CardX: Connectivity Use Case (CIED) (Jira PSS-2490)

This project will create a consistent, unifying standard for the communication of cardiac implantable electronic device (CIED) remote monitoring connectivity information from device manufacturers to clinicians. The first steps in the process are completed by manufacturers (proprietary) and include transmission of data from the CIED device to the patient monitor and from the patient’s monitor to manufacturer’s cloud-based database. At that point clinicians can either query each database or utilize a third party intermediary to aggregate the forms across the manufacturers and provide them to the clinician. FHIR resources will be used to convey standardized connectivity status data from manufacturers to third party intermediaries or directly to clinicians and their electronic health record systems, enabling consistency and uniformity for clinician and patient messaging and management of a panel of CIED patients across all CIED manufacturers.

Cardiac implantable electronic devices (CIEDs), by and large, support data transmission through standardized IDCO/IEEE, however, communication of interoperable CIED data - especially across manufacturers - has not been coordinated. This results in the need for multiple disparate and duplicative workstreams to manage a panel of CIED patients. Furthermore, periodic remote monitoring (RM) of both device status and patient event reporting is the standard of care, however, patients frequently become disconnected from monitoring and reporting services. These issues reduce the efficiency and effectiveness of care of the CIED patient and are a patient safety issue.

This project will create a consistent, unifying standard for the communication of cardiac implantable electronic device (CIED) remote monitoring connectivity information from device manufacturers to clinicians. The first steps in the process are completed by manufacturers (proprietary) and include transmission of data from the CIED device to the patient monitor and from the patient monitor to manufacturers remote monitoring software. FHIR resources will be used to convey standardized connectivity status data from manufacturers to third party intermediaries and electronic health record systems, enabling consistency and uniformity for clinician and patient messaging and management of a panel of CIED patients across all CIED manufacturers. The CardX domain, a community within the HL7 CodeX FHIR Accelerator, has convened global stakeholders to define the use cases and develop FHIR artifacts including profiles and a corresponding implementation guide to improve patient connectivity and outcomes.

Phase 1 of the project is to author a FHIR Implementation Guide specific to the exchange of CIED data that communicates patient connectivity (i.e., patient connectivity in the manufacturer remote monitoring (RM) system). Requisite data elements for the use case will be identified from existing terminology standards where possible. Data elements will include: 1) patient demographics, 2) CIED descriptive data elements and device identifiers, 3) patient monitor descriptive data elements and device identifiers, and 4) observation (connectivity status) representing most recent connectivity timestamps, status and other relevant data.

The IG will address the following connectivity states:

1) Setup not completed - device/monitor setup has not been completed

2) Not applicable - connectivity states not applicable for device

3) Undetermined - connectivity status has not been defined or cannot be calculated

4) Suspended - patient has been temporarily removed from disconnected status

5) Disabled - patient has been permanently removed from disconnected status

6) Connected - CIED and manufacturer server have been communicating within the expected time period

7) Disconnected - CIED and manufacturer server have not been communicating within the expected period.

FHIR resources will include Patient, Device (CIED and monitor), DeviceAssociation, and Observation (connectivity information). We will be balloting as a standard for trial use, and pilot implementation by sites across the manufacturer, health care intermediary, electronic health record, patient, and clinician domains.

The goal of the CIED Connectivity FHIR IG is to facilitate the receipt of connectivity status data in a consistent, standardized, analyzable format regardless of CIED manufacture that enables efficient and effective management of a panel of CIED patients. This will engage patients, improve health outcomes, and reduce clinician burden. Future phases in the CardX domain will focus on solving additional interoperability problems for CIED patients and providers.