1. www.ihe.net Integrating the Healthcare Enterprise International Free Educational Webinar Series 2011 Learn More: www.ihe.net/events/webinars2011.cfm

2. www.ihe.net Planning Committee Ken Fuchs / Steve Merritt Technical Committee John Garguilo / John Rhoads Patient Care Device Domain Update (PCD)

3. www.ihe.net PCD Domain Webinar Agenda Domain & Committee Overview Domain Profiles & Technical Frameworks – Overview Profiles developed – New Profiles developed in 2010-2011 year How to Participate? – IHE International Membership – Planning & Technical Committees Q&A Session 3

4. www.ihe.net Domain & Committee Overview

5. www.ihe.net On the Road to Interoperability: From Standards to Profiles Profile Development Base Standards eHealth Projects IHTSDO IETF Specific Extensions

6. www.ihe.net Role of IHE PCD IHE PCD was formed in 2005 to address issues related to integration of Point-of-Care medical devices: – With each other – With enterprise systems IHE PCD wants to “raise the bar” from the current state of integration projects to out of the box interoperable solutions. IHE PCD’s co-sponsors are HIMSS, ACCE and AAMI.

7. www.ihe.net The Patient Care Device Domain is concerned with use cases in which at least one actor is a patient-centric point-of-care medical device. The PCD coordinates with other IHE clinical specialty based domains such as medical imaging and lab to ensure consistency of medical device integration solutions across all IHE technical frameworks. IHE PCD Charter

8. www.ihe.net IHE Profiles Drafted & Revised 6-13 mos. ImplementationPosted Install Interoperable products in Clinical Settings worldwide Demonstrate at a IHE Improves, Safety, Quality and Efficiency in Clinical Settings. 14-18 mos. Publish in IHE’s Product Registry Test at IHE Connectathons Published For Public Comment IHE Technical Framework Developed IHE Call for Proposals Opens Profile Selection by Committees 1-5 mos. IHE Development Process

9. www.ihe.net 2011-2012 Cycle IHE Profile Cycle Stages Participation Status Open DateClose DateLearn More Call for Proposal CompletedJuly 2010September 2010 Examples of Brief Proposals: ftp://ftp.ihe.net/Patient_Care_Devices/IH EPCDyr5-2009-2011/Cycle_5_Proposals/ ftp://ftp.ihe.net/Patient_Care_Devices/IH EPCDyr5-2009-2011/Cycle_5_Proposals/ Profile Selection CompletedOctober 2010 November 2010 Examples of Detailed Proposals: ftp://ftp.ihe.net/Patient_Care_Devices/IH EPCDyr5-2009-2011/Cycle_5_Proposals/ IHE Profiles drafted in IHE Committees CompletedFebruary 20101 May 2011 Public Comment 1 CompletedMay 2011June 2011 IHE.net- Documents now in PC IHE’s Wiki- PC Process explained Trial Implementation Published CompletedJuly 2011 ftp://ftp.ihe.net/Patient_Care_Devices/Te chnicalFrameworkforTrialImplementation/ IHE N.A. Connectathon Registration OpenAugust 22, 2011 September 30, 2011 www.iheusa.org/connectathon_part icipant.aspx IHE N.A. Connectathon Dates January 9- 14, 2012 www.iheusa.org/connectathon_part icipant.aspx IHE Connectathon European Dates May 21-25, 2012 www.ihe-europe.net

10. www.ihe.net 2012-2013 Cycle IHE Profile Cycle Stages Participation Status Open DateClose DateLearn More Call for Proposal OpenJuly 20, 2011Sept 5, 2011 Examples of Brief Proposals: ftp://ftp.ihe.net/Patient_Care_Devices/IHEPC Dyr5-2009-2011/Cycle_5_Proposals/ ftp://ftp.ihe.net/Patient_Care_Devices/IHEPC Dyr5-2009-2011/Cycle_5_Proposals/ Profile Selection ClosedOctober 2011 December 2011 Examples of Detailed Proposals: ftp://ftp.ihe.net/Patient_Care_Devices/IHEPC Dyr5-2009-2011/Cycle_5_Proposals/ IHE Profiles drafted in IHE Committees ClosedFebruary 2012 May 2012 Public Comment 1 OpenJune 2012 IHE.net- Documents now in PC IHE’s Wiki- PC Process explained Trial Implementation Published OpenN/AAugust 2012 ftp://ftp.ihe.net/Patient_Care_Devi ces/TechnicalFrameworkforTrialImpl ementation/ IHE N.A. Connectathon Registration OpenAugust 2012September 2012 IHE N.A. Connectathon Dates OpenJanuary 2013 IHE Connectathon European Dates OpenSpring 2013

