Personal Health Device Implementation Guide
2.1.0 - STU 2.0 International flag

Personal Health Device Implementation Guide, published by HL7 International / Health Care Devices. This guide is not an authorized publication; it is the continuous build for version 2.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/phd/ and changes regularly. See the Directory of published versions

Resource Profile: PhgDevice

Official URL: http://hl7.org/fhir/uv/phd/StructureDefinition/PhgDevice Version: 2.1.0
Standards status: Trial-use Maturity Level: 3 Computable Name: PhgDevice

Profile for the Device Resource for a PHG

This resource describes the primary features of the Personal Health Gateway (PHG). A PHG does not have any 11073 Objects or attributes though it is required to have an IEEE EUI-64 system identifier. However, for the purposes of reporting the information about the PHG entity, it is treated as if it has an MDS with attributes. For PCHA, the quantities that are required to be reported is the EUI-64 system identifier, the time synchronization method, the manufacturer and model number (of the software, not necessarily the hardware on which the application resides), the regulation status, and the PCHA certified interfaces.

The properties and specifications of the Personal Health Gateway (PHG) are reported in a Device resource. One of the main reasons the PHG information is included at all in this guide is that it plays a critical role in handling the measurement time stamps of PHDs. PHDs tend to have no time synchronization capabilities. They rely on either the PHG or user to set their time or use a default factory setting. The PHG, on the other hand, is required to have time synchronization capability to NTP and local offset. In this manner the PHG can correct any time stamps provided by the PHD if the PHD provides its sense of current time.

PHGs may be implemented on a mobile phone, a personal computer, or in a dedicated set-top box. PHGs may be headless (provide no direct user interface).

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:

'PHG MDS' field Device element
System Identifier identifier
Time sync protocol property

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

'Continua PHG MDS' field Device element
Continua Version version
Certified PHD Interfaces property
Certified H&FS Interfaces property
Regulation status property

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 text element when the system element indicates the MDC coding system "urn.iso.std.iso:11073:10101".

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Item used in healthcare
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
ele-1: All FHIR elements must have a @value or children
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... Slices for identifier 1..* Identifier Information that uniquely describes the personal health device
Slice: Unordered, Open by value:type.coding.system, value:type.coding.code
ele-1: All FHIR elements must have a @value or children
.... identifier:systemIdIdentifier 1..1 Identifier System Id identifier
ele-1: All FHIR elements must have a @value or children
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .


ele-1: All FHIR elements must have a @value or children
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.


ele-1: All FHIR elements must have a @value or children
...... coding Σ 1..1 Coding Indicates this is the IEEE 11073 System Id identifier
ele-1: All FHIR elements must have a @value or children
....... system Σ 1..1 uri Identity of the terminology system
ele-1: All FHIR elements must have a @value or children
Fixed Value: http://hl7.org/fhir/uv/phd/CodeSystem/ContinuaDeviceIdentifiers
....... code Σ 1..1 code Symbol in syntax defined by the system
ele-1: All FHIR elements must have a @value or children
Fixed Value: SYSID
..... system Σ 1..1 uri EUI-64 system identifier
ele-1: All FHIR elements must have a @value or children
Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
..... value Σ 1..1 string System id value from System-Id attribute
ele-1: All FHIR elements must have a @value or children
Example General: 123456
.... identifier:btmacAddressIdentifier 0..1 Identifier Bluetooth MAC Transport address identifier
ele-1: All FHIR elements must have a @value or children
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .


ele-1: All FHIR elements must have a @value or children
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.


ele-1: All FHIR elements must have a @value or children
...... coding Σ 1..1 Coding Indicates this is the Bluetooth Mac address identifier
ele-1: All FHIR elements must have a @value or children
....... system Σ 1..1 uri Identity of the terminology system
ele-1: All FHIR elements must have a @value or children
Fixed Value: http://hl7.org/fhir/uv/phd/CodeSystem/ContinuaDeviceIdentifiers
....... code Σ 1..1 code Symbol in syntax defined by the system
ele-1: All FHIR elements must have a @value or children
Fixed Value: BTMAC
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Fixed Value: http://hl7.org/fhir/sid/eui-48/bluetooth
..... value Σ 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
.... identifier:macAddressIdentifier 0..1 Identifier MAC Transport address identifier
ele-1: All FHIR elements must have a @value or children
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .


