Iso Ieee PHD Tutorial

ISO/IEEE 11073 Personal Health
Devices Tutorial
Douglas P. Bogia
Working Group Chair
on behalf of the
ISO/IEEE 11073 Personal Health
Device Work Group
May 18, 2010
Copyright 2010 by IEEE and Intel
Agenda
Background
History
Personal Health Device Working Group Overview
Environment
Guiding Principles
Base Standard Tutorial (ISO/IEEE Std 11073-20601)

Device Specializations Tutorial (ISO/IEEE 11073104zz)
Demonstration
Summary
Questions (feel free to ask while we go too)
Background: Why was the ISO/IEEE

11073 group selected?
Respected standards body with open participation

Harmonized with ISO for International Standards
Also harmonized with NCCLS/CLSI, HL7, CEN
TC251, ISO TC215, IHE, FDA, and NIST
ISO/IEEE 11073 already formed and active
ISO/IEEE 11073 Charter contains health care devices
Standards structured to be transport portable
Able to support Disease Management, Health and
Fitness, and Independent Living
Low cost for membership and access to standards
Background: IEEE Structure
IEEE Engineering in Medicine and

Biology Society (EMB)
IEEE 11073 (EMB/11073 Elliot Sloane)
IEEE 11073 Clinical/General Committee Work

Group (Todd Cooper)
IEEE 11073 Personal Health Device Work

Group (Doug Bogia)
Many standards under development in this space
See following 2 slides for list of standards
Completed Standards
IEEE Std 11073-10404 Dev specialization Pulse oximeter

IEEE Std 11073-10407 Dev specialization Blood pressure monitor
IEEE Std 11073-10408 Dev specialization Thermometer
IEEE Std 11073-10415 Dev specialization Weighing scale
IEEE Std 11073-10417 Dev specialization Glucose meter
IEEE Std 11073-10420 Dev specialization Body composition
analyzer
IEEE Std 11073-10441 Dev specialization Cardiovascular
IEEE Std 11073-10442 Dev specialization Strength
IEEE Std 11073-10471 Dev specialization Activity hub
IEEE Std 11073-10472 Dev specialization Medication monitor
IEEE Std 11073-20601 Optimized exchange protocol
Projects Underway
Other work being drafted
IEEE P11073-00103 Technical Report Overview

IEEE P11073-10406 Dev specialization Basic ECG
IEEE P11073-10413 Dev specialization Respiration rate
IEEE P11073-10418 Dev specialization INR (blood
coagulation)
IEEE P11073-10419 Dev specialization Insulin pump
IEEE P11073-10421 Dev specialization Peak flow
IEEE P11073-10441 Dev specialization Revision to add
Physical activity monitor (3D accelerometer)
Progress of each standard
Phase 2 standards
Phase 3 standards
Approved and published IEEE stds

Approved international standards
Membership
277 members
153 organizations
Weekly conference calls (for now)
Face to face meetings planned every 2 4
months
International
involvement in
the Work Group
52% North America
29 % Europe
19% Far East
Background: Terminology
Agent
Other terms:
Service
Component
PAN Device
Device
Source
Sensor
Transport
Other terms:
PAN Interface
USB
Bluetooth
Manager
Other terms:
Client
Component
Application
Host Device
Host
Sink
Compute
Engine
Background: Supported Domains
Three domains
Disease Management
Health and Fitness
Agent Examples: Pulse oximeter, Heart rate monitor,

Blood pressure monitor, Thermometer, Weighing scale,
Glucose meter, ECG 1 3 lead, INR, Insulin pump, Body
composition analyzer, Peak flow
Agent Examples: Heart rate monitor, Weighing scale,
Thermometer, Cardiovascular fitness and activity
monitor, Strength fitness equipment, Physical activity
monitor
Independent Living (Aging Independently)
Agent Examples: Disease management devices plus

Independent living activity hub, Medication monitor
10
Background: Example Weight
A person steps on a scale

Measurement is taken
Weight is sent to a Manager for tracking
and trend analysis
If connection fails, weight is queued
until a future time
Same example applies to many other
measurement types: Blood pressure,
glucose, temperature, etc.
11
Background: Example Oxygen

Saturation
A person wears a pulse oximeter

Pulse and oxygen saturation is streamed to
the Manager
Stream packs waveform data as well as other
numeric data such as pulse or SpO2
Alternatively, the data may be stored on the
pulse oximeter (e.g. sleep study) and
transmitted at the end of a session
Same example applies to other measurement
types: fitness equipment, independent living
equipment
12
Background: Device Capabilities
Agents typically have:
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)
Managers typically have:
13
Richer capabilities (RAM,

ROM, CPU)
Connections to multiple
Agents
Wall power or larger
batteries
Background: Guiding Principles
Exchange protocol:
Places more burden on Managers than Agents

Supports multiple data types (episodic, streaming,
store and forward)
Designed to be transport portable (Bluetooth,
USB, etc.)
Optimizes data exchange
Enables efficient reconnections
Targets personal health in home and mobile
environments
14
Background: Personal Health Device

Standards Overview
-00103 Technical Report - Overview
OSI
-20601 Optimized Exchange Protocol
Communication Protocols
Serial
IrDA
Bluetooth
15
USB
ZigBee
Layers 1-4
-10404 -10407 -10408 -10415 -10417 -10441 -10442 -10471 Phase II

Pulse
Blood Thermo- Weighing Glucose Cardio Strength Activity
Oximeter Pressure meter

Scale
Data
Layers 5-7
Device Specializations
Agenda
Background
History
Environment
Guiding Principles

