Protocols, Networks and Standards for point-of-care device communication CEN/ISO/IEEE Standards Med-e-Tel, Luxembourg, 23 April, 2004 Melvin Reynolds, AMS Consulting, Ross-on-Wye, UK Melvin Reynolds, 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, Fraunhofer Institute for Integrated Circuits, Erlangen, D Thomas Norgall, Fraunhofer 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, Breakthrough Solutions, San Diego, USA Todd Cooper, Breakthrough Solutions, San Diego, USA Chair IEEE1073 Medical device communications.

Point-of-care: all change Fixed configuration, e.g. anaesthesia CEN/ISO/IEEE Standards – but changing periodically, and evolving over time Patient Monitor Respirator Syringe Pumps and Infusors Additional Pump Additional Monitor Data Processing System / PDMS

Point-of-care: all change Variable configuration, e.g. intensive care CEN/ISO/IEEE Standards Patient Monitor Respirator Many Syringe Pumps and Infusors Data Processing System / PDMS - changing frequently and within minutes

Interoperability Interoperability: ability of two or more systems or components to exchange information and to use the information that has been exchanged source: IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries, IEEE, 1990 Functional interoperability: Shared Architectures, Methods & Frameworks Semantic interoperability: Shared Data types, Terminologies, Codings CEN/ISO/IEEE Standards

Interoperability Point-of-care medical device communication (IEEE1073) Charter:  Provide real-time plug-and-play interoperability for patient-connected medical devices  Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-of-care, in all health care environments … Leveraging off-the-shelf technologies, scaling across a wide range of system complexities, and supporting commercially viable implementations. CEN/ISO/IEEE Standards

Development A history of co-operative and complementary working: Arrows indicate effective transfer of development and/or maintenance responsibility. CEN/ISO/IEEE Standards

Context Health informatics: Generally interpreted as being in ISO/OSI Level 7 Medical device communication: Works at all ISO/OSI Levels, Directly in ISO/OSI Levels 7 – 5 In Levels 1 – 4, chiefly by reference to other standards (such as IrDA or ) CEN/ISO/IEEE Standards

Architecture Requirements:  True interoperability across all 7-layers - from the ‘connector’ to the end application  Quality of Service mechanisms to support the strong requirements placed on regulated medical devices  Maintainability as communications technology and applications change CEN/ISO/IEEE Standards

Series title (National, e.g. BS) EN ISO/IEEE xyyzz Health informatics - Point-of-care medical device communication - x partition (general): x partition (general): yy subsection (group) - yy subsection (group) - zz detail (specialised) zz detail (specialised) CEN/ISO/IEEE Standards

Series structure CEN/ISO/IEEE Standards Data & Information Definitions xxxx Application Profiles xxxx Transport & Physical Layers xxxx Internetworking Support xxxx Related – some shared concepts xxxx Application Gateways xxxx

xxxx content Semantics needed to communicate a device’s application data, status and control information. Three main components:  Nomenclature:  Domain Information Model (DIM):  Device Specialisations: xx CEN/ISO/IEEE Standards Data & Information Definitions xxxx

xxxx content CEN/ISO/IEEE Standards Nomenclature: A set of numeric codes that identify every item that is communicated between systems.

xxxx content Domain Information Model: An object oriented data model that specifies objects, attributes, attribute groups, event reports, and services that may be used to communicate device data and to control / configure the reporting of information... CEN/ISO/IEEE Standards  Medical Devices and Functionalities  Measured Data and Settings  Alert Information  Remote Control  Patient Information  Communication

Domain Information Model CEN/ISO/IEEE Standards

Development Process CEN/ISO/IEEE Standards Domain Information Model Abstract Syntax (ASN.1) Transfer Syntax (MDER) ‘On-the-Wire’Format

xxxx content Application profile standards...  Provide specific sets of capabilities tailored for a class of communication needs / architectures  Limit the options that are available  Remaining options must be discovered and in some cases negotiated when a connection is made (enabling plug-and-play interoperability!) CEN/ISO/IEEE Standards Application Profiles xxxx