ele-1: All FHIR elements must have a @value or children
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.


ele-1: All FHIR elements must have a @value or children
...... coding Σ 1..1 Coding Indicates this is the Mac address identifier
ele-1: All FHIR elements must have a @value or children
....... system Σ 1..1 uri Identity of the terminology system
ele-1: All FHIR elements must have a @value or children
Fixed Value: http://hl7.org/fhir/uv/phd/CodeSystem/ContinuaDeviceIdentifiers
....... code Σ 1..1 code Symbol in syntax defined by the system
ele-1: All FHIR elements must have a @value or children
Fixed Value: ETHMAC
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Fixed Value: http://hl7.org/fhir/sid/eui-48/ethernet
..... value Σ 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
... manufacturer 0..1 string Manufacturer name
ele-1: All FHIR elements must have a @value or children
... serialNumber 0..1 string Serial number
ele-1: All FHIR elements must have a @value or children
... modelNumber 0..1 string Model number
ele-1: All FHIR elements must have a @value or children
... type 1..1 CodeableConcept Indicates the device is a PHG.
Binding: DeviceType (example): Codes to identify medical devices.


ele-1: All FHIR elements must have a @value or children
.... Slices for coding Σ 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
ele-1: All FHIR elements must have a @value or children
..... coding:MDCType Σ 1..1 Coding Required MDC code system entry
ele-1: All FHIR elements must have a @value or children
...... system Σ 1..1 uri Identifies IEEE 11073-10101 coding system
ele-1: All FHIR elements must have a @value or children
Fixed Value: urn:iso:std:iso:11073:10101
...... code Σ 1..1 code Indicates PHG
ele-1: All FHIR elements must have a @value or children
Fixed Value: 531981
.... text Σ 0..1 string Plain text representation of the concept
ele-1: All FHIR elements must have a @value or children
... Slices for specialization 1..* BackboneElement This element contains an entry for each supported specialization or a generic representation.
Slice: Unordered, Open by value:systemType.coding
ele-1: All FHIR elements must have a @value or children
.... specialization:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
ele-1: All FHIR elements must have a @value or children
.... specialization:MDCType 1..* BackboneElement The specialization(s) supported by the PHG.
ele-1: All FHIR elements must have a @value or children
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... systemType 1..1 CodeableConcept The specialization standard supported by the PHD.
ele-1: All FHIR elements must have a @value or children
...... coding Σ 1..* Coding Code defined by a terminology system
Binding: MDC Device Specialization codes (required)
ele-1: All FHIR elements must have a @value or children
..... version 1..1 string The version of the specialization standard supported by the PHG.
ele-1: All FHIR elements must have a @value or children
... version 1..* BackboneElement A firmware, hardware, software, internal protocol may be reported for a PHG. A Continua version shall be reported.
ele-1: All FHIR elements must have a @value or children
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... type 1..1 CodeableConcept The type of the device version
ele-1: All FHIR elements must have a @value or children
..... Slices for coding Σ 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
ele-1: All FHIR elements must have a @value or children
...... coding:MDCType Σ 1..1 Coding Required MDC code system entry
ele-1: All FHIR elements must have a @value or children
....... system Σ 1..1 uri Indicates the codes come from the MDC coding system
ele-1: All FHIR elements must have a @value or children
Fixed Value: urn:iso:std:iso:11073:10101
....... code Σ 1..1 code A code indicating the type of version the Device.version.value refers to.
ele-1: All FHIR elements must have a @value or children
.... value 1..1 string The version
ele-1: All FHIR elements must have a @value or children
... Slices for property 1..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
Slice: Unordered, Open by value:type
ele-1: All FHIR elements must have a @value or children
.... property:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... type 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
ele-1: All FHIR elements must have a @value or children
.... property:bitProperties 0..* BackboneElement Properties reported in BITs fields
ele-1: All FHIR elements must have a @value or children
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... type 1..1 CodeableConcept Tells what the BITs item is
Binding: ANS1ToHL7 codes defined for non-measurement attributes (required)
ele-1: All FHIR elements must have a @value or children
...... coding Σ 1..1 Coding Required ASN1 code system entry
ele-1: All FHIR elements must have a @value or children
....... system Σ 1..1 uri Identity of the terminology system