11. www.ihe.net Domain Profiles Developed

12. www.ihe.net CPOE/ Pharmacy System Future PCD Current PCD Infusion Pump Barcode Medication Administration System Other Devices Equipment Management System Future Non- PCD Clinical Decision Support System Implantable Device IDCO ACM, DEC, WCM, ADQ, PCIM ACM, MEM ACM: Alarm Communication Management ADQ: Asychronous Device Query DEC: Device Enterprise Communication IDCO: Implantable Device – Cardiac – Observation MEM: Medical Equipment Management PCIM: Point-of-Care Identity Management PIV: Point-of-Care Infusion Verification WCM: Waveform Communication Management Home Based System Ventilation/ Anesthesia System EMR/EHR CIS Physiologic Monitoring System DEC ACM, DEC ACM, DEC, WCM PIV IHE PCD - Profiles EMR/EHR ACM, DEC, WCM, ADQ, PCIM ACM, DEC, WCM, ADQ

13. www.ihe.net Completed Workitems: Completed Workitems:  Rosetta Terminology Management (RTM)  Enterprise sharing of Patient Care Data (DEC)  PCD Alarm Communication Management (ACM)  Point-of-care Infusion Verification (PIV) Implantable Device – Cardiac Observation (IDCO) Waveform Content Message (WCM) Work in Process: Work in Process:  Event Communication (EVT)  Point-of-Care Identity Management (PCIM)  Device Point-of-care Integration (DPI)  Medical Equipment Management (MEM) + Location Services + Cyber Security Management IHE PCD - Profiles

14. www.ihe.net [RTM] Rosetta Terminology Mgmnt.

15. www.ihe.net [DEC] Device to Enterprise Communication

16. www.ihe.net [WCM] Waveform Content Message

17. www.ihe.net [ACM] Alarm Communication Management HL7 Messages per ACM and WCM profiles HL7 Messages per ACM and WCM profiles Parameters, waveforms, etc. as evidentiary data items Parameters, waveforms, etc. as evidentiary data items Device Specific graphics Device Specific graphics Alarm Information Source, Phase, State, Priority PatientLocationInstance Alarm text CallbackTimestamp Evidentiary data Dissemination Status Instance Accepted by AC UndeliverableDeliveredReadAcceptedRejectedCancelled Callback start/stop Alarm Communicator AC Alarm Communicator AC Alarm Manager AM Alarm Manager AMAlarmReporterARAlarmReporterAR Report Alarm PCD-04 → ← PCD-05 Report Alarm Status Disseminate Alarm PCD-06 → ← PCD-07 Disseminate Alarm Status Alarm Source

18. www.ihe.net [PIV] Point of Care Infusion Verification

19. www.ihe.net [IDCO] Implantable Device – Cardiac Observ.

20. www.ihe.net Domain Profiles Under Development

21. www.ihe.net [PCIM] Point-of-Care Identity Management

22. www.ihe.net [ADQ] Asynchronous Data Query Supports retrospective query of PCD data from databases. Supports Use Cases such as Clinical Decision Support, back-filling of EMR databases, etc. EMR, CDSS, CIS, Etc. Data Query PCD-12 Data Response PCD-13 Data Query PCD-12 Data Response PCD-13 Data Requesters Data Servers Full Disclosure Data Server and/or Data Requester Data Query PCD-12 Data Response PCD-13

23. www.ihe.net [MEM] Medical Equipment Management

24. www.ihe.net [MEM] Location Services

25. www.ihe.net [MEM] Medical Device Security & Mgmnt. HIPAA HITECH FDA: 21 CFR 801, 803, 807, 812, 814, 820 MDDS IEC 80001 IHE PCD MDS 2 Medical Device Medical Device Access Control Access Control Privacy CE/IT Manage ment Security Configuration Management Asset Discovery Cyber Protection Network Access Control Lifecycle Mgmt. Encryption ePHI Breach Risk Key Management Authenti- cation

26. www.ihe.net [MEM] Medical Device Security & Mgmnt.

27. www.ihe.net Profiles & Technical Frameworks IHE Technical Frameworks – Introductory information on the various Patient Care Device Technical Frameworks, Profiles, White Papers and User Guides can be found at: http://wiki.ihe.net/index.php?title=Profiles#IHE_Patient_Care_Device_Profiles http://wiki.ihe.net/index.php?title=Profiles#IHE_Patient_Care_Device_Profiles – Links to the Patient Care Device Technical Framework documents can be found on IHE.NET at: http://www.ihe.net/Technical_Framework/index.cfm#pcd http://www.ihe.net/Technical_Framework/index.cfm#pcd Learn More – Previous versions of the IHE PCD Webinar for the IHE Educational Webinar Series can be found at: 2010 Webinar Series- http://www.ihe.net/Events/webinars2010.cfm http://www.ihe.net/Events/webinars2010.cfm 2009 Webinar Series- http://www.ihe.net/Events/webinars2009.cfm http://www.ihe.net/Events/webinars2009.cfm 2008 Webinar Series- http://www.ihe.net/Events/webinars2008.cfm http://www.ihe.net/Events/webinars2008.cfm Handouts or other helpful materials/links Overview