Device Specializations Tutorial (ISO/IEEE 11073104zz)
Demonstration
Summary
16
IEEE P11073-20601 Modeling

ASN.1
Domain
Nomenclature
Information Model
Service Model
Communication Model
ASN.1 language used in the abstract modeling of data and

interactions
Domain Information Model (DIM) describes the device and
physiological data
Nomenclature provides binary codes for terminology
Service Model defines interactions with the device and data
Communication Model manages the connection state machine and
communication characteristics
17
ASN.1
ASN.1 Overview
Domain
Nomenclature
Information Model
Service Model
Communication Model
ASN.1 used to describe objects and services

Can auto-generate C structures and
marshalling code for:
Fixed format binary, packed binary, and XML
Quick reference sheet for ASN.1
INTEGER signed/unsigned integers

BIT STRING bit mask
OCTET STRING string or binary array of bytes
SEQUENCE structure
SEQUENCE OF list
CHOICE union
ANY DEFINED BY void *, an identifier followed by data formatted
according to the identifier
18
ASN.1
Nomenclature
Description
Communication Model
Code block in high 16-bits

Term code in low 16-bits (with sub partitions)
Code blocks group similar term codes together
Service Model
Nomenclature defines 32-bit identifiers

Aids in semantic interoperability
Increases portability to different locales
Fully defined in ISO/IEEE Std 11073-10101
-20601 and -104zz standards repeat relevant parts
Each MDC_* identifier has two parts
Domain
Nomenclature
Information Model
Physiological measurements, dimensions, events, body sites
To reduce packet size, term code can be used alone
Code block must be already known (e.g. standardized)

For example, unit codes are always in dimension code block
19
ASN.1
Domain Information
Model (DIM)
Service Model
Communication Model
Object oriented model

No requirement to implement in object
oriented language
Generic set of classes created
Classes define attributes and methods
Domain
Nomenclature
Information Model
Attribute type defined in ASN.1

Objects are tailored using the attributes
Attributes may be:
Mandatory, optional, or conditional

Static or dynamically changing
20
Object Class Attribute Definitions
Each set of object class attributes are defined in

tabular form
Attribute name used when talking about the attribute
Nomenclature for attribute identification
ASN.1 attribute type definition (see -20601 Annex A
for full details)
Description of attribute usage and requirements
Qualifier: Mandatory, Conditional, Optional
IEEE Std 11073-20601 Health
informaticsPersonal health
device communication
Part 20601: Application profile
Optimized Exchange Protocol

Copyright 2008, IEEE. All
rights reserved.
21
DIM Classes
Class PHD-DIM
: MDS
: PM-Store
1
0..*
: Metric
0..*
Scanner Package
+Scanner
+CfgScanner
+EpiCfgScanner
+PeriCfgScanner
0..*
0..*
0..*
: Numeric
: RealTime-SA
: Enumeration
IEEE P11073-20601a Health

Part 20601a: Application profile

rights reserved.
0..*
: PM-Segment
Medical Device System (MDS) represents the

device
Metric models different forms of measurements
Persistent Metric Store (PM) provides mechanism
to store data for a period of time
Scanner groups and optimizes data transmission
22
Medical Device System Class (1 of 2)
Represents device parameters

Single MDS object whether single function or multi-function
Class code = MDC_MOC_VMS_MDS_SIMP
Attributes include:
Handle
M Object identifier
System-Type-Spec-List
C List of device specializations implemented and their

version numbers
System-Type
C Type of device (e.g. NIBP)
System-Model
M Manufacturer & Model
System-Id
M Unique device identifier as an EUI-64
Dev-Configuration-ID
M Configuration being used
Attribute-Value-Map
C Definition of fixed format message
ProductionSpecification
O Software, hardware, firmware version numbers, serial

number, part number
23
Medical Device System Class (2 of 2)

Mds-Time-Info
C Describes time handling capabilities, accuracy, and

resolutions
Date-and-Time
C Absolute date/time to 1/100th second
Relative-Time
C Offset from a relative point in time to 1/8th of a

millisecond
HiRes-Relative-Time
C High resolution time offset
Date-and-TimeAdjustment
C If Date-and-Time is changed (e.g. daylight savings

time), reports amount of change
Power-Status
O Battery or wall powered
Battery-Level
O Percentage of battery capacity remaining
Remaining-BatteryTime
O Estimate of battery time left
Reg-Cert-Data-List
O List of regulatory and/or certification compliance items

followed by the Agent
Confirm-Timeout
O Information about the length of time an Agent will wait

for a response to a Confirmed Event Report
24
Metric Class (1 of 2)
Base class for measurement classes (not instantiated)

Class code = MDC_MOC_VMO_METRIC
Attributes include:
Handle
M Object identifier
Type
M Type of the object (e.g. weight, oxygen saturation, )
Supplemental-Types
O Information beyond Type and Metric-Id
Metric-Spec-Small
M Specs on the object (periodic vs aperiodically

measured and sent, stores data, agent or manager
initiated, manually entered, calculated, or a setting)
Metric-Structure-Small
O Defines whether a simple or compound structure
Measurement-Status
O Validity of data (e.g. invalid, questionable, test, demo)
Metric-Id
C More specific type qualifier
Metric-Id-List
C List of Ids in a Compound metric
Metric-Id-Partition
O Nomenclature partition for Metric-Id & Metric-Id-List
25
Metric Class (2 of 2)
Unit-Code
O Dimension (e.g. lb, kg, %)
Attribute-Value-Map
C Definition of fixed format message
Source-HandleReference
O Relationship to another object
Label-String
O Text representation of Type
Unit-LabelString
C Text representation of Unit Code
Absolute-Time-Stamp
C Date & Time
Relative-Time-Stamp
C Relative time offset
HiRes-Time-Stamp
C High resolution relative time
Measure-Active-Period
O Time duration of measurement
26
Numeric Class
Represents a numerical measurement

