Abstract
Background: Health 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.
Methods: We 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.
Results: We identified and analysed 29 policies from Australia and beyond, spanning 5 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.
Conclusion: A 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.