28. www.ihe.net IHE Profiles Drafted & Revised 6-13 mos. ImplementationPosted Install Interoperable products in Clinical Settings worldwide Demonstrate at a IHE Improves, Safety, Quality and Efficiency in Clinical Settings. 14-18 mos. Publish in IHE’s Product Registry Test at IHE Connectathons Published For Public Comment IHE Technical Framework Developed IHE Call for Proposals Opens Profile Selection by Committees 1-5 mos. IHE Development Process

29. www.ihe.net NIST Testing Tools

30. www.ihe.net NIST Testing Tools

31. www.ihe.net Connectathon – in the dungeon…

32. www.ihe.net PCD @ HIMSS 2010 PCD – HIMSS Interoperability Showcase 2011

33. www.ihe.net IHE PCD – HIMSS ’10 Wall 1 PCD – HIMSS 2011

34. www.ihe.net PCD – HIMSS 2011

35. www.ihe.net IHE PCD – HIMSS ’10 Wall 2 PCD – HIMSS 2011

36. www.ihe.net How to Participate

37. www.ihe.net Contact Information Project Mgr: Manny Furst – pcd@accenet.org Co-Chair: Ken Fuchs – Mindray North America Co-Chair: Steve Merritt – Baystate Health Google Group – ihepcdplan@googlegroups.com ihepcdplan@googlegroups.com Committee’s Wiki – http://wiki.ihe.net/index.php?title =PCD_Planning_Committee http://wiki.ihe.net/index.php?title =PCD_Planning_Committee PCD PC Committee Responsibilities Planning Committee Recruitment Education Presentations White Papers Review IHE Profile Proposals Identifies committee priorities and problems Meets every 2 weeks alternating with TC

38. www.ihe.net Contact Information Project Mgr: Manny Furst – pcd@accenet.org Co-Chair: John Garguilo – NIST Co-Chair: John Rhoads – Philips Healthcare Google Group email – ihepcdtech@googlegroups.com ihepcdtech@googlegroups.com Committee’s Wiki – http://wiki.ihe.net/index.php?title =PCD_Technical_Committee http://wiki.ihe.net/index.php?title =PCD_Technical_Committee PCD TC Committee Responsibilities Technical Committee Recruitment Development of IHE Profiles Maintenance of IHE Technical Frameworks Development of test scripts Work with NIST on automated testing Meets every 2 weeks alternating with PC

39. www.ihe.net PCD User Handbook 2011 Edition Overview of IHE-PCD Value Propositions for medical device interoperability Advice on how to specify IHE in technology assessment Tools to find IHE-PCD compliant products Guidance on installation testing to confirm that IHE capabilities are functioning properly Issues to consider when installing and configuring IHE-compliant system Identifying and addressing potential problems in order to maximize your benefit despite existing “legacy” systems To be posted for comment shortly, meanwhile the draft is here – wiki.ihe.net/index.php?title=PCD_User_Handbook 2011 Changes include – Appendix H Mapping Clinical Requirements to Purchasing Requirements – Consolidation of the 2 major sections into 1 section – Incorporation of public comments from 2010 edition

40. www.ihe.net RFP Guidance

41. www.ihe.net We are Seeing Green Shoots!! Vendors are starting to release IHE compliant products… – ~20 devices/systems announced so far – We expect ~30 devices by end of ’11 Typically a search of Integration Statements on the IHE web site will give you a list… – http://product-registry.ihe.net http://product-registry.ihe.net – Some vendors are having internal issues getting the appropriate web sites set up.

42. www.ihe.net Let’s Go Shopping!!

43. www.ihe.net How to Participate in IHE PCD? Apply for IHE International Organizational Membership – Visit: www.ihe.net/applywww.ihe.net/apply – Approved monthly by IHE International Board – Review IHE's 400+ Organizational Members Review IHE's 400+ Organizational Members Participate in IHE Domains & Committees – IHE Organizational Members only – 12 Clinical and Operational Domains – Each Domain has one planning and one technical committee Non-members participate in comment periods and implement IHE Technical Frameworks IHE International Membership is Free.

44. www.ihe.net Learn More about IHE International IHE Webinar Series runs June-September 2011 – Visit www.ihe.net for the full list of webinarswww.ihe.net – Registration is free! All webinar recordings and slide decks will be posted online at: www.ihe.net/Events/webinars2011.cfm www.ihe.net/Events/webinars2011.cfm Sign up for the IHE International News – Email secretary@ihe.netsecretary@ihe.net – Sign up for the IHE Webinar Series listservIHE Webinar Series listserv Apply for IHE International’s Free Membership – Visit: www.ihe.net/applywww.ihe.net/apply Important Links and Information

45. www.ihe.net Thank you for your attention Questions?