

DeviceComponent.meta.profile

DeviceComponent.meta.profile:phgProfile

PhgDeviceComponent

DeviceComponent.extension:MyExtension

DeviceComponent.identifier

DeviceComponent.identifier:systemIdIdentifier

DeviceComponent.identifier.system

urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680

DeviceComponent.identifier.value

DeviceComponent.identifier:transportAddressIdentifier

DeviceComponent.identifier.system

DeviceComponent.identifier.value

DeviceComponent.type

DeviceComponent.type.coding

DeviceComponent.type.coding:11073Type

DeviceComponent.type.coding.system

urn:iso:std:iso:11073:10101

DeviceComponent.type.coding.code

531981

DeviceComponent.type.coding.display

DeviceComponent.lastSystemChange

DeviceComponent.source

DeviceComponent.parent

DeviceComponent.operationalStatus

DeviceComponent.parameterGroup

DeviceComponent.measurementPrinciple

DeviceComponent.productionSpecification

DeviceComponent.productionSpecification.specType

DeviceComponent.productionSpecification.specType.coding

DeviceComponent.productionSpecification.specType.coding:11073Type

DeviceComponent.productionSpecification.specType.coding.system

urn:iso:std:iso:11073:10101

DeviceComponent.productionSpecification.specType.coding.code

DeviceComponent.productionSpecification.specType.coding.display

DeviceComponent.productionSpecification.specType.coding:fhirCoding

DeviceComponent.productionSpecification.specType.coding:fhirCoding.system

http://hl7.org/fhir/specification-type

DeviceComponent.productionSpecification.specType.coding:fhirCoding.code

DeviceComponent.productionSpecification.productionSpec

DeviceComponent.languageCode

A JSON example is given in Phg Device JSON Example

Meta Data Profile

The uploader shall populate the Device.meta.profile with http://pchalliance.org/phdfhir/StructureDefinition/PhgDevice indicating this resource is generated following this PHD Implementation Guide.

System Identifier

All 11073 20601 PHGs are required to have a system identifier. It is an EUI-64 consisting of 8 bytes. The system id is mapped to the Device.identifier.value element as a sequence of 8 2-digit bytes as HEX separated by dashes without the '0x' prefix commonly used in programming languages. An example of such a string is FE-ED-AB-EE-DE-AD-77-C3. It shall be reported.

It is strongly encouraged to also report the PHG PAN and H&FS transport addresses in a second and third identifier element. The transport addresses are as follows:

The identifier for the system id:

• identifier.value=system id formatted as above
• identifier.system="urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680"
• identifier.use="official"
• identifier.assigner.display="EUI-64

The identifier for the Bluetooth Address:

• identifier.value=formatted as above
• identifier.system="urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680"
• identifier.assigner.display="EUI-48

Device type

The PHG Device.type is given by the MDC code 531981. The reference identifier for this code is MDC_MOC_VMS_MDS_AHD. "AHD" is the previous name Continua gave to what is now known as the PHG. However, reference identifiers are normative and once accepted, they cannot change. It shall be encoded as follows:

• Device.type.coding.code="531981"
• Device.type.coding.system="urn.iso.std.iso:11073:10101"
• Device.type.coding.display="MDC_MOC_VMS_MDS_AHD: Continua Personal Health Gateway"

Here the display element is optional but highly recommended.

Time synchronization

The time synchronization is mapped as follows:

• Device.property.type.coding.code="68220"
• Device.property.type.coding.system="urn.iso.std.iso:11073:10101"
• Device.property.type.coding.display="MDC_TIME_SYNC_PROTOCOL" (optional)
• Device.property.valueCode.coding.code="32-bit code for sync method"
• Device.property.valueCode.coding.system="urn.iso.std.iso:11073:10101"
• Device.property.valueCode.coding.display="the ref id" (optional)

The 32-bit code for the time synchonization method is given by one of the following values:

Remaining Optional Data

The treatment of fields that would be in mock System-Model, Production-Specification, Reg-Cert-Data-List, and Mds-Time-Info attributes is the same as in the Phd Device Profile. However, there is an extra set of information in the mock Reg-Cert-Data-List regarding the certified Health & Fitness Service (H&FS) interfaces. A PHG has both PAN and H&FS interfaces.

Display elements are always optional.

