Integrating the Healthcare Enterprise International

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

2. Planning Committee Ken Fuchs / Steve MerrittTechnical Committee John Garguilo / John Rhoads Patient Care Device Domain Update (PCD)

3. 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

4. Domain & CommitteeOverview

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

6. 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. IHE PCD Charter 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.

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

9. 2011-2012 Cycle

10. 2012-2013 Cycle

11. Domain Profiles Developed

12. IHE PCD - Profiles Physiologic Monitoring System CPOE/ Pharmacy System Clinical Decision Support System Ventilation/AnesthesiaSystem ACM, DEC, WCM, ADQ,PCIM ACM, DEC, WCM ACM, DEC, WCM, ADQ Barcode Medication Administration System EMR/EHR EMR/EHR Infusion Pump Implantable Device ACM, DEC PIV IDCO CIS ACM, MEM ACM, DEC, WCM, ADQ,PCIM DEC EquipmentManagement System Home Based System Other Devices 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 CurrentPCD FuturePCD Future Non- PCD

13. IHE PCD - Profiles • 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: • Event Communication (EVT) • Point-of-Care Identity Management (PCIM) • Device Point-of-care Integration (DPI) • Medical Equipment Management (MEM) + Location Services + Cyber Security Management

14. [RTM]Rosetta Terminology Mgmnt.

15. [DEC]Device to Enterprise Communication

16. [WCM]Waveform Content Message

17. [ACM]Alarm Communication Management HL7 Messages per ACM and WCM profiles Device Specific graphics Parameters, waveforms, etc. as evidentiary data items Report Alarm PCD-04 → Disseminate Alarm PCD-06 → Alarm Reporter AR Alarm Manager AM Alarm Communicator AC ← PCD-05 Report Alarm Status ← PCD-07 Disseminate Alarm Status AlarmSource Alarm Information Source, Phase, State, Priority Patient Location Instance Alarm text Callback Timestamp Evidentiary data Dissemination Status Instance Accepted by AC Undeliverable Delivered Read Accepted Rejected Cancelled Callback start/stop

18. [PIV]Point of Care Infusion Verification

19. [IDCO]Implantable Device – Cardiac Observ.

20. Domain Profiles Under Development

21. [PCIM]Point-of-Care Identity Management

22. [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. Data QueryPCD-12 Data ResponsePCD-13 Data QueryPCD-12 FullDisclosure EMR, CDSS, CIS, Etc. Data ResponsePCD-13 Data Serverand/orData Requester Data QueryPCD-12 Data ResponsePCD-13 Data Requesters Data Servers

23. [MEM]Medical Equipment Management

24. [MEM]Location Services

25. [MEM]Medical Device Security & Mgmnt. • HIPAA • HITECH • FDA: • 21 CFR 801, 803,807, 812, 814, 820 • MDDS • IEC 80001 • IHE PCD • MDS2 Cyber Protection Configuration Management Asset Discovery Security CE/IT Management Lifecycle Mgmt. Medical Device Network Access Control ePHIBreach Risk Access Control Privacy Authenti-cation Key Management Encryption

26. [MEM]Medical Device Security & Mgmnt.

27. 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 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 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 2009 Webinar Series- http://www.ihe.net/Events/webinars2009.cfm 2008 Webinar Series- http://www.ihe.net/Events/webinars2008.cfm Handouts or other helpful materials/links Overview

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

29. NIST Testing Tools

30. NIST Testing Tools

31. Connectathon – in the dungeon…

32. PCD @ HIMSS 2010 PCD – HIMSS Interoperability Showcase 2011

33. IHE PCD – HIMSS ’10 Wall 1 PCD – HIMSS 2011

34. PCD – HIMSS 2011

35. IHE PCD – HIMSS ’10 Wall 2 PCD – HIMSS 2011

36. How to Participate

37. 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 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 • Committee’s Wiki • http://wiki.ihe.net/index.php?title=PCD_Planning_Committee

38. 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 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 • Committee’s Wiki • http://wiki.ihe.net/index.php?title=PCD_Technical_Committee

39. 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. RFP Guidance

41. 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 Some vendors are having internal issues getting the appropriate web sites set up.

42. Let’s Go Shopping!!

43. How to Participate in IHE PCD? IHE International Membership is Free. • Apply for IHE International Organizational Membership • Visit: www.ihe.net/apply • Approved monthly by IHE International Board • 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

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

45. Thank you for your attention Questions?