Tends to be used in episodic cases
Derives from Metric
Class code = MDC_MOC_VMO_METRIC_NU
Attributes include:
Simple-Nu-Observed-Value
C Observed value in 32-bit FLOAT format
Compound-Simple-Nu-ObservedValue
C Array of Simple-Nu-Observed-Values
Basic-Nu-Observed-Value
C Observed value in 16-bit FLOAT format
Compound-Basic-Nu-ObservedValue
Array of Basic-Nu-Observed-Values
Nu-Observed-Value
C Observed value, measurement state, and unit
Compound-Nu-Observed-Value
C Array of Nu-Observed-Values
Accuracy
C Maximum deviation between observed value

and actual value
27
Real-Time Sample Array Class
Represents a waveform
Tends to be used in streaming cases
Derives from Metric
Class code = MDC_MOC_VMO_METRIC_SA_RT
Attributes include:
Sample-Period
M Time interval between successive samples
Simple-Sa-Observed-Value
M Observed sample array (8, 16, and 32-bit

variants)
Sa-Specification
M Description of number of samples, size,

format, and flags
Scale-and-Range-Specification
M Formula for mapping between samples and

actual values
28
Enumeration Class
Represents status and/or annotation information

May be used in both episodic and streaming cases
Derives from Metric
Class code = MDC_MOC_VMO_METRIC_ENUM
Attributes include:
Enum-Observed-Value-SimpleOID
C Condition reported with a nomenclature code
Enum-Observed-Value-SimpleBit-Str
C Condition reported as a bit string of 32-bits
Enum-Observed-Value-Basic-Str
C Condition reported as a bit string of 16-bits
Enum-Observed-Value-Simple-Str C Condition reported as a ASCII printable string

Enum-Observed-Value
C Condition reported as bit string, oid, or string

along with status and metric-id
Enum-Observed-Value-Partition
O Defines the nomeclature partition for EnumObserved-Value-Simple-OID or EnumObserved-Value
29
PM-Store Class (1 of 2)
Used for storing batches of data for later transmission

May be used in both episodic and streaming cases
Class code = MDC_MOC_VMO_PMSTORE
PM-Segment 1
PM-Segment Attributes
Pm-Segment-Entry-Map
Fix-SegmentData:
PM-Store
Entry
1:
Entry
2:
Entry
3:
SegmentEntryHeader(op
t)
t)
Entry
k:
t)
Element 1 Data
Element 2 Data
Element n Data
Element 1 Data
Element 2 Data
Element n Data
Element 1 Data
Element 2 Data
Element n Data
Element 1 Data
Element 2 Data
Element n Data
t)
PM-Store
Attributes
PM-Segment 2
PM-Segment Attributes
Pm-Segment-Entry-Map
Fix-SegmentData:
Entry
1:
Entry
2:
Entry
3:
t)
t)
Entry
k:
t)
Element 1 Data
Element 2 Data
Element n Data
Element 1 Data
Element 2 Data
Element n Data
Element 1 Data
Element 2 Data
Element n Data
Element 1 Data
Element 2 Data
Element n Data
t)
30
IEEE Std 11073-20601 Health


rights reserved.
PM-Store Class (2 of 2)
Attributes include:
Handle
M Object identifier
PM-Store-Capab
M Describes facilities provided by the PM-Store object
Store-SampleAlgorithm
M Algorithm (e.g. moving average) used on stored data
Store-Capacity-Count
O Maximum number of stored entries
Store-Usage-Count
O Current number of stored entries
Operational-State
M Indicates if store is enabled and adding new entries or

not
PM-Store-Label
O Printable string describing what the store contains
Sample-Period
C Defines frequency at which entries are added
Number-of-Segments
M Number of currently instantiated PM-Segments
Clear-Timeout
M The maximum time for a Clear-Segment action to take

effect
31
PM-Segment Class (1 of 2)
Represents measurement data in a PM-Store

Each segment contains zero or more entries
Class code = MDC_MOC_VMO_PM_SEGMENT
Attributes include:
Instance-number
M Identifier of the instance
PM-Segment-EntryMap
M Describes format and content of the header and

entries
PM-Seg-Person-Id
C Identifier of person associated with the stored data
Operational-State
M Indicates if segment is enabled and adding new

entries or not
Sample-period
C Defines frequency at which entries are added
32
PM-Segment Class (2 of 2)
Segment-Label
O Printable string describing what the segment contains
Segment-Start-AbsTime
O Start date/time for segment
Segment-End-AbsTime
O End date/time for segment
Date-and-TimeAdjustment
C If Date-and-Time is changed (e.g. daylight savings

time), reports amount of change for this segment
Segment-Usage-Count
O Actual number of stored entries
Segment-Statistics
O Array of min/mean/max
Fixed-Segment-Data
M Segment data
Confirm-Timeout
O Information about the length of time an Agent will wait

for a response to a Confirmed Event Report when
transferring segments
Transfer-Timeout
M Information about the length of time a Manager will

wait for complete transfer of a segment
33
Scanner Class
Class of objects that scan / group other

object data
Base class for scanner classes (not
instantiated)
Class code = MDC_MOC_SCAN
Attributes include:
IEEE Std 11073-20601 Health informaticsPersonal health device communication

