1. Patient Care Devices DPI White Paper Discussion (Updated: 2009.08.20)

2. 2 DPI White Paper Section Detail Discussion: Organization

3. 3 DPI WP Organization Major WP SectionsMajor WP Sections –Front Matter (Intro/Definitions/References) Include sections / point to Appendix E & F –Executive Summary –PoC Integration “Device Integration @ Point-of-Care” (vs. POC-T) –Use Context & Clinical Workflow –Stakeholder Benefits & Risks Assessment –Device Reporting –Plug-and-Play –Device Identification & Association –Symmetric / Bi-directional Communication

4. 4 DPI WP Organization Major WP Sections (cont’d)Major WP Sections (cont’d) –Configuration & Deployment –PCD TF DPI Roadmap –Appendix A: Use Cases / Clinical Scenarios –Appendix B: Support for U.S. ONCHIT/HITSP –Appendix C: Support for ASTM “ICE” –Appendix D: ISO/IEEE 11073 Examples –Appendix E: Glossary w/ Acronyms –Appendix F: Bibliography / References

5. 5 DPI White Paper Section Detail Discussion: Front Matter

6. 6Introduction General Front Matter….General Front Matter…. –Introduction Scope Goals Overview Audience Expected Knowledge and references Request for Feedback Open Issues and Questions –Definitions & Acronyms (ref. appendix) –References (ref. appendix)

7. 7Introduction IHE-PCD Charter The Patient Care Device Domain is concerned with use cases in which at least one actor is a patient-centric point- of-care medical device. …

8. 8 DPI: Scope – one actor is a regulated patient centric point-of-care medical device device-to-device communication Device Point-of-care Integration (DPI) is concerned with use cases that include care contexts that fall within the stated charter of the IHE PCD, namely where "at least one actor is a regulated patient centric point-of-care medical device," and that require device-to-device communication.Introduction

9. 9Introduction Device Point-of-Care Integration Discovery and Association (PnP) Discovery and Association (PnP) Real-Time Data Reporting Real-Time Data Reporting Bi-Directional / Symmetric Bi-Directional / Symmetric External Control External Control Enterprise Integration Semantic Interoperability Monitored Parameters Alarms & Limits Waveforms (Real-Time) Control Parameters Semantic Interoperability Monitored Parameters Alarms & Limits Waveforms (Real-Time) Control Parameters Device Reporting, Management & Control Real-Time Clinical Decision Support Point-of-Care Applications Real-Time Closed / Open Loop Control DPI Manager / Enterprise Gateway Include in the intro. Section w/ description (incl. “technical” interop w/ semantic)

10. 10Introduction Heterogeneity – … coexistence in a multi-vendor & multi-modality world, leveraging shared infrastructure Semantic Interoperability – … from the sensor to the EHR Real-time Availability – … facilitating more timely clinical decisions PCD Profile Primary Objectives: Ultimately providing improved – … safety, quality of care & workflow efficiency Reprise in the Intro section & Relate to DPI

11. 11 DPI White Paper Section Detail Discussion: Executive Summary

12. 12 Include the summary section Include the summary section Keep to 2 pages Keep to 2 pages Base summary on FINAL content of the document Base summary on FINAL content of the document Focus on … Focus on … Concise overview Compelling need for DPI Roadmap … Major Components / Issues:

13. 13 DPI White Paper Section Detail Discussion: Point-of-Care Integration

14. 14 Define: Point-of-Care! Define: Point-of-Care! PoC Architectural Alternatives PoC Architectural Alternatives … Major Components / Issues:

15. 15 HIMSS Showcase ’09 - Products DPI!

