1. Integrating the Healthcare Enterprise and the Patient Care Device Domain Emanuel Furst, PhD, CCE Technical Project Coordinator for the PCD efurst@imp-tech.com Prepared for the University HealthSystem Consortium April 6, 2007 © 2007 ACCE, HIMSS, IHE

2. Outline Integrating the Healthcare Enterprise What is the IHE? What is the PCD? Why do I care? What can I do? More slides than time permits for discussion Some are provided for reference and will not be discussed Some of the material is provided to encourage CE/IT discussion

3. What is the IHE? Integrating the Healthcare Enterprise What is the IHE?

4. Interoperability The Goal - Interoperability: the ability of two or more systems or components to exchange and use the information exchanged –Accurately, securely, verifiably –When and where needed Adapted from HL7, www.hl7.org

5. IHE: A Framework for Interoperability Integrating the Healthcare Enterprise A common framework for harmonizing and implementing multiple standardsA common framework for harmonizing and implementing multiple standards Enables seamless health information movement within and between enterprises, regions, nationsEnables seamless health information movement within and between enterprises, regions, nations Promotes unbiased selection and coordinated use of established healthcare and IT standards to address specific clinical needsPromotes unbiased selection and coordinated use of established healthcare and IT standards to address specific clinical needs

6. IHE: Connecting Standards to Care Healthcare professionals working with industryHealthcare professionals working with industry Coordinate implementation of standards to meet clinical and administrative needsCoordinate implementation of standards to meet clinical and administrative needs –Clinicians and HIT professionals identify the key interoperability problems they face –Providers and industry work together to develop and make available standards-based solutions –Implementers are able to follow common guidelines in purchasing and integrating effective systems IHE is not an SDO, but does provide feedbackIHE is not an SDO, but does provide feedback IHE: A forum for agreeing on how to implement standards and processes for making it happen

7. Why Do I Care About the IHE? Integrating the Healthcare Enterprise Value Propositions The IHE supports –Patient safety and reduced medical errors –Effective patient care with information when, where needed –Efficient organizations, less tedious and redundant work –Reduced cost, complexity of interface deployment, management –Best of breed for the organization –National mandate for electronic medical records The IHE is changing –Medical records systems – direct data transfers –Patient data systems – various enterprise configurations –Workflow – contributes to revisions –Staffing patterns

8. 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. For example one Business Case statement for government and regulatory stakeholders is: IHE PCD 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.

9. IHE Patient Care Devices (PCD) Manufacturers also benefit Lower development cost Shorter time to market Better defined requirements More competitive position Value Proposition for companies

10. IHE Participants and Relationships Participants Participants include:Participants include: –Users - Clinicians, Staff, Administrators, CIOs, Governments (e.g. NIST, VA). –Vendors - Information Systems and Equipment e.g., imaging, cardiology, devicese.g., imaging, cardiology, devices –Consultants Relationship with Standards Development Organizations (SDOs):Relationship with Standards Development Organizations (SDOs): –HL7, DICOM, ISO, CDISC, ASTM, W3C, IEEE, IETF, and many others Approved via ISO/TC 215 allowing for IHE profiles to be published as ISO deliverablesApproved via ISO/TC 215 allowing for IHE profiles to be published as ISO deliverables

11. Profiles Simplify Implementation Profiles A profile describes the application of a standard(s) to provide specific requirements to accomplish the communication requirements. –Provides an opportunity for users & vendors to define requirements Requirements for development With Conformance Statements, for purchase Single Standard – Constrain optionality, choose terminology, define dynamic interactions – HL7 Conformance Multiple Standards – Coordinate workflow, define mappings between standards -HL7/DICOM – IHE Radiology -HL7/IEEE 11073 – Patient Care Devices

12. Profiles Simplify Implementation

13. Standards: Necessary…Not Sufficient Standards areStandards are –Foundational - to interoperability and communications –Broad - varying interpretations and implementations –Narrow - may not consider relationships between standards domains –Plentiful - often redundant or disjointed –Focused - standards implementation guides typically focus on a single standard IHE provides a defined process for implementing standards

