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Planning Committee Ken Fuchs / Steve Merritt Technical Committee John Garguilo / John Rhoads

IHE PCD is a committee focused on integrating point-of-care medical devices with each other and with enterprise systems, aiming to improve safety and efficiency in clinical settings.

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Planning Committee Ken Fuchs / Steve Merritt Technical Committee John Garguilo / John Rhoads

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

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

  3. 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. PCD Sponsors

  4. 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. We coordinate 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.

  5. 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.

  6. Example Profile Life Cycle

  7. Domain Profiles Developed

  8. 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

  9. [RTM]Rosetta Terminology Mgmnt.

  10. [DEC]Device to Enterprise Communication

  11. [WCM]Waveform Content Message

  12. [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

  13. [PIV]Point of Care Infusion Verification

  14. [IDCO]Implantable Device – Cardiac Observ.

  15. Domain Profiles Under Development

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

  17. [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

  18. [MEM]Medical Equipment Management

  19. [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

  20. 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.

  21. NIST Testing Tools

  22. Connectathon – in the dungeon…

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

  24. How to Participate

  25. PCD Planning Committee • 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

  26. PCD Technical Committee • 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

  27. PCD User Handbook 2011 Edition1 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 1http://wiki.ihe.net/index.php?title=PCD_User_Handbook

  28. RFP Guidance

  29. Go Shopping!! Mindray Nuvon OZ Systems Philips Emergin Philips Healthcare ScottCare St. Jude Medical Surgical Info. Systems Vocera Welch Allyn • Accent on Integration • Amcom • Biotronik • B Braun • Carefusion • Cerner • Epic • GE Healthcare • Hospira • iMDSoft • iSirona

  30. Thank you for your attention Questions?

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