Integrating the Healthcare Enterprise International Free Educational Webinar Series 2011 Learn More: www.ihe.net/events/webinars2011.cfm www.ihe.net Patient Care Device Domain Update (PCD) Planning Committee Ken Fuchs / Steve Merritt Technical Committee John Garguilo / John Rhoads 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 www.ihe.net Domain & Committee Overview www.ihe.net On the Road to Interoperability: From Standards to Profiles Base Standards eHealth Projects Profile Development IETF IHTSDO Specific Extensions 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. www.ihe.net 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. www.ihe.net IHE Development Process IHE Profiles Drafted & Revised Test at IHE Connectathons Publish in IHE’s Product Registry Implementation Published Posted For Public Comment IHE Technical Framework Developed Profile Selection by Committees IHE Call for Proposals Opens 1-5 mos. 14-18 mos. Demonstrate at a 6-13 mos. IHE Improves, Safety, Quality and Efficiency in Clinical Settings. Install Interoperable products in Clinical Settings worldwide www.ihe.net 2011-2012 Cycle IHE Profile Cycle Stages Participation Status Call for Proposal Completed Profile Selection Completed Open Date Close Date Learn More September 2010 Examples of Brief Proposals: October 2010 November 2010 Examples of Detailed Proposals: July 2010 IHE Profiles drafted in IHE Committees Completed February 20101 May 2011 Public Comment 1 Completed May 2011 June 2011 Trial Implementation Published Completed July 2011 IHE N.A. Connectathon Registration Open August 22, 2011 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/ IHE.net- Documents now in PC IHE’s Wiki- PC Process explained ftp://ftp.ihe.net/Patient_Care_Devices/Te chnicalFrameworkforTrialImplementation/ September 30, 2011 www.iheusa.org/connectathon_part icipant.aspx IHE N.A. Connectathon Dates January 914, 2012 www.iheusa.org/connectathon_part icipant.aspx IHE Connectathon European Dates May 21-25, 2012 www.ihe-europe.net www.ihe.net 2012-2013 Cycle IHE Profile Cycle Stages Participation Status Open Date Close Date Call for Proposal Learn More Open July 20, 2011 Sept 5, 2011 Examples of Brief Proposals: Profile Selection Closed October 2011 December 2011 Examples of Detailed Proposals: IHE Profiles drafted in IHE Committees Closed February 2012 May 2012 Public Comment 1 Open June 2012 June 2012 IHE.net- Documents now in PC IHE’s Wiki- PC Process explained Trial Implementation Published Open N/A August 2012 ftp://ftp.ihe.net/Patient_Care_Devi ces/TechnicalFrameworkforTrialImpl ementation/ IHE N.A. Connectathon Registration Open August 2012 September 2012 IHE N.A. Connectathon Dates Open January 2013 IHE Connectathon European Dates Open Spring 2013 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/ www.ihe.net Domain Profiles Developed www.ihe.net IHE PCD - Profiles CPOE/ Pharmacy System Physiologic Monitoring System Ventilation/ Anesthesia System ACM, DEC, WCM Barcode Medication Administration System PIV Infusion Pump ACM, DEC DEC Home Based System Current PCD Future PCD Future Non- PCD ACM, DEC, WCM, ADQ, PCIM EMR/EHR EMR/EHR Clinical Decision Support System ACM, DEC, WCM, ADQ IDCO CIS ACM, DEC, WCM, ADQ, PCIM Other Devices ACM, MEM Implantable Device Equipment Management System 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 www.ihe.net WCM: Waveform Communication Management 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 www.ihe.net [RTM] Rosetta Terminology Mgmnt. www.ihe.net [DEC] Device to Enterprise Communication www.ihe.net [WCM] Waveform Content Message www.ihe.net [ACM] Alarm Communication Management HL7 Messages per ACM and WCM profiles Alarm Source Alarm Reporter AR Device Specific graphics Parameters, waveforms, etc. as evidentiary data items Report Alarm PCD-04 → ← PCD-05 Report Alarm Status Alarm Manager AM Disseminate Alarm PCD-06 → ← PCD-07 Disseminate Alarm Status Alarm Communicator AC Alarm Information Dissemination Status Source, Phase, State, Priority Patient Location Instance Alarm text Callback Timestamp Evidentiary data Instance Accepted by AC Undeliverable Delivered Read Accepted Rejected Cancelled Callback start/stop www.ihe.net [PIV] Point of Care Infusion Verification www.ihe.net [IDCO] Implantable Device – Cardiac Observ. www.ihe.net Domain Profiles Under Development www.ihe.net [PCIM] Point-of-Care