1. September, 2005What IHE Delivers 1 Todd Cooper, Co-Chair IHE PCD Andrea Poli, University of Trieste, Italy IHE Patient Care Device Domain IHE Europe 2006 - Changing the Way Healthcare Connects IHE Presentation at the World of Health IT show, October 2006

2. 2 Proven Standards Adoption Process Document Use Case Requirements Identify available standards ( e.g. HL7, DICOM, IETF, OASIS) Develop technical specifications Testing at Connectathons IHE Demonstrations Products with IHE Timely access to information Easy to integrate products

3. 3 IHE Organizational Structure Multi-Domain & Multi-National IHE Organizational Structure Multi-Domain & Multi-National Participants contribute Global Development: Radiology, IT Infrastructure, Cardiology, Lab, etc. Delegates IHE Europe IHE North America IHE Asia/Oceania Regional & National Deployment supervises reports IHE (International) Strategic Development Committee Sponsor Co-Chairs Global Interoperability IHE Domain-related Planning and Technical Committees

4. 4 IHE 2006 – Nine Active Domains Close to 200 vendors involved world-wide, 6 Technical Frameworks 51 Integration Profiles, Testing at Connectathons Demonstrations at major conferences world-wide

5. 5 IHE Patient Care Device (PCD) 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)

6. 6 IHE Patient Care Device (PCD) Why patient care devices? For every connected IT Device in the hospital, there are 4 Patient Care Devices that are not connected For every connected IT Device in the hospital, there are 4 Patient Care Devices that are not connected There are over 1500 Patient Care Device manufacturers and over 3500 Make-Model combinations There are over 1500 Patient Care Device manufacturers and over 3500 Make-Model combinations The typical 200 bed hospital contains 1,000s of Patient Care Devices The typical 200 bed hospital contains 1,000s of Patient Care Devices …that are constantly changing with updated/upgraded technology … and require interoperability too?!

7. 7 IHE Patient Care Device (PCD) One Patient – Many Devices

8. 8 IHE Patient Care Device (PCD) REALITY CHECK – Patient Care Devices are quite unique … Many devices are used in multiple clinical contexts, with acquired data having different implications depending upon the clinical setting. Many devices are used in multiple clinical contexts, with acquired data having different implications depending upon the clinical setting. Many devices provide signals or critical alarms that have direct significance to patient safety and well being in real-time, and should be accorded appropriate priority in the system. Many devices provide signals or critical alarms that have direct significance to patient safety and well being in real-time, and should be accorded appropriate priority in the system. Many devices are portable, meaning that connectivity must include wireless portions, direct network connections, and Internet links, all with hacker and virus risks, too. Many devices are portable, meaning that connectivity must include wireless portions, direct network connections, and Internet links, all with hacker and virus risks, too. Many devices provide data that should be automatically and accurately incorporated directly into the information stream that feeds the emerging Electronic Health Record (EHR). Many devices provide data that should be automatically and accurately incorporated directly into the information stream that feeds the emerging Electronic Health Record (EHR).

9. 9 IHE Patient Care Device (PCD) HIMSS Survey IHE pre-2005 Annual Conference results: In Summer 2005, HIMSS conducted a supplemental Patient Care Device survey, which allowed us to drill down to the detailed issues and priorities… In Summer 2005, HIMSS conducted a supplemental Patient Care Device survey, which allowed us to drill down to the detailed issues and priorities… * IHE-Europe survey placed Medical Devices behind Pharmacy & Pathology Survey of all IHE UsersSurvey of all IHE Users Over 50% of those surveyed said patient care devices should be the next area developed for IHE *Over 50% of those surveyed said patient care devices should be the next area developed for IHE *