If these fields are encoded they shall be encoded as follows:

Specializations

The specializations supported by the PHG may be reported. If reported, they shall be reported in the Device.specializations element for each specialization as follows:

• specialization.systemType.coding.code="32-bit specialization code"
• specialization.systemType.coding.system="urn.iso.std.iso:11073:10101"
• specialization.systemType.coding.display"reference-id plus additional text"
• specialization.version="specialization version"

If the PHG supports multiple versions of the specialization and the uploader wants to report this information, additional specializations entries for the additional versions are made. Alternatively the uploader can leave the version field empty.

A PHG is often designed to support all current and future PHDs that support a given version of the 11073-20601 standard. Instead of listing all the specializations individually (which could greatly increase the size of the message) one can use the 'generic' device code. In this case, the specialization.version element, if populated, indicates the version of the 20601 standard. If multiple versions of the 20601 standard are supported and the uploader wants to report this information, a separate 'generic' entries for each version are reported. Alternatively, the version element can be left empty.

An example of generic code use would be as follows

• specialization.systemType.coding.code="528385"
• specialization.systemType.coding.system="urn.iso.std.iso:11073:10101"
• specialization.systemType.coding.display"MDC_DEV_SPEC_PROFILE_GENERIC: supports all 20601 devices"
• specialization.version="2"

The following table gives a list of the more common specialization codes:

In some sense, reporting specialization information about a PHG is superfluous as clearly, if the PHG uploads data from a given device, it supports that device.

PHG Product Information

The table blow provides codes and reference identifiers used in mapping the product information:

Primitives

• manufacturer="PHG manufacturer"
• modelNumber="PHG model number"
• serialNumber="serial number"
• partNumber="part number"

Hardware, Software, Firmware, Protocol, and Continua Versions

• hardware

• version.type.coding.code="531974"

• version.type.coding.system="urn.iso.std.iso:11073:10101"

• version.type.coding.display="MDC_ID_PROD_SPEC_HW + optional text"

• version.value="hardware-version"

• software

• version.type.coding.code="531975"

• version.type.coding.system="urn.iso.std.iso:11073:10101"

• version.type.coding.display="MDC_ID_PROD_SPEC_SW + optional text"

• version.value="software-version"

• firmware

• version.type.coding.code="531976"

• version.type.coding.system="urn.iso.std.iso:11073:10101"

• version.type.coding.display="MDC_ID_PROD_SPEC_FW + optional text"

• version.value="firmware-version"

• protocol

• version.type.coding.code="531977"

• version.type.coding.system="urn.iso.std.iso:11073:10101"

• version.type.coding.display="MDC_ID_PROD_SPEC_PROTOCOL + optional text"

• version.value="protocol-version" (Not 11073-20601 protocol!)

• Continua

• version.type.coding.code="532352"

• version.type.coding.system="urn.iso.std.iso:11073:10101"

• version.type.coding.display="MDC_REG_CERT_DATA_CONTINUA_VERSION + optional text"

• version.value="Continua Version"

The Continua version has a major and minor component separated by a dot (.). For example, "6.1" where "6" is the major version and "1" is the minor version.

Continua Certified PAN interfaces

The Continua certified PAN (Personal Area Network) interfaces are represented as a list of Continua-specified 'PAN' codes. Note there is a difference between certified PAN interfaces and supported PAN interfaces. The Continua-specified certification codes are a combination of a transport 'Tcode' and a specialization code which is based on the 16-bit term code of the MDC code for the specialization. The PAN code is generated by

• PANCode = Tcode * 8192 + (specialization term code - 4096)

The transport 'Tcodes' are as follows:

The special Tcode of 0 is for Continua version 1.0 when there was no transport component in the reported certified PAN interface codes.

The PANCodes are mapped to a list of property.valueCode elements. The property.type element, which identifies the property, is given by the MDC 32-bit code 532353. Its reference id is MDC_REG_CERT_DATA_CONTINUA_CERT_DEV_LIST.

• property.type.coding.code="532353"
• property.type.coding.system="urn.iso.std.iso:11073:10101"
• property.type.coding.display="MDC_REG_CERT_DATA_CONTINUA_CERT_DEV_LIST + text"
• property.valueCodeN.coding.code="PANCodeN"
• property.valueCodeN.coding.system="placeholder/fhir/reg-cert-codes "

Note that the property.valueCode element is an array and one can have many of these in a single property element.

Continua Certified Health & Fitness interfaces

The Continua certified Health and Fitness interfaces are represented as a list of Continua-specified 'H&FS' codes as follows:

The Health and Fitness codes are mapped to a list of property.valueCode elements. The property.type element, which identifies the property, is given by the MDC 32-bit code 532355. Its reference id is MDC_REG_CERT_DATA_CONTINUA_CERT_DEV_LIST.

