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

Document Type: Original Article

Authors

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.

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  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.   
  6. Shuren J, Patel B, Gottlieb S. Fda regulation of mobile medical apps. JAMA. 2018;320(4):337-338. doi:10.1001/jama.2018.8832
  7. Research2guidance. mHealth App Developer Economics 2016. Berlin, Germany: research2guidance; 2016.
  8. Hollis C, Morriss R, Martin J, et al. Technological innovations in mental healthcare: harnessing the digital revolution. Br J Psychiatry. 2015;206(4):263-265. doi:10.1192/bjp.bp.113.142612
  9. Australian Government. Australian Government response to Contributing Lives, Thriving Communities - Review of mental health programmes and services. Canberra, ACT: Commonwealth of Australia; 2015.
  10. Steinhubl SR, Muse ED, Topol EJ. Can mobile health technologies transform health care? JAMA. 2013;310(22):2395-2396.
  11. Huckvale K, Prieto J, Tilney M, Benghozi P-J, Car J. Unaddressed privacy risks in accredited health and wellness apps: a cross-sectional systematic assessment. BMC Med. 2015;13:214. doi:10.1186/s12916-015-0444-y
  12. Giota K, Kleftaras G. Mental health apps: innovations, risks and ethical considerations. E-Health Telecommunication Systems and Networks. 2014;3:19-23.
  13. Torous J, Roberts LW. Needed Innovation in Digital Health and Smartphone Applications for Mental Health: Transparency and Trust. JAMA Psychiatry. 2017;74(5):437-438. doi:10.1001/jamapsychiatry.2017.0262
  14. Pasquale F. The Black Box Society: The Secret Algorithms That Control Money and Information. Cambridge, MA: Harvard University Press; 2015.
  15. Ebeling M. Healthcare and Big Data: Digital Specters and Phantom Objects. New York, NY: Palgrave Macmillan US; 2016. doi:10.1057/978-1-137-50221-6
  16. Buijink AW, Visser BJ, Marshall L. Medical apps for smartphones: lack of evidence undermines quality and safety. Evid Based Med. 2013;18(3):90-92. doi:10.1136/eb-2012-100885
  17. Donker T, Petrie K, Proudfoot J, Clarke J, Birch MR, Christensen H. Smartphones for smarter delivery of mental health programs: a systematic review. J Med Internet Res. 2013;15(11):e247. doi:10.2196/jmir.2791
  18. Proudfoot J, Clarke J, Birch MR, et al. Impact of a mobile phone and web program on symptom and functional outcomes for people with mild-to-moderate depression, anxiety and stress: a randomised controlled trial. BMC Psychiatry. 2013;13:312. doi:10.1186/1471-244X-13-312
  19. Shen N, Levitan MJ, Johnson A, et al. Finding a depression app: a review and content analysis of the depression app marketplace. JMIR Mhealth Uhealth. 2015;3(1):e16. doi:10.2196/mhealth.3713
  20. Seko Y, Kidd S, Wiljer D, McKenzie K. Youth mental health interventions via mobile phones: a scoping review. Cyberpsychology, Behavior and Social Networking. 2014;17(9):591-602.
  21. Daly A. The law and ethics of ‘self-quantified’ health information: an Australian perspective. International Data Privacy Law. 2015;5(2):144-155.
  22. Cortez N. The Mobile Health Revolution? U.C. Davis Law Review. 2013;47:1173-1230.
  23. Lee TT, Kesselheim AS. U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks. Ann Intern Med. 2018;168(10):730-732. doi:10.7326/M17-2715
  24. Mays N, Buse K, Walt G. Making Health Policy. 2nd ed. Maidenhead: McGraw-Hill Education; 2012.
  25. Boulos MNK, Brewer AC, Karimkhani C, Buller DB, Dellavalle RP. Mobile medical and health apps: state of the art, concerns, regulatory control and certification. Online J Public Health Inform. 2014;5(3):229.
  26. Powell AC, Landman AB, Bates DW. In search of a few good apps. JAMA. 2014;311(18):1851-1852.
