1. Patient Care Devices IHE North America Webinar Series 2008 Todd Cooper Breakthrough Solutions Foundry, Inc. Ken Fuchs Draeger Medical Systems, Inc.

2. Agenda  PCD Domain Overview  Published Profiles: DEC, PIB & SPD  New Profiles: RTM, ACM, PIV  Emerging Profiles: MEM, PNP, …  Test Tooling  Showcase Demonstrations  ’08/’09 Schedule & Contacts  Q & A

3. PCD Domain Overview Established in 2005 when the “charter” was awarded to the ACCE Jointly sponsored by ACCE and HIMSS as of July 1, 2006 Technical Framework 2006-7 developed to communicate patient data (asynchronous) Successful demonstration at the 2007 & 2008 Connectathons and HIMSS Interoperability Showcases

4. PCD Domain Overview IHE PCD Charter regulated patient care device The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a regulated patient care device. The PCD coordinates with other IHE clinical specialty based domains such as medical imaging and laboratory.

5. PCD Domain Overview IHE PCD Mission Use Case driven The IHE Patient Care Devices Domain will apply the proven, Use Case driven IHE processes to: –Delivertechnical framework –Deliver the technical framework for the IHE-PCD domain profiles; –Validate Connectathons –Validate IHE-PCD profile implementations via Connectathons; and –Demonstrate public trade shows –Demonstrate marketable solutions at public trade shows.

6. PCD Domain Overview Heterogeneity – Coexistence in a multi- manufacturer / multi-modality world, leveraging shared infrastructure Semantic Interoperability – … from the sensor to the EHR Real-time Availability – Facilitating more timely clinical decisions PCD Profile Value Objectives:

7. Emerging IHE-PCD Workflows Key Objectives 2007/2008 Enterprise sharing of Patient Care Data Patient Identity Binding to Device Data Subscribe to Patient Data Key Objectives 2008/2009 Rosetta Stone Terminology Project PCD Alarm Communication Management Infusion Pump Integration - Drug Administration Key Objectives 2009 and beyond Point of Care Plug and Play (multiyear effort) Real-time data archiving and communication Medical Device Management Mobile, enterprise-wide, reliable vital signs monitoring … many more! Initial device classes… vital sign monitors, bedside monitors, infusion pumps and ventilators

8. PCD - Published Profiles DEC Profile Device to Enterprise Communication

9. Device Enterprise Communication (DEC) Profile - Year 1

10. DEC Profile Mapping Model ISO/IEEE 11073 Domain Information Model and Nomenclature mapped to HL7 (v2.5) Observation Report ISO/IEEE 11073 Data Types mapped to HL7 Data Types Mapping preserves measurement context for complex devices.

11. Measurement Context is Dynamic

12. IEEE 11073 Domain Information Model Defines Device Context 1 0.. n

13. Mapping preserves measurement context

14. Example PCD-01 Message MSH|^~\&|INFO_SRC_PHILIPS^ACDE48234567ABCD^EUI-64||||20061215153500||ORU^R01^ORU_R01|PMS116621490051| P|2.5|||NE|AL||8859/1 PID|||AB60001^^^Philips Medical^PI||Brooks^Albert^^^^^L||19610101|M PV1||I|UNIT_1^^Bed1 OBR|1|PMS116621490051^INFO_SRC_PHILIPS^ACDE48234567ABCD^EUI-64| PMS116621490051^INFO_SRC_PHILIPS^ACDE48234567ABCD^EUI-64| 69837^MDC_DEV_METER_PHYSIO_MULTI_PARAM_MDS^MDC|||20061215153500 OBX|1|ST|184326^MDC_ECG_STAT_ECT^MDC|1.5130.1.184326|""||||||F OBX|2|ST|184327^MDC_ECG_STAT_RHY^MDC|1.5130.1.184327|Sinus Rhythm||||||F OBX|3|NM|150456^MDC_PULS_OXIM_SAT_O2^MDC|1.5238.1.150456|99|262688^MDC_DIM_PERCENT^MDC|||||F OBX|4|NM|147842^MDC_ECG_HEART_RATE^MDC|1.5130.1.147842|81|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|5|NM|150037^MDC_PRESS_BLD_ART_ABP_SYS^MDC|1.5190.1.150036|126|266016^MDC_DIM_MMHG^MDC|||||F OBX|6|NM|150038^MDC_PRESS_BLD_ART_ABP_DIA^MDC|1.5190.1.150036|76|266016^MDC_DIM_MMHG^MDC|||||F OBX|7|NM|150039^MDC_PRESS_BLD_ART_ABP_MEAN^MDC|1.5190.1.150036|92|266016^MDC_DIM_MMHG^MDC|||||F OBX|8|NM|148065^MDC_ECG_V_P_C_CNT^MDC|1.5130.1.148065|0|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|9|NM|150045^MDC_PRESS_BLD_ART_PULM_SYS^MDC|1.5190.1.150044|26|266016^MDC_DIM_MMHG^MDC|||||F OBX|10|NM|150046^MDC_PRESS_BLD_ART_PULM_DIA^MDC|1.5190.1.150044|9|266016^MDC_DIM_MMHG^MDC|||||F OBX|11|NM|150047^MDC_PRESS_BLD_ART_PULM_MEAN^MDC|1.5190.1.150044|14|266016^MDC_DIM_MMHG^MDC|||||F OBX|12|NM|149538^MDC_PLETH_PULS_RATE^MDC|1.5238.1.149538|55|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|13|NM|150067^MDC_PRESS_BLD_ATR_LEFT_MEAN^MDC|1.5190.1.150064|4|266016^MDC_DIM_MMHG^MDC|||||F OBX|14|NM|150087^MDC_PRESS_BLD_VEN_CENT_MEAN^MDC|1.5190.1.150084|12|266016^MDC_DIM_MMHG^MDC|||||F