10. 10 IHE Patient Care Device (PCD) 2005 Summer Survey Results: Highest priority devices for integration are Vital Signs Monitors, Blood Gas Analyzers (POC), and Infusion Pumps Highest priority devices for integration are Vital Signs Monitors, Blood Gas Analyzers (POC), and Infusion Pumps Highest priority departments are ICU, Emergency, OR/Anesthesia, and Lab (POC) Highest priority departments are ICU, Emergency, OR/Anesthesia, and Lab (POC) Highest technology priority is Enterprise Wide Sharing Highest technology priority is Enterprise Wide Sharing Highest priority for clinical application is EHR or CIS integration followed by Improved Management and Decision Support Highest priority for clinical application is EHR or CIS integration followed by Improved Management and Decision Support Highest perceived barrier is Lack of Standards. – Fear of Litigation not a concern Highest perceived barrier is Lack of Standards. – Fear of Litigation not a concern Users are willing, on average, to pay a premium to achieve IHE compliance … with the expectation of a lower overall cost of ownership ! Users are willing, on average, to pay a premium to achieve IHE compliance … with the expectation of a lower overall cost of ownership !

11. 11 IHE Patient Care Device (PCD) Key Benefits of PCD Interoperability: Heterogeneity – Multiple manufacturers + multiple device modalities coexisting over a shared infrastructure Heterogeneity – Multiple manufacturers + multiple device modalities coexisting over a shared infrastructure Semantic Interoperability ( comparability) – shared terminology and data models, interpret data based on the clinical context, compare information from different healthcare facilities, and interrogate systems across enterprises and regions. Semantic Interoperability ( comparability) – shared terminology and data models, interpret data based on the clinical context, compare information from different healthcare facilities, and interrogate systems across enterprises and regions. Real-Time Availability – ability to provide data in a time frame appropriate to the physiologic function being measured, displayed or affected (controlled), typically milliseconds to seconds. Real-Time Availability – ability to provide data in a time frame appropriate to the physiologic function being measured, displayed or affected (controlled), typically milliseconds to seconds.

12. 12 IHE Patient Care Device (PCD) SO, WHAT IS HAPPENING IN THIS DOMAIN? In September, 2005, the PCD gathered 60 vendors, purchasers, providers, and regulators in Washington D.C. for 2 days to explore the value propositions, explore the scope and mission of the domain, and begin the process of use case development.

13. 13 IHE Patient Care Devices (PCD) The PCD 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 rewards for all stakeholders (economic, safety, quality, etc.). Nothing durable can be accomplished with a project like this UNLESS there are clear rewards for all stakeholders (economic, safety, quality, etc.).

14. 14 IHE Patient Care Devices (PCD) Key Stakeholders with Business Cases that are driving the PCD Stakeholders presently fall into four general categories Stakeholders presently fall into four general categories Vendors who sell devices or services Vendors who sell devices or services Purchasers who buy devices - Providers (Clinicians) who use devices Purchasers who buy devices - Providers (Clinicians) who use devices Regulators and Government who represent the public good Regulators and Government who represent the public good

15. 15 IHE Patient Care Device (PCD) PCD Stakeholder Value Propositions: Vendors Simplify product development process Simplify product development process Spend time innovating rather than doing infrastucture work Spend time innovating rather than doing infrastucture work Facilitate clinical decision support - innovation - added functionaliity Facilitate clinical decision support - innovation - added functionaliity Reduce regulatory impact/work Reduce regulatory impact/work Improve patient safety - reduce liability - make operations easier - device aware Improve patient safety - reduce liability - make operations easier - device aware

16. 16 IHE Patient Care Device (PCD) Value Propositions for Purchaser and Provider: Integrity of data – automatic population of all information systems – reducing medical errors Integrity of data – automatic population of all information systems – reducing medical errors Automated systems saves time for clinicians Automated systems saves time for clinicians Improves agility of enterprises to meet varied patient loads Improves agility of enterprises to meet varied patient loads Improved life-cycle cost of ownership Improved life-cycle cost of ownership Automates clinical data capture for EHR Automates clinical data capture for EHR Access to patient data across devices and systems so custom communication interfaces can be eliminated. Allows for best of breed Access to patient data across devices and systems so custom communication interfaces can be eliminated. Allows for best of breed

17. 17 IHE Patient Care Devices (PCD) Value Proposition for Government and Regulatory Stakeholders Value lies in easing regulators tasks by industry adoption and implementation of uniform specifications. 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. 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. 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.

