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Point-of-care: all change

Protocols, Networks and Standards for point-of-care device communication CEN/ISO/IEEE 11073 Standards Med-e-Tel, Luxembourg, 23 April, 2004.

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Point-of-care: all change

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  1. Protocols, Networks and Standards for point-of-care device communicationCEN/ISO/IEEE 11073 Standards Med-e-Tel, Luxembourg, 23 April, 2004 Melvin Reynolds, AMS 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, Fraunhofer Institute for Integrated Circuits, Erlangen, DCo-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, USAChair IEEE1073 Medical device communications.

  2. Data Processing System / PDMS CEN/ISO/IEEE 11073 Standards Point-of-care: all change Fixed configuration, e.g. anaesthesia Syringe Pumps and Infusors Patient Monitor Respirator Additional Pump – but changing periodically, and evolving over time Additional Monitor

  3. CEN/ISO/IEEE 11073 Standards Point-of-care: all change Variable configuration, e.g. intensive care Data Processing System / PDMS Many Syringe Pumps and Infusors Respirator Patient Monitor - changing frequently and within minutes

  4. CEN/ISO/IEEE 11073 Standards 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

  5. CEN/ISO/IEEE 11073 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.

  6. CEN/ISO/IEEE 11073 Standards Development A history of co-operative and complementary working: Arrows indicate effective transfer of development and/or maintenance responsibility.

  7. CEN/ISO/IEEE 11073 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 802.11)

  8. CEN/ISO/IEEE 11073 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

  9. CEN/ISO/IEEE 11073 Standards Series title (National, e.g. BS) EN ISO/IEEE 11073-xyyzz Health informatics - Point-of-care medical device communication - x partition (general): yy subsection (group) - zz detail (specialised)

  10. Data & Information Definitions 11073.1xxxx 11073.2xxxx Application Profiles Transport & Physical Layers 11073.3xxxx Internetworking Support 11073.5xxxx Application Gateways 11073.6xxxx Related – some shared concepts 11073.9xxxx CEN/ISO/IEEE 11073 Standards Series structure

  11. CEN/ISO/IEEE 11073 Standards 11073-1xxxx content 11073.1xxxx Data & Information Definitions Semantics needed to communicate a device’sapplication data, status and control information. Three main components: • Nomenclature: 11073.10101 • Domain Information Model (DIM): 11073.10201 • Device Specialisations: 11073.103xx

  12. CEN/ISO/IEEE 11073 Standards 11073-1xxxx content Nomenclature: A set of numeric codes that identify every item that is communicated between systems.

  13. CEN/ISO/IEEE 11073 Standards 11073-1xxxx 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 . . . • Medical Devices and Functionalities • Measured Data and Settings • Alert Information • Remote Control • Patient Information • Communication

  14. CEN/ISO/IEEE 11073 Standards Domain Information Model

  15. ‘On-the-Wire’ Format Abstract Syntax (ASN.1) Transfer Syntax (MDER) CEN/ISO/IEEE 11073 Standards Development Process Domain Information Model

  16. CEN/ISO/IEEE 11073 Standards 11073-2xxxx content 11073.2xxxx Application Profiles 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!)

  17. CEN/ISO/IEEE 11073 Standards 11073-2xxxx content 11073.2xxxx Application Profiles 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

  18. CEN/ISO/IEEE 11073 Standards 11073-3xxxx content 11073.3xxxx Transport & Physical Layers Available (point-to-point) transport standards… • IrDA-Based Cable Connected (11073.30200) • IrDA-Based Infrared Wireless (11073.30300) Transport standards (LANs) under consideration… • RF Wireless – high emphasis on QoS! (TR 11073.00101) • IP-Based (Ethernet)

  19. CEN/ISO/IEEE 11073 Standards TR: Guidelines … RF wireless 11073.01010 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

  20. CEN/ISO/IEEE 11073 Standards TR: Guidelines … RF wireless 11073.01010 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

  21. CEN/ISO/IEEE 11073 Standards TR: Guidelines … RF wireless Use case topological overview Caution – work-in-progress; known omissions!

  22. CEN/ISO/IEEE 11073 Standards TR: Guidelines … RF wireless Trans-portable monitoring use case architecture Caution – work-in-progress; known omissions!

  23. 11073 11073 11073.3xxxx Infusion Pump Patient Monitor Agent Manager Ventilator Device Manager Pulse-Oximeter Device System Transport 11073 11073 11073.3xxxx 11073.3xxxx 11073.5xxxx Agent Manager Internetworking Device System Transport Transport CEN/ISO/IEEE 11073 Standards 11073-5xxxx content Internetworking Support 11073.5xxxx Examples: LAN Access Points, Wired-to-Wireless Transport Gateways

  24. CEN/ISO/IEEE 11073 Standards 11073-6xxxx content 11073.6xxxx Application Gateways Objectives: Interoperability between different application-layer protocols + Bi-directional transparency 11073 11073.3xxxx 11073.3 /.5xxxx System non-VITAL 11073.6xxxx Gateway Application (Agent/ Transport Transport Manager) Example: HL7 / 11073 Gateway: 11073.60101 HL7 - Observation Reporting Interface

  25. Related – NCCLS POCT-1A 11073.9xxxx CEN/ISO/IEEE 11073 Standards 11073-9xxxx content

  26. CEN/ISO/IEEE 11073 Standards 11073-90101 POCT-1A

  27. CEN/ISO/IEEE 11073 Standards 11073-90101 POCT-1A

  28. 1. Acute Care ECG Device POCT Device Monitor 1073 Cabled MDC Devices Ventilator IEEE 1073 & IrDA AP 5. POC Dev w/ EDI IV Pump POCT1 IR POCT Device IrDA AP 4. POC Dev w/ DMI modem modem modem modem Terminal Server Analog Phone Line modem modem modem modem CEN/ISO/IEEE 11073 Standards POC Devices co-existence DMI EDI D POC Data Mgr. HIS o 2. General Clinic POCt Device CIS ECG Cart o POCT1 IR Other Dev. Pocket PC Palm PDA 3. Remote Device using Modem POCt Device Other Dev. POCT Device Other Dev.

  29. CEN/ISO/IEEE 11073 Standards Conclusions • 11073 is the only comprehensive system of point-of-care medical device communication standards • 11073 modality categories range from real-time-operating medical equipment to point-of-care test devices • 11073 supports wired, wireless IR (and hopefully future wireless RF) network technologies • 11073 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 11073

  30. CEN/ISO/IEEE 11073 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 email lists and co-location of meetings facilitate rapid consensus formation

  31. CEN/ISO/IEEE 11073 Standards Contact details Thank you for your attention • Melvin ReynoldsAMS Consulting Walford Road, Ross-on-Wye, HR9 5PQ, UKmelvinr@ams-consulting.co.ukwww.ieee1073.org

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