1. IHE ITI – Dec 2006What IHE Delivers 1 Nicholas Steblay Implantable Device Cardiac Observations (IDCO) Profile

2. IHE ITI – Dec 2006 2 Implantable Cardiac Devices Pacemakers – therapy for heart rate problems Defibrillators – therapy for life threatening heart rhythms Cardiac Resynchronization – therapy for congestive heart failure

3. IHE ITI – Dec 2006 3 Device Interrogations Implant Clinic Home The act of retrieving data from implanted cardiac devices. Done at implant or during patient follow-ups. Information includes Patient and Device Observations, and Therapy Settings

4. IHE ITI – Dec 2006 4 Market Statistics Sudden Cardiac Death (SCD) is the leading single cause of death in the U.S. - estimates are 19% of all deaths.- 460,000 in 2005. 1 3 to 5% of Americans have atrial fibrillation. 2 About 5 million people in the United States have heart failure, and the number is growing. Each year, another 550,000 people are diagnosed for the first time. It contributes to or causes about 300,000 deaths each year. 3 From 1990 to 2002, 2.25 million pacemakers were implanted and 417,780 ICDs were implanted in the U.S. 4 Estimated total implantable cardiac device market for 2006 is 9.4 – 9.6 billion dollars. Project growth in the market through 2009 is 4 – 8%. 5 Numerous published clinical studies (COMPANION, MADIT, MADIT II, SCDHeft) have shown the efficacy of implanted cardiac rhythm management devices. 1 SCDHeft | 2 ACC | 3 NHLBI | 4 Jama | BSC

5. IHE ITI – Dec 2006 5 Cardiology and EP Workload According to Heart Rhythm Society studies 1  Electrophysiology is the fastest growing of all cardiovascular disciplines.  Demands for cardiologist and electrophysiologist time is projected to increase through 2020. To manage workload EPs and device clinics are looking for more efficient ways of following patients with implantable devices. 1 HRS http://www.hrsonline.com

6. IHE ITI – Dec 2006 6 Clinical Process – Device Follow-up 3.1 Schedule Follow- ups 3.2 Exam Patient & Interrogate Device 3.3 Analyze Information   3.1.1 Schedule In Clinic Follow-ups   3.1.2 Schedule Remote Follow-ups   3.2.1 Exam Patient (Physical & Lab Tests If Needed)   3.2.2 Interrogate Device In Clinic   3.2.3 Interrogate Device Remote   3.3.1 Review Exam and Interrogation Information   Determine New or Adjusted Therapies 3.4 Adjust Therapy and Configure Device   3.3.1 Pharmalogical   3.3.2 Configure and Test Pulse Generator 3.5 Update Medical Record   3.5.1 Record and Follow-up Process and Outcomes   3.5.2 Record Pertinent Data Concerning Device and Pharmalogical   3.5.4 Sign-Off Procedure   3.5.5 Create Follow- up Summary (Referral Letter) for Following Physician 1.0 Diagnosis 2.0 Implant 3.0 Device Follow-up 4.0 Patient Follow-up 5.0 Acute Events Explants Level 0 Level 1 Level 2

7. IHE ITI – Dec 2006 7 Implantable Cardiac Device Follow-up Problems and Opportunities Device follow-up load is significant. ICD patients are typically followed 4 times a year, and Pacemaker patients 2 times a year. The follow-ups can occur in-clinic or remotely in the home healthcare environment. EPs follow patients with implantable cardiac devices from multiple vendors. Each “interrogating” device is vendor proprietary. Access to follow-up information often requires cardiologists and EPs to use multiple vendor specific systems and interfaces, complicating efficiency and quality of workflows. Aggregation of data into a central EMR or device clinic management systems requires manual and paper processes.

