Regulation and accreditation of addictive behaviour applications—navigating the landscape

Khadjesari, Zarnie ORCID:, Brown, Tracey and Naughton, Felix (2021) Regulation and accreditation of addictive behaviour applications—navigating the landscape. Addiction, 116 (12). pp. 3276-3283. ISSN 0965-2140

[thumbnail of Published_Version]
PDF (Published_Version) - Published Version
Available under License Creative Commons Attribution Non-commercial.

Download (220kB) | Preview


Background: mHealth applications (apps) for addictive behaviours offer widespread provision of digital support, with particular benefits for stigmatized groups and those with poor access to treatment services. Regulation and accreditation may encourage the uptake and use of evidence-based addictive behaviour apps, yet this is a complex and confusing landscape. We navigate international regulatory and accreditation guidance, explore some of the implementation challenges and provide implications for app developers, health-care professionals and app users. Analysis: We explore the classification of health and wellbeing, blended support and clinical therapy apps as medical devices by country to help readers navigate the complexity of the guidance. We describe an addictive behaviour app classified as a medical device and explore the innovative approaches to regulation that are currently emerging. We discuss the use of curated on-line app libraries that adhere to thresholds for characteristics such as quality, user satisfaction or effectiveness, which we hope will become the starting-point in the search for suitable apps, rather than commercial app stores. We also explore the ethical concerns associated with apps and how curated libraries address these. Conclusions: International regulation of applications as medical devices varies across countries and would benefit from standardization in a simple, usable and transparent format. Efforts to provide accreditation of non-medical device applications are also variable, and public bodies provide mixed messages concerning endorsement. Health-care professionals and users are encouraged to use accredited applications for addictive behaviours where they exist, or explore other forms of digital intervention with a stronger evidence base.

Item Type: Article
Uncontrolled Keywords: addiction,app accreditation,app regulation,digital health,mhealth,medical device,medicine (miscellaneous),psychiatry and mental health,sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700/2701
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Behavioural and Implementation Science
Faculty of Medicine and Health Sciences > Research Groups > Health Promotion
Faculty of Medicine and Health Sciences > Research Centres > Norwich Institute for Healthy Aging
Related URLs:
Depositing User: LivePure Connector
Date Deposited: 24 Mar 2021 00:41
Last Modified: 20 Apr 2023 20:34
DOI: 10.1111/add.15484

Actions (login required)

View Item View Item