protocols, networks and standards for point-of-care device communication cen/iso/ieee 11073...
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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
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– – 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
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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
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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.
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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.
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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)
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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
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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)
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Series structureSeries structure
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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
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Data & Information Definitions11073.1xxxx
11073-1xxxx content11073-1xxxx content
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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.
11073-1xxxx content11073-1xxxx content
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 . . .
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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
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Development ProcessDevelopment Process
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Domain Domain InformatioInformation Modeln Model
Abstract Abstract SyntaxSyntax(ASN.1)(ASN.1)
Transfer Transfer SyntaxSyntax(MDER)(MDER)
‘‘On-the-On-the-Wire’ Wire’
FormatFormat
11073-2xxxx content11073-2xxxx content
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!)
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Application Profiles11073.2xxxx
11073-2xxxx content11073-2xxxx content
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
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Application Profiles11073.2xxxx
11073-3xxxx content11073-3xxxx content
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)
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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
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TR – Guidelines ... RF wireless ...11073.01010
TR: Guidelines … RF TR: Guidelines … RF wirelesswireless
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
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TR – Guidelines ... RF wireless ...11073.01010
TR: Guidelines … RF TR: Guidelines … RF wirelesswireless
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Use case topological overview
Caution – work-in-
progress; known omissions!
TR: Guidelines … RF TR: Guidelines … RF wirelesswireless
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Caution – work-in-
progress; known omissions!
Trans-portable monitoring use case architecture
11073-5xxxx content11073-5xxxx content
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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
11073-6xxxx content11073-6xxxx content
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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
11073-9xxxx content11073-9xxxx content
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Related – NCCLS POCT-1A11073.9xxxx
POC Devices co-POC Devices co-existenceexistence
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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
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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
CEN/ISO/IEEE 11073 Standards CEN/ISO/IEEE 11073 Standards
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
CEN/ISO/IEEE 11073 Standards CEN/ISO/IEEE 11073 Standards