15. PCD - Published Profiles PIB Profile Patient Identity Binding

16. Patient ID Binding

17. Automates identity association / authentication process using standard ITI profiles. Option for the DEC Profile Async identity access using ITI-21 Patient Demographics Query (PDQ) Sync identity acquisition using ITI-30 Patient Admin Management / Patient Identity Feed (PAM) DEC-PIB profile…

18. PCD - Published Profiles SPD Profile Subscribe to Patient Data

19. Note: SPD is a DEC Profile option. DEC - Subscribe to Patient Data

21. PCD - New Profiles RTM Profile Rosetta Terminology Mapping

22. Rosetta for Semantic Interoperability

24. RTM Cardiovascular (multiple vendors) GroupREFERENCE_ID Vendor_ Description CODE Vendor A Vendor B Vendor C CVS_ECG_HRMDC_ECG_CARD_BEAT_RATEHeart Rate (DBR 326)16770HR CVS_ECG_HRMDC_ECG_CARD_BEAT_RATE_BTBBeat-to-Beat Rate16778btbHR CVS_ECG_HRMDC_ECG_HEART_RATEHeart Rate (DBR 2178)16770HR CVS_ECG_HRMDC_ECG_PACED_BEAT_RATE%PACED 16554%PACED CVS_ECG_HRMDC_ECG_TIME_PD_RR_GLR to R Interval 16168rr_time CVS_ECG_QTMDC_ECG_TIME_PD_QT_GLQT interval 16160QT CVS_ECG_QTMDC_ECG_TIME_PD_QTcQT interval (corrected)16164QTc CVS_ECG_RHYMDC_ECG_ARRHYArrhythmia 4410ARR CVS_ECG_RHYMDC_ECG_V_P_C_CNTPVC rate.16993PVC/min PVC CVS_ECG_STMDC_ECG_AMPL_STST generic label 768ST CVS_ECG_STMDC_ECG_AMPL_ST_AVFST lead aVF 832STaVF ST-AVF ST-aVF CVS_ECG_STMDC_ECG_AMPL_ST_AVLST lead aVL 831STaVL ST-AVL ST-aVL CVS_ECG_STMDC_ECG_AMPL_ST_AVRST lead aVR 830STaVRST-AVRST-aVR

25. RTM Goals for 2008-2009 ExpandExpand the number of numeric parameters supported by PCD-01 from 40 today to nearly 300, providing a more comprehensive set. HarmonizeHarmonize the use of existing nomenclature terms defined by ISO/IEEE 11073-10101. units-of-measureenumerated valuesSpecify the units-of-measure and enumerated values associated with each numeric parameter. Identify and add new nomenclature termsIdentify and add new nomenclature terms that are currently missing from ISO/IEEE 11073- 10101.

26. RTM Technical Steps 1.Create the Rosetta Terminology Mapping Table Current draft (1k) has over 930 rows submitted by six vendors. 2.Identify implementation differences and resolve. Resolve differences in interpretation. Pre- or post-coordinated measurement site location(s). 3.Identify missing terms and propose new terms to standards organizations. IHE PCD – need to add 40+ terms to ISO/IEEE 11073. Continua – need to add 100+ terms to ISO/IEEE 11073. 4.Generate final set of terms, units-of-measure and enumerations for testing. Working with NIST for HL7 test and validation tooling Wiki: http://wiki.ihe.net/index.php?title=PCD_Profile_Rosetta_Terminology_Mappinghttp://wiki.ihe.net/index.php?title=PCD_Profile_Rosetta_Terminology_Mapping

27. PCD - New Profiles ACM Profile Alarm Communication Management

28. ACM Statement 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)

29. 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 Alarm Query AQ (AQ) Alarm Query AQ (AQ) 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 Optional ACM Actors