• property.type.coding.code="532355"
• property.type.coding.system="urn.iso.std.iso:11073:10101"
• property.type.coding.display="MDC_REG_CERT_DATA_CONTINUA_AHD_CERT_DEV_LIST + text"
• property.valueCodeN.coding.code="H&FSCodeN"
• property.valueCodeN.coding.system="placeholder/fhir/reg-cert-wan-codes "

Regulation Status

The PHG regulation status is reported as follows:

• property.type.coding.code="532354.0"
• property.type.coding.system="placeholder/fhir/IEEE.ASN1"
• property.type.coding.display="regulation-status"
• property.valueCode.coding.code="Y/N"
• property.valueCode.coding.system="http://hl7.org/fhir/v2/0136 "
• property.valueCode.coding.display="Y=unregulated N=regulated"

Time Synchronization Accuracy

The time synchronization accuracy is reported in microseconds as follows:

• Device.property.type.coding.code="68221"
• Device.property.type.coding.system="urn.iso.std.iso:11073:10101"
• Device.property.type.coding.display="MDC_TIME_SYNC_ACCURACY" (optional)
• Device.property.valueQuantity.value="time-sync-accuracy"
• Device.property.valueQuantity.system="http://unitsofmeasure.org"
• Device.property.valueQuantity.code="us" (UCUM code for microseconds)

{
	"resourceType": "Device",
	"id": "SysId-ecde3d4e58532d31",
	"identifier": [{
		"system": "urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680",
		"value": "ec-de-3d-4e-58-53-2d-31",
		"assigner": {
			"display": "EUI-64"
		}
	}],
	"manufacturer": "Continua Medical PHGs",
	"type": {
		"coding": [{
			"system": "urn:iso:std:iso:11073:10101",
			"code": "531981",
			"display": "MDC_MOC_VMS_MDS_AHD"
		}]
	},
	"specialization": [{
		"systemType": {
			"coding": [{
				"system": "urn:iso:std:iso:11073:10101",
				"code": "528457",
				"display": "MDC_DEV_SPEC_PROFILE_GENERIC: Handles all 20601 compliant devices"
			}]
		},
		"version": "2"
	}],
	"version": [{
			"type": {
				"coding": [{
					"system": "urn:iso:std:iso:11073:10101",
					"code": "531975",
					"display": "MDC_ID_PROD_SPEC_SW: Software revision"
				}]
			},
			"value": "1.0.0"
		},
		{
			"type": {
				"coding": [{
					"system": "urn:iso:std:iso:11073:10101",
					"code": "532352",
					"display": "MDC_REG_CERT_DATA_CONTINUA_VERSION: Continua version"
				}]
			},
			"value": "6.0"
		}
	],
	"property": [{
			"type": {
				"coding": [{
					"system": "urn:iso:std:iso:11073:10101",
					"code": "68220",
					"display": "MDC_TIME_SYNC_PROTOCOL: Time synchronization protocol"
				}]
			},
			"valueCode": [{
				"coding": [{
					"system": "urn:iso:std:iso:11073:10101",
					"code": "532233",
					"display": "MDC_TIME_SYNC_GSM: "
				}]
			}]
		},
		{
			"type": {
				"coding": [{
					"system": "urn:iso:std:iso:11073:10101",
					"code": "532353",
					"display": "MDC_REG_CERT_DATA_CONTINUA_CERT_DEV_LIST: certified device list as transport-specialization combo"
				}]
			},
			"valueCode": [{
				"coding": [{
					"system": "http://pcha.org/phd/documents/reg-cert-codes",
					"code": "4"
				}]
			}]
		},
		{
			"type": {
				"coding": [{
					"system": "urn:iso:std:iso:11073:10101",
					"code": "532355",
					"display": "MDC_REG_CERT_DATA_CONTINUA_AHD_CERT_LIST: certified Upload classes"
				}]
			},
			"valueCode": [{
					"coding": [{
						"system": "http://pcha.org/phd/documents/reg-cert-wan-codes",
						"code": "2"
					}]
				},
				{
					"coding": [{
						"system": "http://pcha.org/phd/documents/reg-cert-wan-codes",
						"code": "7"
					}]
				}
			]
		},
		{
			"type": {
				"coding": [{
					"system": "http://hl7.org/fhir/IEEE.ASN1",
					"code": "532354.0",
					"display": "regulation-status"
				}]
			},
			"valueCode": [{
				"coding": [{
					"system": "http://hl7.org/fhir/v2/0136",
					"code": "Y",
					"display": "Device is not regulated"
				}]
			}]
		}
	]
}