16. 16 Point-of-Care Integration NIST TOOL [Device] Intermediary Device.xml Device MDIB Agent Device Rosetta.xml HL7 D E C ACM PIV... DPI DPI [x73, incl. PHD] Legacy [incl. HL7v2x] Emulator [“test harness”] MDIB Mgr [Sym ] Transform er Interface (See next slide) Emulate.xml (From 2009.05 PCD F2F @ NIST / Wittenber)

17. 17 Point-of-Care Integration (From 2009.05 PCD F2F @ NIST / Wittenber)

18. 18 DPI White Paper Section Detail Discussion: Use Context & Clinical Workflow

19. 19 Summarize DPI use cases – point to Appendix A (where the details are kept) Summarize DPI use cases – point to Appendix A (where the details are kept) Include overview diag’s for contexts, topologies, data flow types, etc. Include overview diag’s for contexts, topologies, data flow types, etc. … Major Components / Issues:

20. 20 Use Context & Clinical Workflow

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24. 24 DPI White Paper Section Detail Discussion: Stakeholder Benefits & Risks Assessment

25. 25 Identify Stakeholders & DPI Value Propositions Identify Stakeholders & DPI Value Propositions MDMMDM Providers (clinical e.g., “workflow”, biomed, purch., HIT, …)Providers (clinical e.g., “workflow”, biomed, purch., HIT, …) Gov’t/RegulatoryGov’t/Regulatory Patient? (safety, quality of care, improved health care costs, …)Patient? (safety, quality of care, improved health care costs, …) Purchasers (GPOs – group purch. org’s)Purchasers (GPOs – group purch. org’s) Payers? (e.g., insurers & impact on risks)Payers? (e.g., insurers & impact on risks) Identify major business risks/blocks to DPI integration Identify major business risks/blocks to DPI integration Include Paul’s list…Include Paul’s list… Identify major technical risks Identify major technical risks DPI key technical problems to be resolved 80001-1 Key Properties (P/S, Effec., Data & system security) Look forward to Roadmap discussion (to address risks) Look forward to Roadmap discussion (to address risks) Major Components / Issues:

26. 26 Stakeholder Benefits & Risks Assessment Primary focus should be on stakeholder VPs / opportunities and the roadmap. Primary focus should be on stakeholder VPs / opportunities and the roadmap. … Major Components / Issues:

27. 27 DPI White Paper Section Detail Discussion: Device Reporting

28. 28 Describe & characterize requirements around basic device out-bound reporting Describe & characterize requirements around basic device out-bound reporting Motivate and detail the contents of the proposed DPI-DR profile … Motivate and detail the contents of the proposed DPI-DR profile … Major Components / Issues:

29. 29 DPI White Paper Section Detail Discussion: Device Identification & Association

30. 30 Device ID & Association Review PoC device / entity identification issues and requirements (incl. FDA/UDI) Review PoC device / entity identification issues and requirements (incl. FDA/UDI) Factor in need for discovery mechanisms & architectural approaches Factor in need for discovery mechanisms & architectural approaches Factor in the PCD profile proposal for ID management @ PoC (by infusion pump WG participants) Factor in the PCD profile proposal for ID management @ PoC (by infusion pump WG participants) Motivate & detail the contents of the proposed DPI-DnA (Discovery & Association) profile… Motivate & detail the contents of the proposed DPI-DnA (Discovery & Association) profile… … Major Components / Issues:

31. 31 DPI White Paper Section Detail Discussion: Plug-and-Play Connectivity

32. 32 Define PnP Define PnP Describe varilous “levels” of PnP (vs. pre-coordination) Describe varilous “levels” of PnP (vs. pre-coordination) … Major Components / Issues:

33. 33 DPI White Paper Section Detail Discussion: Symmetric / Bi-Directional Communication

34. 34 Symmetric/Bi-directional Comm. Detail scenarios & requirements behind devices not only reporting (-DR) but consuming information from other devices Detail scenarios & requirements behind devices not only reporting (-DR) but consuming information from other devices Incl. wireless / infusion pump U/C’s? Incl. wireless / infusion pump U/C’s? Address discovery & parameter “subscription” w/ QoS requirements Address discovery & parameter “subscription” w/ QoS requirements Indicate relationship to PCLC algorithms/ICE Indicate relationship to PCLC algorithms/ICE Motivate the DPI-SYM profile. Motivate the DPI-SYM profile. … Major Components / Issues:

