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

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

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

4. 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 11073 Standards

5. 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 11073 Standards

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

7. 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) CEN/ISO/IEEE 11073 Standards

8. 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 11073 Standards

9. Series title (National, e.g. BS) EN ISO/IEEE 11073-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 11073 Standards

10. Series structure CEN/ISO/IEEE 11073 Standards Data & Information Definitions 11073.1xxxx Application Profiles11073.2xxxx Transport & Physical Layers 11073.3xxxx Internetworking Support 11073.5xxxx Related – some shared concepts 11073.9xxxx Application Gateways 11073.6xxxx

11. 11073-1xxxx content Semantics needed to communicate a device’s application data, status and control information. Three main components:  Nomenclature: 11073.10101  Domain Information Model (DIM): 11073.10201  Device Specialisations: 11073.103xx CEN/ISO/IEEE 11073 Standards Data & Information Definitions11073.1xxxx

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

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

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

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

16. 11073-2xxxx 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 11073 Standards Application Profiles 11073.2xxxx

17. 11073-2xxxx 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 11073 Standards Application Profiles11073.2xxxx

18. 11073-3xxxx content 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) CEN/ISO/IEEE 11073 Standards Transport & Physical Layers11073.3xxxx

19. 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 11073 Standards TR – Guidelines... RF wireless...11073.01010

20. 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 11073 Standards TR – Guidelines... RF wireless...11073.01010

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

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

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

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

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

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

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

28. POC Devices co-existence CEN/ISO/IEEE 11073 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

29. 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 CEN/ISO/IEEE 11073 Standards

30. 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 CEN/ISO/IEEE 11073 Standards

31. Contact details Thank you for your attention  Melvin Reynolds AMS Consulting Walford Road, Ross-on-Wye, HR9 5PQ, UK melvinr@ams-consulting.co.uk www.ieee1073.org CEN/ISO/IEEE 11073 Standards