ele-1: All FHIR elements must have a @value or children
Fixed Value: http://hl7.org/fhir/uv/phd/CodeSystem/ASN1ToHL7
....... code Σ 1..1 code Symbol in syntax defined by the system
ele-1: All FHIR elements must have a @value or children
...... text Σ 0..1 string Plain text representation of the concept
ele-1: All FHIR elements must have a @value or children
..... valueCode 1..1 CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
ele-1: All FHIR elements must have a @value or children
...... Slices for coding Σ 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
ele-1: All FHIR elements must have a @value or children
....... coding:V2Binary Σ 1..1 Coding Required V2 Binary code system entry
ele-1: All FHIR elements must have a @value or children
........ system Σ 1..1 uri Identity of the terminology system
ele-1: All FHIR elements must have a @value or children
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0136
........ code Σ 1..1 code Symbol in syntax defined by the system
ele-1: All FHIR elements must have a @value or children
.... property:quantitiesProperty 0..* BackboneElement The PHG properties represented by quantities such as time synchronization accuracy
ele-1: All FHIR elements must have a @value or children
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... type 1..1 CodeableConcept The type of time quantity
Binding: Quantity 11073 Attributes (required)
ele-1: All FHIR elements must have a @value or children
...... coding Σ 1..* Coding Required MDC code system entry
ele-1: All FHIR elements must have a @value or children
....... system Σ 1..1 uri Identity of the terminology system
ele-1: All FHIR elements must have a @value or children
Fixed Value: urn:iso:std:iso:11073:10101
....... code Σ 1..1 code Symbol in syntax defined by the system
ele-1: All FHIR elements must have a @value or children
...... text Σ 0..1 string Plain text representation of the concept
ele-1: All FHIR elements must have a @value or children
..... valueQuantity 1..1 Quantity Property value as a quantity
ele-1: All FHIR elements must have a @value or children
.... property:codedListProperties 0..* BackboneElement The device properties represented by a list of codes such as the list of certified PHD or H-FS interfaces
ele-1: All FHIR elements must have a @value or children
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... type 1..1 CodeableConcept What the coded list is
Binding: CodeableConcept 11073 Attributes (required)
ele-1: All FHIR elements must have a @value or children
...... coding Σ 1..* Coding Required MDC code system entry
ele-1: All FHIR elements must have a @value or children
....... system Σ 1..1 uri Identity of the terminology system
ele-1: All FHIR elements must have a @value or children
Fixed Value: urn:iso:std:iso:11073:10101
....... code Σ 1..1 code Symbol in syntax defined by the system
ele-1: All FHIR elements must have a @value or children
...... text Σ 0..1 string Plain text representation of the concept
ele-1: All FHIR elements must have a @value or children
..... valueCode 1..* CodeableConcept There shall be one valueCode entry for every item supported by the PHG in the list
ele-1: All FHIR elements must have a @value or children
...... coding Σ 1..* Coding Code defined by a terminology system
ele-1: All FHIR elements must have a @value or children
....... system Σ 1..1 uri Identity of the terminology system
ele-1: All FHIR elements must have a @value or children
....... code Σ 1..1 code Symbol in syntax defined by the system
ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.identifier:systemIdIdentifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.identifier:systemIdIdentifier.typeextensibleIdentifier Type Codes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Device.identifier:btmacAddressIdentifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.identifier:btmacAddressIdentifier.typeextensibleIdentifier Type Codes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Device.identifier:macAddressIdentifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.identifier:macAddressIdentifier.typeextensibleIdentifier Type Codes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.typeexampleDeviceType
http://hl7.org/fhir/ValueSet/device-type
from the FHIR Standard
Device.specialization:MDCType.systemType.codingrequiredDeviceTypes11073MDC
http://hl7.org/fhir/uv/phd/ValueSet/DeviceTypes11073MDC
from this IG
Device.property:bitProperties.typerequiredASN1attribute
http://hl7.org/fhir/uv/phd/ValueSet/ASN1attribute
from this IG
Device.property:quantitiesProperty.typerequiredQuantity11073MDC
http://hl7.org/fhir/uv/phd/ValueSet/Quantity11073MDC
from this IG
Device.property:codedListProperties.typerequiredCodeableConcept11073MDC
http://hl7.org/fhir/uv/phd/ValueSet/CodeableConcept11073MDC
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorDeviceIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

