CardX - Cardiac Implantable Electronic Devices
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CardX - Cardiac Implantable Electronic Devices, published by HL7 International / Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/CardX-CIED/ and changes regularly. See the Directory of published versions

Artifacts Summary

Contents:

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Behavior: Capability Statements

The following artifacts define the specific capabilities that different types of systems are expected to have in order to comply with this implementation guide. Systems conforming to this implementation guide are expected to declare conformance to one or more of the following capability statements.

CardX CIED Connectivity Server Capability Statement

This capability statement describes the requirements for systems that make CIED Connectivity data available.

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

Device - CIED Monitor Profile

The CardX Device - CIED Monitor profile inherits characteristics from ISO/IEEE 11073-10103 - Implantable device, cardiac. The same CIED Device data elements that are included in ISO/IEEE 11073-10103, are must support for CIED Monitors in the FHIR profile.
Device - Cardiovascular Implantable Electronic Device (CIED)

The CardX CIED Device profile is interoperable with ISO/IEEE 11073-10103 - Implantable device, cardiac. The cardinality of the profile aligns with the optionality of the ISO/IEEE 11073/10103 terms.

The following data-elements must always be present (Mandatory definition) or must be supported if the data is present in the sending system (Must Support definition). Within IEEE 11073-10103, MDC_IDC_DEV contains the following data elements: MDC_IDC_DEV_TYPE, MDC_IDC_DEV_MODEL, MDC_IDC_DEV_SERIAL, MDC_IDC_DEV_MFG
Observation - CIED Connectivity

Profile of the observation resource to present the most recent connectivity status and associated information for a CIED/Monitor combination. In most instances there will be one observation per CIED/monitor pair per patient, however some manufacturers may allow multiple CIEDs implanted in a patient to connect to a single monitor and have a single connectivity status for the entire system of devices.

CIEDs and monitors connect at regular intervals to exchange data ranging from every few minutes to every other week depending on the device/monitor configuration and manufacturer. The connectivity observation profile is a snapshot in time and is not intended to be used to query historical log information that may have been captured by the remote monitoring IoT platform. A single observation will be returned for every CIED/monitor pair.

Connectivity status is based on the actual time difference between the most recent successful communication and the present date. To manage disconnected patients, manufacturers have implemented additional functionality in their platforms. The connectivity modifier is included to represent an action performed by the user or business logic applied by the manufacturer. Examples of these are a user suspending a patient from appearing on the disconnected list in the remote monitoring system or the system automatically marking a patient as inactive after a prolonged disconnection period to remove them from appearing on the disconnected list in the user interface.
Patient - CIED Patient Profile

The CardX CIED patient profile is interoperable with the PID segment of the IHE Patient Care Device Technical Framework, Vol. 2, Section 3.9 - Communicate IDC Observations. The data elements in the FHIR profile are aligned, including allowing for the use of a concatenated Device Model and Serial Number to represent a unique patient identifier.

Structures: Extension Definitions

These define constraints on FHIR data types for systems conforming to this implementation guide.

CIED Device Extension

Extension to represent cardiac implantable device(s) which generated the observation.

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

CIED Connectivity Status Modifier Value Set

Additional modifiers to connectivity status as calculated by the CIED manufacturer
CIED Connectivity Status Value Set

The overall system connectivity status as calculated by the CIED manufacturer
CIED Monitor Types

The type of CIED monitor
CIED Patient Identifier

Identifier which can be used to identify CIED patients.
MDC IDC Device Types

ValueSet for ISO/IEEE 11073-10103 Nomenclature Codes for MDC_IDC_ENUM_DEV_TYPE (Device Type).

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

CardX CIED FHIR IG Code System

Codes system for CardX CIED FHIR Implementation Guide Codes.

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

uc1ACMEICD

An example CIED device for CIED connectivity example 1.
uc1ACMEPatient

An example CIED patient for CIED connectivity example 1.
uc1ConnectivityACME

An example CIED connectivity status for CIED connectivity example 1.
uc2ACMEPacemaker

An example CIED device for CIED connectivity example 2.
uc2ACMEPatient

An example CIED patient for CIED connectivity example 2.
uc2CIEDMonitor

An example CIED monitor for CIED connectivity example 2.
uc2ConnectivityACME

An example CIED connectivity status for CIED connectivity example 2.
uc3ACMEPacemaker

An example CIED device for CIED connectivity example 3.
uc3ACMEPatient

An example CIED patient for CIED connectivity example 3.
uc3CIEDMonitor

An example CIED monitor for CIED connectivity example 3.
uc3ConnectivityACME

An example CIED connectivity status for CIED connectivity example 3.
uc4ACMEPacemaker

An example CIED device for CIED connectivity example 4.
uc4ACMEPatient

An example CIED patient for CIED connectivity example 4.
uc4CIEDMonitor

An example CIED monitor for CIED connectivity example 4.
uc4ConnectivityACME

An example CIED connectivity status for CIED connectivity example 4.
uc5ACMEPacemaker

An example CIED device for CIED connectivity example 5.
uc5ACMEPatient

An example CIED patient for CIED connectivity example 5.
uc5CIEDMonitor

An example CIED monitor for CIED connectivity example 5.
uc5ConnectivityACME

An example CIED connectivity status for CIED connectivity example 5.