1. Interoperability Showcase IHE Domain Updates: Interoperability Showcase IHE Domain Updates: Patient Care Devices Co-Chairs: Todd CooperKen Fuchs Steve MerrittJohn Rhoads

2. Welcome and Overview Brief IHE Overview – big picture Domain overview - Mission/scope Profile overview New Profiles for 2010 Future Work – Roadmap Upcoming events & Resources Q & A & Wrap

3. IHE Overview IHE is… a global initiative started in 1997 that creates the framework for passing vital health information seamlessly – from application to application, system to system, and setting to setting – across multiple healthcare enterprises.

4. IHE Overview IHE is… led by volunteer members and sponsors representing diverse communities: – 300 organizational members worldwide on four continents and over 24 countries representing – Academic Medical professionals – Practicing Clinicians – Healthcare Administrators – Membership Organizations [ACP, HIMSS< RSNA etc] – HIT Vendors, Consultants – And more

5. IHE Overview IHE … hosts two major types of activities: – Conformance testing at Connectathons – Demonstrations at Interoperability Showcases

6. IHE Process Overview

7. 12 IHE Development Domains IHE Domains Anatomic Pathology Cardiology Eye Care IT Infrastructure Laboratory Mammography Nursing SC Patient Care Coordination (PCC) Patient Care Devices (PCD) Pharmacy Quality, Research & Public Health Radiology Radiation Oncology Future Domains may include: Dentistry Surgery …And more

8. 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 Connectathons and HIMSS Interoperability Showcases since 2007

9. PCD Domain Overview IHE PCD Charter The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a patient-centric point- of-care medical device that communicates with at least one other actor such as a medical device or information system. The PCD domain coordinates with and supports other domains, such as Radiology (medical imaging), Laboratory, and Cardiology to ensure consistency in use cases involving regulated medical devices as they occur throughout the Enterprise.

10. PCD Domain Overview Heterogeneity – Coexistence & interoperability in a multi- manufacturer / multi-modality world, leveraging shared infrastructure Semantic Interoperability – … from the sensor to the HER Reduce healthcare delivery cost by improving efficiency, reliability, and operational flexibility for healthcare providers Expand the international marketplace for patient care device vendors Enable innovative patient care capabilities Improve patient safety and clinical efficacy PCD Profile Value Objectives:

11. Device Enterprise Communication (DEC) Profile - Year 1 HL7 v2.6 ORU Message ISO/IEEE 11073 Semantics Preserves device “context”

12. Device Data Subscription & Filtering

13. Rosetta for Semantic Interoperability

14. IHE PCD Rosetta Terminology Management Vendor Terms RTM 1400 rows Harmonized Terms hRTM 440 terms ISO/IEEE 11073 Semantic Standards Vendor A Vendor B Vendor C HL7 V2 Messages HL7 V3 CDA/CCD 11073 PnP Comm Vendor Semantics IHE PCD Technical Framework Content Open consensus process Observation identifiers and co-constraints New terms incorporated into standards hRTM used for conformance testing

15. 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 Alarm Communication Management

16. Alarm Reporter Alarm Manager Alarm Communicator HL7 HL7 Messages per ACM and WCM profiles HL7 Messages per ACM and WCM profiles Alarm Archiver Waveforms and annotations as evidentiary data items Waveforms and annotations as evidentiary data items Device Specific graphics Device Specific graphics Profile defined data items Profile defined data items Historical Storage Alarm Information Source, Phase, State, Priority Patient Location Instance Alarm text Callback Timestamp Evidentiary data (WCM) Dissemination Status Instance Accepted by AC Undeliverable Delivered Read Accepted Rejected Cancelled Callback start/stop Alarm Source Communication Device HL7 ACM & Waveform Comm. Management (WCM)

17. Point-of-Care Infusion Verification (PIV)

18. Point-of-Care Infusion Verification - Actors

19. Implantable Device – Cardiac Observation (IDCO) Device is interrogated via inductive or wireless telemetry in clinic or home environment using vendor proprietary equipment Information is transferred to clinic system as structured HL7 v2.6 ORU message using IEEE 11073 IDC nomenclature [PCD-09]

20. Implantable Device – Cardiac Observation (IDCO)

21. Device Point-of-Care Integration Discovery and Association (PnP) Discovery and Association (PnP) Real-Time Data Reporting Real-Time Data Reporting Bi-Directional / Symmetric Bi-Directional / Symmetric External Control External Control Enterprise Integration Semantic Interoperability Monitored Parameters Alarms & Limits Waveforms (Real-Time) Control Parameters Semantic Interoperability Monitored Parameters Alarms & Limits Waveforms (Real-Time) Control Parameters Device Reporting, Management & Control Real-Time Clinical Decision Support Point-of-Care Applications Real-Time Closed / Open Loop Control DPI Manager / Enterprise Gateway

22. [Source: IEEE 11073- 00101, Figure 2] DEC Device Enterprise Communication DPI Device PoC Integration DPI Device PoC Integration DPI Device PoC Integration DPI Device PoC Integration DPI Device PoC Integration DPI Device PoC Integration DPI Device PoC Integration DPI & DEC Profile Scopes

23. Medical Equipment Management (MEM)

24. NIST - Test Tooling Support 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 Schema XML 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

25. NIST Test Tooling Support DIM XSchema Compare Devices HL7/OBX Mapping (XML) Device UML Diagram ISO/IEEE 11073 DIM Part 10201 Nomenclature Part 10101 ICSGenerator www.nist.gov/medicaldevices Now Developing Terminology Management Tools

26. PCD & SDO Coordination PCD coordination with SDOs… IHE - HL7 (MoU) IHE - HL7 (MoU) IHE - IEEE EMB (MoU) IHE - IEEE EMB (MoU) IHE – ISO TC215 (Liaison) IHE – ISO TC215 (Liaison) … … don’t reinvent the wheel or “base” standards!

27. PCD & ICE-PAC JWG (From ICE-PAC Overview Update 2009.06.22 to IHE PCD)

28. PCD & Continua Health Alliance Continua & IHE established a Memorandum of Understanding (“MoU”) to “enable and promote interoperability of healthcare devices.” Continua & IHE established a Memorandum of Understanding (“MoU”) to “enable and promote interoperability of healthcare devices.” See http://www.ihe.net/News/ihe-continua_mou_release_2008-10-28.cfm See http://www.ihe.net/News/ihe-continua_mou_release_2008-10-28.cfm Joint participation in 2010 IHE Showcase! Joint participation in 2010 IHE Showcase! Coordination on HITSP RMON SDE#2 is laying the foundation for interoperability from bedroom to OR! Coordination on HITSP RMON SDE#2 is laying the foundation for interoperability from bedroom to OR!

29. HIMSS ’09 IHE Showcase Sponsors

30. PCD & HITSP Support for ARRA / HITECH & Meaningful Use

31. Get involved Membership is free! To learn more, visit www.ihe.net/governance / www.ihe.net/governance / Visit the PCD “cube”! PCD Contact: Manny Furst (efurst@imp-tech.com)

32. Thanks for joining us! Find out more at ihe.net