xxxx content Application profile standards...  Define a generic (non-device specific) set of data and services needed to initiate, configure, and maintain communication: Connect / Disconnect, Create / Delete, Get / Set, Event Report, Invoke, etc.  Specify the use of Standard Service Elements: ACSE, ROSE, CMISE, ASN.1, MDER (based on BER+), etc.  Provide optional packages, e.g for remote control  For XML & Web Services are under development CEN/ISO/IEEE Standards Application Profiles xxxx

xxxx content Available (point-to-point) transport standards…  IrDA-Based Cable Connected( )  IrDA-Based Infrared Wireless( ) Transport standards (LANs) under consideration…  RF Wireless – high emphasis on QoS! (TR )  IP-Based (Ethernet) CEN/ISO/IEEE Standards Transport & Physical Layers xxxx

TR: Guidelines … RF wireless Benefits of wireless communication…  No cable ‘spaghetti’ in conventional medical device use environments  Increased freedom available to users – healthcare professionals and patients alike  Expanded areas of use – community and global mobility CEN/ISO/IEEE Standards TR – Guidelines... RF wireless

TR: Guidelines … RF wireless Possible difficulties to be overcome…  High importance of data communicated  ‘Unknown’ communication capacity available  Security implications for different types of medical information remain difficult to determine – and standardise CEN/ISO/IEEE Standards TR – Guidelines... RF wireless

TR: Guidelines … RF wireless CEN/ISO/IEEE Standards Use case topological overview Caution – work-in-progress; known omissions!

TR: Guidelines … RF wireless CEN/ISO/IEEE Standards Caution – work-in-progress; known omissions! Trans-portable monitoring use case architecture

xxxx content CEN/ISO/IEEE Standards Internetworking Support xxxx Agent Device Manager System xxxx Transport Patient Monitor Device Manager Infusion Pump Ventilator Pulse-Oximeter Examples:LAN Access Points, Wired-to-Wireless Transport Gateways Agent Device Manager System xxxx Internetworking xxxx Transport xxxx Transport

xxxx content CEN/ISO/IEEE Standards Application Gateways xxxx Objectives: Interoperability between different application-layer protocols + Bi-directional transparency Bi-directional transparency Example: HL7 / Gateway: HL7 - Observation Reporting Interface HL7 - Observation Reporting Interface System (Agent/ Manager) non-VITAL Application xxxx Gateway xxxx Transport /.5xxxx Transport

xxxx content CEN/ISO/IEEE Standards Related – NCCLS POCT-1A xxxx

POCT-1A CEN/ISO/IEEE Standards

POCT-1A CEN/ISO/IEEE Standards

POC Devices co-existence CEN/ISO/IEEE Standards POC Dev w/ DMI 4. Monitor IEEE 1073 & IrDA AP ECG Device POCT Device MDC Devices Ventilator IV Pump POCT Device 1073 Cabled 1. Acute Care POCT1 IR POCt Device ECG Cart Other Dev. Pocket PC Palm PDA POCT1 IR 2. General Clinic IrDA AP POCt Device Other Dev. POCT Device Other Dev. 3. Remote Device using Modem Terminal Server modem Analog Phone Line modem POC Dev w/ EDI 5. DMI POC Data Mgr. HIS CIS EDI D o o

Conclusions  is the only comprehensive system of point-of-care medical device communication standards  modality categories range from real-time-operating medical equipment to point-of-care test devices  supports wired, wireless IR (and hopefully future wireless RF) network technologies  provides plug-and-play, internetworking and application gateway capabilities  If health care providers and management organisations want point-of-care to record transparency of information, then they must demand medical device interoperability using CEN/ISO/IEEE Standards

Conclusions  To meet continued user demand,11073 must deliver plug- and-play, internetworking and application gateway capabilities  Wherever possible use existing, commodity, standards as the basis for covering the range of requirements  Use deliberate co-ordination of simultaneous development, comment and ballot in all the participating bodies  In addition to the core development bodies, the activity co- ordinates regularly with other health informatics activities – notably HL7, DICOM, NCCLS and IHE  Weekly conference calls, specific lists and co- location of meetings facilitate rapid consensus formation CEN/ISO/IEEE Standards

Contact details Thank you for your attention  Melvin Reynolds AMS Consulting Walford Road, Ross-on-Wye, HR9 5PQ, UK CEN/ISO/IEEE Standards