1. Authors : Jack Harrington, Ray Zambuto, Todd Cooper 20070227 Integrating the Healthcare Enterprise- Patient Care Device Domain (IHE-PCD)

2. Jack Harrington, Ray Zambuto, Todd Cooper 200702272 Agenda Evolution of the IHE PCD Year 1 - Device Enterprise Communication Profile Year 2 – Survey and Proposed Profile Development

3. Jack Harrington, Ray Zambuto, Todd Cooper 200702273

4. 4 Over 100 vendors involved world-wide, 5 Technical Frameworks 39 Integration Profiles, Testing at Connectathons Demonstrations at major conferences world-wide 16 Active national chapters on 4 continents

5. Jack Harrington, Ray Zambuto, Todd Cooper 200702275 IHE Patient Care Devices (PCD) HIMSS Survey IHE pre-2005 Annual Conference results: Survey of all IHE UsersSurvey of all IHE Users Over 50% of those surveyed said patient care devices should be the next area developed for IHE *Over 50% of those surveyed said patient care devices should be the next area developed for IHE *

6. Jack Harrington, Ray Zambuto, Todd Cooper 200702276 IHE 2005 Summer Survey Results Highest priority devices for integration are Vital Signs Monitors, Blood Gas Analyzers (POC), and Infusion PumpsHighest priority devices for integration are Vital Signs Monitors, Blood Gas Analyzers (POC), and Infusion Pumps Highest priority departments are ICU, Emergency, OR/Anesthesia, and Lab (POC)Highest priority departments are ICU, Emergency, OR/Anesthesia, and Lab (POC) Highest technology priority is Enterprise Wide SharingHighest technology priority is Enterprise Wide Sharing Highest priority for clinical application is EHR or CIS integration followed by Improved Management and Decision SupportHighest priority for clinical application is EHR or CIS integration followed by Improved Management and Decision Support

7. Jack Harrington, Ray Zambuto, Todd Cooper 200702277 IHE PCD Formed in September 2005 In September, 2005, the PCD gathered 60 vendors, purchasers, providers, and regulators in Washington D.C. for 2 days to explore the value propositions, explore the scope and mission of the domain, and begin the process of use case development. IHE Charter - 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. Current membership is 100+ and growing.

8. Jack Harrington, Ray Zambuto, Todd Cooper 200702278 IHE-PCD Domain Vision Statement The IHE Patient Care Device Domain (IHE PCD) is the nexus for vendors and providers to jointly define and demonstrate unambiguous interoperability specifications, called profiles, which are based on industry standards, and which can be brought to market.

9. Jack Harrington, Ray Zambuto, Todd Cooper 200702279 IHE-PCD Mission The IHE Patient Care Devices Domain will apply the proven, Use Case driven IHE processes to:The IHE Patient Care Devices Domain will apply the proven, Use Case driven IHE processes to: –Deliver the technical framework for the IHE-PCD domain profiles; –Validate IHE-PCD profile implementations via Connectathons; and –Demonstrate marketable solutions at public trade shows.

10. Jack Harrington, Ray Zambuto, Todd Cooper 2007022710 Agenda Evolution of the IHE PCD Year 1 - Device Enterprise Communication Profile Year 2 – Survey and Proposed Profile Development

11. Jack Harrington, Ray Zambuto, Todd Cooper 2007022711 IHE Patient Care Devices (PCD) One Patient – Many Devices

12. Jack Harrington, Ray Zambuto, Todd Cooper 2007022712 Profiles Simplify Implementation Single Standard – Constrain optionality, choose terminology, define dynamic interactions – HL7 Conformance Multiple Standards – Coordinate workflow, define mappings between standards -HL7/DICOM – IHE Radiology -HL7/IEEE 11073 – Patient Care Devices

13. Jack Harrington, Ray Zambuto, Todd Cooper 2007022713 Static Message Profile

14. Jack Harrington, Ray Zambuto, Todd Cooper 2007022714 Profiles Simplify Implementation

15. Jack Harrington, Ray Zambuto, Todd Cooper 2007022715 IHE Process IHE Integration Profiles B IHE Integration Profile A Easy to Integrate Products IHE Demonstration User Site RFP Standards IHE Technical Framework Product IHE Integration Statement IHE Connect-a-thon Product With IHE IHE Connect-a-thon Results

16. Jack Harrington, Ray Zambuto, Todd Cooper 2007022716

17. Jack Harrington, Ray Zambuto, Todd Cooper 2007022717

18. Jack Harrington, Ray Zambuto, Todd Cooper 2007022718 Device Enterprise Communication (DEC) Profile - Year 1

19. Jack Harrington, Ray Zambuto, Todd Cooper 2007022719 DEC Profile Mapping Model ISO/IEEE 11073 Domain Information Model and Nomenclature mapped to HL7 Observation Report ISO/IEEE 11073 Data Types mapped to HL7 Data Types Mapping preserves measurement context for complex devices.