 

Other representations of profile: CSV, Excel, Schematron

Notes:

System Identifier

All IEEE 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 PHD and H&FS transport addresses in a second and third identifier element. The transport addresses are as follows:

transport format example
Bluetooth EUI-48 00-E5-DE-AD-77-C3
ZigBee EUI-64 36-ED-9A-EE-DE-AD-77-C3
USB vid.pid 0043.F90D
MAC EUI-48 EE-FF-DE-AD-77-01

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.type.coding.system="http://hl7.org/fhir/uv/phd/CodeSystem/ContinuaDeviceIdentifiers
  • identifier.type.coding.code="SYSID"

The identifier for the Bluetooth Address:

  • identifier.value=formatted as above
  • identifier.system="http://hl7.org/fhir/sid/eui-48/bluetooth"
  • identifier.type.coding.system="http://hl7.org/fhir/uv/phd/CodeSystem/ContinuaDeviceIdentifiers
  • identifier.type.coding.code="BTMAC"

An example of a gateway reporting both its Bluetooth and MAC addresses is shown here

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.text="MDC_MOC_VMS_MDS_AHD: Continua Personal Health Gateway"

Here the text 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.text="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.text="the ref id" (optional)

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

32-bit code Reference identifier description partition:term code
532224 MDC_TIME_SYNC_NONE An uncalibrated and unsynchronized local clock source 8::7936
532234 MDC_TIME_SYNC_EBWW A manually set time, by ‘eyeball and wristwatch’ 8::7946
532225 MDC_TIME_SYNC_NTPV3 Network Time Protocol Version 3.0 (RFC 1305) 8::7937
532226 MDC_TIME_SYNC_NTPV4 Network Time Protocol Version 4.0 (under dev) 8::7938
532227 MDC_TIME_SYNC_SNTPV4 Simple Network Time Protocol v4 (RFC 2030) 8::7939
532228 MDC_TIME_SYNC_SNTPV4330 Simple Network Time Protocol v4 (RFC 4330) 8::7940
532229 MDC_TIME_SYNC_BTV1 Bluetooth Medical Device Profile 8::7941
532235 MDC_TIME_SYNC_USB_SOF Synced to the 1kHz USB "start-of-frame" clock 8::7947
532230 MDC_TIME_SYNC_RADIO Atomic Clock synchronization through RF 8::7942
532231 MDC_TIME_SYNC_HL7_NCK Synchronized via Health Level 7 NCK (network clock) 8::7943
532232 MDC_TIME_SYNC_CDMA CDMA mobile telecommunications synchronization 8::7944
532233 MDC_TIME_SYNC_GSM GSM - Network Identity and Time Zone (NITZ) 8::7945
532236 MDC_TIME_SYNC_OTHER A time sync method that is out of scope for IEEE 11073 8::7948
532237 MDC_TIME_SYNC_OTHER_MOBILE A time sync method based on other mobile network technology that is not listed above 8::7949
532238 MDC_TIME_SYNC_GPS A time sync method based on GPS information 8::7950

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 PHD and H&FS interfaces.

Text 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.text"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

{
  "resourceType" : "Device",
  ...
  "specialization" : [
    {
      "systemType" : {
        "coding" : [
          {
            "system" : "urn:iso:std:iso:11073:10101",
            "code" : "528457",
            "display" : "MDC_DEV_SPEC_PROFILE_GENERIC"
          }
        ],
        "text" : "Generic 11073 compliant PHD device"
      },
      "version" : "2"
    }
  ],
  ...
}

All defined IEEE PHD device specializations can be found in the IEEE 11073 Device Types value set.

