1. Integrating the Healthcare Enterprise and the Patient Care Devices Domain Ken Fuchs Draeger Medical Systems, Inc. (Andover, MA) IHE Patient Care Devices Domain Co-Chair Ken.Fuchs@ieee.org NESCE October 9, 2008 © 2008 ACCE, HIMSS, IHE

2. 2 This presentation can be found as follows: Go to FTP Site: ftp://ftp.ihe.net/Patient_Care_Devices/Presentations / Look for: NESCE Presentation 2008-10-09

3. 3 Outline What is Interoperability? What is the IHE? What is the PCD? –What is the IHE PCD Process? –What are the IHE PCD Profiles? Why Should You Care about IHE? What Can You do? References and Contacts

4. 4 What is Interoperability?

5. 5 Current State of Affairs Proprietary protocols or variations on Standard protocols Hard to integrate with collaborating systems –difficult, expensive, and requiring continued monitoring Hard to integrate with competing vendors systems –difficult, expensive and requiring continuing negotiation for cooperation Hard to change from one vendor to another Requires careful selection, contracting, collaboration

6. 6 Interoperability The Goal - Interoperability: The ability of two or more systems or components to exchange and use the information exchanged –Accurately, securely, verifiably –When and where needed Adapted from HL7, www.hl7.orgwww.hl7.org –With minimal or no effort, Plug and Play

7. 7 What is IHE?

8. 8 Integrating the Healthcare Enterprise International The IHE An international umbrella organization sponsored by RSNA, HIMSS and others… Voluntary, non-profit, operating in public view –Largely manufacturers, users, regulators An initiative by healthcare professionals and industry to improve the way computer systems share information. Systems developed in accordance with IHE Profiles communicate with one another better, are easier to implement, and enable care providers to use information more effectively.

9. 9 What is IHE? What does IHE Do? In a nutshell: –IHE identifies Real-World Interoperability problems –Brings people together to design, test and demonstrate solutions using existing standards.

10. 10 IHE International

11. 11 What is the IHE? Value Propositions The IHE supports –Patient safety and reduced medical errors –Effective patient care with information when, where needed –Efficient organizations, less tedious and redundant work –Reduced cost Development is facilitated now, more in the future Complexity of interface deployment, management Regulatory compliance –Best of breed for the organization –National mandate for electronic medical records

12. 12 Standards: Necessary…Not Sufficient Generally Standards are: –Foundational - to interoperability and communications –Broad - varying interpretations and implementations –Narrow - may not consider relationships between standards domains –Plentiful - often redundant or disjointed –Focused - standards implementation guides typically focus on a single standard IHE provides a defined process for implementing standards

13. 13 IHE: Connecting Standards to Care Coordinate implementation of standards to meet clinical and administrative needs –Clinicians and HIT professionals identify the key interoperability problems they face –Providers and industry work together to develop and make available standards-based solutions –Implementers are able to follow common guidelines in purchasing and integrating effective systems SDOIHE is not an SDO, but does provide feedback IHE: A forum for defining needs, implementing standards and processes for making it happen

14. 14 International Adoption of IHE FranceUSAGermanyItalyJapanUKCanadaKoreaTaiwan Norway HollandSpainChina Year 1 (1999) Year 2 (2000) Year 3 (2001) Year 4 (2002) Year 5 (2003) Year 6 (2004) Year 7 (2005) Year 8 (2006)

15. 15 IHE Domains Radiology (18) IT Infrastructure for Healthcare (17) Cardiology (7) Laboratory (6) Radiation Oncology (1) Patient Care Coordination (5) Patient Care Devices (1) Quality Eye Care (3) Veterinary Endoscopy Pathology Pharmacy Year 1 (1999) Year 2 (2000) Year 3 (2001) Year 4 (2002) Year 5 (2003) Year 6 (2004) Year 7 (2005) Year 8 (2006) Year 9 (2007) Over 100 vendors involved world-wide Over 100 vendors involved world-wide 8 Technical Frameworks 8 Technical Frameworks 48 Integration Profiles 48 Integration Profiles Testing at Connectathons world-wideTesting at Connectathons world-wide Demonstrations at major conferences world-wide Demonstrations at major conferences world-wide

16. 16 Two Foundational Domains IT Infrastructure Domain –Common foundational profiles ADT – including patient identity CT – consistent time Document transactions Security Patient Care Coordination Domain –Coordination between specific domains

17. 17 What are Profiles? A profile describes the application of a standard(s) to provide specific requirements to accomplish the communication requirements. –Provides an opportunity for users & vendors to define requirements Requirements for development With Conformance Statements, for purchase Examples –HL7/DICOM – IHE Radiology –HL7/IEEE 11073 – Patient Care Devices

18. 18 What is the Process? Define needs Set priorities Develop profiles with use cases Recruit volunteers for each profile to be developed Develop the technical solutions Demonstrate successful implementation –Connectathons –Showcases Publish for public access, comment at various stages

19. 19 IHE – One Year Cycle Q2Q3Q4Q1 Survey & Propose Use Cases (Profiles) Develop Use Cases Prioritize Use Cases Document Technical Profiles Develop Product SW Bench Test Software Connectathon(s) Public Demonstration(s)

20. 20 What is PCD?

