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

Abstract

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.