  27. Torous J, Powell AC. Current research and trends in the use of smartphone applications for mood disorders. Internet Interventions. 2015;2(2):169-173. doi:10.1016/j.invent.2015.03.002
  28. Christensen H, Petrie K. State of the e-mental health field in Australia: where are we now? Aust N Z J Psychiatry. 2013;47(2):117-120. doi:10.1177/0004867412471439
  29. Lee TT. Recommendations for Regulating Software-Based Medical Treatments: Learning from Therapies for Psychiatric Conditions. Food and Drug Law Journal. 2018;73(1):66-102.
  30. Coulon SM, Monroe CM, West DS. A systematic, multi-domain review of mobile smartphone apps for evidence-based stress management. Am J Prev Med. 2016;51(1):95-105. doi:10.1016/j.amepre.2016.01.026
  31. Perry Y, Werner-Seidler A, Calear AL, Christensen H. Web-based and mobile suicide prevention interventions for young people: a systematic review. J Can Acad Child Adolesc Psychiatry. 2016;25(2):73-79.
  32. Proudfoot J. The future is in our hands: the role of mobile phones in the prevention and management of mental disorders. Aust N Z J Psychiatry. 2013;47(2):111-113. doi:10.1177/0004867412471441
  33. Wichman A. Using apps for mental healthcare. Digitalgov. 2015. https://www.digitalgov.gov/2015/06/25/using-apps-for-mental-healthcare/.  
  34. World Health Organization (WHO). Mental health action plan 2013-2020. Geneva: WHO; 2013.
  35. NHS England. Mental health patients set to benefit from pioneering new digital services. UK: NHS England; 2017.
  36. Bacchi CL. Analysing policy: what’s the problem represented to be? Frenchs Forest, NSW: Pearson Education; 2009.
  37. Palys T. Purposive sampling. In: Given LM, ed. The SAGE Encyclopedia of Qualitative Research Methods. Thousand Oaks, CA; 2008.
  38. Drumm J, White N, Swiegers M. Mobile consumer survey 2016: The Australian cut. https://www2.deloitte.com/au/en/pages/technology-media-and-telecommunications/articles/mobile-consumer-survey-2016.html.  Published2016.
  39. Department of Health. Head to  Health. 2017. https://headtohealth.gov.au/.   Accessed November 1, 2017.
  40. Firth J, Torous J. Smartphone apps for schizophrenia: a systematic review. JMIR Mhealth Uhealth. 2015;3(4):e102. doi:10.2196/mhealth.4930
  41. U.S. Government. Food and Drug Administration Safety and Innovation Act. Section 618. 2012.
  42. Carpenter D. Confidence games: how does regulation constitute markets? In: Balleisen E, Moss D, eds. Towards a New Theory of Regulation. New York: Cambridge University Press; 2010:164-190.
  43. Danzis S. FDA takes first public mobile app enforcement action. Inside Medical Devices. 2013. https://www.insidemedicaldevices.com/2013/05/fda-takes-first-public-mobile-app-enforcement-action/.   Accessed October 4, 2018.
  44. Armontrout JA, Torous J, Cohen M, McNiel DE, Binder R. Current regulation of mobile mental health applications. J Am Acad Psychiatry Law. 2018;46(2):204-211. doi:10.29158/JAAPL.003748-18
  45. Federal Trade Commission (FTC). FTC cracks down on marketers of “melanoma detection” apps. https://www.ftc.gov/news-events/press-releases/2015/02/ftc-cracks-down-marketers-melanoma-detection-apps.   Accessed March 15, 2017. Published 2015.
  46. Federal Trade Commission (FTC). FTC charges marketers of ‘vision improvement’ app with deceptive claims. https://www.ftc.gov/news-events/press-releases/2015/09/ftc-charges-marketers-vision-improvement-app-deceptive-claims.   Accessed March 15, 2017. Published 2015.
  47. Comstock J. Emails between Apple and FDA hint at future plans. MobiHealthNews. November 28, 2016. https://www.mobihealthnews.com/content/scoop-emails-between-apple-and-fda-hint-future-plans.  
  48. European Union. General Data Protection Regulation. 2016/679. Brussels: Offical Journal of the European Union; 2018.