The "Hot Potato" of Mental Health App Regulation: A Critical Case Study of the Australian Policy Arena

Author:

Parker Lisa1,Bero Lisa1,Gillies Donna2,Raven Melissa34,Grundy Quinn5

Affiliation:

1. Charles Perkins Centre, Faculty of Medicine and Health School of Pharmacy, The University of Sydney, NSW, Sydney, Australia.

2. NDIS Quality and Safeguards Commission, Penrith, NSW, Australia.

3. Critical and Ethical Mental Health Research Group, Robinson Research Institute, The University of Adelaide, Adelaide, SA, Australia.

4. Discipline of Public Health, Flinders University, Adelaide, SA, Australia.

5. Faculty of Nursing, University of Toronto, Toronto, ON, Canada.

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.

Publisher

Maad Rayan Publishing Company

Subject

Health Policy,Health Information Management,Leadership and Management,Management, Monitoring, Policy and Law,Health (social science)

Reference48 articles.

1. U.S. Food and Drug Administration (FDA). General wellness: Policy for low risk devices. Rockville, MD: U.S. Food and Drug Administration; 2016.

2. Kaminsky H. FDA states it will not regulate fitness trackers and wellness apps. Digital Trends. July 31, 2016. https://www.digitaltrends.com/health-fitness/fda-will-not-regulate-fitness-wellness-apps/.

3. Ruoff A. Fitness trackers, wellness apps won’t be regulated by FDA. Bloomberg BNA. July 29, 2016. https://www.bna.com/fitness-trackers-wellness-n73014445597/.

4. Staff writer. Medical innovation and digital snake oil: AMA CEO speaks out. AMA Wire. July 17, 2016. https://wire.ama-assn.org/life-career/medical-innovation-and-digital-snake-oil-ama-ceo-speaks-out.

5. Parks T. Self-regulation key to the future of health care tech. AMA Wire. September 27, 2016. https://wire.ama-assn.org/life-career/self-regulation-key-future-health-care-tech.

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