Protocols, Networks and Standards for point-of-care device communication CEN/ISO/IEEE 11073...

Protocols, Networks and Protocols, Networks and Standards forStandards for

point-of-care device point-of-care device communicationcommunication

CEN/ISO/IEEE 11073 Standards CEN/ISO/IEEE 11073 Standards Med-e-Tel, Luxembourg, 23 April, 2004Med-e-Tel, Luxembourg, 23 April, 2004

Melvin Reynolds, Melvin Reynolds, AMS Consulting, Ross-on-Wye, UKAMS Consulting, Ross-on-Wye, UKChair CEN TC251 WGIV Health informatics – Technologies for interoperability, Co-chair ISO TC215 WG2 Health informatics – Messages and communications; Chair ISO TC215 WG2.1 Health informatics – Device communications, Co-chair IEEE1073 Medical device communications.

Thomas Norgall, Thomas Norgall, Fraunhofer Institute for Integrated Circuits, Erlangen, DFraunhofer Institute for Integrated Circuits, Erlangen, D Co-chair CEN TC251 WGIV Health informatics – Technology for interoperability, Co-chair ISO TC215 WG2.1 Health informatics – Device communications, Co-chair HL7 LAPOCT SIG.

Todd Cooper, Todd Cooper, Breakthrough Solutions, San Diego, USABreakthrough Solutions, San Diego, USA Chair IEEE1073 Medical device communications.

Point-of-care: all changePoint-of-care: all change

Fixed configuration, e.g. anaesthesiaFixed configuration, e.g. anaesthesia

CEN/ISO/IEEE 11073 StandardsCEN/ISO/IEEE 11073 Standards

– – but changing but changing periodically, and periodically, and evolving over evolving over timetime

Patient Patient MonitorMonitor

RespiratoRespiratorr

Syringe Pumps and InfusorsSyringe Pumps and Infusors

Additional Additional PumpPump

Additional Additional MonitorMonitor

Data Data Processing Processing System / PDMSSystem / PDMS

Point-of-care: all changePoint-of-care: all change

Variable configuration, e.g. intensive care Variable configuration, e.g. intensive care


Patient Patient MonitorMonitor

RespiratorRespirator

Many Syringe Pumps and Many Syringe Pumps and InfusorsInfusors

Data Data Processing Processing System / PDMSSystem / PDMS

- changing - changing frequently and frequently and within minuteswithin minutes

InteroperabilityInteroperability

Interoperability: Interoperability: ability of two or more systems or components ability of two or more systems or components to exchange information and to use the to exchange information and to use the information that has been exchangedinformation that has been exchanged

source: IEEE Standard Computer Dictionary: A Compilation source: IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries, IEEE, 1990of IEEE Standard Computer Glossaries, IEEE, 1990

Functional interoperability:Functional interoperability:Shared Architectures, Methods & FrameworksShared Architectures, Methods & Frameworks

Semantic interoperability:Semantic interoperability:Shared Data types, Terminologies, CodingsShared Data types, Terminologies, Codings


InteroperabilityInteroperability

Point-of-care medical device communication Point-of-care medical device communication (IEEE1073) Charter:(IEEE1073) Charter:

Provide real-time plug-and-play interoperability Provide real-time plug-and-play interoperability for patient-connected medical devicesfor patient-connected medical devices

Facilitate the efficient exchange of vital signs Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-and medical device data, acquired at the point-of-care, in all health care environmentsof-care, in all health care environments

… … Leveraging off-the-shelf technologies, scaling Leveraging off-the-shelf technologies, scaling across a wide range of system complexities, across a wide range of system complexities, and supporting commercially viable and supporting commercially viable implementations.implementations.


DevelopmentDevelopment

A history of co-operative and A history of co-operative and complementary working:complementary working:

Arrows indicate effective transfer of development Arrows indicate effective transfer of development and/or maintenance responsibility.and/or maintenance responsibility.


ContextContext

Health informatics:Health informatics:Generally interpreted as being Generally interpreted as being in ISO/OSI Level 7in ISO/OSI Level 7

Medical device Medical device communication:communication:

Works at all ISO/OSI Levels,Works at all ISO/OSI Levels,

Directly in ISO/OSI Levels 7 – 5Directly in ISO/OSI Levels 7 – 5

In Levels 1 – 4, chiefly by In Levels 1 – 4, chiefly by reference to other standards reference to other standards (such as IrDA or 802.11)(such as IrDA or 802.11)


ISO/OSI Level 7: Application

ISO/OSI Level 6: Presentation

ISO/OSI Level 5: Session

ISO/OSI Level 4: Transport

ISO/OSI Level 3: Network

ISO/OSI Level 2: Datalink

ISO/OSI Level 1: Physical

ArchitectureArchitecture

Requirements:Requirements: True interoperability across all 7-layers - True interoperability across all 7-layers -

from the ‘connector’ to the end from the ‘connector’ to the end applicationapplication

Quality of Service mechanisms to Quality of Service mechanisms to support the strong requirements placed support the strong requirements placed on regulated medical deviceson regulated medical devices