PHG Product Information

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

11073 Attribute description MDC code MDC reference identifier
System-Model Model number 531969 MDC_ID_MODEL_NUMBER
System-Model Manufacturer name 531970 MDC_ID_MODEL_MANUFACTURER
Production-Specification Unspecified 531971 MDC_ID_PROD_SPEC_UNSPECIFIED
Production-Specification Serial number 531972 MDC_ID_PROD_SPEC_SERIAL
Production-Specification Part number 531973 MDC_ID_PROD_SPEC_PART
Production-Specification Hardware revision 531974 MDC_ID_PROD_SPEC_HW
Production-Specification Software revision 531975 MDC_ID_PROD_SPEC_SW
Production-Specification Firmware revision 531976 MDC_ID_PROD_SPEC_FW
Production-Specification Protocol revision 531977 MDC_ID_PROD_SPEC_PROTOCOL
Production-Specification Global Medical Device Nomenclature (GMDN) 531978 MDC_ID_PROD_SPEC_GMDN
Reg-Cert-Data-List Continua version 532352 MDC_REG_CERT_DATA_CONTINUA_VERSION
Reg-Cert-Data-List Continua Certified Device List 532353 MDC_REG_CERT_DATA_CONTINUA_CERT_DEV_LIST
Reg-Cert-Data-List Regulation status 532354 MDC_REG_CERT_DATA_CONTINUA_REG_STATUS
PHG only Continua Certified H&FS List 532355 MDC_REG_CERT_DATA_CONTINUA_AHD_CERT_LIST
Mds-Time-Info Synchronization method 68220 MDC_TIME_SYNC_PROTOCOL
Mds-Time-Info Time capabilities 68219 MDC_TIME_CAP_STATE
Mds-Time-Info High resolution relative time resolution 68224 MDC_TIME_RES_REL_HI_RES
Mds-Time-Info Relative time resolution 68223 MDC_TIME_RES_REL
Mds-Time-Info Absolute Time time resolution 68222 MDC_TIME_RES_ABS
Mds-Time-Info Base offset time resolution 68226 MDC_TIME_RES_BO
Mds-Time-Info Time synchronization accuracy 68221 MDC_TIME_SYNC_ACCURACY

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.text="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.text="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.text="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.text="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.text="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 PHD interfaces

The Continua certified PHD (Personal Area Network) interfaces are represented as a list of Continua-specified 'PHD' codes. Note there is a difference between certified PHD interfaces and supported PHD 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 PHD code is generated by

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

The transport 'Tcodes' are as follows:

Tcode Transport
0 Continua version 1.0
1 USB
2 Bluetooth HDP
3 ZigBee
4 Bluetooth Low Energy
5 NFC

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

The PHDCodes 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.text="MDC_REG_CERT_DATA_CONTINUA_CERT_DEV_LIST + text"
  • property.valueCodeN.coding.code="PHDCodeN"
  • property.valueCodeN.coding.system="http://hl7.org/fhir/uv/phd/CodeSystem/ContinuaPHD "

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:

Health & Fitness Interface H&FS code Reference name
PCD-01 web services 0 observation-upload-soap
Consent enabled PCD-01 web service 1 consent-enabled-soap
Capability exchange 2 capabilities
PCD-01 upload using hData 3 observation-upload-hdata
Consent enabled PCD-01 using hData 4 consent-enabled-hdata
Questionnaire CDA 5 questionnaire
Authenticated Persistent Sessions 6 aps
FHIR resource upload 7 observation-upload-fhir

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_AHD_CERT_DEV_LIST.

  • property.type.coding.code="532355"
  • property.type.coding.system="urn.iso.std.iso:11073:10101"
  • property.type.text="MDC_REG_CERT_DATA_CONTINUA_AHD_CERT_DEV_LIST + text"
  • property.valueCodeN.coding.code="H&FSCodeN"
  • property.valueCodeN.coding.system="http://hl7.org/fhir/uv/phd/CodeSystem/ContinuaHFS "

Regulation Status

The PHG regulation status is reported as follows:

  • property.type.coding.code="532354.0"
  • property.type.coding.system="http://hl7.org/fhir/uv/phd/CodeSystem/ASN1ToHL7"
  • property.type.text="regulation-status"
  • property.valueCode.coding.code="Y/N"
  • property.valueCode.coding.system="http://terminology.hl7.org/CodeSystem/v2-0136 "
  • property.valueCode.text="Y=unregulated N=regulated"

One could enter some time capabilities as additional 'bits' components if desired.

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.text="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)

Examples:

An example of an Android PHG mapping is given here