Planning Committee Ken Fuchs / Steve Merritt Technical Committee John Garguilo / John Rhoads Patient Care Device Domain Update (PCD)

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

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

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. IHE PCD Charter

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 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

Example Profile Life Cycle IHE Profile Cycle Stages Open Date Close Date Learn More Call for Proposals (2011) July 2011Sept 2011 Examples of Brief Proposals: ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr /Cycle_5_Proposals/ ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr /Cycle_5_Proposals/ Profile Selection Oct 2011Dec 2011 Examples of Detailed Proposals: ftp://ftp.ihe.net/Patient_Care_Devices/IHEPCDyr /Cycle_5_Proposals/ Profiles drafted in Committees Feb 2012May 2012 Public Comment on Supplement June 2012 Call for Proposals (2012) July 2012Sept 2012 Trial Implementation (TI) PublishedN/AAug 2012 ftp://ftp.ihe.net/Patient_Care_Devices/TechnicalFram eworkforTrialImplementation/ Test at Connectathon H N.A., EU, Korea, etc. Update Profile TI H Re-Test at Connectathons 2014, 2015 Need minimum of 3 Test Cycles Update Profile TI, Final Text 2014, 2015 Public Comment on Final Text Q1 2015Q Publish Final Text Q2 2015Q3 2015

Domain Profiles Developed

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

[RTM] Rosetta Terminology Mgmnt.

[DEC] Device to Enterprise Communication

[WCM] Waveform Content Message

[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

[PIV] Point of Care Infusion Verification

[IDCO] Implantable Device – Cardiac Observ.

Domain Profiles Under Development

[PCIM] Point-of-Care Identity Management

[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

[MEM] Medical Equipment Management

[MEM] Medical Device Security & Mgmnt. HIPAA HITECH FDA: 21 CFR 801, 803, 807, 812, 814, 820 MDDS IEC 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

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 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

NIST Testing Tools

Connectathon – in the dungeon…

HIMSS 2010 PCD – HIMSS Interoperability Showcase 2011

How to Participate

Contact Information Project Mgr: Manny Furst – Co-Chair: Ken Fuchs – Mindray North America Co-Chair: Steve Merritt – Baystate Health Google Group – Committee’s Wiki – =PCD_Planning_Committee =PCD_Planning_Committee 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 – Co-Chair: John Garguilo – NIST Co-Chair: John Rhoads – Philips Healthcare Google Group – Committee’s Wiki – =PCD_Technical_Committee =PCD_Technical_Committee 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

PCD User Handbook 2011 Edition 1 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 1

RFP Guidance

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

Thank you for your attention Questions?