21. 21 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.

22. 22 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

23. 23 PCD Participation in IHE

24. 24 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.

25. 25 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:

26. 26 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 and patient monitors, infusion pumps, ventilators and anesthesia systems

27. 27 Process Process Survey Brief Profile Proposals Vetting by Planning and Technical Committees Setting priorities Development of Technical Framework Supplements Design of new profiles Virtual testing Face-to-Face testing at Connectathon Demonstration at HIMSS

28. 28 IHE-PCD Surveys 2005 and 2006 Surveys To set priorities, direction Survey Managed by HIMSS Analytics Open Solicitation to HIMSS, ACCE, AdvaMed, Anesthesia Patient Safety Foundation, ECRI membership 171 Responses, (103 Users, 68 Vendors) Please return and review at leisure

29. 29 IHE Patient Care Devices (PCD) HIMSS Survey IHE pre-2005 Annual Conference results: Further, 56% said theyd pay more for IHE-compliant products!Further, 56% said theyd pay more for IHE-compliant products! Survey of all IHE Users Over 50% of those surveyed said patient care devices should be the next area developed for IHE *

30. 30 2006 Survey Question: How important is it for the following devices to become integrated under IHE? = Users= Vendors Percent of respondents that consider it important

31. 31 2006 - Survey Question: Which clinical applications should IHE target? = Users= Vendors Percent of respondents that consider it important

32. 32 Brief Profile Proposal Description of the Problem Key Use Case(s) (example of how the proposed solution will work) –Describe a short use case scenario from the user perspective. The use case should demonstrate the integration/workflow problem. Standards and Systems Available Discussion

33. 33 Development of Technical Document Brief Profile Proposal Evaluation of Feasibility Prioritization of Feasible Profiles Detailed Profile Proposal A Technical Committee Working Group Develops Detail Public Review and Modification Publication as Trial Implementation Version

34. 34 Implementation and Testing Vendors Volunteer to Test the Trial Implementation Version and Prototype Systems at a Connectathon TI Versions May be Modified Vendors With Successful Systems –May demonstrate at a Showcase –Can claim conformance after two or three tests

35. 35 IHE Connectathon 2008 – Hyatt Chicago

36. 36 PCD Profiles

37. 37 PCD - Published Profiles DEC Profile Device to Enterprise Communication

38. 38 DEC Profiles PCD DEC profiles support the communication of patient clinical data from devices. This data can include: –Vital Signs (profile available) –Alarm information (2008/2009 profile) –Waveform information (future profile) –Etc.

39. 39 DEC - Subscribe to Patient Data

40. 40 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.

41. 41 IEEE 11073 Domain Information Model Defines Device Context 1 0.. n

42. 42 Mapping preserves measurement context

43. 43 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

44. 44 PCD - Published Profiles PIB Profile Patient Identity Binding

45. 45 Patient ID Binding

46. 46 Patient ID Binding 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…

47. 47 PCD - New Profiles 08/09 RTM Profile Rosetta Terminology Mapping

48. 48 Rosetta for Semantic Interoperability

49. 49 Rosetta for Semantic Interoperability

50. 50 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

51. 51 PCD - New Profiles 08/09 ACM Profile Alarm Communication Management

52. 52 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)

53. 53 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

54. 54 PCD - New Profiles 08/09 PIV Profile Point-of-Care Infusion Verification

55. 55 PIV Statement 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.

56. 56 PIV Benefits 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.

57. 57 PIV as part of overall workflow…

58. 58 PIV Actors

59. 59 PCD – In the Works For the coming year, PCD is currently in the process of evaluating a number of Brief Profile Proposals: –WCM – Waveform Comm. Management –DPI – Device Point-of-Care Integration –MEM – Medical Equipment Mgmnt –Extensions to DEC ACM PIV etc.

60. 60 PCD - Showcase HIMSS Showcase Where we get to show off !!

