Protocols, Networks and Protocols, Networks and Standards for Standards for point-of-care device point-of-care device communication communication CEN/ISO/IEEE 11073 Standards CEN/ISO/IEEE 11073 Standards Med-e-Tel, Luxembourg, 23 April, 2004 Med-e-Tel, Luxembourg, 23 April, 2004 Melvin Reynolds, Melvin Reynolds, AMS Consulting, Ross-on-Wye, UK AMS Consulting, Ross-on-Wye, UK Chair 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, Fraunhofer Institute for Integrated Circuits, Erlangen, D 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, USA Breakthrough Solutions, San Diego, USA
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Protocols, Networks and Standards for point-of-care device communication CEN/ISO/IEEE 11073 Standards Med-e-Tel, Luxembourg, 23 April, 2004 Melvin Reynolds,
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Protocols, Networks and Protocols, Networks and Standards forStandards for
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
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
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.
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.
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)
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
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
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 . . .
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!
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
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 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
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