Non-medical device apps for good health and well-being: regulatory challenges

Conference paper

George, C. 2025. Non-medical device apps for good health and well-being: regulatory challenges. George, C., Whitehouse, D. and Duquenoy, P. (ed.) MDX 2025 Health IT Workshop on Emerging Technologies in Healthcare: Legal, Ethical, Social & Governance Aspects. Middlesex University, London, UK 26 - 27 Jun 2025 Middlesex University. pp. 66-71
TypeConference paper
TitleNon-medical device apps for good health and well-being: regulatory challenges
AuthorsGeorge, C.
Abstract

General healthcare/well-being awareness and technological innovations have resulted in numerous smartphone apps (especially powered by artificial intelligence (AI)) being developed and marketed to the public. Due to the widespread use of smartphones, apps can be easily downloaded and are hence widely available. Revenue from digital fitness and well-being apps (e.g., to address anxiety, depression, stress, panic attacks, mindfulness, meditation, mood tracking and self-care) in the United Kingdom (UK) is projected to reach £.1.65 billion in 2025 and £2.16 billion by 2029. Most fitness and well-being apps are not categorised as medical devices, and are therefore not regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). This paper discusses medical device apps versus non-medical device apps with a focus on the regulatory challenges of the latter especially in the UK context.

KeywordsNon-Medical Apps; Artificial Intelligence; Regulation
Sustainable Development Goals3 Good health and well-being
Middlesex University ThemeHealth & Wellbeing
Research GroupAspects of Law and Ethics Related to Technology group
ConferenceMDX 2025 Health IT Workshop on Emerging Technologies in Healthcare: Legal, Ethical, Social & Governance Aspects
Page range66-71
Proceedings TitleProceedings of the MDX 2025 Health IT Workshop on Emerging Technologies in Healthcare: Legal, Ethical, Social & Governance Aspects
EditorsGeorge, C., Whitehouse, D. and Duquenoy, P.
PublisherMiddlesex University
Copyright Year2025
Publication dates
Online21 Oct 2025
Publication process dates
Accepted10 Sep 2025
Deposited24 Oct 2025
Output statusPublished
Accepted author manuscript
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File Access Level
Open
Copyright Statement

© Middlesex University. This work is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed.

Web address (URL) of conference proceedingshttps://doi.org/10.60528/2q6192
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Is part ofProceedings of the MDX 2025 Health IT Workshop on Emerging Technologies in Healthcare: Legal, Ethical, Social & Governance Aspects
LanguageEnglish
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