35. 35 DPI White Paper Section Detail Discussion: Device Control

36. 36 Define types / categories of control Define types / categories of control Review X73 PnP external control model Review X73 PnP external control model Motivate the DPI-XDC profile Motivate the DPI-XDC profile Look forward to “ICE” requirements Look forward to “ICE” requirements … Major Components / Issues:

37. 37 Device Control

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39. 39 DPI White Paper Section Detail Discussion: Configuration & Deployment

40. 40 Detail device configuration semantic layer Detail device configuration semantic layer DPI Deployment architectures DPI Deployment architectures MEM – Remote Maintenance Support? MEM – Remote Maintenance Support? MEM – Device config mgmt support? MEM – Device config mgmt support? … Major Components / Issues:

41. 41 Test Tool Support – HL7 v2

42. 42 Test Tooling Support - NIST NIST Test ToolsNIST Test Tools –ICSGenerator Medical Device Profiles (specializations) Implementation Conformance Statements –ValidatePDU X73 Application Layer Message Syntax and Semantic Validation NIST Medical Device Standards WorkNIST Medical Device Standards Work –ISO/IEEE 11073 Standard (X73): Medical Device Communication XML SchemaXML Schema : NIST P11073-10202 Domain Information Model CollaborationsCollaborations –Integrating Health Enterprise - Patient Care Devices (IHE-PCD) –IEEE 11073 Personal Health Devices (PHD) Working Group (WG) –ISO/IEEE 11073 WG On-going Work and Future Direction…On-going Work and Future Direction… HL7 V2 & V3 –IHE-PCD profile and message generation and testing (includes enterprise – e.g., HL7 V2 & V3) Continua –PHD X73 profile and message testing (Continua) –X73 Java Class Library NIST Team MembersNIST Team Members –John Garguilo (john.garguilo@nist.gov 301-975-5248), Sandra Martinez, Maria Cherkaoui (guest researcher), and Richard Theimer (contractor)john.garguilo@nist.govhttp://www.nist.gov/medicaldevices

43. 43 DPI White Paper Section Detail Discussion: PCD TF & DPI Roadmap

44. 44 Show relationship of DPI profile components to the PCD TF Show relationship of DPI profile components to the PCD TF Establish a roadmap for phased development of DPI components Establish a roadmap for phased development of DPI components … Major Components / Issues:

45. 45 PCD TF & DPI Roadmap RTM RTM DEC DEC DEC-PIB (& ID binding management) DEC-PIB (& ID binding management) DEC-SPD DEC-SPD ACM ACM PIV / Infusion Pump Integration PIV / Infusion Pump Integration MEM MEM WCM … ? DPI & Existing enterprise-oriented profiles: Factor in Jan’s Table from New Directions + Annotate diagrams on subsequent slides

46. 46 PCD TF: DPI & Rosetta DPI Semantics are 100% in the “Gold” Semantic Database

47. 47 Device Enterprise Communication (DEC)

48. 48 (DEC-PIB) Patient ID Binding ITI-PAM ITI-PDQ Note: This is an option to DEC for coordinating authenticated patient IDs. No Significant Changes

49. 49 SPD - Subscribe to Patient Data Note: This is an option to DEC for configuring PCD-01 content & frequency. No Significant Changes

50. 50 SPD - Subscribe to Patient Data

51. 51 ACM Data Flows Alarm Source Alarm Aggregator Alarm Receiver Alarm Coordinator Alarm Disseminator Alarm Communication Alarm Endpoint Alarm Communication AC Alarm Communication AC Alarm Management AM Alarm Management AM Alarm Reporter AR Alarm Reporter AR Alarm Reporter Alarm Cache Communication detailed in ACM profile Communication not detailed in ACM profile........................ PCD Inputs (PM, NC, Resp, Pump, etc.) PCD Inputs (PM, NC, Resp, Pump, etc.) Output Devices (Marquee Sign, Pager, Wi-Fi Phone or Badge, etc.) Output Devices (Marquee Sign, Pager, Wi-Fi Phone or Badge, etc.) HIS, EMR Alarm Archiver AA Alarm Archiver AA Report Alarm   Alarm Status* *Note: Implementation TBD  Subscribe to Alarm * * * Disseminate Alarm   Dissemination Status *  Report Alarm Subscribe to Alarm *  Gap !