Maintainability as communications Maintainability as communications technology and applications changetechnology and applications change


Series titleSeries title

(National, e.g. BS) EN ISO/(National, e.g. BS) EN ISO/IEEEIEEE

111073-xyyzz1073-xyyzz

Health informatics -Health informatics -

Point-of-care medical device Point-of-care medical device communication -communication -

x partition (general):x partition (general):

yy subsection (group) - yy subsection (group) -

zz detail (specialised)zz detail (specialised)


Series structureSeries structure


Data & Information Definitions11073.1xxxx

Application Profiles11073.2xxxx

Transport & Physical Layers11073.3xxxx

Internetworking Support11073.5xxxx

Related – some shared concepts11073.9xxxx

Application Gateways

11073.6xxxx

11073-1xxxx content11073-1xxxx content

Semantics needed to communicate a Semantics needed to communicate a device’sdevice’sapplication data, status and control application data, status and control information. information. Three main components:Three main components:

Nomenclature: 11073.10101Nomenclature: 11073.10101 Domain Information Model (DIM): 11073.10201Domain Information Model (DIM): 11073.10201 Device Specialisations: 11073.103xxDevice Specialisations: 11073.103xx


Data & Information Definitions11073.1xxxx



31 . . . . . . 23 . . . . . . . 15 . . . . . . . 7 . . . . . .0

msblsb

Codeblock Number (Hi-order 16 bits)1 Object-Oriented (OO)2 Supervisory Control and Data

Acq’n (SCADA)3 Events4 Dimensions (Units of Msmt)5 Virtual Attributes6 Parameter Groups7 [Body] Sites8 Infrastructure…256 External Nomenclature Ref's…1024 Private

Term Code (Lo-order 16 bits)Context-sensitive parts

Context-free code

Nomenclature:Nomenclature:A set of numeric codesA set of numeric codes

that identify every itemthat identify every item

that is communicatedthat is communicated

between systems.between systems.


Domain Information Model:Domain Information Model:

An object oriented data model that specifies An object oriented data model that specifies objects, attributes, attribute groups, event objects, attributes, attribute groups, event reports, and services that may be used to reports, and services that may be used to communicate device data and to control / communicate device data and to control / configure the reporting of information . . . configure the reporting of information . . .


Medical Devices Medical Devices and and FunctionalitiesFunctionalities

Measured Data Measured Data and Settingsand Settings

Alert InformationAlert Information

Remote ControlRemote Control Patient InformationPatient Information CommunicationCommunication

Domain Information Domain Information ModelModel

CEN/ISO/IEEE 11073 Standards CEN/ISO/IEEE 11073 Standards

Development ProcessDevelopment Process


Domain Domain InformatioInformation Modeln Model

Abstract Abstract SyntaxSyntax(ASN.1)(ASN.1)

Transfer Transfer SyntaxSyntax(MDER)(MDER)

‘‘On-the-On-the-Wire’ Wire’

FormatFormat


Application profile standards...Application profile standards... Provide specific sets of capabilities tailored Provide specific sets of capabilities tailored

for a class of communication needs / for a class of communication needs / architecturesarchitectures

Limit the options that are availableLimit the options that are available Remaining options must be discovered and in Remaining options must be discovered and in

some cases negotiated when a connection is some cases negotiated when a connection is made (enabling plug-and-play made (enabling plug-and-play interoperability!)interoperability!)




Application profile standards...Application profile standards... Define a generic (non-device specific) set of data Define a generic (non-device specific) set of data

and services needed to initiate, configure, and and services needed to initiate, configure, and maintain communication: Connect / Disconnect, maintain communication: Connect / Disconnect, Create / Delete, Get / Set, Event Report, Invoke, Create / Delete, Get / Set, Event Report, Invoke, etc.etc.

Specify the use of Standard Service Elements: Specify the use of Standard Service Elements: ACSE, ROSE, CMISE, ASN.1, MDER (based on ACSE, ROSE, CMISE, ASN.1, MDER (based on BER+), etc.BER+), etc.

Provide optional packages, e.g for remote controlProvide optional packages, e.g for remote control For XML & Web Services are under development For XML & Web Services are under development




Available (point-to-point) transport standards…Available (point-to-point) transport standards… IrDA-Based Cable ConnectedIrDA-Based Cable Connected (11073.30200)(11073.30200) IrDA-Based Infrared WirelessIrDA-Based Infrared Wireless (11073.30300)(11073.30300)

Transport standards (LANs) under Transport standards (LANs) under consideration…consideration… RF Wireless – high emphasis on QoS! RF Wireless – high emphasis on QoS!

