Interoperability Showcase IHE Domain Updates: Patient Care Devices

1. Interoperability Showcase IHE Domain Updates:Patient Care Devices Co-Chairs: Todd Cooper Ken Fuchs Steve Merritt John Rhoads

2. Welcome and Overview

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. IHE Domains 12 IHE Development Domains

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 ISO/IEEE 11073Semantic Standards VendorTerms RTM 1400 rows HarmonizedTerms hRTM 440 terms VendorSemantics IHE PCD Technical Framework Content HL7 V2 Messages Vendor A HL7 V3 CDA/CCD Vendor B 11073PnP Comm Vendor C • Open consensus process • Observation identifiers and co-constraints • New terms incorporated into standards • hRTM used for conformance testing

15. Alarm CommunicationManagement PCD Inputs (PM, NC, Resp, Pump, etc.) Output Devices (Marquee Sign, Pager, Wi-Fi Phone or Badge, etc.) Alarm Reporter (AR) Alarm Management (AM) Alarm Communication (AC) Alarm Source Alarm Aggregator Alarm Receiver Alarm Coordinator Alarm Disseminator Alarm Communication Alarm Endpoint Alarm Reporter . . . . . . Alarm Cache Optional Alarm Query (AQ) Communication detailed in ACM profile HIS, EMR Communication not detailed in ACM profile

16. ACM & Waveform Comm. Management (WCM) HL7 Messages per ACM and WCM profiles Device Specific graphics Waveforms and annotations as evidentiary data items Profile defined data items HL7 AlarmSource CommunicationDevice HL7 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 Historical Storage Alarm Manager Alarm Communicator Alarm Archiver Alarm Reporter

17. Point-of-Care Infusion Verification (PIV) Nurse Nurse Pharmacist reviews Pharmacist reviews Review Review order detail order detail (Pharmacy (Pharmacy System) System) MAR Entry eMAR Entry Physician reviews Physician reviews eMAR updated eMAR updated data and places data and places Orders Orders Nurse Confirms 5 Nurse Confirms 5 Rights: Rights: Right Patient, Right Patient, Medication, Medication, Medication Medication Medication Medication Nurse removes Nurse removes Dose, Time, Route Dose, Time, Route Dispensed Dispensed Administered Administered Medication Medication AT THE BEDSIDE AT THE BEDSIDE from Dispensing from Dispensing Unit or Med Room Unit or Med Room

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

22. Medical EquipmentManagement (MEM)

23. 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: 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… IHE-PCD profile and message generation and testing (includes enterprise – e.g., HL7 V2 & V3) 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) http://www.nist.gov/medicaldevices

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

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

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

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

28. HIMSS ’09 IHE Showcase Sponsors

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

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

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