1. IHE Electrophysiology Remote Implantable Rhythm Control Device Interrogation Eliot L. Ostrow November 2005 Rev 0.0

2. IHE EP Page 2 Remote Interrogation Problem Statement Each manufacturer of implantable rhythm control devices (i.e., pacemakers and ICDs) provides the physician and patient with its own proprietary system for performing remote device follow-up. This creates a number of difficulties for clinicians who follow patients with these devices. Among those difficulties are: Need for training staff and patients on different systems (patient hardware and method of receiving/retrieving information Lack of single source for retrieving information from patients, regardless of device manufacturer Physicians would prefer that all device vendors remote systems be capable of transmitting a key subset of device data (device identification, stored electrograms, selected programmed parameters and diagnostics, alerts, etc.) to all other vendors systems.

3. IHE EP Page 3 Remote Interrogation Problem Statement No standard currently exists for device communication. Therefore, each implanted device company has its own proprietary communication protocol for retrieving data from its devices. It is out of the scope of IHE, at least at present, to address the desire for a single set of interrogator (transmitter) hardware that could be given to the patient, and which would work with any vendors implantable device. However, the ability to standardize the retrieval and viewing of information from any system in a single, centralized location, and the subsequent storage of that data, is within the scope of IHE.

4. IHE EP Page 4 Remote Interrogation Proposed Approach This proposed IHE integration profile will be used to facilitate the transmission of key identification data, parameter data, and alert information to the following physician or his/her designee. This transmission may be mediated by a system that provides aggregation with previously collected patient data. The profile will not specify the organizational location of the data aggregation system, which could be managed by individual device manufacturers and/or by third party vendors. The profile will facilitate the creation of a meta-data registry, which could locate and allow retrieval of the data from individual data repositories. This approach should be aligned with the approach taken for in-office collection of follow-up data. The proposed HL-7 information model may provide the basis for the identification, parameter, and alert information.

5. IHE EP Page 5 Remote Follow-Up Scenario 1 At scheduled time, an interrogation device (transmitter) collects data from the implantable rhythm control device (with or without patient interaction), converts it into IHE-compliant format (e.g., PDF/XML version of manufacturer-generated reports, HL-7 compliant identification, parameter, and diagnostic data), and transmits it to a central data repository Repository may be server operated by device manufacturer, organization (e.g., HRS), third party service provider (e.g., Raytel), dedicated in-office/in-hospital device follow-up database (e.g., Pace Art), or EMR system Physician logs onto physician viewer (which may be website or part of database/EMR system), and views list of newly available remote follow-ups List provides patient identification information (e.g., name, ID number, etc.), device ID (manufacturer, model and serial number), and alert conditions for follow-ups that requires high priority attention Clinician requests retrieval of specific data sets for review or printing Clinician reviews the data, adds appropriate notations, electronically approves Report is forwarded by e-mail to other interested clinicians, and is sent to an EMR system for permanent storage.

6. IHE EP Page 6 Remote Interrogation Profile Diagram-Model 1

7. IHE EP Page 7 Remote Follow-Up-Alternative Scenarios Variants on Remote Follow-Up Scenario 1 Process could be initiated in emergency situation by the patient at other than regularly-scheduled times. Data could be stored on multiple servers, with registry providing links to access the data Data could be sent in raw form to a server (e.g., a server run by a device manufacturer), which transforms the data into IHE-compliant format Server could combine newly acquired data with previously acquired data to provide additional information (e.g., trending)

8. IHE EP Page 8 Remote Interrogation Profile Diagram-Model 2

9. IHE EP Page 9 Remote Follow-up Profile Actors Interrogator-A remote device capable of receiving data transmission from an implanted pacemaker or ICD and transmitting it Patient Data Aggregator (optional)-Combines data received from transmitter with previously acquired data Data Formatter-Transforms raw data into IHE-compliant format Data Repository-Stores data for retrieval Registry (optional)-Stores ID, header, alert information, and location of data Physician Viewer-Portal from which clinician receives notification of available data, accesses full data set

10. IHE EP Page 10 Remote Follow-up Profile Transactions Device data interrogation-Retrieval of raw data from implanted rhythm control device Patient data aggregation-Combines newly acquired data with previously acquired data to provide additional analysis and information (e.g., trends) Data formatting-Transformation of raw information into IHE-compliant format Availability notification-Provides clinician with identification and alert information for newly available data Data query-Request for retrieval of full data from data repository Data transfer-Transmission of full data to physician viewer

11. IHE EP Page 11 Phased Approach Phase I Implementation of IHE compliant format for company-specific reports, header/identification data, parameter and diagnostic data Phase II Facilitation of meta-data registry that would allow for single-point access to data stored in multiple locations

12. IHE EP Page 12 Open Issues ???