Zio XT Service is a remote cardiac monitoring system used for detecting cardiac arrhythmia. It is comprised of the Zio patch, a wearable 1-lead ambulatory electrocardiogram (ECG), and the Zio report, a summary of the recorded data that have been analysed using an Artificial Intelligence led algorithm. This technology is being evaluated as part of NICE's pilot project to evaluate digital health technologies (DHTs). NICE is currently working to respond to the operational challenges posed to our normal work programmes. The stakeholders and advisory committees involved in the development of our guidance include a large number of frontline NHS staff. We know that their priority in this crisis is caring for patients and we do not want to draw them away from this vital work. For this reason, we are reviewing all of our guidance in development and will be prioritising only therapeutically critical topics at this time. Therefore, the public consultation for this topic has been paused and will be restarted once it is appropriate to do so; we will advise all registered stakeholders of the new dates in due course. Please accept our apologies for any disappointment this may cause. This is a rapidly changing situation and we will keep our approach under review. Our priority is to support the NHS to care for people during this difficult time. At present we’re not able to confirm the key dates for this guidance topic.
 
Status In progress
Process MT

Provisional Schedule

Committee meeting: 2 24 April 2020
Resolution 25 May 2020
Expected publication 06 July 2020

Project Team

Project lead Rebecca Brookfield

Email enquiries

Stakeholders

Manufacturers iRhythm Technologies
Others Boston Scientific
  Department of Health and Social Care
  Devices for Dignity
  Greater Manchester Health & Social Care Partnership
  Healthcare Improvement Scotland
  Johnson & Johnson Medical Ltd
  Medicines and Healthcare Products Regulatory Agency (MHRA)
  NHS England
  NHS Digital
Patient carer organisations Arrhythmia Alliance
  Atrial Fibrillation Association
  Heart Rhythm Alliance
Professional groups Association of British Healthcare Industries (ABHI)
  Association of Healthcare Technology Providers for Imaging, Radiotherapy and Care (AXrEM)
  HealthTech Alliance
  Medical Technology Group
  The British In Vitro Diagnostics Association (BIVDA)

Timeline

Key events during the development of the guidance:

Date Update
13 March 2020 - 27 March 2020 Draft guidance: 1
10 September 2019 Scope published
15 August 2019 Stakeholder registration opens

For further information on how we develop guidance, please see our page about NICE medical technologies guidance