Part 20601: Application profileOptimized Exchange Protocol
Copyright 2008, IEEE. All rights reserved.
: Scanner
: CfgScanner
: EpiCfgScanner
: PeriCfgScanner
Handle
M Object identifier
Operational-State
M Indicates if scanner is enabled to send data
Scan-Handle-List
C List of objects that might be reported in a Scanner

initiated event report
Scan-Handle-Attr-ValMap
C Definition of fixed format message with multiple

scanned objects
34
CfgScanner Class
Base class for scanner classes (not instantiated)

Derived from Scanner class
Class code = MDC_MOC_SCAN_CFG
Attributes include:
Confirm-Mode
M Defines whether event reports are sent confirmed or

unconfirmed
Confirm-Timeout
C Reports the length of time to wait for confirmation
Transmit-Window
O Reports maximum number of allowable outstanding

event reports. For this version, the value is always 1
35
EpiCfgScanner Class
Scans episodic objects (no fixed period)

Derived from CfgScanner class
Class code = MDC_MOC_SCAN_CFG_EPI
Attributes include:
Min-Reporting-Interval
O Estimated minimum time between two event reports
36
PeriCfgScanner Class
Scans objects using a fixed time interval

Derived from CfgScanner class
Class code = MDC_MOC_SCAN_CFG_PERI
Attributes include:
Reporting-Interval
M Reporting period of the event reports
37
Information Model Extensibility
Additional object attributes can be

borrowed from full DIM
Private nomenclature portions for
proprietary information exist (0xF000
0xFFFF)
Managers must ignore information they
do not understand
38
Configurations
An Agent supports one or more configuration

of objects
A configuration defines:
The objects that are present and their handles

Attributes in the object and their values
Configurations are assigned DevConfiguration-Ids to distinguish which is being

used
Configurations can be memorized by a
Manager avoiding the overhead of
transmission each association
39
Standard and Extended Configurations
There are two types of configuration:
Standard configuration
Extended configuration
All aspects are defined in one of the ISO/IEEE 11073-104zz device

specializations
Well-known Dev-Configuration-Ids are assigned to Standard
Configurations
Known a priori by Agent and Manager so they can pre-code that
configuration
Any Agent with the predefined Dev-Configuration-Id uses the same
configuration
Optimizes configuration phase since configuration normally does not
need to be sent
Agent must still be able to send configuration for cases where Manager
does not know the configuration (e.g. version mismatches)
A vendor defines a configuration
The Manager must not assume that two Agents with the same
extended Dev-Configuration-Id define the same configuration
For either type, adjustments can be made to the configuration

after association
40
Example
Weight : Numeric
Metric
Handle = 1
Type = MDC_MASS_BODY_ACTUAL
Metric-Spec-Small = 0xD040
Attribute-Value-Map
...
Simple-Nu-Observed-Value = 175.0
Unit-Code = MDC_DIM_LB
...
+Handle
+Type
-Metric-Spec-Small
-Attribute-Value-Map
-...
Numeric class is instantiated to

create a weight object
All mandatory attributes are included
(Handle, Type, Metric-Spec-Small)
Meets the conditions in the remarks column
for 2 conditional attributes (Attribute-ValueMap, Simple-Nu-Observed-Value)
Includes one optional attribute (Unit-Code)
NOTE: The weighing scale specialization
makes this mandatory, but -20601 does not
No other attributes are included
Numeric
+Simple-Nu-Observed-Value
+Unit-Code
-...
41
ASN.1
Service Model
Service Model
Format described in ASN.1

Available services
Config, Data Update
Object Access Service
Communication Model
Event Reporting Service
Domain
Nomenclature
Information Model
Get, Set, Actions (Methods)
Association Service
Assoc request/response, release

request/response, abort
42
Event Reporting Service (1 of 2)
Configuration Event Report
Describes a particular configuration

Describes all Agent objects
Transmits infrequently changing attributes
Optionally describes fixed and grouped
message formats
Manager accepts / rejects based on ability
to support
43
Event Reporting Service (2 of 2)
Data Update Event Reports
Formats
Support for
Single person reporting

Multi-person reporting
Transmission types
Variable sends type, length, data

Fixed send the type and length at configuration time
Scanner (Grouped) further optimization to remove
transmission of handles
Confirmed
Unconfirmed
PM-Segment Data Event Report
Used when transferring PM-Segments to Manager
44
Data Update Event Report Differences

Comparision between different reporting formats
Value_2_1
Variable
format is most
flexible
Fixed
optimizes per
object
Grouped
optimizes
across objects
Value_n_1
Value_n_1
IEEE Std 11073-20601 Health informatics

Personal health device communication
Copyright 2008, IEEE. All rights reserved.
Value_n_2
Value_n_2
45
Obj-handle x
2 bytes (Using MDER)
Attribute ID x_y
Length x_y
4 bytes (Using MDER)
Variable Format
Fixed Format
Grouped Format
Obj-handle 1
Obj-handle 1
Scanner Handle
Attribute ID 1_1
Length 1_1
Value_1_1
Value_1_1
Value_1_1
Value_1_2
Value_1_2
Attribute ID 1_2
Length 1_2
Value_1_2
Attribute ID 1_3
Length 1_3
Value_1_3
Obj-handle 2
Value_1_3
Value_1_3
Obj-handle 2
Attribute ID 2_1
Length 2_1
Value_2_1
Obj-handle n
Value_2_1
Obj-handle n
Attribute ID n_1
Length n_1
Value_n_1
Attribute ID n_2
Length n_2
Copyright 2010
by IEEE and Intel
Value_n_2
Object Access Service (1 of 2)
Currently defined Gets and Sets
Get
Types
Objects
Get all attributes (Mandatory)

