1. Benefits of IHE PCD Standards-Based Interoperability June 1, 2014 | 8:30 AM Jeff McGeath – Iatric Systems, Inc. John Garguilo – NIST Monroe Pattillo – PHI, LLC © 2014 Association for the Advancement of Medical Instrumentation www.aami.org

2. PATIENT CARE DEVICE OVERVIEW Jeff McGeath IHE PCD Technical Committee Co-Chair Vice President Patient Care Device Integration Iatric Systems, Inc.

3. PATIENT CARE DEVICE Overview Medical devices are on the market today that support IHE PCD standards-based interoperability. Purchasing these devices shortens the learning curve, increases uniformity of conveyed information and reduces the amount of customization required for implementation, which is expected to reduce overall cost of ownership. The focus of this presentation will be on why and how to acquire medical devices that support IHE PCD standards-based medical device interoperability. IHE PCD domain sponsors are HIMSS, ACCE, and AAMI

4. PATIENT CARE DEVICE What is IHE PCD? Integrating the Healthcare Enterprise www.ihe.net Patient Care Device domain www.ihe.net/Patient_Care_devices

5. PATIENT CARE DEVICE The Old Way Purchase device by type Identify what you want to accomplish Identify vendors in the space Identify vendor technical contacts Learn what each vendor product does Translate vendor capabilities to common terms to identify interoperability Identify whether or not each product says that it does what is required Potentially customize products to talk to each other Perform the required use case functionality Communicate the required information Verify that the products perform as expected Lots of learning, lots of guesswork, potential customization just to get things to talk to each other, and then to integrate in a documented manner to achieve the use case expectations

6. PATIENT CARE DEVICE A Better Way Buy products that conform to Internationally recognized open standards Openly accessible profiles that define common… use cases, actors, transactions, content, terminology Have been independently verified Test scripts are openly available Test results are openly available Have independent certification potential IHE-USA / ICSA Labs Certification program Are openly listed as commercial offerings Technical contacts for more information Vendors offer statement of integration

7. PATIENT CARE DEVICE What Does IHE PCD do? Starts with standards – HL7 Selects a version – HL7 2.6 Identifies use cases PCD defines Profile then Trial Implementation Documents use cases, actors, transactions, content, terminology, and examples Profile-actor implementations verified at a Connectathon IHE posts to Connectathon Results Browser Vendors’ profile/actor can become IHE-USA/ICSA Labs certified Add profile as supplement to IHE domain Technical Framework Vendors list in PCD Commercial Products list Vendors produce integration statements

8. PATIENT CARE DEVICE Benefits of an Independent View Open standards based (HL7) Standards have gray areas, IHE PCD tightens things up Open access to IHE PCD documents Domain Technical Framework Profile Trial Implementations Test scripts NIST Test Tools Readily accessible verification tools Connectathon Results Browser 3rd party confirming successful participation in verification IHE-USA/ICSA Labs Certification testing PCD Commercial Solutions list

9. PATIENT CARE DEVICE NIST AND IHE PCD John Garguilo IHE PCD Technical Committee Co-Chair Computer Scientist Software and System Division National Institute of Standards and Technology

10. PATIENT CARE DEVICE NIST Test Tools Online 24x7 autonomous access and use Readily accessible – web based Based upon IHE PCD profiles RTMMS for consistent terminology and units Available in active testing and verification modes Active peer to peer testing Message verification (paste and verify) Produces verification report Optional storage of report under login

11. PATIENT CARE DEVICE Use of NIST Test Tools by IHE PCD Used by vendors during product development Anonymously during unrecorded tests Used by IHE PCD during IHE Pre-Connectathon Anonymously during unrecorded tests By vendor specific login to record test reports for grading Used by IHE PCD during IHE Connectathon For grading of evidentiary test data

12. PATIENT CARE DEVICE IHE PCD AND COMMERCIAL SOLUTIONS Monroe Pattillo IHE PCD Planning Committee Co-Chair Managing Member Practical Health Interoperability, LLC

13. PATIENT CARE DEVICE IHE PCD List of Commercial Solutions Identified by profile and actor Technical contact information Integration statements

14. PATIENT CARE DEVICE IHE-USA/ICSA Labs Certification Some IHE PCD profiles can be certified Specific profiles in Final Text within the IHE PCD Technical Framework DEC – Device to Enterprise Communication ACM – Alert Communication Management PIV – Point-of-care Infusion Verification Some Profiles at Trial Implementation status (provisionary) DEC POI – Pulse Oximetry Integration EC IPEC – Infusion Pump Event Communication For specifics contact IHE-USA or ICSA Labs

15. PATIENT CARE DEVICE Why Buy IHE-PCD Standards-Based Solutions? Implementations operating to an independently identified set of rules for defined functionality HL7 v2.6 IHE PCD Profiles Use cases, actors, transactions, content, terminology Independently verified implementations NIST Test Tools IHE Connectathon & Results Browser IHE-USA/ICSA Labs Certification

16. PATIENT CARE DEVICE How do I buy IHE PCD Standards-Based Solutions? What type of device are you looking for (examples): Physio Mon, Infusion Pump, Interface System, EMR/EHR What are the use case to IHE PCD Profile mappings? Device data recording to EMR (DEC) Infusion pump programming (PIV) Alert communication to staff wired/wireless devices (ACM) Event communication between systems (IPEC) Implantable Cardiac Device data recording to EMR (IDCO) What are the profile actor systems referred to as? Reporters, Programmers (senders) Consumers (receivers) Managers, Communicators (are both receivers and senders)

17. PATIENT CARE DEVICE Buying IHE PCD Standards-Based Solutions? IHE PCD list of commercially available systems Locate the profile Locate the actor Identify the vendors Identify the availability Connectathon Results Browser identifies verification ICSA Labs identification certification Integration statement identifies vendor commitment Identify the technical contacts

18. PATIENT CARE DEVICE IHE PCD Commercially Available Devices and Systems ftp://ftp.ihe.net/Patient_Care_Devices/Deployment/Com mercially_Available_PCD_Systems/ IHE PCD Commercially Available Systems (local copy) Request IHE Conforming Interoperable Products Ask when they will be commercially available

19. PATIENT CARE DEVICE Visit the IHE PCD Demonstration at AAMI Live demonstrations of IHE PCD interoperability Medical device data to EMR (DEC profile) Alarms and Advisories to clinicians (ACM profile) Programming of infusion pumps (PIV profile) CMMS equipment management (MEM DMC) Equipment/people location data (MEM LS) IHE PCD sponsors – HIMSS, AAMI, ACCE AAMI 2014 booth 108

20. PATIENT CARE DEVICE Q&A Jeff McGeath John Garguilo Monroe Pattillo See IHE PCD live interoperability demonstrations AAMI booth 108 AAMI 2014 booth 108

21. PATIENT CARE DEVICE For More Information IHE PCD Planning Committee Co-Chairs Monroe Pattillo, PHI, LLC Greg Staudenmaier, VA IHE PCD Technical Committee Co-Chairs John Garguilo, NIST Jeff McGeath, Iatric Systems, Inc. IHE PCD Secretariat Paul Sherman pcd@accenet.org IHE – www.ihe.net IHE PCD – www.ihe.net/Patient_Care_Devices Connectathon Results – http://connectathon-results.ihe.net Folder containing PCD list of Commercially Available solutions ftp://ftp.ihe.net/Patient_Care_Devices/Deployment/Co mmercially_Available_PCD_Systems/ See IHE PCD live interoperability demonstrations AAMI booth 108 AAMI 2014 booth 108