Phd Device Profile

The properties and specifications of the PHD are reported in the Device resource. These are the static fields of the attributes reported in the PHD MDS object or Bluetooth Low Energy Device Information Service. Dynamic and observational attributes such as the battery level, remaining battery time, and power status are reported using the Observation resource.

There are six MDS attributes that are reported. The Mds-Time-Info attribute has fields that are dynamic and static, and it is only the static entries which are required should the attribute be present. The following table summarizes these attributes and the Device elements to which they are mapped:

The transport address and friendly name are not provided by the MDS but come from the transport protocols. They may not be available are therefore optional. However, if the PHD does not report a System Id, which may happen if one needs to map non-certified and/or proprietary devices, a transport address should be reported. It is still strongly recommended that the transport address is reported as it is often beneficial to the data consumers. Transport addresses of wireless devices are often printed on the device or the device packaging whereas the system id is not. Most PHD transports provide a means of obtaining a transport address or an equivalent identifier such as a USB VID and PID.

There are several CodeableConcept data types in this mapping where the Coding data type has a 'display' element. It is recommended to put the MDC reference identifier as part of the display element if known and when the system element indicates the MDC coding system "urn.iso.std.iso:11073:10101".

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

DeviceComponent

DeviceComponent.meta

DeviceComponent.meta.profile

DeviceComponent.meta.profile:phdProfile

phdParentDeviceComponent

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

DeviceComponent.type.coding.display

DeviceComponent.lastSystemChange

DeviceComponent.source

DeviceComponent.parent

DeviceComponent.parent.reference

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 Phd Device JSON Example

Meta Data Profile

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

System Identifier

All 11073 20601 PHDs 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. Though required for Continua compliance, it is not required in the Bluetooth Low Energy health device specifications. When a PHG encounters such a device it shall enter 00-00-00-00-00-00-00-00 and it is highly recommended to provide a transport address as a means of uniquely identifying the PHD.

The transport addresses are as follows:

The identifier is encoded as follows:

Device.type

The Device type is the same for all PHDs and it indicates that the device is a PHD. The details of what the PHD does is found in the Device.specializations element. The MDC code being used is 65573 (reference id MDC_MOC_VMS_MDS_SIMP). In 11073-10201 this code is described as indicating "a single-purpose medical device". The code is also used in 11073-20601 to identify the MDS object, but there is no particular description as to its interpretation.

The Device.type shall be encoded as follows:

• Device.type.coding.code="65573"
• Device.type.coding.system="urn.iso.std.iso:11073:10101"
• Device.type.coding.display="MDC_MOC_VMS_MDS_SIMP: Continua Personal Health Device"

The display element is optional but highly recommended.

System Type Spec List

The System-Type-Spec-List attribute contains a list of specializations the PHD complies to. The elements in the list indicate not only what the PHD does, but that it does so in a manner specified in the specialization documents. Each element in the list contains the specialization and its version. The specialization is reported as a 16-bit MDC term code with an assumed partition of INFRA (8) and the version is an interger. In most cases there is just one entry in the list.

For each entry in the System-Type-Spec-List a specializations entry is encoded as follows:

where "code" is the 32-bit nomenclature code computed from the partition INFRA and the term code from System-Type-Spec-List.type and "version" is the version from System-Type-Spec-List.version.

The display element is optional but it is highly recommended that it be included and the reference id be in the description. The table below gives a list of some of the most common specializations and their codes:

The 'generic' device on the PHD side indicates that the device follows 20601 but not any specialization. On the PHG side it indicates that the PHG understands anything following the 20601 standard. That would include all specializations since all specializations are a subset of the 20601 standard.

The table below gives the set of 32-bit MDC codes and reference identifiers used in the subsequent mappings.

System Model

The System-Model attribute contains two strings, the manufacturer name and the model number. The Device resource has stand-alone primitive elements for these two fields. The mapping is straight forward:

Production-Specification

The Production-Specification attribute values are mapped to three separate elements in the Device, the Device.serialNumber, Device.partNumber, and Device.version. The serialNumber and partNumber elements are string primitives, thus it is not possible to map the PrivateOid of those two values without extensions. The version element, on the other hand, is a Backbone element which will allow such a mapping without the use of extensions.