Get list of attributes
MDS Object
PM-Store
Set
Scanner Operational State
46
Object Access Service (2 of 2)
Currently defined Actions (Methods):
MDS Object:
MDS-Data-Request (optional):
Set-Time (optional)
Poll for data

Enable data transmission timed
Enable data transmission untimed
Query for all attributes, list of attributes, or by class
Set time and date on Agent
PM-Store:
Clear-Segments Remove data from segment

Get-Segment-Info Retrieve information about segment
Trig-Segment-Data-Xfer Transfer contents of segment
47
Association Service
Association Request (aarq)
Association Response (aare)
Agent or Manager drop the association (session)
Release Response (rlre)
Manager responds
Release Request (rlrq)
Agent initiates an association with the Manager
Peers Response
Abort (abrt)
Agent or Manager abort the association (usually a

fault condition)
48
ASN.1
Domain
Nomenclature
Information Model
Communication
Model
Communication model describes:
Service Model
Communication Model
Communication characteristics
Connection state machine
Legal interactions in each state
Conversion Service
Fixed format binary, packed binary, XML
49
Common Communication
Characteristics
Connections are point to point

Generally, an Agent works with a single Manager. A
Manager may work with multiple Agents
Application Protocol Data Unit (APDU) must be
processed atomically
APDUs may be segmented and reassembled
Maximum APDU (unless device specialization
reduces further)
63K to Manager, 8K to Agent
Allows for two types of communication:
Reliable
Best effort / flushable
50
Reliable Communication
Characteristics
APDUs shall be delivered in order, free
of detectable errors, not duplicated, and
not missing
APDUs may be delayed due to retries
Comm layer shall indicate connection
started and should report disconnects
Comm layer shall indicate failure to
send APDU
Flow control shall be supported for full
APDU
51
Best Effort Communication

Characteristics
APDUs may be delayed, misordered, or
duplicated
APDUs shall have application level
sequencing numbering
APDUs may arrive at a rate that causes
buffer exhaustion
52
R
x
R
O
R
(
Connection
State Machine:
Disconnected
Agent starts off
disconnected
When
transport
indicates a
connection, it
moves to
Connected

Part 20601: Application profileOptimized Exchange Protocol. Copyright 2008, IEEE. All rights reserved.
53
R
x
R
O
R
(
Unassociated
Once
connected, the
Agent
determines
when to create
an association
and moves to
Associating
State

54
Associating
T
q
O
R
T
R
O
R
(
The Agent sends

the Association
Request command
Contains DevConfiguration-ID
Manager
determines whether
it knows the config
(accepted), needs
the configuration
(acceptedunknown-config),
rejects, or aborts

55
Configuring
T
R
x
R
O
R
(
q
O
If Manager needs
config, the Agent
sends it
Manager
determines
whether it can
use it. Sends
accepted-config
or unsupportedconfig
Agent repeats
sending configs
until one is
accepted or no
more remain

56
Operating
T
All Data Event

Reporting occurs during
this state
q
O
R
T
All Access services are

available
R
O
R
(
Agent initiated
Mgr initiated data
transfer
Variable, fixed,
grouped
PM segments
Get MDS (any time

when associated) or
PM-Store
Set Scanner
Mgr poll for data
Mgr initiated timed
Mgr initiated untimed
Set-Time
PM-Store Actions

57
Disassociating
T
R
x
R
O
R
(
q
O
When the Agent

wishes to release
the association it
moves to
Disassociating
The Association
Release is sent
When
acknowledged,
moves to
Unassociated

58
Example - Weight
Weight : Numeric
Metric
Handle = 1
Type = MDC_MASS_BODY_ACTUAL
Metric-Spec-Small = 0xD040
Attribute-Value-Map
...
Simple-Nu-Observed-Value = 175.0
Unit-Code = MDC_DIM_LB
...
+Handle
+Type
-Metric-Spec-Small
-Attribute-Value-Map
-...
Numeric
Weighing scale associates with Manager
+Simple-Nu-Observed-Value
+Unit-Code
First time, Manager needs config (an
-...
optimization will be shown later)
Agent sends object class, Handle, Type, Metric-SpecSmall, Attribute-Value-Map, and Unit-Code in
Configuration Event Report
Whenever the weight (Simple-Nu-Observed-Value)
changes, just the new weight value is communicated
in a Data Update Event Report
During next association Agent does not have to send
configuration if Manager remembers it
59
Example Pulse Ox
Agent associates
First time, Manager needs config
Agent sends:
Objects for Pulse, Oxygen Saturation, Waveform, Scanner,

and PM-Store
Static attributes in all the objects
If stream is started, the Scanner packs the waveform,

pulse, and Oxygen Saturation in a Data Update Event
report
If a sleep study was captured, the PM-Store is
transferred when queried by the Manager
During next association Agent does not have to send
configuration if Manager remembers it
60
Example Message Creation (Data

Event Report)
All messages start with ApduType
ApduType ::= CHOICE {
aarq [57856] AarqApdu,
aare [58112] AareApdu,
rlrq
[58368] RlrqApdu,
rlre
[58624] RlreApdu,
abrt [58880] AbrtApdu,
prst
[59136] PrstApdu
}
PrstApdu ::=
OCTET STRING
PrstAdpu contains encoded DataApdu