20. Jack Harrington, Ray Zambuto, Todd Cooper 2007022720 Measurement Context is Dynamic

21. Jack Harrington, Ray Zambuto, Todd Cooper 2007022721 IEEE 11073 Domain Information Model Defines Device Context 1 0..n0..n

22. Jack Harrington, Ray Zambuto, Todd Cooper 2007022722 Mapping preserves measurement context

23. Jack Harrington, Ray Zambuto, Todd Cooper 2007022723 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

24. Jack Harrington, Ray Zambuto, Todd Cooper 2007022724 IHE PCD Connectathon Systems LiveData OR Mgr GE Centricity Periop CIS Philips CareVue CIS DOR DOC ADT A04 Feed MWB Draeger Innovian CIS GE Aware GW Philips IIC GW B. Braun DoseTrac GW Welch Allyn Connex CIS Validated VS, Vent, Anesth & Med Export, max every 3 minutes Validated Vitals export, Batch Unvalidated VS, Vent, Anesth. Data export every 1 minute VS Mon Pt Mon, Vent, Anesthesia Pt Mon, Vent, Anesthesia Pt Mon, Vent, Anesthesia Infusion Devices CT (Time) Feed Philips CareVue CIS Pt Mon, Vent, Anesthesia Validated VS, Vent, Anesth & Med Export, max every 5 minutes Unvalidated Med (Infusion System) exported every 1 minute

25. Jack Harrington, Ray Zambuto, Todd Cooper 2007022725 Connectathon 2007: 430 engineers, 80+ organizations, 160+ systems and applications

26. Jack Harrington, Ray Zambuto, Todd Cooper 2007022726

27. Jack Harrington, Ray Zambuto, Todd Cooper 2007022727 HIMSS Showcase Scenario Welch Allyn Connex TM DataManagementSystem Vital Signs Monitor GEAwareGateway Patient Monitor, Ventilator PhilipsIntellivueInformationCenter Patient Monitor, Ventilator Emergency CareIntensive Care LiveDataOR-DashBoardGE Centricity ® Periop Anesthesia Draeger Innovian ® Solution Suite Patient Monitor, Anesthesia Sys B. Braun DoseTrac TM InfusionManagementSoftware Infusion Devices Perioperative Care Philips Intellivue Clinical InformationPortfolio

28. Jack Harrington, Ray Zambuto, Todd Cooper 2007022728 Agenda Evolution of the IHE PCD Year 1 - Device Enterprise Communication Profile Year 2 – Survey and Proposed Profile Development

29. Jack Harrington, Ray Zambuto, Todd Cooper 2007022729 Device Enterprise Communication Profile – Year 2

30. Jack Harrington, Ray Zambuto, Todd Cooper 2007022730 Process for Year 2 2006 Survey Call for Short Proposals Vetting by Planning and Technical Committees Setting of Priorities

31. Jack Harrington, Ray Zambuto, Todd Cooper 2007022731 IHE-PCD Survey Summer-Fall 2006 Survey Managed by HIMSS Analytics Open Solicitation to HIMSS, ACCE, AdvaMed, Anesthesia Patient Safety Foundation, ECRI 171 Responses, (103 Users, 68 Vendors)

32. Jack Harrington, Ray Zambuto, Todd Cooper 2007022732 Respondent Demographics 171 Individual Responses = Hospital Based

33. Jack Harrington, Ray Zambuto, Todd Cooper 2007022733 Vendor Position on IHE and Interoperability 68 Vendor Responses (Checking all that apply)

34. Jack Harrington, Ray Zambuto, Todd Cooper 2007022734 Vendor Demographics: Vendor Products 68 Vendor Responses

35. Jack Harrington, Ray Zambuto, Todd Cooper 2007022735 Demographics: User Organization Types 77 Hospital Based Respondents* *26 of the 103 Non-Vendor Respondents do not work in hospitals

36. Jack Harrington, Ray Zambuto, Todd Cooper 2007022736 Relationship of Clinical Engineering and IT at Respondents Hospitals 77 Hospital Based Respondents* *26 of the 103 Non-Vendor Respondents do not work in hospitals

37. Jack Harrington, Ray Zambuto, Todd Cooper 2007022737 Importance of Interoperability to Hospital Based Respondents

38. Jack Harrington, Ray Zambuto, Todd Cooper 2007022738 Survey Question: With respect to Medical Devices, how important is it for the following devices to become integrated under the IHE? = Users= Vendors Percent of respondents that consider it important

39. Jack Harrington, Ray Zambuto, Todd Cooper 2007022739 Survey Question: Rate the importance to each department below in terms of the benefit from implementing IHE = Users= Vendors Percent of respondents that consider it important

40. Jack Harrington, Ray Zambuto, Todd Cooper 2007022740 Survey Question: Which clinical applications should IHE target? = Users= Vendors Percent of respondents that consider it important

