1. ICEPAC Project Prospectus - Draft 2a Jan Wittenber ISO/IEEE 11073 Upper Layers Subcmte Chair November 13, 2008

2. 2 Developed for IHE PCD DPI “ICEPAC” working group Scope and purpose: To provide initial set of materials for discussion concerning technical content and project planning

3. 3 Topics  Technical content  Overview  Detail  Topology (Care areas, Modalities, Info)  Data flow  Risk-managed Sup’y Ctl & Data Acq’n (SCADA)  ICE perspective  Risk Mgmt perspective  Standards considerations  Architectural  “Roadmap” See Appendix A for Abbreviations

4. 4 Technical content – Modeling overview Supervisory Control and Data Acquisition (SCADA) perspective Topological perspective Risk Analysis cases ICE Use cases Devices (Medical, Network Infrastructure, User I/F) Care areas (Use contexts), e.g. ICU, PACU, OR Data Types Data Flows Control characteriz’n Risk/Safety considerations

5. 5 Detail – Topological perspective

6. 6 Detail – Info Vectors A B A) B)

7. 7 Detail – Data Flow (Left side, e.g. ICU)

8. 8 Detail – Data Flow (Right side, e.g. OR)

9. 9 Detail – ICE Use Cases Examples

10. 10 Detail – Risk Management (RM) perspective Example

11. 11 Topological perspective Topological perspective Detail – Risk managed Supervisory Control and Data Acquisition (SCADA) perspective Risk Managed SCADA

12. 12 Detail – Risk managed Supervisory Control and Data Acquisition (SCADA) perspective SCADA Risk Managed

13. 13 Detail – Risk managed SCADA – Xray-Resp Sync - Schema WHILE EXC_DATA_LOSS = TRUE {ALERT, INHIBIT ACTUATION} ACTUATE XRAY EXPOSURE WHEN END_INSPIRATION = TRUE

14. 14 Standards considerations - x73 data language – Service and Control subject Activate Operation ActuateXRayExposure; StartApneaCtlMode; etc. e.g. Limit Alert Operation Hi/Lo HR, RR, SpO2, etc. Set Value Operation InfRate, RespRate, Gain, etc. Select Item Operation Choice of SampleRate or Period, Gain, etc. Toggle Flag Operation ToggleAlarmsOnOff; TogglePauseResume; etc. e.g.:

15. 15 Standards considerations – x73 data language (“MDDL”) – overview See detail NomenclatureDIMMDIB in operating context

16. 16 Standards considerations – x73 data language impacts l Nomenclature adaptations needed l “Virtual Attributes” partition finalized, incl. l X73-10203 “Remote Control Package (RCoP)” l IHE PCD “Rosetta”, esp. Ventilator extensions l ICEPAC extensions l Control sequences imply need for rigorous control “language” to express safety criteria and [effective] performance l Is “C[++] acceptable? l Some specialized control language? l FSM-oriented? l OO abstractions (e.g. “Interlock”) may be needed

17. 17 Standards considerations – x73 architecture ICE Svc Elem Specializations Generalizations For standards modeling purposes, assume that there is an ICE “SE”. Combination of components: - Information objects (OO abstractions) - Nomenclature - Services - Protocols - Management (e.g. “system health test; conformance)

18. 18 Standards considerations – x73 : ICE : IHE relationships ICE Svc Elem Specializations Generalizations IHE PCD DPIIEEE 11073 ICE “SE” ? CAN ISO 11898-1

19. 19 Standards considerations – “Roadmap” relationships IHE PCD DPI+DECIEEE 11073ICE “SE” -Nomenclature -ApplProfiles -RCoP -Common Svcs -Conformance Tooling Rosetta (Rev 1) DPI (Rev 1) DPI PAC DPI IHE x73 ASTM ICE -Part 1 (Revn) ICE DEC PCD RTM PCD01 Rosetta (Rev 2) UL LL -InterLAN ASTM ICE -Parts1-n See Appendix A for Abbreviations

20. 20 Appendix A - Abbreviations ASN.1Abstract Syntax Notation One [of ISO] ASTMAmerican Society of Test and Measurement CENCommittee for European Normalization DECDevice-Enterprise Communication [of IHE PCD] DIMDomain Information Model [of x73] DPIDevice Point of care Integration [of IHE PCD] FSMFinite State Model [/Machine] HL7Health Level Seven ICEIntegrating the Clinical Environment (of ASTM) IECInternational Electrotechnical Commission IEEEInstitute of Electronics and Electrical Engineers IHEIntegrating the Healthcare Enterprise ISOInternational Standards Organization LLLower Layers [of x73] MDAPMedical Device Appl’n Profile [of x73] MDDLMedical Device Data Language [of x73] MDIBMedical Device Information Base [of x73] MD PnPMedical Device Plug and Play OOObject-Oriented OSIOpen Systems Interconnection [of OSI] PACPCD Analysis Committee [of IHE PCD DPI] PCAPatient Controlled Analgesia PCDPatient Care Devices [of IHE] PHDPersonal Health Devices [of x73] RARisk Analysis RCoPRemote Control Package [of X73] RMRisk Management RTMRosetta Terminology Mapping [of IHE PCD] SCADASupervisory Control and Data Acq’n [of x73] SEService Element ULUpper Layers [of x73] X73ISO/IEEE 11073 series

21. 21 Appendix B - References Health informatics - Point-of-care medical device communication - Part 10101: NomenclatureHealth informatics - Point-of-care medical device communication - Part 10101: Nomenclature $320.00 Health informatics - Interoperability of telehealth systems and networks - Part 1: Introduction and definitionsHealth informatics - Interoperability of telehealth systems and networks - Part 1: Introduction and definitions $92.00 ISO 11783-1:2007 Tractors and machinery for agriculture and forestry -- Serial control and communications data network -- Part 1: General standard for mobile data communication $189.00 ISO 11898-1:2003 Road vehicles - Controller area network (CAN) - Part 1: Data link layer and physical signalling $141