1. Clinical Trials virtual tour HL7-IHE Demonstration HIMSS 2004

2. Presented by Meredith Nahm –Director of Clinical Data Integration –Duke Clinical Research Institute Durham, North Carolina

3. Virtual Tour High-level animated walkthrough Detailed view –Application tools –Standards and Profiles

4. Clinical Trial Community Acquired Pneumonia Clinical Trial 250 Patients and 12 sites QT prolongation is a potential adverse event in the class of drugs under study Trial uses a Core Lab for Central reading of ECG’s

5. Adobe Berdy Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Clinical Trials: Integrating with patient care aECG Arden CCOW CDA CT EUA LDM ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Patients seen at PCP, hospitals ECGs sent to Core Lab; annotated on site or at Core Lab Hospital Core Lab Sponsor FDA PCP Imaging Central Lab

6. Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Clinical Trials: Integrating with patient care Imaging aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Sponsor identifies QT prolongation Requests additional documentation Hospital Core Lab Sponsor FDA Registry PCP Central Lab Dictation Repository Query broker, trusted 3 rd party

7. Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Clinical Trials: Integrating with patient care aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Patients seen at PCP, hospitals ECGs sent to Core Lab; annotated on site or at Core Lab

8. Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Clinical Trials: Integrating with patient care aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Patients seen at PCP, hospitals ECGs sent to Core Lab; annotated on site or at Core Lab

9. Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Clinical Trials: Integrating with patient care aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Intervals for Analysis imported into Clinical Data Management System at Core Lab

10. Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Clinical Trials: Integrating with patient care aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Analysis data in ODM/SDM delivered to Sponsor Sponsor uses FDA Viewer to view waveforms

11. Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Clinical Trials: Integrating with patient care aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Sponsor identifies QT prolongation Polls registry through a Third Party Broker

12. Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Clinical Trials: Integrating with patient care aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Sponsor requests additional information Queries NIST registry, and obtains documents through a Third Party broker

13. Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Clinical Trials: Integrating with patient care Sponsor submits SDM data to the FDA Using HL7 v3 message and CDISC/HL7 standards aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3

14. Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Clinical Trials: Integrating with patient care FDA uses Patient Profile Viewer and ECG Viewer To view SDM and waveform data aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3

15. Adobe Berdy Medical Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Medical Systems Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS Clinical Trials: Integrating with patient care Imaging aECG Arden CCOW CDA CT EUA ODM PIX PSA RID RIM SDM SPL SWF V2 V3 Patients seen at PCP, hospitals ECGs sent to Core Lab, Sponsor and FDA Hospital Core Lab Sponsor FDA Registry Query broker, trusted 3 rd party Repository PCP Central Lab Dictation Repository

16. Adobe Berdy Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS HL7 aECG Arden CCOW CDA ODM LDM RIM SDM SPL V2 V3 IHE CT EUA PIX PSA RID SWF Special thanks to Mallinckrodt Institute of Radiology –Patient Identifier Cross Referencing (PIX) server Fred Behlen, Laitek Technologies –DICOM SR to CDA transformation The SIMI Group –State Department of Health application Michael Palmer, Zurich Biotech –SAS to ODM conversion NorthEast Monitoring –Corelab software integrating aECGs CSS Informatics –FDA Patient Profile Viewer AMPS –FDA aECG Viewer Amnon Shabo, IBM Haifa –Sample CDA Botulism Case Report Data Conversion Labs –Sample Structured Product Labeling transformation

17. Adobe Berdy Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS HL7 aECG Arden CCOW CDA ODM LDM RIM SDM SPL V2 V3 IHE CT EUA PIX PSA RID SWF Demo Executive Committee HL7 –Karen Van Hentenryck, HL7 Associate Director –Landen Bain, Co-chair, HL7 Marketing Committee IHE –Joyce Sensmeier, HIMSS –Chris Carr, RSNA

18. Adobe Berdy Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS HL7 aECG Arden CCOW CDA ODM LDM RIM SDM SPL V2 V3 IHE CT EUA PIX PSA RID SWF Invitation to Tour Guided Tours start on the quarter hour Self-guided Tours anytime –Maps available at Reception Complete a tour, win a prize –Get each location initialled by participant –Go to reception with completed map –Enter a business card to win HL7 Working Group Registration (drawing 1/day) HIMSS 2005 Registration (drawing 1/week)

19. GE RA600 Guided tours on the quarter hour; Self-guided tours any time Take A Tour, Win A Prize! Get a stamp at every stop on a tour Take stamped Tour Guide to receptionist Enter to win a Prize! -HL7 Registration or -HIMSS 2005 Registration Continuity of Care Tour Clinical Trials Tour Patient Safety Tour Public Health Tour aECG Annotated ECG (V3) 4, 16, 19, 20,21, 27 Arden Arden Syntax Medical Logic Modules 17, 19, 26 CCOW Clinical Context Object Workgroup 1,14, 15, 17, 18, 28, 29, 30 CDA Clinical Document Architecture (RIM) 2, 6, 7, 9, 10, 11, 12, 13, 20, 22, 23, 24, 25, 26, 32 CT Integration Profile for Consistent Time 1, 2, 18, 30 EUA Enterprise User Authentication (Kerberos) 1, 2, 14, 18, 28, 30 Integration Profiles: 1, 2, 3, 6, 8, 10, 11, 14, 15, 18, 28, 29, 30, 31 LDM Lab Data Model (V3, CDISC) 20 ODM Operational Data Model (CDISC) 20, 21 PIX Patient Identifier Cross Referencing (V2) 1, 11 PSA Patient Synchronized Application (CCOW) 1, 14, 18,28, 29, 30, RID Retrieve Information for Display 1,8, 10,11,15,18,29, 30 RIM Reference Information Model (V3) 2, 4,6, 7, 9, 10, 11, 12, 13, 16,19,20,21, 22, 23, 24, 25, 26, 27,32 SDS Submissions Data Standard (CDISC) 20, 21 SPL Structured Product Label (CDA) 19 SWF Scheduled Work Flow (V2, DICOM) 1,2,3,29,31 V2 Version 2 messaging 1,5,6, 8, 9,11,12,17,18,22,25,26,32 V3 Version 3 messaging 4,9,10,11,16,19,20,21,22,24,27,32 Start GE CWeb Kodak GE Solar Carefx/GE Mortara GE ED Eclipsys DigitalInfuzion DCRI CDC/ UCDavis Philips Adobe Epic GE CPortal Sentillion INFINITT Ximis Kryptiq CommerceNet MS InfoPath GE MUSE ACP/FDA NIST Start Berdy MS BTS Raining Data Dictaphone Soarian SNOMED Siemens OL 1 2 3 T H E A T E R C L A S S R O O M Misys 4 5 6 7 8 9 13 10 12 11 232425 2627 282930 31 32 21 22 14 15 1817 16 19 20 AISLE Tour Guide HL7-IHE Interoperability Demonstration Booth 4638 Walking Tour

20. Adobe Berdy Carefx CommerceNet DCRI Dictaphone Digital Infuzion Eclipsys Epic GE Heartlab IBM INFINITT Kodak Kryptiq Microsoft Misys Mortara NIST Philips Raining Data Sentillion Siemens SNOMED XIMIS HL7 aECG Arden CCOW CDA ODM LDM RIM SDM SPL V2 V3 IHE CT EUA PIX PSA RID SWF Thank you Questions? Tours starting now This presentation will be available on www.rsna.org/IHE/hl7ihedemo