The mapping is as follows:

*The PrivateOid is only a 16-bit unsigned number. To give it some meaning, the system-id of the device is placed in the Identifier 'system' value to link the PrivateOid to this physical device in the presence of some other possible identifiers.

**The display elements are optional but it is encouraged to include them and populate them with at least the reference identifier.

Reg-Cert-Data-List

The Reg-Cert-Data-List contains the Continua version, list of certified PAN interfaces, and the regulation status. The Continua version is mapped to an additional Device.version element and the other two fields are mapped to a Device.property element.

Reg-Cert-Data-List Continua version

The Continua version has a major and minor component which are 8-bit unsigned integers. The code reported in the Device.versions element is obtained by concatenating the major-version, a dot (.), and the minor version. For example, "6.1" where "6" is the major version and "1" is the minor version.

The Continua version code is mapped to a Device.version element.

Reg-Cert-Data-List Continua Certified PAN interfaces

The Reg-Cert-Data-List attribute reports the list of Continua certified PAN (Personal Area Network) interfaces 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 obtained from the Reg-Cert-Data-List are a combination of a transport code, Tcode, and a specialization code which is based on the 16-bit term code of the MDC code for the specialization. The obtained code was generated from

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

Consumers of the data will need to know this relationship in order to interpret the code.

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.

Reg-Cert-Data-List Regulation Status

The regulation status element is a 16-bit ASN1 BITs 'state' value. At the current time only Mder bit 0 is defined. Being a state value, both set and cleared states are reported. In fact, it is the cleared state which represents that the device is regulated.

The regulation status is mapped to an additional Device.property.valueCode element. The Device.property.type element, which identifies the property, is given by 532354.0 following the ASN1 BITs mapping where the code 532354 is the MDC code for the regulation status. Its reference identifier is MDC_REG_CERT_DATA_CONTINUA_REG_STATUS. The '0' appended to the regulation status code indicates Mder bit 0. The Device.property.valueCode will indicate either "Y" (set) or "N" (cleared).

The following table summarizes the mapping of the Reg-Cert-Data-List information to FHIR:

Display elements are receommended but optional.

Mds-Time-Info

The Mds-Time-Info attribute is required on PHDs that support a real time clock of some type and report time stamps in their measurements. In Bluetooth Low Energy devices these properties must be inferred from other information like the Current Time Service. If the PHD does NOT report a time stamp in any of its measurements, there is no need to report the static time information.

Time Capabilities

The Mds-Time-Info attribute has a 16-bit ASN1 BITs field for the time capabilities. They are mapped as follows:

The required remaining property elements in each reported case are as follows:

• property.type.coding.system="placeholder/fhir/IEEE.ASN1"
• property.valueCode.coding.code="Y/N"
• property.valueCode.coding.system="http://hl7.org/fhir/v2/0136 "

An optional display element containing at least the ASN.1 name from the above table is encouraged:

• property.type.coding.display="ASN.1 name + any additional text"

Only the static fields shall be reported and all the static fields are treated as events thus they only need to be reported if set. Reporting cleared static states is optional.

Time Synchronization

The Mds-Time-Info.time-sync-protocol indicates the method of time synchronization which has one of the term code values in the following table:

If the Mds-Time-Info.time-sync-protocol indicates some other value besides 7936 (no time synchronization) the uploader must look at the time capabilities bits 8, 9, 10, or 13 to see if the PHD actually is synchronized. If the time capabilities bits indicate that the PHD is synchronized, then the time synchronization method in Mds-Time-Info.time-sync-protocol is reported in the Device.property element. Otherwise the uploader reports that the PHD is unsynchronized.

The uploader maps the state of synchronization to the Device.property 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)

To date there are no PHDs that support an external time synchronization. However, many PHDs have the PHG set its time and PHGs are required to support an external time synchronization. The IEEE PHD WG is working on providing some means to indicate synchronization by the PHG. In lieu of that, a consumer can only infer that the PHG probably set the time on the PHG if

• the PHD indicates that set time is supported
• the current time clock differences between the PHG and PHD are about 0.

