1. www.HL7.org 1 HL7 Working Group Session May 3-7, 2004 San Antonio, TX Standards for Implantable Devices - Cardiac

2. 2 Overview Project Progress Next Steps Artifact Review Appendix: –Implantable Cardiac Device Overview –Current Clinician Environment –Implantable Device – Cardiac (IDC) Project Overview –Participants

3. 3 Project Progress Validated requirements through interviews and site visits Compiled HL7 v3.0 artifacts for Device Summary message –Storyboard –Application Roles –Trigger Event –Message Type –Interaction Diagram –Refined Message Information Model (R-MIM) –Hierarchical Message Definition (HMD) Identified nomenclature terms to be balloted via IEEE Vital Signs Nomenclature

4. 4 Next Steps Obtain feedback from participants and enhance current artifacts Prepare Device Summary artifacts for ballot Participate in enhancements to IEEE Vital Signs Nomenclature Gather additional requirements through interviews and site visits Create new HL7 v3.0 artifacts to support additional messages in this area

5. 5 Scenario Overview: Office Follow-Up

6. 6 Device Summary Data Aggregated set of data that is typically filed in the patient’s chart at follow-up Implanted Device Data Types: –Device Therapy Settings Pacing settings Defibrillation settings –Arrhythmia Logging Data Event Counters –Diagnostic Data Diagnostics on device functionality (e.g., lead impedance, sensing thresholds, pacing thresholds)

7. 7 Office Follow-Up: Interaction Diagram

8. 8 Office Follow-Up: Interactions, Roles & Trigger Events

9. 9 R-MIM

10. 10 Appendix –Implantable Cardiac Device Overview –Current Clinician Environment –Implantable Device – Cardiac (IDC) Project Overview

11. 11 Implantable Cardiac Device Overview Pacemakers Implantable Cardioverter Defibrillators Heart Failure devices Sensors Programmer Implantable cardiac devices exist as siloed subsystems

12. 12 Current Clinician Environment Implantable Cardiac Device Data Referring, Implanting & Following Physicians Integrated EHR/HIS/CIS Clinicians will prefer systems that integrate with their CIS Data Integration Opportunity

13. 13 IDC Project Overview Current Working Relationships Project under the sponsorship of the O&O Tech. Cmte. Participate in LAPOCT SIG and IEEE Joint Working Group Work with IEEE on extending Nomenclature Intended Working Relationships Monitor the work of the Vocabulary Tech. Cmte. This group will stay alert to and be prepared to work with any outside organization with similar or related goals, including: –DICOM WG1 –IEC (International Electrotechnical Commission) SC62D –IHE (Integrating the Healthcare Enterprise) Cardiology –NASPE (North American Society of Pacing and Electrophysiology) – Heart Rhythm Society –SNOMED

14. 14 Participants Implantable Device Companies & Medical Instrument Companies Interested Clinicians EHR Vendors Providers Payors Remote Monitoring Companies Electrophysiology (EP) Lab Diagnostic Vendors Healthcare Consulting Companies

15. 15 Implantable Cardiac Device Process Flow

16. 16 Device Data Overview Implanted Device Data Types: –Device Therapy Settings Pacing settings Defibrillation settings Therapy tuning features –Arrhythmia Logging Data Stored details on each episode Electrograms and event markers before, during, and after an event –Diagnostic Data Trended diagnostics on device functionality (e.g., lead impedance, sensing thresholds, pacing thresholds) Diagnostic data for titration of patient therapy –Data from in-clinic testing Inductions Various device status tests