18. 18 IHE Patient Care Device (PCD) IHE-PCD Charter The Patient Care Device Domain is concerned with Use Cases in which at least one actor is a regulated patient care device. The PCD coordinates with other IHE clinical specialty based domains such as IHE RAD and IHE LAB.

19. 19 IHE Patient Care Device (PCD) IHE-PCD Domain Vision Statement The IHE Patient Care Device 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, 1. improve patient safety and clinical efficacy, 2. optimize healthcare delivery cost by improving 2. optimize healthcare delivery cost by improving efficiency, reliability, and operational flexibility for efficiency, reliability, and operational flexibility for healthcare providers, healthcare providers, 3. enable innovative patient care capabilities, and 3. enable innovative patient care capabilities, and 4. expand the international marketplace for patient care 4. expand the international marketplace for patient care device vendors. device vendors.

20. 20 IHE Patient Care Device (PCD) IHE-PCD Mission The IHE Patient Care Device Domain will apply the proven, Use Case driven IHE processes to: The IHE Patient Care Device Domain will apply the proven, Use Case driven IHE processes to: Deliver the technical framework for the IHE-PCD domain profiles; Deliver the technical framework for the IHE-PCD domain profiles; Validate IHE-PCD profile implementations via Connectathons; and Validate IHE-PCD profile implementations via Connectathons; and Demonstrate marketable solutions at public trade shows. Demonstrate marketable solutions at public trade shows.

21. 21 IHE Patient Care Device (PCD) PCD Roadmap… Year 1: Year 1: Enterprise sharing of Patient Care Data Enterprise sharing of Patient Care Data Patient & Device ID Binding to Device (deferred) Patient & Device ID Binding to Device (deferred) Initial device classes – vital sign monitors, infusion pumps, ventilators … and possibly others Initial device classes – vital sign monitors, infusion pumps, ventilators … and possibly others

22. 22 IHE Patient Care Device (PCD) Year 2++ Year 2++ Home health Home health Emergency Care Emergency Care Real-time data archiving and communication Real-time data archiving and communication PCD Alarm Management + smart alarms & interlocks PCD Alarm Management + smart alarms & interlocks Medication Management Medication Management Device Control (e.g., Hospital Bed–Blood Pressure Coordination) Device Control (e.g., Hospital Bed–Blood Pressure Coordination) Mobile, enterprise-wide, reliable vital signs monitoring Mobile, enterprise-wide, reliable vital signs monitoring … many more! … many more!

23. 23 IHE Patient Care Device (PCD) 2006 Development Schedule: 2006 Development Schedule: Planning Committee decision:mid-January Planning Committee decision:mid-January Issue Public Comment version: June 2006 Issue Public Comment version: June 2006 Public Comment Due:July 2006 Public Comment Due:July 2006 Issue Trial Implementation version: August 8, 2006 Issue Trial Implementation version: August 8, 2006 IHE Connectathon: January 2007 IHE Connectathon: January 2007 HIMSS Demo: February 2007 HIMSS Demo: February 2007 Next Face-to-Face: Next Face-to-Face: 2006-10-31 Oak Brook Illinois U.S.A.

24. 24 PCD Year 1 Profiles

25. 25 IHE PCD Practical Aspects for PCD Implementation in Europe

26. 26 Question After the previous lecture, a question could be raised through the audience: From the Vendors perspective From the Vendors perspective Why should I produce, test and sell PCD compliant devices? Why should I produce, test and sell PCD compliant devices? From the Healthcare Providers perspective From the Healthcare Providers perspective Why should I ask for PCD compliant devices? Why should I ask for PCD compliant devices?

27. 27 Benefits Theoretically speaking the PCD benefits have been well explained: Heterogeneity Heterogeneity Semantic Interoperability Semantic Interoperability Real-Time Availability Real-Time Availability But practically what could be the benefits of PCD implementations? Two interesting examples are reported. Two interesting examples are reported.

28. 28 Vendor perspective How PCD could help me in rationalization of my internal resources? Most telemedicine applications are delivered by so called small-medium companies They commonly assemble sensors in a package that can deliver data to a central managing and storage facility

29. 29 Waste for re-design A 10 years experience company is forced to REDESIGN its systems every time technology, interfaces and enterprise side information system changes. This is an extreme waste of time and resources

30. 30 Solutions PCD could save resources and improve business. In a complete PCD framework, a change in the system does not necessitate a redesign of interfaces. This allows companies to focus their expertise on device development.