Identity Management 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. Data Query PCD-12 Data Query PCD-12 Data Response PCD-13 Data Response Full PCD-13 Disclosure EMR, CDSS, CIS, Etc. Data Server and/or Data Requester Data Query PCD-12 Data Response PCD-13 Data Servers Data Requesters www.ihe.net [MEM] Medical Equipment Management Location Services Current location Previous locations (Trending) Boundary controls (Alarm when device leaves area) Operational Status and Monitoring Is the device currently in use Usage history Alarms – which are active, what the trigger levels, how long has the alarm been on Day/time of last self check and its result Event log recording Preventative Maintanence Patch Management Last PM Next scheduled PM Last repair time/date Pending patches Patch history Device Configuration Management Battery Management On A/C or D/C? Charge level (% of full)/Est. operating time left. Charging / Discharging history Battery type and installation date Est. battery life Recall Management Unique device identification Hardware configuration (serial numbers, etc) Software configuration (revision numbers, etc) Device Reconfiguration Use profiles (NICU vs. CICU) Risk Management Risk analysis Risk evaluation Verification of risk control measures Residual risks www.ihe.net [MEM] Location Services www.ihe.net [MEM] Medical Device Security & Mgmnt. HIPAA Cyber Protection HITECH IEC 80001 Network Access Control IHE PCD Authentication Lifecycle Mgmt. Medical Device Access Control MDS2 Asset Discovery CE/IT Manage ment Security FDA: • 21 CFR 801, 803, 807, 812, 814, 820 • MDDS Configuration Management ePHI Breach Risk Privacy Key Management Encryption www.ihe.net [MEM] Medical Device Security & Mgmnt. www.ihe.net Profiles & Technical Frameworks Overview • 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 www.ihe.net IHE Development Process IHE Profiles Drafted & Revised Test at IHE Connectathons Publish in IHE’s Product Registry Implementation Published Posted For Public Comment IHE Technical Framework Developed Profile Selection by Committees IHE Call for Proposals Opens 1-5 mos. 14-18 mos. Demonstrate at a 6-13 mos. IHE Improves, Safety, Quality and Efficiency in Clinical Settings. Install Interoperable products in Clinical Settings worldwide www.ihe.net NIST Testing Tools www.ihe.net NIST Testing Tools www.ihe.net Connectathon – in the dungeon… www.ihe.net @ HIMSS 2010 PCD –PCD HIMSS Interoperability Showcase 2011 www.ihe.net IHE PCD – HIMSS ’10 Wall 1 PCD – HIMSS 2011 www.ihe.net PCD – HIMSS 2011 www.ihe.net IHE PCD – HIMSS ’10 Wall 2 PCD – HIMSS 2011 www.ihe.net How to Participate www.ihe.net 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 www.ihe.net 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 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 www.ihe.net RFP Guidance 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 – Some vendors are having internal issues getting the appropriate web sites set up. www.ihe.net Let’s Go Shopping!! COMPANY Amcom PCD PROFILES ACM St. Jude Medical, Inc. SYSTEM TYPE Event Notification Middleware Implantable Cardiac Device Home Monitoring Service Center Observer System Outlook Infusion Pump Infusion Pumps Space Infusion System Infusion Pumps DoseTrac Infusion Management Software "Gateway" software Datacaptor Interface System CareAware iBus Interface System EpicCare Inpatient and associated modules EMR/EHR Medtronic Mainspring Implantable Device Follow-up Connected System Gateway System eGateway Integration Manager HL7 Gateway A5 Anesthesia machine VEGA™ Interface System eScreener Plus Interface Emergin Alarm Manager HL7 Gateway Implantable Cardiac Device Merlin.net MN5000 Observer System Surgical Information Systems SIS Periop Periop CIS ACM, DEC Surgical Information Systems SIS Anesthesia Anesthesia CIS ACM, DEC Welch Allyn Connex VM VSM HL7 Gateway DEC BIOTRONIK SE & Co. KG B Braun B Braun B Braun Capsule Cerner Epic Medtronic Mindray DS USA, Inc. Mindray DS USA, Inc. Nuvon OZ Systems Philips Philips SYSTEM Commtech Messenger IDCO DEC, ACM, PIV DEC, ACM, PIV DEC, ACM, PIV DEC PIV, DEC, ACM DEC, PIV,ICDO IDCO ACM, DEC ACM, DEC DEC DEC ACM DEC IDCO www.ihe.net 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 www.ihe.net 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 www.ihe.net Thank you for your attention Questions? www.ihe.net