Interoperability & QoS Implications of ISO TC215 WG2.1

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1 International Telecommunication Union Interoperability & QoS Implications of ISO TC215 WG2.1 Todd Cooper Chairman, IEEE 1073 Technical Director, MDCIG / IEEE-ISTO President, Breakthrough Solutions Workshop on Standardization in E-health Geneva, May 2003

2 Overview ISO TC215 Interoperability & QoS TC215 WG 2.1 X73 Standards QoS for Point-of-Care Medical Device Communication 2

3 ISO TC 215 Interoperability ITU-T o 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 o Functional interoperability Shared Architectures, Methods & Frameworks o Semantic interoperability Shared data types, terminologies, codings 3

4 o ISO TC 215 Interoperability WG 1: EHR architecture and modeling o WG 2: Messaging architecture & methods o WG 3: Terminology Methods o WG 4: Shared security architecture o WG 5: Shared health card framework 4

5 ISO TC 215 Interoperability o For Quality of Service : WG 1 - Health indicators conceptual framework WG 2 - Quality indicators for health information made available on the Internet 5

6 ISO TC215 Health Informatics ISO/OSI Level 7: Application o Focus is primarily on Level 7 Interoperability ISO/OSI Level 6: ISO/OSI Level 5: Presentation Session ISO/OSI Level 4: Transport o Medical Device Communications covers all 7 layers. ISO/OSI Level 3: ISO/OSI Level 2: Network Datalink ISO/OSI Level 1: Physical 6

7 ISO TC215 Health Informatics WG1: Models and Messages WG2: Terminology WG3: Security WG4: Technology for Interoperability CEN TC251 European National Standards Bodies International National Standards Bodies e.g USA (ANSI) HL7 ASTM IEEE MOU NCCLS DICOM WG1: Models ISO TC215 WG2: Messages and Communications WG3: Terminology "Pilot Process "Pilot Process Type A Liaison WG4: Security WG5: Cards 7

8 ISO/IEEE/CEN X73 Process Establish Work Plan for Standard (incl. resolution of all issues between IEEE, ISO, and CEN) Completed Published Standard Develop and Ballot Draft Using IEEE Process Draft passes IEEE ballot Ballot Approved IEEE Document Using ISO Process (DIS/FDIS) Draft passes ISO DIS/FDIS ballots Publish ISO/IEEE/CEN Standard Standard fails ISO DIS/FDIS ballot 8

9 ISO/IEEE Standards X73 Charter: Provide real-time plug-n-play interoperability for patient-connected medical devices Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-ofcare, in all health care environments leveraging off-the-shelf technologies, scaling across a wide range of system complexities, and supporting commercially viable implementations. 9

10 ISO/IEEE Standards Primary focus is on Point-of-Care (POC) Medical Device Communications ISO/IEEE Health informatics Point-of-care medical device communications - 10

11 ISO/IEEE Standards ITU-T X73 s architecture ensures True interoperability across all 7-layers: From the connector to the end application! QoS mechanisms designed to support the strong requirements placed on regulated medical devices Maintainability as communications technology and applications change 11

12 ISO/IEEE Standards x Device Data & Services x General Application Services x Transport & Physical Layers x Internetworking Support x Application Gateways 12

13 ISO/IEEE Standards ITU-T x Device Data & Services Medical Device Data Language (MDDL): Semantics needed to communicate a device s application status and control information. Consists of three main components: Nomenclature ( ) Domain Information Model (DIM) ( ) Device Specializations ( x) 13

14 ISO/IEEE Standards ITU-T Nomenclature: A set of numeric codes that identify every item that is communicated between systems. Codeblock Number (Hi-order 16 bits) 1 Object-Oriented (OO) 2 Supervisory Control and Data Acq n (SCADA) 3 Events 4 Dimensions (Units of Msmt) 5 Virtual Attributes 6 Parameter Groups 7 [Body] Sites 8 Infrastructure 256 External Nomenclature Ref's 1024 Private Context-sensitive parts Term Code (Lo-order 16 bits) Context-free code 14

15 ISO/IEEE Standards ITU-T 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. Does not imply a specific implementation technology Objects include Medical Device System, Virtual Medical Device, Numeric, Enumeration, Real-Time Sample Array, Battery, Scanners, Alert Monitor, 15

16 ISO/IEEE Standards ITU-T Domain Information Model Subject Areas Archival.9 Patient- Archive Session- Archive Top Patient.10 Patient Demographics System Extended Services MDS Scanner.7.5 Medical Communication Communication Controller Alert VMD.8 Alert Control.4 Channel Service+ Control.3 Metric.6 16

17 ISO/IEEE Standards ITU-T VMO MDS (from System) Session-Test (from Archival) 0..n VMD n Channel n Metric 0..n 0..n 0..n PM-Store 0..n 0..n 1 Numeric Sample Array Enumeration 1..n Complex Metric 0..n 0..n PM-Segment Time-SA Distribution-SA RealTime-SA 17

18 ISO/IEEE Standards x General Application Services Generalized application profile standards 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. Standard Services: ACSE, ROSE, CMISE, ASN.1, MDER (based on BER+), Etc. Beginning work on XML & Web Services profile 18

