1. Patient Care Devices HIMSS10 Webinar Series; October 22 2009

2. 2Agenda  PCD Domain Overview  Published Profiles: DEC, PIV, ACM, IDCO, RTM  New Profiles/White Papers: DPI, WCM, MEM  Considered for PCD Cycle 5  Showcase Demonstrations  Contacts  Q & A NOTE: Update to 2008, 2009 IHE PCD Webinar NOTE: Update to 2008, 2009 IHE PCD Webinar

3. 3 IHE Patient Care Devices (PCD) 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. The PCD coordinates with other IHE clinical specialty based domains such as medical imaging and lab to ensure consistency of medical device integration solutions across all IHE technical frameworks. NOTE: Formed in 2005 & sponsored by HIMSS & ACCE NOTE: Formed in 2005 & sponsored by HIMSS & ACCE

4. 4 PCD Domain Overview 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

5. 5 PCD - Published Profiles DEC Profile Device to Enterprise Communication Trial Implementation

6. 6 Device Enterprise Communication (DEC)

7. 7 (DEC-PIB) Patient ID Binding ITI-PAM ITI-PDQ Note: This is an option to DEC for coordinating authenticated patient IDs.

8. 8 SPD - Subscribe to Patient Data Note: This is an option to DEC for configuring PCD-01 content & frequency.

9. 9 SPD - Subscribe to Patient Data

10. 10RTM RTM Profile Rosetta Terminology Mapping Trial Implementation

11. 11 Rosetta for Semantic Interoperability

12. 12

13. 13 RTM Goals Expand Expand the number of numeric parameters supported by PCD-01 from 40 today to over 350 terms, providing a more comprehensive set for development and validation. Harmonize Harmonize the use of existing nomenclature terms defined by ISO/IEEE 11073-10101. Specifyunits-of-measureenumerated values Specify the units-of-measure, enumerated values and measurement sites associated with each parameter. Identify and add new nomenclature terms Identify and add new nomenclature terms that are currently missing from ISO/IEEE 11073- 10101. http://wiki.ihe.net/index.php?title=PCD_RTM_Ventilator NOTE: Respiratory / Ventilator terms are a major area. See http://wiki.ihe.net/index.php?title=PCD_RTM_Ventilator

14. 14ACM ACM Profile Alarm Communication Management Trial Implementation

15. 15 Alarm Communication Management (ACM) Alarm Communication Management enables systems to deliver the right alarms, with the right priority, to the right individuals via devices with the right content, escalating to other individuals via devices (based on system configuration) Alarm Communication Management enables systems to deliver the right alarms, with the right priority, to the right individuals via devices with the right content, escalating to other individuals via devices (based on system configuration) Trial Implementation

16. 16 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 !

17. 17 ACM Updates Fill Gap: Alarm Manager (AM) to Alarm Communicator (AC) Define alarm identifier codes (RTM for alarms) Extend implementation of actors & transactions Expand to additional IHE domains

18. 18PIV PIV Profile Point-of-Care Infusion Verification Trial Implementation

19. 19 Point-of-Care Infusion Verification supports the electronic transfer of infusion parameters from a Barcode Point of Care (BPOC) system, also known as a Bar Code Medication Administration (BCMA) system, to an infusion pump. PIV Statement

20. 20 PIV Workflow This is the focus of PIV … only!

21. 21 Actors PIV ActorsDEC!

22. 22IDCO IDCO Profile Implantable Device – Cardiac – Observation Trial Implementation

23. 23 Implantable Device – Cardiac – Observation Profile IDCO specifies the creation, transmission, and processing of discrete data elements and report attachments associated with implantable cardiac device interrogations (observations) or messages.IDCO specifies the creation, transmission, and processing of discrete data elements and report attachments associated with implantable cardiac device interrogations (observations) or messages.

24. 24 Implantable Cardiac Device Implantable Cardiac Device Leads for Sensing or Delivering Electrical Therapy

25. 25 IDCO Profile Context Device is interrogated via inductive or wireless telemetry in clinic or home environment using vendor proprietary equipment Information is transferred to clinic system as structured HL7 v2.6 ORU message using IEEE 11073 IDC nomenclature [PCD-09]

26. 26 IDCO Actors

27. 27 PCD – Emerging Profiles Emerging Profiles Implanted Cardiac Devices (IDCO) Implanted Cardiac Devices (IDCO) Waveform Communication Management (WCM) Waveform Communication Management (WCM) Medical Equipment Management (MEM) Medical Equipment Management (MEM) Real Time Location Tracking Real Time Location Tracking Device Point-of-Care Integration (DPI, a multiyear effort) Device Point-of-Care Integration (DPI, a multiyear effort) Real-time data archiving and communication Real-time data archiving and communication Mobile, enterprise-wide, reliable vital signs monitoring Mobile, enterprise-wide, reliable vital signs monitoring … many more! … many more!

28. 28DPI Device Point-of-Care Integration [DPI]

29. 29 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. IHE PCD Profile: DPI

30. 30 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

31. 31 PCD - MEM Medical Equipment Management [MEM] Imagine … What if I.T. & device vendors gave me EVERYTHING I ever wanted?! What if I.T. & device vendors gave me EVERYTHING I ever wanted?!