8. IHE ITI – Dec 2006 8 IDCO Value Proposition Enable management of follow-up information in a central system such as an EMR, Cardiology Information System or Device Clinic Management System Improve efficiency and quality of related clinical processes  Single point of access for information  Automation of current manual processes for data collection, aggregation and analysis  Standardization of workflow processes  Enabling of analytics

9. IHE ITI – Dec 2006 9 IDCO Profile Approach Rallied domain vendors around a profile that defines a standard approach to integrating implantable cardiac device follow-up information into a receiving clinic system Enabled the needed systems integration by profiling the use of standard, domain applicable messaging protocols, structures and data semantics  HL7 Therapeutic Device Domain – Implantable Device Cardiac messaging standards  ISO/IEEE 11073 Point of Care Medical Device Communication Standards nomenclature Defined actors, transactions and constraints consistent with existing and evolving IHE profiles and contexts  Aligning with future EP Workflow and other related profiles

10. IDCO Profile Systems Model

11. IHE ITI – Dec 2006 11 EMR Interest in IDCO Profile Do any EMR vendors have plans in place to support the IDCO profile in future product? What will it take to get EMR vendors interested in IDCO profile participation for 2008? What factors drive potential participation? How did EMR vendors decide to participate in their current portfolio of supported IHE profiles? Who should be contacted within the EMR vendor companies to discuss this further?

12. IHE ITI – Dec 2006 12 EMR Interest continued Do EMR vendors need help from IMD device vendors to understand the domain and data mapping. Would that be useful and positive factor in decision making to support the profile? If the IDCO message would be extended with nontrivial EGM waveforms and annotations data, histograms and trends data – what would EMR vendors like to parse  XML document  Discrete OBX segments  DICOM objects?

13. IHE ITI – Dec 2006 13 HL7 v2 and v3 Current IDCO profile requires the use of an embedded HL7 v3 message structure within a HL7 v2 ORU message. Current profile has specified an option for a standard HL7 v2 ORU message. Would EMR vendors be more likely to participate if the IDCO profile specified compliance using a standard v2 ORU message?

14. IHE ITI – Dec 2006What IHE Delivers 14 Appendix IDCO Profile - Details

15. IHE ITI – Dec 2006 15 IDCO Profile Use Cases In-Clinic Implants or Follow-ups  Patients present themselves in-clinic for implantation or follow-ups  Information is collected using vendor specific “programmers”  Information is sent from interrogation system to a central Device Clinic Management System or EMR Remote Follow-ups  Patients devices are interrogated in the home health care environment  Information is collected using vendor specific communication devices and systems  Information is sent from interrogation system to a central Device Clinic Management System or EMR

16. IHE ITI – Dec 2006 16 IDCO Actors and Transaction

17. IHE ITI – Dec 2006 17 IDCO Actors Observation Creator - A system that creates and transmits diagnostic or therapeutic observational data. Observation Processor and Repository – Systems that receive clinical observations and further process them or store them for retrieval and display. Grouped with PIX and PAM actors for patient identification and demographics management (not required first year).

18. IHE ITI – Dec 2006 18 IDCO Actors Alternative Actor configuration HL7 Router - A system that receives HL7 messages, routes them to one or more configured actors, and handles transport level acknowledgements. Router will manage patient identification cross-referencing

19. IHE ITI – Dec 2006 19 Potential Participants Observation Creator  Implantable Cardiac Device Vendors Observation Processor and Repository  EMR or Device Clinic Management System Vendors HL7 Router  Integration Engine Vendors Others (?)

20. IHE ITI – Dec 2006 20 IDCO Transaction CARD-12  Unsolicited HL7 v2.5 ORU message  OBX contains XML payload based on HL7 v3 IDC message  XML payload coded using ISO/IEEE 11073.1.1.3 IDC nomenclature containing Device Observations, Patient Observations, Device Therapy Settings  Options for standard v2.5 OBX and embedded PDF report  Audit Trail and Node Authentication (ATNA) profile recommended for remote follow-ups across non-trusted networks

21. IHE ITI – Dec 2006 21 Embedded XML Data Payload in OBX Based on v3 IDC RMIM

22. Option for Standard OBX Segment

23. IHE ITI – Dec 2006 23 Observations Coded Using ISO/IEEE 11073 IDC Nomenclature

24. IHE ITI – Dec 2006 24 Example Transaction Flow

25. IHE ITI – Dec 2006 25 Potential Extended Actor Groupings Basic IDCO Report Display using Retrieve Information for Display Profile (RID) IDCO Data Incorporation into a Report using Displayable Reports Profile (DRPT) IDCO Discrete Data Storage using Evidence Documents Profile (ED) IDCO Submission to an EHR using Cross Domain Document Sharing Profile (XDS)

26. IHE ITI – Dec 2006 26