52. 52 Actors PIV ActorsDEC!

53. 53 MEM

54. 54WCM WCM will cover the following prioritized Use Cases: WCM will cover the following prioritized Use Cases: 1.Current Multi-Channel Waveform (MCW) snapshot as defined by the source is created/pushed by alarm source based on event occurrence 2.Current MCW snapshot as defined by source on request to source 3.Continuous MCW streams 4.MCW snapshot archive query 5.Periodic trend data on request It is not expected that all Use Cases will be covered during the first cycle. It is not expected that all Use Cases will be covered during the first cycle.

55. 55WCM In addition to defining the waveform representation scheme, attributes will need to be defined, including: In addition to defining the waveform representation scheme, attributes will need to be defined, including:  Sampling Rate  Range and Offset  Filtering  Display Attributes  Annotations (time points and time intervals)  Beat identification  Breath identification  Optional parametric data (e.g. HR, IBP, …)  Etc.  Status  Out-of-range  Leads Off  Zero  Artifact, Noise  Etc.  Etc…

56. 56 DPI White Paper Section Detail Discussion: General DPI Use Cases

57. 57 Appendix: General DPI Use Cases Detail the use cases / clinical scenarios identified in DPI proposals Detail the use cases / clinical scenarios identified in DPI proposals Format? Level of Detail? Format? Level of Detail? Include scenario diags from 2008/10 DPI F2F in Boston? Include scenario diags from 2008/10 DPI F2F in Boston? … Major Components / Issues:

58. 58 DPI White Paper Section Detail Discussion: Support for ONCHIT / HITSP

59. 59 PCD & HITSP (from HITSP TC Orientation 2009.02.17)

60. 60 Appendix: ONCHIT / HITSP Support Indicate DPI support for the NHIN & HITSP Deliverables (incl. CmDC) Indicate DPI support for the NHIN & HITSP Deliverables (incl. CmDC) Sync with proposed HITSP CmDC Technical Note Sync with proposed HITSP CmDC Technical Note Include diag’s from HITSP discussion earlier in 2009 Include diag’s from HITSP discussion earlier in 2009 … Major Components / Issues:

61. 61 DPI White Paper Section Detail Discussion: Support for ASTM “ICE”

62. 62 Appendix: “ICE” Support Show how DPI components can support ICE- based implementations / arch’s Show how DPI components can support ICE- based implementations / arch’s Include ICE-PAC analysis w.r.t. DPI Include ICE-PAC analysis w.r.t. DPI Note: See Rhoads draft appendix. Note: See Rhoads draft appendix. Start with ICE overview & ICE-PAC work review Start with ICE overview & ICE-PAC work review Include requirements for DPI + how this relates to the PCD TF roadmap (main section) Include requirements for DPI + how this relates to the PCD TF roadmap (main section) … Major Components / Issues:

63. 63 Appendix C: ICE Support (From ICE-PAC Overview Update 2009.06.22 to IHE PCD)

64. 64 DPI White Paper Section Detail Discussion: ISO/IEEE 11073 Messaging Examples

65. 65 Appendix: 11073 Examples Worked examples from the MDCIG Demo II effort Worked examples from the MDCIG Demo II effort Update per Infusion Pump models Update per Infusion Pump models “Examples” … not duplication of the Demo II document! “Examples” … not duplication of the Demo II document! Information ModelInformation Model Sequence / Interaction DiagsSequence / Interaction Diags Message ExamplesMessage Examples … Major Components / Issues:

66. 66 DPI White Paper General Issues: ….

67. 67