September, 2005What IHE Delivers Integrating the Healthcare Enterprise- Patient Care Device Domain (IHE-PCD) Authors : Jack Harrington, Ray Zambuto, Todd Cooper

1 Agenda Evolution of the IHE PCD Year 1 - Device Enterprise Communication Profile Year 2 – Survey and Proposed Profile Development

2 IHE Patient Care Device (PCD) – A New Domain

3 IHE Patient Care Device (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 *

4 IHE 2005 Summer Survey Results Highest 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 technology priority is Enterprise Wide Sharing Highest technology priority is Enterprise Wide Sharing Highest priority for clinical application is EHR or CIS integration followed by Improved Management and Decision Support

5 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 Device 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.2

6 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. 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.

7 IHE-PCD Mission The IHE Patient Care Device 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.

8 Agenda Evolution of the IHE PCD Year 1 - Device Enterprise Communication Profile Year 2 – Survey and Proposed Profile Development

9 IHE Patient Care Devices (PCD) One Patient – Many Devices

10 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

11 IHE PCD Technical Framework Volume1 Integration Profiles

12 IHE PCD Technical Framework Volume 2 Transactions

13 Device Enterprise Communication (DEC) Profile - Year 1

14 DEC Profile Mapping Model ISO/IEEE Domain Information Model and Nomenclature mapped to HL7 Observation Report ISO/IEEE Data Types mapped to HL7 Data Types Mapping preserves measurement context for complex devices.

15 Measurement Context is Dynamic

16 IEEE Domain Information Model Defines Device Context 1 0..n0..n

17 Mapping preserves measurement context

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

19 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

20 Connectathon 2007: 430 engineers, 80+ organizations, 160+ systems and applications

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22 HIMSS Showcase Scenario Welch Allyn Connex TM DataManagementSystem Vital Signs Monitor GEAwareGateway Patient Monitor, Ventilator PhilipsIntellivueInformationCenter Patient Monitor, Ventilator Emergency Care Intensive 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

23 Agenda Evolution of the IHE PCD Year 1 - Device Enterprise Communication Profile Year 2 – Survey and Proposed Profile Development

24 Device Enterprise Communication Profile – Year 2

25 Process for Year Survey Call for Short Proposals “Vetting” by Planning and Technical Committees Setting of Priorities

26 IHE-PCD Survey Summer-Fall 2006 Survey Managed by HIMSS Analytics Open Solicitation to HIMAA, ACCE, AdvaMed, Anesthesiologist Patient Safety Foundation, ECRI 171 Responses, (103 Users, 68 Vendors)

27 Respondent Demographics 171 Individual Responses = Hospital Based

28 Vendor Position on IHE and Interoperability 68 Vendor Responses (Checking all that apply)

29 Vendor Demographics: Vendor Products 68 Vendor Responses

30 Demographics: User Organization Types 77 Hospital Based Respondents* *26 of the 103 Non-Vendor Respondents do not work in hospitals

31 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

32 Importance of Interoperability to Hospital Based Respondents

33 Survey Question: With respect to Medical Devices, how important is it for the following devices to become integrated under the IHE? 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

34 Survey Question: Rate the importance to each department below in terms of the benefit from implementing IHE 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

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

36 Survey Question: Which technological areas are the most important for Patient Care Device integration? Survey Question: Which technological areas are the most important for Patient Care Device integration? = Users= Vendors

37 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.

38 Short Proposals Submitted for 2007 VersionAuthor/ Champion Profile File NameNo. Name Patient ID4.11 Ray Zambuto RealTimeClinicalDataManagementStorageAndRetrieval1.0 Jack Harrington CrossEnterpriseSharingofPatientCareDeviceData-Synchronous1.0 Jack Harrington IHE-ECG-Workflow1.0 Jack Harrington InfusionPumpIntegrationToBPOC1.0 Scott Zaffrin PoCRealTimePnPDeviceIntegration1.0 Todd Cooper SmallDataElementExchange1.1 Karen Witten, Beth Hurter HomeTelehealth1.1 Vern Williams, Jim McCain AlarmInteroperability1.0 Elliot Sloane, Tobey Clark PCAInfusionSafety1.0 Julian M. Goldman, MD PCD-02Query1.0 Paul Schluter

39 Short Proposals Vetting 2007 vs reconsideration in 2008 VersionAuthor/ Champion Profile File NameNo. Name Patient ID4.11Ray Zambuto RealTimeClinicalDataManagementStorageAndRetrieval1.0Jack Harrington CrossEnterpriseSharingofPatientCareDeviceData-Synchronous1.0Jack Harrington IHE-ECG-Workflow1.0Jack Harrington InfusionPumpIntegrationToBPOC1.0Scott Zaffrin PoCRealTimePnPDeviceIntegration1.0Todd Cooper SmallDataElementExchange1.1Karen Witten, Beth Hurter HomeTelehealth1.1Vern Williams, Jim McCain AlarmInteroperability1.0Elliot Sloane, Tobey Clark PCAInfusionSafety1.0Julian M. Goldman, MD PCD-02Query1.0Paul Schluter

40 Short Proposals Setting Priorities Polling Results of Planning Committee Three Proposals for 2007* Author/ Champion Profile File Name Name Patient ID Ray Zambuto PCD-02Query Paul Schluter PoCRealTimePnPDeviceIntegration Todd Cooper HomeTelehealth Vern Williams, Jim McCain SmallDataElementExchange Karen Witten, Beth Hurter PCAInfusionSafety Julian M. Goldman, MD * Based on resource limitations. Additional work can be added if author/champion demonstrates sufficient additional resources

41 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 Vendors and 8 systems/applications tested at Connectathon 2007 Process for developing Year 2 profiles is in progress.

42 Your Participation in IHE PCD is Encouraged PCD CoChairs:  Todd Cooper -  Jack Harrington -  Ray Zambuto - Other Contacts:  Manny Furst -  Elliott Sloane -

September, 2005What IHE Delivers