14. What is the IHE? The IHE An umbrella organization –Sponsored by three professional societies: RSNA, ACC, HIMSS Non-profit, operating in public view Voluntary –Largely manufacturers, users, regulators International

15. Integrating the Healthcare Enterprise Achieving Interoperability through Implementation of Standards 1997: Founded in Radiology (RSNA) and IT (HIMSS) Many professional societies (stakeholder representation)Many professional societies (stakeholder representation) –American Academy of Ophthalmology (AAO) –American College of Cardiology (ACC) –American College of Physicians (ACP) –American College of Clinical Engineering (ACCE) –American College of Emergency Physicians (ACEP) –American Society for Therapeutic Radiation Oncology (ASTRO) –GMSIH (IT France), JAHIS (IT Japan), SFIL (laboratory) –Healthcare Information Management Systems Society (HIMSS) –Radiological Society of North America (RSNA) –And many more….

16. IHE Organizational Structure ACC ACP HIMSS RSNA JAHIS JIRA JRS METI-MLHW MEDIS-DC JAMI GMSIH SFR SFIL ACCE SIRM BIR EuroRec COCIR EAR-ECR DRG ESC Professional Societies / Sponsors Contributing & Participating Vendors IHE (International) Strategic Development Committee Global Development Radiology Cardiology IT Infrastructure Patient Care Coordination Patient Care Devices Laboratory Pathology Pharmacy / Medication Admin Radiation Oncology IHE Europe IHE North America France USA Canada IHE Asia-Oceania Japan KoreaTaiwan Netherlands Spain Sweden UK Italy Germany Norway Regional Deployment China

17. International Adoption of IHE FranceUSAGermanyItalyJapanUKCanadaKoreaTaiwan Norway HollandSpainChina Year 1 (1999) Year 2 (2000) Year 3 (2001) Year 4 (2002) Year 5 (2003) Year 6 (2004) Year 7 (2005) Year 8 (2006)

18. What is the process? Process Define needs Set priorities Develop profiles with use cases Recruit volunteers for each profile to be developed Develop the technical solutions Demonstrate successful implementation –Connectathons –Showcases Publish for public access, comment at various stages

19. 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 IHE Demonstrations Products with IHE Timely access to information Easy to integrate products

20. Growth in IHE Domains Radiology (18) IT Infrastructure for Healthcare (17) Cardiology (7) Laboratory (6) Radiation Oncology (1) Patient Care Coordination (5) Patient Care Devices (1) Quality Eye Care (3) Veterinary Endoscopy Pathology Pharmacy Year 1 (1999) Year 2 (2000) Year 3 (2001) Year 4 (2002) Year 5 (2003) Year 6 (2004) Year 7 (2005) Year 8 (2006) Year 9 (2007) Over 100 vendors involved world-wide Over 100 vendors involved world-wide 8 Technical Frameworks 8 Technical Frameworks 48 Integration Profiles 48 Integration Profiles Testing at Connectathons world-wideTesting at Connectathons world-wide Demonstrations at major conferences world-wide Demonstrations at major conferences world-wide

21. What is the PCD? Integrating the Healthcare Enterprise What is IHE? What is the PCD?

22. IHE Patient Care Devices (PCD) Providers and vendors working together to deliver interoperable health information systems within and between enterprises and settings The PCD, helping to fulfill the general IHE Vision:

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

24. IHE Patient Care Devices (PCD) Patient Care Devices are unique … 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 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).

25. The Patient Care Device Domain The PCD Established in 2005 when the charter was awarded to the ACCE Jointly sponsored by ACCE and HIMSS as of July 1, 2006 Technical Framework 2006-7 developed to communicate patient data (asynchronous) Successful demonstration at the 2007 Connectathon and HIMSS 2007 Interoperability Showcase

26. IHE Patient Care Devices (PCD) HIMSS Survey IHE pre-2005 Annual Conference results: Further, 56% said theyd pay more for IHE-compliant products!Further, 56% said theyd pay more for IHE-compliant products! Survey of all IHE Users Over 50% of those surveyed said patient care devices should be the next area developed for IHE *

27. IHE Patient Care Devices (PCD) Key Benefits of PCD Interoperability Heterogeneity – Multiple manufacturers + multiple device modalities coexisting over a shared infrastructure Semantic Interoperability ( comparability) – shared terminology and data models permit users to 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).

