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

The CIED Diagnostic Report Profile contains the metadata, device references,observation references, and attachments for an interrogated device transmission. Several device and observation references may exist depending on the number of devices implanted in a patient and how the observation data are associated with the devices. Separate observations may also be created during additional post-processing by the remote monitoring software or other processing systems used to interrogate the device data.

The CIED Interrogation Procedure profile contains the session information for a device interrogation.

The CIED Practioner profile contains the metadata for a healthcare provider associated with a device interrogation.

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.

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

The CardX CIED Device Lead 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_LEAD_MODEL, MDC_IDC_LEAD_SERIAL, MDC_IDC_LEAD_MFG, MDC_IDC_LEAD_ADVISORY_INFO_STATUS

Device association contains to relationship between the CIED, leads, and other devices associated with a patient. The resource may contain both active and historical associations.

Observation profile to support implantable cardiac device measurements, settings, statistics, episodes, notifications, and nomenclature

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.

The CIED Organization profile contains the metadata for an organization associated with a device interrogation.

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.

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

Extentension to support expanding number of reportable data beyond constrained number defined in nomenclature.

Extension to capture the MDC Display Name for an IDC Observation Component Code

Abnormal Flags Included in the IHE PCD Technical Framework to communicate IDC Observations

Additional modifiers to connectivity status as calculated by the CIED manufacturer

The overall system connectivity status as calculated by the CIED manufacturer

The type of CIED monitor

Identifier which can be used to identify CIED patients.

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

ValueSet for the MDC IDC partition.

Codes system for CardX CIED FHIR Implementation Guide Codes.

Example IDCO

An example CIED device for CIED connectivity example 1.

An example CIED patient for CIED connectivity example 1.

An example CIED connectivity status for CIED connectivity example 1.

An example CIED device for CIED connectivity example 2.

An example CIED patient for CIED connectivity example 2.

An example CIED monitor for CIED connectivity example 2.

An example CIED connectivity status for CIED connectivity example 2.

An example CIED device for CIED connectivity example 3.

An example CIED patient for CIED connectivity example 3.

An example CIED monitor for CIED connectivity example 3.

An example CIED connectivity status for CIED connectivity example 3.

An example CIED device for CIED connectivity example 4.

An example CIED patient for CIED connectivity example 4.

An example CIED monitor for CIED connectivity example 4.

An example CIED connectivity status for CIED connectivity example 4.

An example CIED device for CIED connectivity example 5.

An example CIED patient for CIED connectivity example 5.

An example CIED monitor for CIED connectivity example 5.

An example CIED connectivity status for CIED connectivity example 5.