DataApdu ::= SEQUENCE {
invoke-id
InvokeIDType,
message
CHOICE {
roiv-cmip-event-report
[256]
EventReportArgumentSimple,
roiv-cmip-confirmed-event-report
[257]
EventReportArgumentSimple,
roiv-cmip-get
[259]
GetArgumentSimple,
-- Additional structure omitted
}
}
EventReportArgumentSimple ::= SEQUENCE {

obj-handle HANDLE,
event-time RelativeTime,
event-type OID-Type,
event-info ANY DEFINED BY event-type
}
Event-type =
MDC_NOTI_SCAN_REPORT_FIXED so
event-info is ScanReportInfoFixed
ScanReportInfoFixed ::= SEQUENCE {
data-req-id
DataReqId,
scan-report-no
INT-U16,
obs-scan-fixed
SEQUENCE OF
ObservationScanFixed
}
ObservationScanFixed ::= SEQUENCE {
obj-handle
HANDLE,
obs-val-data
OCTET STRING
}
Obs-val-data holds the data in the format that

was defined in Attribute-Value-Map at
configuration time

61
Conversion Service
Utilize Encoding Rules facility from

ASN.1
Medical Device Encoding Rules (MDER)
Converts to a fixed format layout

Produces a format for simple Agents using
templates
Transmission uses network byte order (big
endian)
Packed Encoding Rules (PER)

XML Encoding Rules (XER)
62
Agenda
Background
History
Environment
Guiding Principles

Device Specializations Tutorial (IEEE 11073-104zz)
Demonstration
Summary
63
Specialization Overview
Device specializations describe

particular usages of -20601
Narrows definitions to constructs
required for type of device
Increases likelihood of interoperability
by defining specific objects, attributes,
nomenclature ids, and services
64
ISO/IEEE Std 11073-10404 Pulse Oximeter

SpO2 : Numeric
Pulse : Numeric
1..*
1..*
Device/Sensor Annunciation : Enumeration
1
MDS Object : MDS
1
1
0..1
Physiological Threshold Flags : Enumeratio
1
1
Pulse Amplitude : Numeric
0..*
1
0..*
1
1 1
0..*
0..*
Physiological Threshold Limits : Enumeration
Collection : PM-Store
0..1
Plethysmogram : RT-SA
0..*
0..*
Streaming : PeriCfgScanner
0..*
Pulse Character : Enumeration
1
0..*
Session : PM-Segment
Pulse Event : Enumeration

Device specializationPulse oximeter. Copyright 2008, IEEE. All rights reserved.
Measures blood oxygen saturation and pulse

Standard completed
Support for episodic, streaming, and off-line modes
Standard Config for episodic mode
Uses nomenclature from -10101 and adds new
nomenclature to support a range of pulse oximeter
types
65
ISO/IEEE P11073-10406 Basic ECG (1 to 3lead)
IEEE P11073-10406 Health informaticsPersonal health device

communication Device specializationBasic ECG (1 to 3-lead
ECG). Copyright 2010, IEEE. All rights reserved.
Measures 1 to 3-lead
electrocardiogram
In drafting stage, subject to
change.
Some data items being
proposed include: ECG
resolution, sampling
interval, sample size,
baseline, time, signal
length, heart rate
66
ISO/IEEE Std 11073-10407 Blood Pressure Monitor

MDS Object : MDS
1
1
0..1
Pulse : Numeric
1
Diastolic,Systolic,MAP : Compound Numeric

Device specializationBlood pressure monitor. Copyright 2008, IEEE. All rights reserved.
Measures blood pressure and optionally pulse

Standard completed
Support for episodic mode
Standard Config defined
Uses Compound Numeric to collect multiple
values together
Uses nomenclature from -10101
67
ISO/IEEE Std 11073-10408 Thermometer

Thermometer : MDS
1
1..*
Body Temperature : Numeric

Device specializationThermometer. Copyright 2008, IEEE. All rights reserved.
Measures body temperature

Standard completed
Uses nomenclature from -10101 and
adds two new codes (armpit & GI Tract)
68
IEEE P11073-10413 Respiration rate
Measures respiration rate

In drafting stage, subject to change.
Brand new work
Initial model anticipated around June
2010
69
ISO/IEEE Std 11073-10415 Weighing Scale

1
Weighing Scale : MDS
1
Body Weight : Numeric
1
1
0..1
0..1
Body Mass Index : Numeric
Body Height : Numeric

Device specializationWeighing scale. Copyright 2008, IEEE. All rights reserved.
Measures weight and optionally BMI

Standard completed
Uses nomenclature from -10101 and
adds a new term for BMI
70
ISO/IEEE Std 11073-10417 Glucose Meter

PHD-Glucose meter object instances
Glucose : Numeric
Glucose Meter : MDS
Observations : PM-Store
1
0..1
1
ContextExercise : Numeric
0..1
0..1
ContextDiet : Numeric
0..1
ContextMedication : Numeric
0..1
0..1
ContextHbA1C : Numeric
0..1
0..1
0..1
0..1
ContextHealth : Enumeration
EventDeviceErr : Enumeration
ContextMeal : Enumeration
ContextSampleLocation
: Enumeration
ContextTester : Enumeration

Device specializationGlucose meter. Copyright 2009, IEEE. All rights reserved.
Measures blood glucose

Standard completed
Two use cases: home use and carrying to a doctors office
Uses nomenclature from -10101 and adds new terms for Glucose
71
ISO/IEEE P11073-10418 INR