28. IHE Patient Care Devices (PCD) IHE-PCD Charter The Patient Care Devices 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 medical imaging. The Patient Care Devices 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 medical imaging.

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

30. IHE Patient Care Devices (PCD) 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: improve patient safety and clinical efficacy, reduce healthcare delivery cost by improving efficiency, reliability, and operational flexibility for healthcare providers, enable innovative patient care capabilities, and expand the international marketplace for patient care device vendors.

31. 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 IHE Demonstrations Products with IHE Timely access to information Easy to integrate products

32. IHE PCD Connectathon 2007 Systems LiveData OR Mgr GE Centricity Periop CIS Philips CareVue CIS DOR DOC ADT A04 Feed MWB Draeger Innovian CIS GE Aware GW Philips IIC GW B. Braun DoseTrac GW Welch Allyn Connex CIS Validated VS, Vent, Anesth & Med Export, max every 3 minutes Validated Vitals export, Batch Unvalidated VS, Vent, Anesth. Data export every 1 minute VS Mon Pt Mon, Vent, Anesthesia Pt Mon, Vent, Anesthesia Pt Mon, Vent, Anesthesia Infusion Devices CT (Time) Feed Philips CareVue CIS Pt Mon, Vent, Anesthesia Validated VS, Vent, Anesth & Med Export, max every 5 minutes Unvalidated Med (Infusion System) exported every 1 minute

33. PCD HIMSS Showcase Scenario Welch Allyn Connex TM DataManagementSystem Vital Signs Monitor GEAwareGateway Patient Monitor, Ventilator PhilipsIntellivueInformationCenter Patient Monitor, Ventilator Emergency CareIntensive Care LiveDataOR-DashBoardGE Centricity ® Periop Anesthesia Draeger Innovian ® Solution Suite Patient Monitor, Anesthesia Sys B. Braun DoseTrac TM InfusionManagementSoftware Infusion Devices Perioperative Care Philips Intellivue Clinical InformationPortfolio

34. IHE PCD in the HIMSS 2007 Interoperability Showcase

35. Process for Year 2 Year 2 2006 Survey (to be discussed) Call for Short Proposals Vetting by Planning and Technical Committees Setting of Priorities Development of the Technical Framework Design and testing of new profiles Demonstration at HIMSS 2008

36. IHE-PCD Survey Summer-Fall 2006 The Survey Survey Managed by HIMSS Analytics Open Solicitation to HIMSS, ACCE, AdvaMed, Anesthesia Patient Safety Foundation, ECRI 171 Responses, (103 Users, 68 Vendors)

37. Respondent Demographics 171 Individual Responses = Hospital Based

38. Vendor Position on IHE and Interoperability 68 Vendor Responses (Checking all that apply)

39. Vendor Demographics: Vendor Products 68 Vendor Responses

40. Demographics: User Organization Types 77 Hospital Based Respondents* *26 of the 103 Non-Vendor Respondents do not work in hospitals

41. Relationship of Clinical Engineering and IT at Respondents Hospitals 77 Hospital Based Respondents* *26 of the 103 Non-Vendor Respondents do not work in hospitals

42. Importance of Interoperability to Hospital Based Respondents

43. Survey Question: With respect to Medical Devices, how important is it for the following devices to become integrated under the IHE? = Users= Vendors Percent of respondents that consider it important

44. Survey Question: Rate the importance to each department below in terms of the benefit from implementing IHE = Users= Vendors Percent of respondents that consider it important

45. Survey Question: Which clinical applications should IHE target? = Users= Vendors Percent of respondents that consider it important

46. Survey Question: Which technological areas are the most important for Patient Care Device integration? = Users= Vendors

47. IHE Patient Care Devices (PCD) Examples of emerging IHE-PCD Work flows Enterprise sharing of Patient Care Data* Patient & Device ID Binding* Point of Care Plug and Play* (multiyear effort) Home Telehealth* (multiyear effort) Real-time data archiving and communication PCD Alarm Management Drug Administration Hospital Bed–Blood Pressure Coordination Mobile, enterprise-wide, reliable vital signs monitoring … many more! Initial device classes – vital sign monitors, bedside monitors, infusion pumps and ventilators * Key Objectives for 2006/2007

