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.

Smartphone applications for intervening on addictive behaviors: efficacy is just one phase of the marathon*

“…Khadjesari et al . [1] provide a timely contribution to the growing discussion of smartphone applications (apps) for addictive behaviors. While there are thousands of these apps, very few have proved efficacious [2].…”

“…Khadjesari et al . [1] explore a number of approaches that could help to address these challenges, including regulatory approval and accreditation in curated online app libraries.…”

“…Partnering with pre‐certified developers, as proposed by Khadjesari et al . [1], is unlikely to solve this dilemma, as pre‐certification is merely a pilot Food and Drug Administration (FDA) program; there are now only nine FDA‐approved developers (the majority are major corporations such as Apple, Inc.). These developers would need to accept liability for the new apps, and FDA approval of these new apps would not be automatic [8].…”

“…Kadjesari et al . [1] propose that accreditation via curated online app libraries may be a solution to barriers to increasing use of evidence‐based addictive behavior apps. Although such libraries could have the advantages enumerated by Kadjesari et al .…”

“…Although such libraries could have the advantages enumerated by Kadjesari et al . [1], they are unlikely to prove a panacea. Few consumers are aware of app libraries, and this will not change without major investments in marketing and continuous attention to quality review.…”