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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    7c. KardiaMobile 6L Early Value Guidance Consultation Document [noACIC].docx

    The National Institute for Health and Care Excellence (NICE) is producing early value guidance on using KardiaMobile 6L. The diagnostics advisory committee has considered the evidence and the views of clinical and patient experts. This topic is the first pilot using the new early value assessment approach. The aim of early value guidance is to provide quicker conditional recommendations from NICE on promising medical technologies while uncertainty in their evidence base is being addressed.

    This document has been prepared for public consultation. It summarises the evidence and views that have been considered and sets out the evidence generation recommendations made by the committee. NICE invites comments from registered stakeholders, healthcare professionals and the public. This document should be read with the evidence (an early value assessment report, cost and resource use report).

    The advisory committee is interested in receiving comments on the following:

    • Has all of the relevant evidence been considered?

    • Are the summaries of clinical effectiveness, costs and resource use reasonable interpretations of the evidence?

    • Are the recommendations sound, and a suitable basis for early value guidance to the NHS?

    NICE would also welcome comments on the style and presentation of this guidance and how suitable it is for informing practitioners, commissioners and managers in the NHS.

    Equality issues

    NICE is committed to promoting equality of opportunity, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. Please let us know if you think that the recommendations may need changing to meet these aims. In particular, please tell us if the recommendations:

    • could have a different effect on people protected by the equality legislation than on the wider population, for example by making it more difficult in practice for a specific group to access the technology

    • could have any adverse effect on people with a particular disability or disabilities.

    Please provide any relevant information or data you have about such effects and how they could be avoided or reduced.

    Note that this document is not NICE's final guidance on KardiaMobile 6L for measuring cardiac QT interval in people having antipsychotic medication. The conditional recommendations in section 1 and the accompanying points on evidence generation in section 4 may change after consultation.

    After consultation, NICE will consider the comments received. The final recommendations will be the basis for NICE's early value guidance on using the technology with evidence generation.

    Key dates:

    Closing date for comments: 25 August 2022