19 ISO/IEEE Standards Domain Information Model On-the-Wire Format Abstract Syntax (ASN.1) Transfer Syntax (MDER) 19

20 ISO/IEEE Standards Generalized application profile standards Profiles: Specific set of capabilities tailored for a class of communication needs / architectures Limits the options that are available Remaining options must be discovered and in some cases negotiated when a connection is made (enabling plug-n-play interoperability!) 20

21 ISO/IEEE Standards 21

22 x ISO/IEEE Standards Transport & Physical Layers 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! IP-Based (Ethernet) Key: Shared IT infrastructure with guaranteed QoS 22

23 x ISO/IEEE Standards Internetworking Support Infusion Pump Ventilator Pulse-Oximeter 1073 Agent Device x Transport 1073 Manager System Patient Monitor Device Manager 1073 Agent Device x Transport Internetworking x Transport 1073 Manager System Examples: LAN Access Points, Wired-to-Wireless Transport Gateways, 23

24 ISO/IEEE Standards x Application Gateways Objective: Interoperability between different application-layer protocols + Bi-Directional Transparency 1073 System (Agent/ Manager) x Transport Gateway (poss Internetworking) /.5 Transport non-vital Application Example: HL7 / IEEE Gateway: IEEE HL7 - Observation Reporting Interface! 24

25 ISO/IEEE Standards ITU-T 1073 System 1073 Network HL7/1073 Gateway HL7 Network HL7 System 1073 System HL7 System HL7-IEEE JWG Project Scope: Identification and definition of interfaces to support interoperability between HL7 and based systems for Point-Of-Care testing / monitoring use cases. 25

26 ISO/IEEE Standards o X73 Real-time plug-n-play interoperability across all 7-layers ISO/OSI Level 7: ISO/OSI Level 6: ISO/OSI Level 5: Application Presentation Session o From Device-to-device up to Device-to-EMR ISO/OSI Level 4: ISO/OSI Level 3: ISO/OSI Level 2: ISO/OSI Level 1: Transport Network Datalink Physical 26

27 ISO/IEEE Standards X73 includes QoS management support: Negotiated Bandwidth at association Start-up configuration minimizes network usage to that which is needed for client applications. Management Information Bases (MIBs) provide dynamic visibility to communications performance State models and confirmed delivery provide a high level of reliability for medical data transfer 27

28 ISO/IEEE Standards Drivers of X73 QoS: Regulated industry: Safe & Effective Clinical Use Cases for devices esp. real-time requirements: User needs & expectations! Transport and service profile technologies (LAN based vs. point-to-point) System wide topologies (local vs. wide area) Non-clinical stakeholders ( finance) 28

29 ISO/IEEE Standards Key X73 QoS considerations: Reliability FMEA, error detection & mitigation Latency from device detection to end annunciation for the data client Priority Not all medical device data has the same communications priority Bandwidth Allocation and dynamic management 29

30 ISO/IEEE Standards X73 Data Categorization: Alerts (both physiological & technical) Real-time Waveforms Real-time Parameters (Breath-to-breath) Non-RT Parameters (battery level, metric label) Non-RT Event (low battery) Controls History / Archival Web Browsing 30

31 Data Type Bandwidth Priority Reliability Latency ITU-T Alerts RT-Waves Lo (64B/Al.), Intermittent Hi (120 to 4KB/s/chan) Predictable Highest High Hi Hi 3 sec <RT> or CS=3 sec RT-Param s Lo-Med, Predictable High Hi 3 sec Non-RT Param s Lo (20B/p), Unpredict. High Hi --- Non-RT Events Lo-Med, Unpredict. Medium Hi PoC: 3 sec CS: 5 sec Controls Lo, Unpredict. Medium Hi PoC: 3 sec CS: 5 sec History / Archive Hi, Bursty, Unpredict. Low Med->Hi Push: >5 sec; Pull: < 5 sec Web Browsing Hi, Bursty, Unpredict. Low Med->Hi 3-5 sec 31

32 ISO/IEEE Standards ITU-T X73 QoS Issues: Latency: Prioritization support Shared Bandwidth management architecture (across multiple manufactures / devices) Reliability: Prioritization policies guaranteed B/W Network fault detection & Annunciation Graceful system performance degradation Co-existence Management (esp. RF wireless) 32

33 ISO/IEEE Standards And what about Remote Control: a virtual plug-n-play remote control network! Global access: Real-time vital signs viewing across the world (w/security, authentication, ) 33

34 ISO/IEEE Standards ITU-T Conclusions X73 are the only comprehensive point-of-care medical device communication standards on the horizon! Need additional pilot projects to show capabilities of X73 protocols Health care providers and management organizations must demand medical device interoperability using X73 We welcome support in adding security, web services, and rigorous LAN-based QoS support to our standards 34

ISO: Overview of TC215/WG2 activity in the telemedicine-related area

International Telecommunication Union ISO: Overview of TC215/WG2 activity in the telemedicine-related area Melvin Reynolds Senior Partner, AMS Consulting, UK Deputy Chair ISO/TC215/WG2, Vice Chair IEEE1073,