Integrating the Healthcare Enterprise- Patient Care Device Domain (IHE-PCD)

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

Context and History R. Gilbert Jost, MD Chairman, Mallinckrodt Institute of Radiology Board of Directors, Radiological Society of North America

1996 1997 1998 Andover Working Group Medical HL7 Enterprise Communication Framework Version 1.0

Discussion at 1996 RSNA annual meeting 1997 1998 Discussion at 1996 RSNA annual meeting Kees Smedema – Philips Bill Mortimore – Merge Jack Harrington – Hewlett-Packard

1996 1997 1998

1998 1999 2000

Process Problem Identification: Clinicians and IT experts identify common integration problems in access to information, clinical workflow, administration and underlying infrastructure. Integration Profile Specification: Stakeholders select standards that address each identified integration need. The technical specifications for implementing these standards are documented in the IHE Technical Framework. Implementation and Testing: Vendors implement these profiles and test their systems with software tools and at a face-to-face Connectathon, where they test interoperability with other vendors’ systems. Integration Statements and RFPs: Vendors publish IHE Integration Statements to document the integration profiles supported by their products. Users can reference integration profiles in requests for proposals, simplifying the systems acquisition process.

Philips/AWG Contribution to IHE Process

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

Static Message Profile

Profiles Simplify Implementation

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

IHE Patient Care Devices (PCD) HIMSS Survey IHE pre-2005 Annual Conference results: Survey of all IHE Users Over 50% of those surveyed said patient care devices should be the next area developed for IHE *

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 priority for clinical application is EHR or CIS integration followed by Improved Management and Decision Support

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.

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.

IHE-PCD Mission 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.

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

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

Product IHE Integration Statement IHE Process Product IHE Integration Statement IHE Connect-a-thon Results IHE Connect-a-thon Product With IHE IHE Demonstration Easy to Integrate Products IHE Technical Framework Standards IHE Integration Profiles B Profile A User Site RFP

Device Enterprise Communication (DEC) Profile - Year 1

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.

Measurement Context is Dynamic

IEEE 11073 Domain Information Model Defines Device Context

Mapping preserves measurement context

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

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

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

HIMSS Showcase Scenario Emergency Care Intensive Care Perioperative Care Philips Intellivue Clinical Information Portfolio LiveData OR-DashBoard GE Centricity® Periop Anesthesia Welch Allyn ConnexTM Data Management System GE Aware Gateway Philips Intellivue Information Center B. Braun DoseTracTM Infusion Management Software Draeger Innovian® Solution Suite Vital Signs Monitor Patient Monitor, Ventilator Patient Monitor, Ventilator Infusion Devices Patient Monitor, Anesthesia Sys

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

Device Enterprise Communication Profile – Year 2

Process for Year 2 2006 Survey Call for Short Proposals “Vetting” by Planning and Technical Committees Setting of Priorities

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)

Respondent Demographics 171 Individual Responses = Hospital Based

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

Vendor Demographics: Vendor Products 68 Vendor Responses

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

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

Importance of Interoperability to Hospital Based Respondents

Survey Question: With respect to Medical Devices, how important is it for the following devices to become integrated under the IHE? Percent of respondents that consider it important = Vendors = Users

Survey Question: Rate the importance to each department below in terms of the benefit from implementing IHE Percent of respondents that consider it important = Vendors = Users

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

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

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.

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

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

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

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.

To Learn More This Week – Visit the IHE PCD in the HIMSS Interoperability Showcase

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