Guidance
Evidence-based recommendations on KardiaMobile for detecting atrial fibrillation.
Last reviewed: 25 July 2023
This guidance was withdrawn between December 2022 and July 2023. During this time the supply of KardiaMobile to the NHS was paused while the company worked towards meeting the Digital Technology Assessment Criteria (DTAC). This criteria has now been met and accepted by NHS England and supply has resumed.
This guidance replaces NICE's medtech innovation briefing on KardiaMobile for the ambulatory detection of atrial fibrillation (MIB232).
Next review: This guidance will be reviewed if there is new evidence that is likely to change the recommendations.
Implementation
NICE has developed tools and resources, in association with relevant stakeholders, to help organisations put this guidance into practice.
Guidance development process
How we develop NICE medical technologies guidance
NICE medical technologies guidance addresses specific technologies notified to NICE by companies. The ‘case for adoption’ is based on the claimed advantages of introducing the specific technology compared with current management of the condition. This case is reviewed against the evidence submitted and expert advice.
Your responsibility
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.