32. 32 MEM

33. 33 MEM Status 2009 – White Paper 2009 – White Paper Ongoing work Ongoing work –Cycle 5 Brief Profile Proposal Real Time Location TrackingReal Time Location Tracking –Location Boundary Alarms –Battery Management –Semantic Content Requirements

34. 34 PCD - WCM Waveform Communication Management [WCM]

35. 35WCM Waveform Communication Management will extend the [DEC] profile to provide a method for passing near real-time waveform data using HL7 v2 observation messages between a Reporter and a Consumer. A filter will be an optional elementA filter will be an optional element

36. 36WCM 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.

37. 37WCM A number of existing standards will be evaluated as references:A number of existing standards will be evaluated as references: –MFER (ISO 11973-92001) –FEF (ISO 14271) –FDA HL7 v3 Annotated ECG Guideline –DICOM Supplement 30 – Waveform Interchange –Previous HL7 v2 waveform spec (deprecated) Our scope is to create a profile which leverages existing IHE PCD Profiles and “principles” of using HL7 v2.x and IEEE 11073 nomenclature.Our scope is to create a profile which leverages existing IHE PCD Profiles and “principles” of using HL7 v2.x and IEEE 11073 nomenclature.

38. 38WCM Key requirements: Key requirements:  Leverage existing IHE PCD Profiles and “principles” of using HL7 v2.x and IEEE 11073 nomenclature.  Provide raw data and not bit-maps or pdf files Supports rendering at end clientSupports rendering at end client Supports further analysis at end clientSupports further analysis at end client  Support “snapshots”, data “streams” and retrospective “trend” data types  Minimize optionality Focus on simplicity and avoid complexityFocus on simplicity and avoid complexity

39. 39 PCD - Cycle 5 Under Consideration for the Next Cycle

40. 40 Proposed Work for Cycle 5 (out for ballot) Asynchronous Data Query Location Tracking Medical Equipment Management Query for Bulk Data Device to Patient Association Device Integration (specific devices) Device Integration - General Content Event Communication

41. 41 PCD - Testing Test Tooling Support VA’s Message Workbench NIST Tools

42. 42 PCD & SDO Coordination PCD coordination with SDOs… IHE - HL7 (MoU) IHE - HL7 (MoU) IHE - IEEE EMB (MoU) IHE - IEEE EMB (MoU) IHE – ISO TC215 (Liaison) IHE – ISO TC215 (Liaison) …

43. 43 PCD & HITSP (from HITSP TC Orientation 2009.02.17)

44. 44 PCD & Continua Health Alliance Continua & IHE established a Memorandum of Understanding (“MoU”) to “enable and promote interoperability of healthcare devices.” Continua & IHE established a Memorandum of Understanding (“MoU”) to “enable and promote interoperability of healthcare devices.” Provides for joint participation in Interoperability Showcases (e.g., @ HIMSS ’10) Provides for joint participation in Interoperability Showcases (e.g., @ HIMSS ’10) Coordination on HITSP RMON SDE#2 is laying the foundation for interoperability from bedroom to OR! Coordination on HITSP RMON SDE#2 is laying the foundation for interoperability from bedroom to OR!

45. 45 PCD & ASTM “ICE” / CIMIT MDPnP (From ICE-PAC Overview Update 2009.06.22 to IHE PCD) ICE-PCD Analysis Committee (ICE-PAC) ICE-PCD Analysis Committee (ICE-PAC) – JWG underway to perform a map & gap analysis between “ICE” use case analyses, ISO/IEEE 11073 standards & the IHE DPI WG.

46. 46 PCD & ICE-PAC JWG (From ICE-PAC Overview Update 2009.06.22 to IHE PCD)

47. 47 PCD - Showcase HIMSS Showcase Where we get to show off !!

48. 48 HIMSS Showcase ’09 - Products

49. 49 HIMSS Showcase ’09 - OR

50. 50 HIMSS Showcase ’09 - ICU

51. 51 HIMSS Showcase ’09 – Step Down Unit

52. 52 PCD @ HIMSS 2009

53. 53 HIMSS ’09 IHE Showcase Sponsors

54. 54 Why use IHE PCD profiles? Simplified standards-based integration of point-of-care device info & services Multi-vendor product integration testing @ Connectathons Visibility of products with care providers and peer technology organizations in Showcases Path to programs such as the U.S. National Health Information Network (NHIN) PCD profiles will enable…

55. 55 IHE PCD DEC: Simplified Specs

56. 56 For Further Information InternetInternet –Web:www.ihe.net/pcd www.accenet.org/ihe –Wiki:wiki.ihe.net/index.php?title=Patient_Care_Device PCD Co-ChairsPCD Co-Chairs –Ken FuchsPlanning Committeeken.fuchs@draeger.com –Steve Merritt Planning Committeesteve.merritt@bhs.org –Todd Cooper Technical Committeet.cooper@IEEE.org –John RhoadsTechnical Committeejohn.rhoads@Philips.com PCD Technical Project ManagerPCD Technical Project Manager –Manny Furstefurst@IEEE.org Sponsor RepresentativesSponsor Representatives –Jack HarringtonHIMSSjackh82@comcast.net –Elliot SloaneIHE Internationalebsloane@IEEE.org –Ray ZambutoACCERay.Zambuto@techmed.lincfs.com

57. 57