Summary

The COVID-19 pandemic is exacerbating an existing mental health crisis to such a degree that many fear it will overwhelm the fragmented mental health delivery system in the United States. Rates of mental health problems—including depression, trauma- and stressor-related disorders, substance abuse, suicidal ideation, and suicide attempts—have increased during the COVID-19 pandemic. Scarce access to mental health services compounds the problem. Nearly 25 million Americans with mental health needs go untreated each year, and half of U.S. counties have no access to mental health care whatsoever. However, the current moment presents an opportunity. Even as the pandemic increased needs for mental health services, so too did pandemic-related shifts reveal the broad utility of and interest in digital solutions such as mobile apps, digital therapeutics, and digital therapy.

In the absence of regulation, however, ineffective and potentially harmful digital mental health products may make their way into consumer hands. Estimates suggest that over 20,000 digital mental health products exist, yet only five have received Food and Drug Administration (FDA) clearance. The FDA temporarily reduced their enforcement and review of these products due to COVID-19. But moving forward, addressing the largely unregulated space of digital mental health products is critical to mitigate harm of unverified digital mental health solutions. As examples of potential harms, companies have used digital products to offer services but from unlicensed providers, withheld client information from providers, or made data available to various third parties without following stated terms of services. Developing an infrastructure to regulate these products while also helping provide and reimburse effective and safe digital mental health solutions is essential to meet the overwhelming need for mental health services and ensure quality and equity in mental health care.