O b je c t PH D - I N R o b jec t ins ta nce s
MDS
I NR
Numeric
P rothrom bin time
Qu ic k va lu e
I NR
Batch c od e
I SI
Numeric
Numeric
Numeric
Numeric
0 ..1
0 ..1
Schedule
Cu rren t medication sc hed ule
0 ..1
Numeric
C urren t medicatio n level
0. .1
Schedule
New medicatio n sc hed ule
1.. 1
1.. 1
0. .1
Numeric
New me dic atio n level
0. .1
Numeric
1 ..1
0 ..1
Ad ditiona l in formatio n
Enumeration
D evic e alarm
0.. 1
Review period
Enumeration
M easu rement s tat us
0 ..1
1.. 1
Numeric
T arget therapeu tic rang e
1.. 1
Measures blood
coagulation ability
In the balloting
stage, subject to
change
INR =
International
normalized ratio
Project approved
Early model
shown
IEEE P11073-10418 Health informaticsPersonal health device communication

Device specializationInternational Normalized Ratio (INR) Monitor. Copyright 2010, IEEE. All rights reserved.
72
ISO/IEEE P11073-10419 Insulin pump

o
1
1

Device specializationInsulin pump. Copyright 2010, IEEE. All rights reserved.
73
Measures
basal and
bolus insulin
delivery
In the balloting
stage, subject
to change
ISO/IEEE Std 11073-10420 Body composition

analyzer
Class PHD-Body Composition Analyzer object instances
MDSMDS
Weighing
Scale analyzer
Body
composition
1
Body fat
0..1
Numeric
Fat Free Mass
0..1
Numeric
Soft Lean Mass
Numeric
1
Numeric
Body height
1
0..1
Numeric
Body Water
0..1
Numeric
Body mass index
Numeric
Body weight
1
Measures key items

of body makeup
using bioelectrical
impedance analysis
Standard completed
Shares weight,
height, BMI from
11073-10415

Device specializationBody composition analyzer. Copyright 2010, IEEE. All rights reserved.
74
ISO/IEEE P11073-10421 Peak flow

Device specializationPeak expiratory flow monitor (peak flow). Copyright 2010, IEEE. All rights reserved.
In the balloting stage, subject to change

PEF = peak expiratory flow
FEVx = forced expiratory volume in x
seconds
75
ISO/IEEE Std 11073-10441 Cardiovascular Fitness and Activity Monitor

MDS
Heart Rate
Speed
*
Altitude Gain
Slopes
Altitude Loss
Activity Time
Intensity
Distance
Sub-Session
Resistance
Session
Incline
Stride Length
Power
Height
Weight
Breathing Rate
User Max Heart Rate

*
Energy Expended
Carbohydrate Calories Ingested
Program Identifier
Calories Ingested
Sustained Phys Activity Threshold
Ascent Time and Distance
Altitude
Age
Cadence
Descent Time and Distance

Device specializationCardiovascular fitness and activity monitor. Copyright 2008, IEEE. All rights reserved.
General model for many types of cardio devices

Standard completed
No standard configurations
Uses nomenclature from -10101 and adds new code block and
term codes
76
ISO/IEEE P11073-10441 (Cardio) Revision

Adding physical activity monitor
[b1]

Device specializationPhysical Activity Monitor. Copyright 2010, IEEE. All rights reserved.
77
Measures physical
activity (e.g. 3D
accelerometer) and
reports in near realtime
In drafting stage,
subject to change
RMS = root mean
squared
ZCM = zero crossing
mode
PIM = proportional
integral mode
TAT = time above
threshold
ISO/IEEE Std 11073-10442 Strength Fitness Equipment

1
MDS
1
1
1
0..*
Resistance
0..*
Exercise Modifier
0..*
0..*
Set
Repetition Count
0..*
Repetition

Device specializationStrength fitness equipment. Copyright 2008, IEEE. All rights reserved.
General model for many types of strength building equipment

Standard completed
No standard configurations
Uses nomenclature from -10101 and adds new code block and
term codes
78
ISO/IEEE Std 11073-10471 Independent Living Activity Hub

MDS
Independent Living Activity Hub
1
Enumeration
Fall Sensor
0..*
0..*
Enumeration
Smoke Sensor
Enumeration
Motion Sensor
0..*
0..*
Enumeration
Property Exit Sensor
Enumeration
Enuresis Sensor
0..*
0..*
Enumeration
Temperature Sensor
Enumeration
Contact Closure Sensor
0..*
0..*
Enumeration
Usage Sensor
Enumeration
Switch Use Sensor
0..*
0..*
Enumeration
PERS Sensor
Enumeration
Medication Dosage
0..*
0..*
0..*
0..*
Enumeration
Water Sensor
Enumeration
CO Sensor
Enumeration
Gas Sensor
General model for

different home sensor
devices
Standard completed
Support for episodic
mode
No standard
configurations
Uses nomenclature
from -10101 and adds
new code block and
term codes

Device specializationIndependent living activity hub. Copyright 2008, IEEE. All rights reserved.
79
ISO/IEEE Std 11073-10472 Medication

monitor
Measures
dispensing of
medication(s)
Standard
completed
Current model
shown

Device specializationMedication monitor. Copyright 2009, IEEE. All rights reserved.
80
Agenda
Background
History
Environment
Guiding Principles
Base Standard Tutorial (IEEE 11073-20601)

Device Specializations Tutorial (IEEE 11073-104zz)
Demonstration
Summary
81
Tooling Support for IEEE 11073
National Institute of Standards and