61. 61 Block Diagram of IHE PCD HIMSS Showcase 2008 GE Aware Gateway Patient Monitor, Ventilator Intensive Care Philips Intellivue Clinical InformationPortfolio Draeger Innovian ® Solution Suite Capsule Philips Intellivue InformationCenter Patient Monitor Emergency CarePerioperative Care LiveData OR – DashBoard TM GE Centricity ® Periop Anesthesia Epic Epic InPatient Enterprise PDQ/PAM Server Time Server Spacelabs Intesys Clinical Suite Patient Monitor Welch Allyn Connex TM Data Mgmt System Vital Signs Monitor DORDOR DOCDOC B. Braun DoseTrac TM Infusion Mgmt SW Infusion Devices Draeger Infinity Gateway Patient Monitor, Anesthesia Sys

62. 62 PCD @ HIMSS Showcase 08

63. 63 HIMSS Showcase 08 – ER & OR

64. 64 HIMSS Showcase 08 – ICU

65. 65 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…

66. 66 Year 3 Implementation Companies registered for the 2009 Connectathon and HIMSS Showcase –B Braun, Cardinal, Hospira IV pumps with DEC, PIV –Draeger, GE, Philips, Capsule - monitors, ventilators, anesthesia systems, with DEC –Capsule, Cardinal, LiveData, Philips, Draeger - with ACM, DEC Above as of Oct. 1

67. 67 Why Should You Care?

68. 68 Why Should You Care? Significance for Users/Purchasers You Job (CE and IT) –CE and IT must collaborate on selection, specification, installation, maintenance and support of these systems –New knowledge and skills are required

69. 69 Why Should You Care? Significance for Users/Purchasers Clinical implications –Patient safety –Enterprise wide access to the patients data –Quality of care –Ability to implement best of breed –Workflow improvements Financial implications –Rapid changes in technology increase risk –Interoperability reduces risk –Interoperability improves efficiency

70. 70 What Can You Do?

71. 71 What Can You Do? Plan, Evaluate, Purchase Conforming Devices In continuing discussions with vendors – at all levels –Push IHE, Interoperability Refer to lower deployment, maintenance costs –Encourage vendors active IHE participation Lower development, installation, support costs –Refer to profiles Leverage public and objective commitments In RFPs –Refer to profiles, Conformance Statements –Use Conformance Statements to nail down vendors representations –Adopt very specific language Raise the Bar!!

72. 72 What Can You Do? Participate The Planning Committee (PC): Set member based priorities Conduct Surveys Develop Use Cases Manage Connectathon, Showcase The Technical Committee (TC): Determine technical feasibility Research standards Develop Technical Framework Establish conformance tests

73. 73 What Can You Do? To Help Define the Future Become a member of a Domains Planning or Technical Committees –Help establish priorities – what the domain will work on –Help define profiles – clinical, IT requirements –Provide the business case to encourage developments Provide Public Comments on Technical Framework Supplements Attend Demonstrations, Educational Events and Workshops To join or ask questions send me an email: ken.fuchs@ieee.org

74. 74 References Parisot, Charles. What IHE Delivers for Vendors, Purchasers, Users and Patients. IHE Interoperability Workshop Sept. 2004. http://www.ihe.net/Participation/upload/2_What%20IHE%20Delivers_final.ppt#319,1,Int egrating the Healthcare Enterprise Gauvin, Alain. How to Purchase IHE Functionality. IHE Canada Workshop 2006. http://www.ihe-canada.com/Events/2006/06SepGauvin2.pdf http://www.ihe-canada.com/Events/2006/06SepGauvin2.pdf Haramati, Nogah and Goodhew, Beth. Purchasing IHE Functionality. IHE Canada Workshop 2006. http://www.ihe-canada.com/Events/2006/06SepHaramati-Goodhew.pdf http://www.ihe-canada.com/Events/2006/06SepHaramati-Goodhew.pdf Bak, Peter. Achieving Interoperability Across Canada. IHE Workshop, June 2006. http://www.ihe.net/Events/upload/IHE%20Workshop%20June%202006%20Bak%20Info way%20v2.ppt#724,1,Slide 1 Braithwaite, William. IT at the Core of Healthcare Transformation. Proceedings, HIMSS 2007.

75. 75 References PCD Resources http://www.ihe.net/ http://www.ihe.net/pcd http://www.ihe.net/Technical_Framework/index.cfm#pcd http://wiki.ihe.net/index.php?search=PCD+Proposals+2009- 2010http://wiki.ihe.net/index.php?search=PCD+Proposals+2009- 2010 ftp://ftp.ihe.net/Patient_Care_Devices/Presentations ftp://ftp.ihe.net/Patient_Care_Devices/

76. 76 Resources This presentation can be found as follows: Go to FTP Site: ftp://ftp.ihe.net/Patient_Care_Devices/Presentations / Look for: NESCE Presentation 2008-10-09

77. 77 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 Strategic Development Committee Co-Chair: – Elliot Sloaneebsloane@villanova.eduebsloane@villanova.edu

78. 78 Thank You for Your Attention !!