48. Why do I care? Integrating the Healthcare Enterprise What is IHE? What is the PCD? Why do I care?

49. Why Do I Care About the IHE PCD? Significance Clinical implications –Patient safety –Enterprise wide access to the patients data –Quality of care –Ability to implement best of breed for your applications –Workflow improvements

50. Why Do I Care About the IHE PCD? Significance My job –CE and IT must collaborate on selection, specification, support of these systems –New knowledge and skills are required Financial implications –Rapid changes in technology increase risk –Interoperability reduces risk –Interoperability improves efficiency

51. Examples of Purchaser and User Value Propositions (i.e, ROI and other motivations) Automatic population of all information systems – reducing medical errors - integrity of data 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 best of breed selection for your application Efficiency of care, testing and training - Reduces redundancy

52. User/Provider/Purchaser Benefit ExamplesSignificance 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

53. What can I do? Integrating the Healthcare EnterpriseIntegrating the Healthcare Enterprise What is IHE? What is the PCD? Why do I care? What can I do?

54. What Can I Do? To Plan, Evaluate, Purchase In continuing discussions with vendors – at all levels –Push IHE, Interoperability Refer to lower deployment, maintenance costs –Encourage vendors active IHE participation Lower development, installation, support costs –Refer to profiles Leverage public and objective commitments In RFPs –Refer to profiles, Conformance Statements –Use Conformance Statements to nail down vendors representations –Adopt very specific language Raise the bar

55. What Can I Do? To Define the Future Become a member of a Domains Planning or Technical Committees –Help establish priorities – what the domain will work on –Help define profiles – clinical, IT requirements –Provide the business case to encourage developments Provide Public Comments on Technical Framework Supplements Attend Demonstrations, Educational Events and Workshops Raise the bar – to join send me an email

56. PCD Contacts PCD CoChairs: – Todd Cooper - t.cooper@ieee.orgt.cooper@ieee.org – Jack Harrington - jack.harrington@philips.comjack.harrington@philips.com – Ray Zambuto - rzambuto@techmed.comrzambuto@techmed.com PCD Technical Project Manager: – Manny Furst - efurst@imp-tech.comefurst@imp-tech.com IHE Strategic Development Committee CoChair – Elliot Sloane - elliot.sloane@villanova.eduelliot.sloane@villanova.edu

57. Sources of Slides Most slides were copied from the following presentations, and some have been modified for this presentation: IHE 2007 Theater welcome -V8 –Introductory presentation at HIMSS Interoperability Showcase Theatre 20070227-IHE-PCD-Overview -HIMSS-C –Jack Harringtons presentation at HIMSS HIMSS2006-IHEShowcase –Todd Coopers presentation at HIMSS IHE-PCD2006Survey –ACCE/HIMSS Survey Used with permission

58. References Internet and Other Resources http://www.ihe.net/About/ihe_faq.cfm http://www.ihe.net/Resources/ihe_integration_profiles.cfm#acquiring –Includes useful definitions, links to additional information http://www.rsna.org, http://www.acc.org, Parisot, Charles. What IHE Delivers for Vendors, Purchasers, Users and Patients. IHE Interoperability Workshop Sept. 2004. http://www.ihe.net/Participation/upload/2_What%20IHE%20Delivers_final.p pt#319,1,Integrating the Healthcare Enterprise Gauvin, Alain. How to Purchase IHE Functionality. IHE Canada Workshop 2006. http://www.ihe-canada.com/Events/2006/06SepHaramati- Goodhew.pdf Haramati, Nogah and Goodhew, Beth. Purchasing IHE Functionality. IHE Canada Workshop 2006. http://www.ihe- canada.com/Events/2006/06SepGauvin2.pdf Bak, Peter. Achieving Interoperability Across Canada. IHE Workshop, June 2006. http://www.ihe.net/Events/upload/IHE%20Workshop%20June%202006%20 Bak%20Infoway%20v2.ppt#724,1,Slide 1 Braithwaite, William. IT at the Core of Healthcare Transformation. Proceedings, HIMSS 2007.