1. Patient Care Device Domain Overview

2. The Patient Care Device Domain PCD History 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 2007 & 2008 Connectathons and HIMSS Interoperability Showcases

3. IHE Patient Care Devices (PCD) IHE-PCD 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 and laboratory. 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 and laboratory.

4. Emerging IHE-PCD Workflows Key Objectives 2007/2008 Enterprise sharing of Patient Care Data Patient Identity Binding to Device Data Subscribe to Patient Data Key Objectives 2008/2009 Rosetta Stone Terminology Project PCD Alarm Communication Management Infusion Pump Integration - Drug Administration Key Objectives 2009 and beyond Point of Care Plug and Play (multiyear effort) Real-time data archiving and communication Medical Device Management Mobile, enterprise-wide, reliable vital signs monitoring … many more! Initial device classes… vital sign monitors, bedside monitors, infusion pumps and ventilators

5. Patient Care Device Key Values Heterogeneity – Coexistence in a multi- manufacturer / multi-modality world, leveraging shared infrastructure Semantic Interoperability – … from the sensor to the EHR Real-time Availability – Facilitating more timely clinical decisions PCD Profile Value Propositions:

6. HIMSS Showcase 08

7. HIMSS Showcase 08 - Products

8. HIMSS Showcase 08 – ER & OR

9. HIMSS Showcase 08 – ICU

10. Relevant Domains and Profiles IHE PCD profiles… DEC – Device-to-Enterprise Communication –Send data acquired from devices to enterprise applications using consistent syntax & semantics PIB – Patient ID Binding –Methods for binding an authenticated patient identity information with device data updates. SPD – Subscribe to Patient Data –Configure [DEC] data updates per desired information … avoid the Fire Hose effect!

11. Relevant Domains and Profiles IHE PCD profiles – new this cycle! RTM – Rosetta Terminology Map –Correlates comprehensive vendor-specific semantics with a standardized representation ACM – Alarm Communication Management –Profiles the semantics and protocols for communicating and managing device alarm events PIV – Point-of-Care Infusion Verification –Verify that the drug about to be delivered is for the right patient, right drug, right dose, right interval and right path.

12. Rosetta for Semantic Interoperability

14. Relevant Domains and Profiles IHE profiles also leveraged… CT – Consistent Time –Ensures system clocks and time stamps are well synchronized (median error < 1 second) PAM – Patient Administration –Provides a stream of patient demographics updates, ensuring continuity & integrity of patient data PDQ – Patient Demographics Query –Allows applications to query a central patient information server to retrieve demographic & visit information

15. Test Tooling Support - NIST 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 SchemaXML 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

16. IHE PCD Active Profiles & HITSP RMON = Potentially applicable to RMON U/C

17. IHE PCD & HITSP RMON

18. Device Device Intermediary (DI) EHR System Remote Monitoring Mgmt System (RMS) PHR System Health Info Exchange (HIE Interface #1 Interface #2 Interface #3 Interface #4 Interface #5 Interface #6 Interface #7 Actor #1 Actor #2 Actor #3Actor #4 Actor #5

19. PCD Contacts PCD CoChairs: – Todd Cooper t.cooper@ieee.orgt.cooper@ieee.org – Ken Fuchsken.fuchs@draeger.comken.fuchs@draeger.com – Ray Zambuto ray.zambuto@techmed.lincfs.comray.zambuto@techmed.lincfs.com PCD Technical Project Manager: – Manny Furstefurst@imp-tech.comefurst@imp-tech.com IHE (International) Strategic Development Committee Co- Chair: – Elliot Sloaneebsloane@villanova.eduebsloane@villanova.edu