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.
Highlights
In 2016, the US Food and Drug Administration (FDA) stated it did not intend to regulate mobile applications that focused only general health and wellness.[1]
There is a lack of regulatory focus on consumer protection for app users, with regulation instead concentrating on reducing burdens of consumer choice
Mental health apps are subject to the same regulatory oversight as apps that focus on somatic health issues, while all health data is sensitive, mental health data is so, highlighting the importance of mental health app user privacy.[8]
Summary
In 2016, the US Food and Drug Administration (FDA) stated it did not intend to regulate mobile applications (apps) that focused only general health and wellness.[1] The news was welcomed by the digital health industry, which promptly expressed its approval at being “free[d]...from rules that could potentially slow progress in the field,”[2] explaining that “regulations...can be time-consuming and expensive.”[3] Dr James Madara, CEO of the American Medical Association, was more cautious, suggesting that oversight was needed to. Parker et al reduce patient harm from the “scam[s]” and “digital snake oil” that currently exist within the “tsunami” of health apps.[4,5] He agreed, that avoiding “heavy-handed” interference from government regulatory agencies in digital health was a good thing.[5] A recent viewpoint by FDA leadership published in the Journal of the American Medical Association confirms this stance for the majority of health-related apps and signals their intention to harmonize regulations internationally.[6]. This may mean health app users experience financial and other costs without any offset of benefit.[8,12,17,18] Apps may cause direct harm to health.[13,19] For example, apps that encourage self-monitoring and/or sharing may lead to anxiety in users who cannot keep up with recommended activities or find their results compare unfavourably with others.[20]
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