joe cafazzo: "introduction to ieee health informatics standards" at the fall 2014...
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Introduction to IEEE
Communication Standards
Health informatics—Personal health device communication
Part 10425: Device Specialization— Continuous Glucose Monitor
Health informatics—Personal health device communication
Part 10419: Device Specialization— Insulin Pump
D-Data Exchange
November 20, 2014
Melanie Yeung, BASc., MHSc.
Centre for Global eHealth Innovation
Overview Background
Optimized Exchange Protocol Standard (ISO/IEEE Std
11073-20601)
Device Specialization Tutorial
Continuous Glucose Monitor (IEEE 11073-10425)
Insulin Pump (IEEE 11073-10419)
Standards Workshops and Toolkits
IEEE 11073
Personal Health Device Standards
3
-00103 Overview
Serial IrDA Bluetooth USB ZigBee Layers
1-4
Layers
5-7
OSI
Communication Protocols
NFC
-20601 Optimized Exchange Protocol
-10404Pulse
Oximeter
-10407Blood
Pressure
-10408Thermo-meter
-10415Weighing
Scale
-10417Glucose
-10419
Insulin
Pump
-10425CGM
-10471ActivityData
…
Device Specializations
IEEE Terminology
Agent
Other terms:
• Service Component
• PAN Device
• Device
• Source
• Sensor
Manager
Other terms:
• Client Component
• Application Host Device
• Host
• Sink
• Compute Engine
Transport
Other terms:
l PAN Interface
l USB
l Bluetooth
l Zigbee
BGM
CGM
Insulin Pump
Smartphone
Computer
Properties
Agents
Limited capabilities (RAM, ROM, CPU)
Connection to a single Manager
Limited power resource (small battery)
Low cost (consumer device)
Fixed configurations (data type and format does not change)
Intermittent connections (disconnect when inactive)
Manager
Richer capabilities (RAM, ROM,
CPU)
Connections to multiple Agents
Wall power or larger batteries
Exchange ProtocolISO/IEEE 11073-20601 defines the communication (PAN Interface) between the agent
and the manager.
Places more burden on Managers than Agents
Supports multiple data types (episodic, streaming, store and forward)
Designed to be transport portable (Bluetooth, USB, Zigbee, etc.)
Optimizes data exchange
Enables efficient reconnections
Targets personal health in home and mobile environments
Object-oriented systems management paradigm. The overall system model is
divided into three principal components:
1) Domain information model (DIM),
2) Service model, and
3) Communication model.
Does NOT state what manager does with the data.
CGM Receiver Agent• Takes measurements (has the sensor)
• Simple (minimal hardware requirements)
• Highly specialized (does just one thing)
• Server device
CGM Sensor/Transmitter Agent• May periodically send the results
• Exchange may take place after a
“session”
• Manager may request stored results of
a dedicated time period.
Domain Information Model Describes an agent as a set of objects.
Objects and their attributes represent:
elements that control behavior and report on the status of the
agent
data that an agent can communicate to a manager
DIM:
Object 4Object 1 Object 2 Object 3
Agent DIM
attribute 1attribute 1 attribute 1 attribute 1
attribute 2
attribute 3
attribute 2
attribute 3
attribute 4
attribute 2 attribute 2
attribute 3
attribute 4
Services
ActionsServices
Actions
Services
Actions
Services
Actions
Eventing
Eventing
Eventing
Types of ’Objects’
Sensor
PM-Store object n:Agent’s hard disk
*optional*
MDS ObjectAgent’s bureaucratic and
system information,
*must have*
Metric object kDescribes a measurement,
status, waveform
*optional*
Scanner object m(eventing formatter and organizer)
*optional*
Agent has “Objects” to describe its features
Continuous Glucose Monitor DIM
12
Agent Configurations
Configurations are assigned IDs
Configurations can be memorized by a Manager
Standard configurations
Extended configurations
An agent may have several configurations
Different kinds of configurations:
CGM Standard Configuration
Dev-Configuration-Id = 0x09C4
One Numeric Object: Glucose (interstitial fluid, subcutaneous tissue)
14
Numeric
Glucose
Handle = 1
Type = MDC_CONC_GLU_ISF
Supplemental Type = MDC_CTXT_GLU_SAMPLELOCATION_SUBCUTANEOUS
Metric-Spec-Small = 0xC042 (available intermediate, available stored, agent
initiated, calculation)
Unit-Code = MDC_DIM_MILLI_G_PER_DL
Attribute-Value-Map = {MDC_ATTR_NU_VAL_OBS_BASIC, then
MDC_ATTR_TIME_STAMP_BO
Basic-Nu-Observed-Value = 104 mg/dL
Base-Offset-Timestamp = (date and time of the glucose measurement)
CGM Standard Configuration
CGM Extended Configuration Must include the Glucose object and may include one or more of the optional numeric
and enumeration objects.
