Lisa Parker - Charles Perkins Centre, Faculty of Medicine and Health School of Pharmacy, The University of Sydney, NSW, Sydney, Australia
Lisa Bero - Charles Perkins Centre, Faculty of Medicine and Health School of Pharmacy, The University of Sydney, NSW, Sydney, Australia
Donna Gillies - NDIS Quality and Safeguards Commission, Penrith, NSW, Australia
Melissa Raven - Critical and Ethical Mental Health Research Group, Robinson Research Institute, The University of Adelaide, Adelaide, SA, Australia
Quinn Grundy - Faculty of Nursing, University of Toronto, Toronto, ON, Canada

BackgroundHealth apps are a booming, yet under-regulated market, with potential consumer harms in privacy and health safety. Regulation of the health app market tends to be siloed, with no single sector holding comprehensive oversight. We sought to explore this phenomenon by critically analysing how the problem of health app regulation is being presented and addressed in the policy arena. MethodsWe conducted a critical, qualitative case study of regulation of the Australian mental health app market. We purposively sampled influential policies from government, industry and non-profit organisations that provided oversight of app development, distribution or selection for use. We used Bacchi’s critical, theoretical approach to policy analysis, analysing policy solutions in relation to the ways the underlying problem was presented and discussed. We analysed the ways that policies characterised key stakeholder groups and the rationale policy authors provided for various mechanisms of health app oversight. ResultsWe identified and analysed ۲۹ policies from Australia and beyond, spanning ۵ sectors: medical device, privacy, advertising, finance, and digital content. Policy authors predominantly framed the problem as potential loss of commercial reputations and profits, rather than consumer protection. Policy solutions assigned main responsibility for app oversight to the public, with a heavy onus on consumers to select safe and high-quality apps. Commercial actors, including powerful app distributors and commercial third parties were rarely subjects of policy initiatives, despite having considerable power to affect app user outcomes. ConclusionA stronger regulatory focus on app distributors and commercial partners may improve consumer privacy and safety. Policy-makers in different sectors should work together to develop an overarching regulatory framework for health apps, with a focus on consumer protection.

Mobile Applications, mhealth, Regulation, Policy Analysis, Mental Health, Australia