NICE publishes first draft guidance from its Early Value Assessment pilot project recommending smartphone-linked ECG device

It is the first recommendation to be issued by NICE’s diagnostics advisory committee via its Early Value Assessment pilot project.

A man holding a KardiaMobil ECG recording device

NICE has today (Friday 12 August 2022) issued draft guidance recommending KardiaMobile 6L for measuring cardiac QT interval in people having antipsychotic medication.

People taking antipsychotic medication may need testing for heart problems before starting treatment and at regular intervals during their treatment. Detecting heart problems such as rhythm disturbances can inform the choice of medicines, their dosing, whether to stop them, and potentially avoid severe cardiac events.

NICE has identified there is an unmet clinical need for a more easily accessible and available ways to measure heart rhythm disturbance such as QT interval in the psychiatric service setting.

The KardiaMobile 6L is a portable ECG recording device that is a less intrusive way of measuring heart changes that may affect the choice of medication taken for psychiatric disorders. It has two electrodes on the top that are touched to the fingers, and one on the bottom to make contact with the skin of the left leg.

The ECG can be recorded using KardiaMobile 6L, in any psychiatric setting, including during a home visit by a community health professional which may reduce the stress and anxiety of people attending an outpatient’s appointment. The data is recorded and transmitted wirelessly to a mobile device such as a smartphone or tablet.

Current practice to measure QT interval is to use a 12-lead ECG device. This needs the person to partially undress and use conductive gel on the skin to create contact with the electrodes. This can cause reluctance and distress.

The recommendation is that using KardiaMobile 6L should be offered as an option in psychiatric services to measure heart rhythm disturbances, such as a QT interval, in people taking or about to take antipsychotic medication while further real-world evidence is generated. This is to address uncertainty around how well using KardiaMobile 6L works for measuring QT interval in the psychiatric service setting.

The NICE Early Value Assessment pilot project has been created to drive innovation into the hands of health and care professionals by actively drawing in digital products, medical devices and diagnostics that address national unmet needs.

It will provide quicker assessments of early value to identify the most promising technologies that can be used in the NHS. It means clinicians and patients can benefit from medical technologies while further data is collected to inform a full NICE assessment of the device’s cost and clinical effectiveness.

Once real-world evidence is generated, the appraisal will return to the independent NICE committee for it to undergo full assessment.

A consultation has started on the recommendations contained in the early value guidance consultation document which appraises KardiaMobile 6L for measuring cardiac QT interval in people having antipsychotic medication. Comments must be submitted by Thursday 25 August 2022 via