Personal Health Device Implementation Guide
1.0.0 - STU 1
Personal Health Device Implementation Guide
1.0.0 - STU 1
This page is part of the Personal Health Device FHIR IG (v1.0.0: STU 1) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions 
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”.
The structure definition for the PHG Device Profile is given here
A JSON example is given in PHG Device JSON Example
The uploader shall populate the Device.meta.profile with http://hl7.org/fhir/uv/phd/StructureDefinition/PhgDevice indicating this resource is generated following this PHD Implementation Guide.
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 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:
The identifier for the Bluetooth Address:
An example of a gateway reporting both its Bluetooth and MAC addresses is shown here
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:
Here the text element is optional but highly recommended.
The time synchronization is mapped as follows:
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 |
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:
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:
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
The following table gives a list of the more common specialization codes:
| Specialization | MDC Code partition:term code | Reference Identifier |
|---|---|---|
| Generic 20601 | 8::4169 | MDC_DEV_SPEC_PROFILE_GENERIC |
| Pulse Oximeter | 8::4100 | MDC_DEV_SPEC_PROFILE_PULS_OXIM |
| Electro cardiograph | 8::4102 | MDC_DEV_SPEC_PROFILE_MIN_ECG |
| Blood Pressure Cuff | 8::4103 | MDC_DEV_SPEC_PROFILE_BP |
| Thermometer | 8::4104 | MDC_DEV_SPEC_PROFILE_TEMP |
| Respiration rate | 8::4109 | MDC_DEV_SPEC_PROFILE_RESP_RATE |
| Weight Scale | 8::4111 | MDC_DEV_SPEC_PROFILE_SCALE |
| Glucose Monitor | 8::4113 | MDC_DEV_SPEC_PROFILE_GLUCOSE |
| Coagulation meter | 8::4114 | MDC_DEV_SPEC_PROFILE_COAG |
| Insulin Pump | 8::4115 | MDC_DEV_SPEC_PROFILE_INSULIN_PUMP |
| Body Composition Analyzer | 8::4116 | MDC_DEV_SPEC_PROFILE_BCA |
| Peak Flow meter | 8::4117 | MDC_DEV_SPEC_PROFILE_PEAK_FLOW |
| Sleep Apnea Breathing Equipment | 8::4120 | MDC_DEV_SPEC_PROFILE_SABTE |
| Continuous Glucose Monitor | 8::4121 | MDC_DEV_SPEC_PROFILE_CGM |
| Cardiovascular Device | 8::4137 | MDC_DEV_SPEC_PROFILE_HF_CARDIO |
| Strength Equipment | 8::4138 | MDC_DEV_SPEC_PROFILE_HF_STRENGTH |
| Independent Activity/Living Hub | 8::4167 | MDC_DEV_SPEC_PROFILE_AI_ACTIVITY_HUB |
| Medication Monitor | 8::4168 | MDC_DEV_SPEC_PROFILE_AI_MED_MINDER |
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.
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 |
version.value=”hardware-version”
version.value=”software-version”
version.value=”firmware-version”
version.value=”protocol-version” (Not 11073-20601 protocol!)
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.
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
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.
Note that the property.valueCode element is an array and one can have many of these in a single property element.
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.
The PHG regulation status is reported as follows:
One could enter some time capabilities as additional ‘bits’ components if desired.
The time synchronization accuracy is reported in microseconds as follows:
An example of an Android PHG mapping is given here
IG © 2016+ HL7 International - Health Care Devices Work Group. Package hl7.fhir.uv.phd#1.0.0 based on FHIR 4.0.1. Generated 2022-05-12
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