30. AR – knows originating alarm, ultimately responsible for clearing it, knows how to get the alarm to the AM AM – a giant offloading engine, dumb or intelligent, dispatching, escalation, filtering, assignments, content harmonization, knows how to communicate with multiple, potentially proprietary, AC actors, may know end device distinctions, may gather RTLS samples at alarm time AC – data communication gateway to the endpoint device, understands how to communicate to end devices across things like Wi-Fi and WANs, knows device specific characteristics, and concepts like presence, read, read receipt, accept, cancel, etc. and how to communicate those back to the AM, might also know how to bridge to telephony and web based systems for things like callbacks and hyperlinks AQ – standalone optional subscriber and query source for gathering ad-hoc or long term information AR – knows originating alarm, ultimately responsible for clearing it, knows how to get the alarm to the AM AM – a giant offloading engine, dumb or intelligent, dispatching, escalation, filtering, assignments, content harmonization, knows how to communicate with multiple, potentially proprietary, AC actors, may know end device distinctions, may gather RTLS samples at alarm time AC – data communication gateway to the endpoint device, understands how to communicate to end devices across things like Wi-Fi and WANs, knows device specific characteristics, and concepts like presence, read, read receipt, accept, cancel, etc. and how to communicate those back to the AM, might also know how to bridge to telephony and web based systems for things like callbacks and hyperlinks AQ – standalone optional subscriber and query source for gathering ad-hoc or long term information What Actor does What?

31. AlarmCommunication(AC)AlarmCommunication(AC)AlarmManagement(AM)AlarmManagement(AM)AlarmReporter(AR)AlarmReporter(AR) AlarmQuery(AQ)AlarmQuery(AQ)  Alarm Status [ACM-02]* Disseminate Alarm [ACM-03]   Dissemination Status [ACM-04] Subscribe to Alarm Cache [ACM-06]*  Query for Alarm [ACM-07]*   Subscribe to Alarm [ACM-05]*  Report Alarm [ACM-01] Inputs Outputs Historical Capture and Reporting Historical Capture and Reporting Optional Report Alarm [ACM-01]  * Not planned for implementation in 2008/09 ACM Data Flows

32. PCD - New Profiles PIV Profile Point-of-Care Infusion Verification

33. 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

34. reduce errors increase caregiver productivity PIV will reduce errors by eliminating keystroke errors and by increasing the use of automatic dosage checking facilitated by onboard drug libraries. In addition to the reduction of medication administration errors, this integration may also increase caregiver productivity and provide more contextual information regarding infusion data. PIV Benefits

35. PIV as part of overall workflow…

36. PIV Actors

37. PCD - Emerging Profiles

38. PCD - Testing Test Tooling Support

39. Test Tooling Support - NIST NIST Test Tools –ICSGenerator Medical Device Profiles (specializations) Implementation Conformance Statements –ValidatePDU X73 Application Layer Message Syntax and Semantic Validation NIST Medical Device Standards Work –ISO/IEEE 11073 Standard (X73): Medical Device Communication XML SchemaXML Schema : NIST P11073-10202 Domain Information Model Collaborations –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… 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 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

40. What is NIST doing? Test Tools! Test ToolsICSGeneratorValidatePDU What is it?Implementation Conformance Statement Generator, Profile builder X73 Message validation: profile and standard Why?Easy to use interface Based on standard Promote Interoperability Who’s using it?Most major medial device manufacturers –IHE-PCD participants (pre-connectathon, connectathon, HIMSS) –PHD participants (smaller devices - Continua effort) A few small manufactures have expressed interest Countries participating: US, Europe, Japan, Korea, Canada How is it being used? As a requirement to standard (ICSs) Early stage interoperability Help produce more accurate standards documentation IHE-PCD profile validation Message validation Who are we working with? IHE-Patient Care Domain IEEE 11073 Personal Health Device WG IEEE 11073 WG

41. Test Tool Support – HL7 v2

42. Test Tool Support – R-T PnP

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

44. PCD @ HIMSS Showcase ‘08

45. HIMSS Showcase ’08 - Products

46. HIMSS Showcase ’08 – ER & OR

47. HIMSS Showcase ’08 – ICU

48. 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…

49. PCD 2008 Important Dates 2008.07.07 Public Comment Closes2008.07.07 Public Comment Closes PCD Webinar2008.07.08 PCD Webinar @ 11:00 Central 2008.07.22 ITI Webinars 2008.08.01 Trial Implementations Published 2008.09.30 Connectathon Reg. Due 2008.10.31 PCD Cycle 4 Proposals Due 2009.02.23-272009 Connectathon (Chicago) 2009.04.04-082009 HIMSS Showcase (Chicago)www.IHE.net/pcd

50. PCD Contacts PCD CoChairs: – Todd Cooper t.cooper@ieee.orgt.cooper@ieee.org – Ken Fuchsken.fuchs@draeger.comken.fuchs@draeger.com – Ray Zambuto ray.zambuto@techmed.lincfs.comray.zambuto@techmed.lincfs.com PCD Technical Project Manager: – Manny Furstefurst@imp-tech.comefurst@imp-tech.com IHE (International) Strategic Development Committee Co- Chair: – Elliot Sloaneebsloane@villanova.eduebsloane@villanova.edu