Charles Perkins Centre, Faculty of Medicine and Health School of Pharmacy, The University of Sydney, NSW, Sydney, Australia.
NDIS Quality and Safeguards Commission, Penrith, NSW, Australia.
Int J Health Policy Manag. 2019 Mar 1;8(3):168-176. doi: 10.15171/ijhpm.2018.117.
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.
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.
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.
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.
健康类应用程序市场蓬勃发展，但监管不足，存在隐私和健康安全方面的潜在消费者危害。健康类应用程序市场的监管往往各自为政，没有任何一个部门能够全面监管。我们试图通过批判性地分析健康类应用程序监管问题在政策领域中的呈现和处理方式来探讨这一现象。
我们对澳大利亚心理健康类应用程序市场的监管进行了批判性的定性案例研究。我们有针对性地选择了来自政府、行业和非营利组织的有影响力的政策，这些政策对应用程序的开发、分发或选择使用进行了监督。我们使用 Bacchi 的批判性政策分析理论方法，根据呈现和讨论潜在问题的方式来分析政策解决方案。我们分析了政策对关键利益相关者群体的特征，以及政策制定者为各种健康类应用程序监督机制提供的理由。
我们从澳大利亚和其他国家确定并分析了 29 项政策，涵盖了 5 个部门：医疗器械、隐私、广告、金融和数字内容。政策制定者主要将问题框架为潜在的商业声誉和利润损失，而不是消费者保护。政策解决方案将应用程序监督的主要责任分配给公众，消费者承担选择安全和高质量应用程序的重任。商业行为者，包括有影响力的应用程序分发商和商业第三方，尽管对应用程序用户的结果有相当大的影响力，但很少成为政策举措的对象。
对应用程序分发商和商业伙伴的监管加强可能会提高消费者的隐私和安全性。不同部门的政策制定者应共同努力，为健康类应用程序制定一个全面的监管框架，重点是保护消费者。