Numeric Objects
Glucose (mandatory)
Sensor Calibration (periodic calibration of the sensor is required for most CGMs)
Sensor run-time (embedded sensors only last for a period of days)
Glucose sampling interval (time between glucose samples)
Compound Numeric Objects
Patient high/low thresholds (indicates patient glucose goals)
Device hypo/hyper thresholds (indicates hypoglycemia hyperglycemia levels)
Glucose rate of change thresholds (indicates patient change in glucose goals)
16
CGM Extended Configuration (Cont’d)
Enumeration Objects
PHD DM Status (General disease management status object with common bit
definitions across all specializations)
CGM Status (CGM specific status bits)
17
Compound Numeric
Patient low/high threshold
Handle = assigned by the implementation, cannot be zero
Type = MDC_CONC_GLU_PATIENT_THRESHOLDS_LOW_HIGH
Metric-Spec-Small = (mss-avail-stored-data | mss-upd-aperiodic | mss-
acc-agent-initiated | mss-cat-setting | mss-cat-manual)
Metric-Structure-Small = ms-struct-compound-fix
Metric-Id-List = MDC_CONC_GLU_PATIENT_THRESHOLD_LOW then
MDC_CONC_GLU_PATIENT_THRESHOLD_HIGH
Unit-Code = MDC_DIM_MILLI_MOLE_PER_L
Compound-Basic-Nu-Observed-Value = { 4 mmol/l, 7 mmol/l }
Base-Offset-Timestamp = (date and time of the patient low/high entry)
Extended (Unknown) Configuration
Extended (Known) Configuration
ApplicationProtocolDataUnit
(APDU) Example
20
APDU Example (Cont’d)
21
Insulin Pump Agent
Insulin Pump
Manager
Insulin Pump DIM
23
Insulin Pump
Standard ConfigurationDev-Configuration-Id = 0x076C
Two Numeric Objects: Bolus Delivered, Current Basal Rate Setting
24
Numeric
Bolus Delivered
Handle = 1
Type = MDC_INS_BOLUS
Supplemental Type List = MDC_INS_BOLUS_FAST, MDC_INS_BOLUS_MEAL
Metric-Spec-Small = mss-avail-intermittent | mss-avail-stored-data | mss-upd-aperiodic | mss-
msmt-aperiodic | mss-acc-manager-initiated | mss-acc-agent-initiated |
mss-cat-calculation
Unit-Code = MDC_DIM_X_INTL_UNIT
Attribute-Value-Map = {MDC_ATTR_NU_VAL_OBS_BASIC, then
MDC_ATTR_TIME_STAMP_BO
Basic-Nu-Observed-Value = 0.8 IU
Base-Offset-Time-Stamp = (date and time of the bolus delivered)
Numeric
Current Basal Rate Setting
Handle = 2
Type = MDC_INS_BASAL_RATE_SETTING
Metric-ID = MDC_INS_BASAL_DEVICE
Supplemental Type = MDC_INS_BASAL_PRGM
Metric-Spec-Small = mss-avail-intermittent | mss-avail-stored-data | mss-upd-aperiodic | mss-
acc-manager-initiated | mss-acc-agent-initiated | mss-cat-setting
Unit-Code = MDC_DIM_X_INTL_UNIT_PER_HR
Attribute-Value-Map = {MDC_ATTR_NU_VAL_OBS_BASIC, then
MDC_ATTR_TIME_STAMP_BO
Basic-Nu-Observed-Value = 2.4 IU/h
Base-Offset-Time-Stamp = (date and time of the bolus delivered)
Insulin PumpExtended Configuration
Must include the Bolus Delivered and Current Basal Rate Setting objects and may
include one or more of the optional numeric and enumeration objects.
Numeric Objects
Bolus Delivered (mandatory)
Current Basal Rate Setting (mandatory)
Current Bolus Setting
Pending Bolus Delay
Basal Delivered
Insulin Reservoir Remaining
Insulin Concentration
Enumeration Objects
Operational Status
PHD DM Status (General disease management status object with common bit
definitions across all specializations)
Insulin Pump Status (Insulin Pump specific status bits)
25
Insulin PumpExtended Configuration (Cont’d)
Schedule-Store Objects
Basal Rate Profile Settings
Insulin to Carbohydrate Ratio Profile Settings
Insulin Sensitivity Profile Settings
26
Contains
Numeric
Objects!
Standards
Workshops and
Toolkits
Adoption of Standard Accelerate manufacturer adoption and implementation
of standards, enabling novel applications and systems
to access patient data from diabetes devices without
excessive barriers.
We Want To Help
To investigate the barriers confronted by individual
manufacturers when implementing standards
To develop software/hardware toolkits
To deliver custom workshops for knowledge transfer and
distribute toolkits to both support and accelerate adoption of
standardized protocols into their technologies
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