1. Todd Cooper President and Founder, Breakthrough Solutions Inc. t.cooper@ieee.org Co-Chair of the American College of Clinical Engineering (ACCE) IHE-PCD Domain Task Force HIMSS 2006 IHE Interoperability Showcase The New IHE Patient Care Devices (PCD) Domain: Business Cases and Warp Speed Ahead to Patient Care Device Interoperability!

2. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 2 The IHE-Patient Care Devices (IHE-PCD) Domain Integrating the Healthcare Enterprise Patient Care Devices (IHE-PCD) Domain Helping to fulfill the general IHE Vision: Providers and vendors working together to deliver interoperable health information systems within and between enterprises and settings

3. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 3 The IHE-Patient Care Devices (IHE-PCD) Domain BioBrief: Todd Cooper 25+ Years of Software Engineering & Medical Device Expertise Founder and President of Breakthrough Solutions, a medical device connectivity component software & consulting firm International Medical Technology Standards Leader –Chair, IEEE EMBS 1073 Medical Device Communication Standards –Convenor, ISO TC215 WG7 Health Informatics – Devices –Co-chair, HL7 Health Care Devices SIG –Board Member, ANSI/HIMSS Health I.T. Standards Panel (HITSP) Member of the American College of Clinical Engineering, and Co-Chair of this IHE Patient Care Devices Domain

4. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 4 The IHE-Patient Care Devices (IHE-PCD) Domain In June, 2005, The American College of Clinical Engineering (ACCE) was appointed the Domain Sponsor for Patient Care Devices by IHEs principal sponsors, ACC, HIMSS, and RSNA. A Clinical Engineer is a professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology. Founded in 1991, ACCE is the professional college of Clinical Engineers throughout the US. (www.ACCEnet.org)

5. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 5 The IHE-Patient Care Devices (IHE-PCD) Domain What do we mean by Business Case? What outcomes of IHE-PCD Domain will create real, tangible value for the participants (i.e., What is the Value Proposition, or, Why should we do this, and why now?) Nothing durable can be accomplished with a project like this UNLESS there are clear economic, regulatory, and other rewards for the stakeholders.

6. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 6 The IHE-Patient Care Devices (IHE-PCD) Domain HIMSS Survey IHE pre-2005 Annual Conference results: Further, 56% said theyd pay more for IHE-compliant products! So, in Summer 2005, HIMSS conducted a supplemental Patient Care Devices survey, which allowed us to drill down to the detailed issues and priorities… Over 50% of those surveyed said patient care devices should be the next area developed for IHE

7. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 7 The IHE-Patient Care Devices (IHE-PCD) Domain Summer Survey Question re: Devices: How important is it for each device listed to become integrated under the IHE? Highest priority devices are Vital Signs Monitors, Blood Gas Analyzers (POC), and Infusion Pumps

8. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 8 The IHE-Patient Care Devices (IHE-PCD) Domain Departments: Rate each department in terms of the benefit from implementation of IHE Highest priority departments are ICU, Emergency, Surgery, and Lab (POC)

9. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 9 The IHE-Patient Care Devices (IHE-PCD) Domain Technologies: Which technological areas are most important for patient care device integration? Highest priority technology is Cross Enterprise Sharing

10. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 10 The IHE-Patient Care Devices (IHE-PCD) Domain Applications: Which clinical applications would you like to see IHE target?

11. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 11 The IHE-Patient Care Devices (IHE-PCD) Domain Barriers: What do you see as the biggest barriers to IHE integration of patient care devices? Highest perceived barrier is Lack of Technology Standards.

12. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 12 The IHE-Patient Care Devices (IHE-PCD) Domain Cost: Would you buy IHE compliant devices over non compliant, at equal price?

13. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 13 The IHE-Patient Care Devices (IHE-PCD) Domain Premium: How much of a premium would you pay for IHE compliance?

14. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 14 The IHE-Patient Care Devices (IHE-PCD) Domain REALITY CHECK Patient Care Devices are quite unique, e.g., Many devices are used in many clinical contexts, filling roles in one context that may be very different in another setting. In the arena of interoperability, which cannot be separated from the IHE requirements for connectivity, many of the signals and information from the devices – such as life-critical alarms -- have direct significance to patient safety and well being in real-time, and should be accorded appropriate priority in the system. Since many of the devices are portable, means of connectivity will of necessity include wireless portions, direct network connections, and Internet links, all with hacker and virus risks, too. Most PCDs provide data that should be automatically and accurately incorporated directly into the information stream that feeds the emerging Electronic Health Record (EHR).

15. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 15 The IHE-Patient Care Devices (IHE-PCD) Domain Who are the key Stakeholders with Business Cases that are driving this NOW? Stakeholders presently fall into four general categories –Providers who sell equipment or services –Purchasers who buy –Users who consume –Regulators and Government who represent the public good

16. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 16 The IHE-Patient Care Devices (IHE-PCD) Domain SO, WHAT IS HAPPENING IN THIS DOMAIN? In September, 2005, the PCD gathered 60 vendors, purchasers, users, and regulators in Washington DC for 2 days to explore the value propositions and set initial priorities. Here is what they said…

17. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 17 The IHE-Patient Care Devices (IHE-PCD) Domain Business Case for the Provider (Vendor) as a stakeholder Value lies in the ability to attract, retain, or deepen a customer relationship For example IHE PCDD will enable new market development would be a value proposition

18. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 18 The IHE-Patient Care Devices (IHE-PCD) Domain Vendor Business Case Value Propositions (e.g., ROI and other motivations): Develop a minimum feature set Vendors can comply to - Simplify product development process -Get out of business of things that we do not do well Spend time innovating rather than doing infrastucture work e.g cell phone (US multi std, ROW single std) Reduce regulatory impact/work (resubmitting 510Ks) Allow vendors to aggregate devices and create new solutions and clinical models Improve patient safety - reduce liability - make operations easier - device aware Facilitate clinical decision support - innovation - added functionaliity Create "Open Source" environment to allow a greater focus on clincal rather than technical -- floats all boats" Will be a mandate from either - customer or regulatory agency Remove "customer" perceived technical barrier to interoperability Customer risk mitigation Facilitate innovation - Small companies do not have to take on enterprise integration projects Key applications : Charting, decision support, web based, mobile (include wide area) remote access - cross vendor/cross domain integration currently restricted - open new domains to us Provide a good communication tool between "buyer" and "seller" Standard user interface - reduce training impact - reduce errors - patient safety

19. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 19 The IHE-Patient Care Devices (IHE-PCD) Domain Business Case for the Purchaser/User Stakeholders Value lies in simplifying quality buying decision criteria For example IHE PCDD will reduce the complexity of the purchase would be a value proposition User stakeholders Purchaser stakeholders Value lies in the benefit you derive For example IHE PCDD will simplify workflow would be a value proposition

20. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 20 The IHE-Patient Care Devices (IHE-PCD) Domain Examples of Purchaser and User Value Propositions (i.e, ROI and other motivations): Integrity of data – automatic population of all information systems – reducing medical errors Automated systems saves time for clinicians Defined and easily accessible audit trails Eases integration of multiple modalities into a single system; provides one consistent view of patient data Facilitates intelligent systems to support clinical reasoning International standardization of systems so that international outcomes research can be accomplished Common and safe user authentication Access to patient data across devices and systems so custom communication interfaces can be eliminated. Allows for best of breed Reduce redundancy of testing and training

21. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 21 The IHE-Patient Care Devices (IHE-PCD) Domain User/Provider/Purchaser Benefit Examples Improves agility of enterprises to meet varied patient loads Improved life-cycle cost of ownership –Facilitates heterogeneous brand and model deployment –May allow use of technologies over longer periods of time, reducing the obsolescence effect Vendor-provided IHE-PCD conformance statements will ease selection decisions and reduce risks Automates clinical data capture for EHR

22. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 22 The IHE-Patient Care Devices (IHE-PCD) Domain Examples of emerging IHE-PCD Use Cases Enterprise sharing of Patient Care Data Patient ID reconciliation Real-time data archiving Ventilator-to-X-ray synchronization Mobile, enterprise-wide, reliable vital signs monitoring … many more!

23. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 23 The IHE-Patient Care Devices (IHE-PCD) Domain Sample Business Cases for Government Payor and Regulatory Stakeholders Value lies in easing regulators tasks by industry adoption and implementation of uniform specifications. –For example one Business Case statement for government and regulatory stakeholders is: IHE PCDD can simplify the approval process for medical devices and related clinical information systems. IHE-PCD accelerates the fulfillment of key clinical requirements for Efficacy, Efficiency, and Safety in the emerging Electronic Health Record programs that have been mandated by President Bush and Health and Human Services leadership.

24. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 24 The IHE-Patient Care Devices (IHE-PCD) Domain IHE-PCD Domain Vision Statement The IHE Patient Care Devices Domain (IHE PCD) is the nexus for vendors and providers to jointly define and demonstrate unambiguous interoperability specifications, called profiles, which are based on industry standards and which can be brought to market. IHE-PCD profiles: 1. improve patient safety and clinical efficacy, 2. reduce healthcare delivery cost by improving efficiency, reliability, and operational flexibility for healthcare providers, 3. enable innovative patient care capabilities, and 4. expand the international marketplace for patient care device vendors.

25. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 25 The IHE-Patient Care Devices (IHE-PCD) Domain IHE-PCD Mission The IHE Patient Care Devices Domain will apply the proven, Use Case driven IHE processes to: 1.Deliver the technical framework for the IHE- PCD domain profiles; 2.Demonstrate IHE-PCD profile implementations via Connectathons; and 3.Publicly demonstrate marketable solutions at Association trade shows.

26. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 26 The IHE-Patient Care Devices (IHE-PCD) Domain IHE-PCD Scope The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a regulated patient care device (or is embedded within another device or Domain) which does not fall within one of the other IHE clinical specialty based domains such as medical imaging.

27. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 27 The IHE-Patient Care Devices (IHE-PCD) Domain In order to join the IHE-PCD Domain Team see or email any of the following: Todd Cooper (t.cooper@ieee.org) Emanuel (Manny) Furst (efurst@imp-tech.com) Jack Harrington (jack.harrington@philips.com) Elliot Sloane (ebsloane@villanova.edu) Ray Zambuto (rzambuto@techmed.com) … or visit us at www.ACCEnet.org/IHE

28. American College of Clinical Engineering (ACCE) - Todd Cooper - HIMSS 2006 IHE Interoperability Showcase 28 The IHE-Patient Care Devices (IHE-PCD) Domain Thank You! Questions – Comments? Todd Cooper T.Cooper@ieee.orgT.Cooper@ieee.org President, Breakthrough Solutions American College of Clinical Engineering (ACCE) www.ACCEnet.org www.ACCEnet.org/IHE