Regulation and accreditation of addictive behaviour applications—navigating the landscape

Abstract

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.