Article Abstract

Article Abstract

Online ISSN: 1099-176X Print ISSN: 1091-4358
The Journal of Mental Health Policy and Economics
Volume 24, Issue 3, 2021. Pages: 101-108
Published Online: 1 September 2021

PERSPECTIVE
The Digital Health App Policy Landscape: Regulatory Gaps and Choices Through the Lens of Mental Health

Kelila Kahane,¹ Josie François,² John Torous³*

¹MPH, Harvard T.H. Chan School of Public Health, Boston, MA; SUNY Downstate College of Medicine, New York, NY, & Division of Digital Psychiatry, Beth Israel Deaconess Medical Center, Boston, MA, USA
²MPH, Harvard T.H. Chan School of Public Health, Boston, MA & Harvard Medical School, Boston, MA, USA
³MD, Harvard Medical School, Boston, MA & Division of Digital Psychiatry, Beth Israel Deaconess Medical Center, Boston, MA, USA

* Correspondence to: John Torous, 330 Brookline Ave, Boston, MA, 02115, USA.
E-mail: jtorous@bidmc.harvard.edu

Source of Funding: Argosy Foundation.

Abstract

Interest in and use of mental health apps have grown over the past decade, and now further with the COVID-19 pandemic. Digital mental health offers potential to increase access to care, but tangible risks around safety and poor efficacy remain common. This perspective seeks to outline how mental health apps are regulated in light of their high demand but also evolving risks. We conduct a select analysis of U.S. and international published evidence, government websites, grey literature, and media outlets. We present the marked discordance around digital mental health policy, as these frameworks grapple with the challenges of regulating in this sphere. We propose four next steps for guiding policy: (i) clear clarification of the categorical status of mental health apps; (ii) objective methodology for assessing apps on a premarket basis; (iii) well-designed, detailed procedures for iterative post-market app review; (iv) clinician and patient education which empowers informed decision making.

Background: Interest in and use of mental health apps have grown over the past decade, and now further with the COVID-19 pandemic. Digital mental health offers potential to increase access to care, but tangible risks around safety and poor efficacy remain common.

Methods: We conduct a select analysis of U.S. and international published evidence, government websites, grey literature, and media outlets. We present the marked discordance around digital mental health policy, as these frameworks grapple with the challenges of regulating in this sphere.

Results: Across the world, there is no consensus around evaluation with countries piloting or proposing different models. Common barriers include the defining the scope and risk of health apps, creating processes able to update evaluation with software updates, lacking better data to inform evaluation, and educating users to the risks and benefits.

Discussion: We propose four next steps for guiding any future policy: (i) clear clarification of the categorical status of mental health apps; (ii) objective methodology for assessing apps on a premarket basis which does not solely rely on self-reporting; (iii) well-designed, detailed procedures for iterative post-market app review; (iv) clinician and patient education which empowers users to make smart mental health app choices.

Received 30 March 2021; accepted 15 June 2021