Technologies (NIST) has support for
PHD in their test tools
Frontline Test Equipment has IEEE
11073 PHD support with three modes
(see next slides)
Continua has reference code available
for members
82
www.fte.com
Frontline IEEE 11073-CESL Analyzer

FREE! IEEE 11073-20601 Analyzer available for Continua Alliance
developers using CESL Platform.
Frontline Bluetooth Protocol Analyzer (FTS4BT) now supports

IEEE 11073-20601 over
Frontline USB Analyzer now supports IEEE11073-20601 over
Available at www.fte.com/Products
www.fte.com
Faster Time to Market
for Continua Alliance developers.
FREE PC Based Protocol analyzer for Continua Alliance

CESL Platform users.
No additional hardware cost. FREE.
Complete decoding of the IEEE11073-20601 run over CESL Platform
Interoperability issues solved with Protocol analyzer.
Helps Debug, Test and Verify your device code
www.fte.com/products
www.fte.com
Continua Alliance CESL Platform users.

Debug, Test and Verify (PC based analyzer, No hardware interface required).
CESL Program Modules
PC based analyzer, No hardware interface required
Free IEEE 11073-20601 Protocol Analyzer

for Continua Alliance CESL Platform users
www.fte.com/products
Summary
Optimized exchange protocol:
Places more burden on Managers than Agents. Agent is in

charge, Manager adapts
Supports multiple data types (episodic, streaming, store and
forward)
Designed to be transport portable (Bluetooth, USB, etc.)
Optimizes data exchange (data transmission sizes, run-time
construction, and parsing overhead)
Enables efficient reconnections (Agent not always
connected, configuration transferred a single time)
Targets personal health in home and mobile environments
Leverages traditional Domain Information Model to enable
leveraging other IEEE 11073 specifications
Device specializations:
Narrows a broad framework to a specific application

Enable interoperability for each device type
86
Questions and Answers
Join Information:
No cost to join the work group and

participate in development activities
To participate in final ballot, the costs are <
$250 USD per individual per year for an
IEEE and IEEE Standards Association
membership
To join the work group, contact:
phd-chair@ieee.org
87
Backup
Example of PM-Segment Offsets
PresentationMode Done
Time
Passage
Adjustment
to
[0] -60 0
current
min
clock
X XX
15
min
Segment 1
Oct 9, 07 16:00 175

Oct 10, 07 16:10 176
Nov 1, 07 15:50 174

Nov 2, 07 16:00 176
Nov 3, 07 16:30 175
[0] 60
X
X 75
[0] 15
min
[0]
Segment 2
Segment 3
Segment 4
min min
Nov 4, 07 15:50 176

Nov 5, 07 16:00 177
Nov 6, 07 16:30 176
Mar 4, 08 16:00 179
Mar 5, 08 16:00 178
Mar 3, 08 16:00 180
Time changed back

Time changed forward Time changed forward
1 hour due to Daylight 1 hour due to Daylight 15 minutes due to user
Savings Time
Savings Time
desires
89

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ISO/IEEE 11073 Personal Health

Base Standard Tutorial (ISO/IEEE Std 11073-20601)

Copyright 2010 by IEEE and Intel

Background: Why was the ISO/IEEE

Respected standards body with open participation

Copyright 2010 by IEEE and Intel

Background: IEEE Structure

IEEE Engineering in Medicine and

IEEE 11073 (EMB/11073 Elliot Sloane)

IEEE 11073 Clinical/General Committee Work

IEEE 11073 Personal Health Device Work

Copyright 2010 by IEEE and Intel

Many standards under development in this space

See following 2 slides for list of standards

IEEE Std 11073-10404 Dev specialization Pulse oximeter

Copyright 2010 by IEEE and Intel

Other work being drafted

IEEE P11073-00103 Technical Report Overview

Copyright 2010 by IEEE and Intel

Progress of each standard

Approved and published IEEE stds

Approved international standards

Copyright 2010 by IEEE and Intel

Copyright 2010 by IEEE and Intel

Background: Supported Domains

Health and Fitness

Agent Examples: Pulse oximeter, Heart rate monitor,

Independent Living (Aging Independently)

Copyright 2010 by IEEE and Intel

Agent Examples: Disease management devices plus

Background: Example Weight

A person steps on a scale

Copyright 2010 by IEEE and Intel

Background: Example Oxygen

A person wears a pulse oximeter

Copyright 2010 by IEEE and Intel

Background: Device Capabilities

Agents typically have:

Limited capabilities (RAM,

Copyright 2010 by IEEE and Intel

Managers typically have:

Richer capabilities (RAM,

Background: Guiding Principles

Places more burden on Managers than Agents

Copyright 2010 by IEEE and Intel

Background: Personal Health Device

-20601 Optimized Exchange Protocol

Copyright 2010 by IEEE and Intel

-10404 -10407 -10408 -10415 -10417 -10441 -10442 -10471 Phase II

Oximeter Pressure meter

Base Standard Tutorial (ISO/IEEE Std 11073-20601)

Copyright 2010 by IEEE and Intel

IEEE P11073-20601 Modeling

ASN.1 language used in the abstract modeling of data and

Copyright 2010 by IEEE and Intel

ASN.1 used to describe objects and services

Fixed format binary, packed binary, and XML

Quick reference sheet for ASN.1

INTEGER signed/unsigned integers

Copyright 2010 by IEEE and Intel

Code block in high 16-bits

Code blocks group similar term codes together

Nomenclature defines 32-bit identifiers