Time Synchronization Accuracy

The time synchronization accuracy is given by the Mds-Time-Info.time-sync-accuracy field. This value shall not be reported if the PHD reports a value of 0xFFFFFFFF which indicates unknown. Otherwise the value reported is in units of 1/8^th millisecond. When reported in the Device.property element it is scaled to microseconds. The mapping is 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="125 x Mds-Time-Info.time-sync-accuracy"
• Device.property.valueQuantity.system="http://unitsofmeasure.org"
• Device.property.valueQuantity.code="us" (UCUM code for microseconds)

Time Resolution

The Mds-Time-Info attribute has three fields that report the resolution of its time clocks.

The Mds-Time-Info.time-resolution-abs-time represents the resolution of the absolute-time clock when the sensor supports an absolute time clock. If the sensor supports a base-offset time clock it represents the resolution of the base-offset time clock. The sensor is not allowed to support both time clocks simultaneously during an association. Which time clock is supported is indicated by the settings of the Mder 0 and 7 bits of the time capabilities (Mds-Time-Info.mds-time-caps-state).

The sensor may additionally support both relative time clocks or just one or both of the relative time clocks without any ‘wall time’ clock. In practice, support of more than one real time clock at the same time is rare.

If the respective time resolution has a value of 0, it indicates that the resolution is unknown and it shall not be reported. In all other cases, the resolutions are reported.

All time resolution values shall be scaled to units of microseconds. When supporting absolute time, the Mds-Time-Info.time-resolution-abs-time is in units of 1/100th of a second. When supporting base-offset time, the Mds-Time-Info.time-resolution-abs-time is in units of 1/65536th of a second. In the base-offset case, the special value of 0xFFFF means one second. The Mds-Time-Info.time-resolution-rel-time is in units of 1/8th millisecond and the Mds-Time-Info.time-resolution-hi-res-relative-time is in units of microseconds.

The encoding is as follows:

Consumer of the PHD Device Profile

For the Consumer of this profile the following table gives a quick guide to the main features

{
	"resourceType": "Device",
	"id": "SysId-01040302f0000000",         // This resource is being uploaded as an Update
	"meta": {
		"profile": ["http://pchalliance.org/phdfhir/StructureDefinition/PhdDevice"]
	},
	"identifier": [{
		"system": "urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680",
		"value": "01-04-03-02-f0-00-00-00",
		"assigner": {
			"display": "EUI-64"
		}
	},
	{
		"system": "urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680",
		"value": "12-34-56-78-9A-BC",
		"assigner": {
			"display": "EUI-48"
		}
	}],
	"manufacturer": "Renesas Electronics",
	"serialNumber": "13456-BPM-BTLE",
	"deviceName":[{
	    "name": "Continua BP Monitor",
		"type": "user-friendly-name"
		}],
	"modelNumber": "Synergy-12345-Demo",
	"partNumber": "63-555",
	"type": {
		"coding": [{
			"system": "urn:iso:std:iso:11073:10101",
			"code": "65573",
			"display": "MDC_MOC_VMS_MDS_SIMP: Continua Personal Health Device"
		}]
	},
	"specialization": [{
		"systemType": {
		    "coding":[{
				"system": "urn:iso:std:iso:11073:10101",
			    "code": "528391",
			    "display": "MDC_DEV_SPEC_PROFILE_BP: Blood pressure Monitor"
			}]
		},
		"version": "1"
	}],
	"version":[
	{
		"type": {
			"coding": [{
				"system": "urn:iso:std:iso:11073:10101",
				"code": "531976",
				"display": "MDC_ID_PROD_SPEC_FW: Firmware revision"
			}]
		},
		"value": "1.0.0"
	},
	{
		"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": "531974",
				"display": "MDC_ID_PROD_SPEC_HW: Hardware 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": "6.1"
	}],
	"property": [{
		"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": "32775"
				// In HEX this is 0x8007 Tcode = 8 which is the code
				// for Bluetooth Low Energy and 4096 + 7 = 4103 which is the term code in partition
				// Infra for the Blood Pressure specialization
			}]
		}]
	},
	{
		"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"
			}]
		}]
	},
	{
		"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": "532224",
				"display": "MDC_TIME_SYNC_NONE: "
			}]
		}]
	}]
}