41. Jack Harrington, Ray Zambuto, Todd Cooper 2007022741 Survey Question: Which technological areas are the most important for Patient Care Device integration? = Users= Vendors

42. Jack Harrington, Ray Zambuto, Todd Cooper 2007022742 IHE Profile Proposal (Short) Proposed Profile: Patient Identification Proposal Editor: Ray Zambuto Date: February 16, 2006 Version: 3 Domain: Patient Care Devices The Problem Manual entry of patient identification to Patient Care Devices is inefficient and subject to error. Patient Identification is perhaps the most essential component of any interoperability and communication process, particularly when PCD data is exported to the enterprise. It is the basis for communication and control of any medical device, data analysis, reporting and record keeping. Automation of the entry of patient identification to Patient Care Devices has the potential for reducing errors, and is an essential component of any effort to increase safety, device and drug effectiveness, and efficiency. Key Use Case 1) Setup of PCD. The caregiver connects the patient to a Patient Care Device. The patient is physically identified by some institutionally unique means of identification such as a wrist band barcode, RFID or other means which may or may not be solely considered as authoritative. The caregiver uses the information from the physical patient identification to obtain an authoritative electronic identifier which is associated with all data communicated from the PCD. The interaction may involve direct entry of the data to the device based on the physical identifier, a dialog between a PCD Manager and an authoritative source, and the use of more than one identifier. The end result is that data communicated from the PCD or PCD Manager contains an authoritative institutionally unique identifier. 2) Disconnect PCD. The caregiver removes the PCD causing the data from that device to no longer be communicated to the enterprise. Standards & Systems This profile is intended for identification of patients by patient monitors, infusion pumps, ventilators, point of care glucometers etc..> ISO/IEEE 11073, HL7, IHE-ITI Patient Administration, IHE-ITI PDQ Discussion Patient identification is a fundamental requirement for any electronic communication from or to a medical device. As such, the IHE with its broad scope, full range of stakeholders, and present or future involvement in the development of interoperability specifications for the vast number of types of medical devices and information technology is the ideal (and only) logical place for this universally needed specification.

43. Jack Harrington, Ray Zambuto, Todd Cooper 2007022743 Short Proposals Submitted for 2007 Profile Name Patient ID Cross-Enterprise Sharing of Patient Care Device Data Synchronous Real-Time Clinical Data Management Storage and Retrieval IHE-ECG-Workflow Infusion Pump Integration to Medication Administration Process PoC Real-Time PnP Device Integration Small Data Element Exchange HomeTelehealth Alarm Interoperability PCA Infusion Safety PCD-02 Query

44. Jack Harrington, Ray Zambuto, Todd Cooper 2007022744 Short Proposals Vetting 2007 vs reconsideration in 2008 Profile Name Patient ID Cross-Enterprise Sharing of Patient Care Device Data-Synchronous Real-Time Clinical Data Management Storage and Retrieval IHE-ECG-Workflow Infusion Pump Integration to Medication Administration Process PoC Real-Time PnP Device Integration Small Data Element Exchange Home Telehealth Alarm Interoperability PCA Infusion Safety PCD-02 Query

45. Jack Harrington, Ray Zambuto, Todd Cooper 2007022745 Short Proposals Setting Priorities Polling Results of Planning Committee Three Proposals for 2007* Profile Name Patient ID PCD-02 Query PoCRealTimePnPDeviceIntegration HomeTelehealth Small Data Element Exchange PCA Infusion Safety 1 2 3 * Based on resource limitations. Additional work can be added if author/champion demonstrates sufficient additional resources

46. Jack Harrington, Ray Zambuto, Todd Cooper 2007022746 Summary From its inception in September 2005 the IHE PCD has grown to 100+ members representing vendors, purchasers, providers, and regulatory agencies. The Device Enterprise Communication (DEC) Framework for Trial Implementation published in August 2006. 6 Vendors and 8 systems/applications tested at Connectathon 2007 Process for developing Year 2 profiles is in progress.

47. Jack Harrington, Ray Zambuto, Todd Cooper 2007022747 To Learn More This Week – Visit the IHE PCD in the HIMSS Interoperability Showcase

48. Jack Harrington, Ray Zambuto, Todd Cooper 2007022748 Your Participation in IHE PCD is Encouraged http://www.ihe.net/Technical_Framework/index.cfm PCD CoChairs: – Todd Cooper - t.cooper@ieee.orgt.cooper@ieee.org – Jack Harrington - jack.harrington@philips.comjack.harrington@philips.com – Ray Zambuto - rzambuto@techmed.comrzambuto@techmed.com Other Contacts: – Manny Furst - efurst@imp-tech.comefurst@imp-tech.com – Elliot Sloane - elliot.sloane@villanova.eduelliot.sloane@villanova.edu