31. 31 User Perspective You negotiate a full range of products from Vendor X You negotiate each device, focusing on the best quality/cost ratio P. C. D. Choices mean saving money

32. 32 Vendors/Users perspective Open Standard / interoperability means saving money No longer Black Box approach…

33. 33 Clinical Engineers role in IHE CEs have a important role within IHE, because they contribute, with their wide spectrum of knowledge, to help clinicians and administrative staff in the new technology acquisition process. They are able to educate them to require IHE compliance. They are able to educate them to require IHE compliance. So CEs must be aware and trained about IHE framework!

34. 34 CEs Role in PCD CEs role in PCD domain is crucial because: CEs manage directly devices CEs manage directly devices CEs have a complete vision of devices used within the Healthcare Enterprise CEs have a complete vision of devices used within the Healthcare Enterprise CEs have the capability to think overgapping the barriers accross clinical Specialities CEs have the capability to think overgapping the barriers accross clinical Specialities PCD is a multidisciplinary domain!

35. 35 Health Technology Assessment and PCD In 2003 Eucomed (European Medical Technology Industry Association) has produced the HTA Europe Position Paper: "Health technology assessment for medical devices in Europe - What has to be considered" "Health technology assessment for medical devices in Europe - What has to be considered"

36. 36 Health Technology Assessment and PCD Pre-assessment of new products, is considered by the position paper But pre-assessment of ICT-based medical devices is inherently very difficult PCD can help very much the ICT-based medical devices pre-assessment, pushing them quickly into the market for a wide e-health integration

37. 37 From 15 years, SSIC-HECE and its network offer a Multi Level Education process for students and PROFESSIONISTS in Clinical Engineering all across and outside Europe The Alpe-Adria Universities Initiative (ALADIN) The Adriatic Balcanic Ionian Cooperation on Biomedical Engineering (ABIC-BME) AND

38. 38 SSIC-HECE SSIC-HECE has well understood the importance of IHE and it has been the first school that has decided to offer to the future CEs some IHE targeted courses. From this year, the school has introduced PCD as a Teaching subject.

39. 39 Future Expectations Very soon in Europe there will be CEs aware about PCD. IHE-PCD community will continue to organize seminars and initiatives across Europe for each stakeholders SO SO We expect to have very soon some explicit request of IHE-PCD compliant devices ….and vendors?

40. 40 Conclusions Inter-European diversity (economical, geographical, linguistic and cultural) is huge. The PCD process must take care of that. As soon as possible a European group working on PCD should be born. This group should feedback requirements into profiles that address European needs

41. 41 Conclusions There are still few European participants in the PCD development process There are NO European SME vendors or associations involved There are NO European providers or professional organizations involved We need YOUR experience!

42. 42 IHE Web site: www.IHE.net Frequently Asked Questions Integration Profiles in Technical Frameworks: See Volume 1 of each TF for Use cases Cardiology Cardiology IT Infrastructure IT Infrastructure Laboratory Laboratory Patient Care Coordination Patient Care Coordination Radiology Radiology Patient Care Devices Patient Care Devices Connectathon Result: www.ihe.net/Events/connectathon_results.cfm Products Integration Statements Participation in Committees & Connectathons

43. 43 IHE Patient Care Device (PCD) Come and join the IHE-PCD Domain Team - see or email any of the following PCD leaders: Todd Cooper (t.cooper@ieee.org) Todd Cooper (t.cooper@ieee.org) Jack Harrington (jack.harrington@philips.com) Jack Harrington (jack.harrington@philips.com) Melvin Reynolds(MelvinR@AMS-Consulting.com) Melvin Reynolds(MelvinR@AMS-Consulting.com) Andrea Poli (Poli@ssic.units.it) Andrea Poli (Poli@ssic.units.it) … or visit us at www.ACCEnet.org/IHE … or visit us at www.ACCEnet.org/IHE

44. 44 … Patient Care Devices!