(TR (TR 11073.00101)11073.00101)

IP-Based (Ethernet)IP-Based (Ethernet)


Transport & Physical Layers11073.3xxxx

TR: Guidelines … RF TR: Guidelines … RF wirelesswireless

Benefits of wireless communication…Benefits of wireless communication… No cable ‘spaghetti’ in conventional No cable ‘spaghetti’ in conventional

medical device use environmentsmedical device use environments Increased freedom available to users – Increased freedom available to users –

healthcare professionals and patients healthcare professionals and patients alikealike

Expanded areas of use – community and Expanded areas of use – community and global mobility global mobility


TR – Guidelines ... RF wireless ...11073.01010


Possible difficulties to be overcome…Possible difficulties to be overcome… High importance of data communicatedHigh importance of data communicated ‘‘Unknown’ communication capacity Unknown’ communication capacity

availableavailable Security implications for different types Security implications for different types

of medical information remain difficult of medical information remain difficult to determine – and standardiseto determine – and standardise


TR – Guidelines ... RF wireless ...11073.01010



Use case topological overview

Caution – work-in-

progress; known omissions!



Caution – work-in-

progress; known omissions!

Trans-portable monitoring use case architecture



Internetworking Support11073.5xxxx

11073Agent

Device

11073ManagerSystem

11073.3xxxx

Transport

Patient MonitorDevice Manager

Infusion PumpVentilator

Pulse-Oximeter

Examples:Examples: LAN Access Points, LAN Access Points, Wired-to-Wireless Transport Wired-to-Wireless Transport

GatewaysGateways

11073AgentDevice

11073ManagerSystem

11073.5xxxxInternetworking

11073.3xxxx

Transport

11073.3xxxx

Transport



Application Gateways11073.6xxxx

ObjectivesObjectives: Interoperability between different: Interoperability between different application-layer protocols application-layer protocols

++ Bi-directional transparencyBi-directional transparency

Example: HL7 / 11073 Gateway: 11073.60101Example: HL7 / 11073 Gateway: 11073.60101

HL7 - Observation Reporting InterfaceHL7 - Observation Reporting Interface

11073System(Agent/

Manager)

non-VITALApplication11073.6xxxx Gateway

11073.3xxxx

Transport

11073.3 /.5xxxx

Transport



Related – NCCLS POCT-1A11073.9xxxx

11073-90101 POCT-1A11073-90101 POCT-1A


POC Devices co-POC Devices co-existenceexistence


POC Dev w/ DMI4.

Monitor

IEEE 1073& IrDA AP

ECG Device

POCT Device

MDC Devices

Ventilator

IV Pump

POCT Device

10

73 C

able

d

1. Acute Care

POCT1 IR

POCt Device

ECG Cart

Other Dev.

Pocket PC

Palm PDA

PO

CT1 IR

2. General Clinic

IrDA AP

POCt Device

Other Dev.

POCT Device

Other Dev.

3. Remote Device using Modem

Terminal Server

modem modem

Analog Phone Linemodem modem

modem modem

modem modem

POC Dev w/ EDI5.

DMI

POC Data Mgr.

HIS

CIS

EDID

o

o

ConclusionsConclusions

11073 is the only comprehensive system of point-of-11073 is the only comprehensive system of point-of-care medical device communication standardscare medical device communication standards

11073 modality categories range from real-time-11073 modality categories range from real-time-operating medical equipment to point-of-care test operating medical equipment to point-of-care test devicesdevices

11073 supports wired, wireless IR (and hopefully future 11073 supports wired, wireless IR (and hopefully future wireless RF) network technologieswireless RF) network technologies

11073 provides plug-and-play, internetworking and 11073 provides plug-and-play, internetworking and application gateway capabilities application gateway capabilities

IfIf health care providers and management organisations health care providers and management organisations want point-of-care to record transparency of want point-of-care to record transparency of information, information, thenthen they must demand medical device they must demand medical device interoperability using 11073interoperability using 11073


ConclusionsConclusions

To meet continued user demand,11073 must deliver To meet continued user demand,11073 must deliver plug-and-play, internetworking and application gateway plug-and-play, internetworking and application gateway capabilities capabilities

Wherever possible use existing, commodity, standards Wherever possible use existing, commodity, standards as the basis for covering the range of requirements as the basis for covering the range of requirements

Use deliberate co-ordination of simultaneous Use deliberate co-ordination of simultaneous development, comment and ballot in all the development, comment and ballot in all the participating bodiesparticipating bodies

In addition to the core development bodies, the activity In addition to the core development bodies, the activity co-ordinates regularly with other health informatics co-ordinates regularly with other health informatics activities – notably HL7, DICOM, NCCLS and IHE activities – notably HL7, DICOM, NCCLS and IHE

Weekly conference calls, specific email lists and co-Weekly conference calls, specific email lists and co-location of meetings facilitate rapid consensus location of meetings facilitate rapid consensus formationformation


Contact detailsContact details

Thank you for your attentionThank you for your attention

Melvin ReynoldsMelvin ReynoldsAMS Consulting AMS Consulting Walford Road, Ross-on-Wye, HR9 5PQ, UKWalford Road, Ross-on-Wye, HR9 5PQ, UK

[email protected]@ams-consulting.co.uk

www.ieee1073.orgwww.ieee1073.org


Protocols, Networks and Standards for point-of-care device communication CEN/ISO/IEEE 11073...

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