Background

Among adults 18 years of age and older in the United States, the prevalence of ‘mental disorders in the past year’ increased from 17.7 percent (or 39.8 million people) in 2008 to 20.6 percent (or 51.5 million people) in 2019.¹ Of this latter population, 26.0 percent (or 13.3 million people) perceived an unmet need for mental health services. The most common reason given for unmet need was affordability, with other barriers including mental health stigma, provider shortages, and wait time.²

According to the World Health Organization, “mental health is a state of well-being in which an individual realizes his or her own abilities, can cope with the normal stresses of life, can work productively and is able to make a contribution to his or her community.”³ Mobile health apps (mHealth) have great potential to provide much needed access and equity in mental health care and wellness. Mobile health apps are applications that run on smartphones or tablet devices and contain content to facilitate health and wellness. Mental health apps, a subset of mobile health apps, are being used to support assessment, diagnosis, treatment, and management of mental health, as well as to provide wellness support through meditation and mindfulness. Some mental health apps can provide diagnostic support or assist in the diagnostic pathway by improving time to diagnosis, for example by offering automated standardized mental health assessments. Apps might also facilitate treatment for certain mental health conditions and provide therapeutic support. Firth et al. found in their meta-analysis that apps targeting depression through self-management significantly reduced symptoms of depression when compared to controls.^{4, 5} The use of mental health apps can also reduce anxiety compared with controls.⁶

Mental health apps provide patients with relevant health information and help enhance quality of care by supporting patients through access to knowledge and other skill-building resources. At an individual level, mental health apps can be a resource that provides psychoeducation and medication management, skill building, and symptom tracking thereby amplifying the benefits of existing therapy. They also add the convenience of accessing mental health care remotely and may provide more privacy than in-person mental health visits, potentially avoiding stigma associated with seeking mental health care. Additionally, they may further improve access by lowering the cost of care.⁷ Mental health apps can be readily disseminated with minimal need for staff training or resource investment, and thereby reduce the burden on healthcare settings. Furthermore, technology-enhanced healthcare approaches are increasingly being reimbursed by insurers,⁸ making such apps more likely to be integrated into the toolkits of healthcare providers. Improved care coordination, more touchpoints to enhance treatment with a provider, and addressing patient-centered care is another potential benefit of mental health apps.⁷ Some apps deliver greater efficiency by providing feedback loops and assessments for providers in between appointments and also deliver round-the-clock support and direct access to crisis lines for patients.⁹

Significant racial and ethnic disparities exist in access to and use of mental health care services.^{10, 11} While some studies explain that disparities exist owing to a lack of access to care (including a lack of insurance coverage), others, when comparing similar sociodemographic factors, suggest that the differences may be more related to mistrust of traditional mental health services, discrimination, language, and cultural factors.¹² Black and Asian individuals are screened for depression at a lower rate compared with white individuals and, for those that receive screening, Black individuals, Latino males, and Asian individuals receive mental health care at a lower rate compared with their white counterparts.¹³ Disparities between urban and rural populations’ access to mental health services exist as well. Up to 65 percent of non-urban counties lack psychiatrists, while more than 60 percent of Americans in rural areas live in a Mental Health Provider Shortage Area.¹⁴ Apps could help address disparities in mental health services and provide a gateway to care for those who do not trust health professionals or have not benefitted from traditional mental health services. Many mental health apps are affordable, offer a way to reach rural populations and traditionally hard-to-reach groups, and can reduce patients’ feelings of stigmatization or discomfort with traditional treatment.¹⁵

The market for mental and behavioral health is booming, turbocharged by funding through private and venture-backed investors. In 2020, $2.4 billion was raised for startups working in mental health, equivalent to 17 percent of all funding for digital health in 2020.¹⁶ Segmenting the space into only apps, $1.2 billion were raised in 2021, which is a 50 percent increase compared with the prior year.¹⁷ Some driving factors for funding may be the huge increase in demand for digital mental health services owing to isolation, job loss, economic and financial hardships and other detrimental effects of the COVID-19 pandemic. For the first time, during the pandemic, the Food and Drug Administration (FDA) began approving digital mental health therapeutics solutions and federal regulatory requirements allowed more flexibility for telehealth.¹⁸

Mobile apps which fall into the Software as a Medical Device (SaMD) category for the FDA follow the same regulatory guidelines as other medical devices with three classifications for approval. Class I medical devices have a low to moderate risk to the patient and/or user and a premarket notification application and FDA clearance is not required before marketing the device in the United States. However, the manufacturer is required to register and list their product with the FDA. Class II medical devices have a moderate to high risk to the patient and/or user. For example, a computerized behavioral therapy device for psychiatric disorders regulated under 21 CFR 882.5801 is a prescription-only device intended to provide a computerized version of condition-specific behavioral therapy as an adjunct to clinician supervised outpatient treatment to patients with psychiatric conditions. The FDA may remove from the market any Class II and Class III devices that are determined to be fraudulent or potentially harmful. An example of a such a circumstance includes apps with treatment claims for specific psychiatric conditions where the underlying condition may require an urgent or immediate clinical intervention and for which the delay of the intervention may pose significant harm to the patient (e.g., treatment of suicidality). Class III medical devices are those devices that have a high risk to the patient and/or user. These devices usually sustain or support life, or present potential unreasonable risk of illness or injury.

Not all mental health apps are considered SaMD. While there are about 20,000 mental health apps on the market in the Apple App Store or Google Play Store, only five of them have FDA approval.¹⁹ The first prescription digital therapeutic for mental health, which launched in 2017, was Pear Therapeutics’ reSET therapy, which is powered through an app.²⁰ The FDA has taken a “hands-off” approach to the regulation of low risk, general wellness apps. The FDA has also introduced a Software Precertification (Pre-Cert) Pilot Program that provides streamlined regulatory oversight of software-based medical devices developed by certain manufacturers that have consistently demonstrated quality and organizational excellence. By pre-certifying organizations instead of specific products, the program aims to reduce burdensome regulatory oversight for these organizations as they develop high quality SaMD products.^{21, 22}

Rapid proliferation of health apps has resulted in both haphazard and sub-optimal use of these apps, with potential dangers to patients and end-users because the health system and providers may not be well-versed enough regarding the purpose, safety, and efficacy of these apps to recommend or prescribe them. There is no existing gold standard tool for informing the selection of mental health apps for patients and clinicians. “Prescribing” an app in a medical setting is challenging owing to the limited evidence on the efficacy of the apps, as well as emerging concerns about the usability, privacy, and safety risks.²³

Apps that target individuals who may be vulnerable to scams or fraud owing to their mental health impairment can pose a serious risk.²³ Mental health apps may pose a high risk to users with serious or acute mental disorders, such as untreated psychosis and suicide ideation, especially if the apps do not provide easy access to crisis lines in case of emergency. According to Martinengo et al., there have been more than 2 million downloads of mental health apps with inaccurate or without suicide crisis phone numbers.²⁴ Privacy and security, particularly related to private health information, is also a concern for mental health apps. Dehling et al. ranked the level of damage to users owing to privacy infringement and found that 95 percent of apps pose at least some threat.²⁵ Additionally, mental health apps have possible data security risks and the risk of misinformation.²⁶ The regulatory framework has not kept up with the proliferation of mental health apps. One major risk involves data security such as data breaches resulting in exposures to various risks such as scams, identity theft, and exposure to marketing. Mental health app content could provide harmful advice, disseminate false information, or could have iatrogenic impacts due to insensitive homophobic or racist content. Mental health providers should consider liability when recommending an app to a patient.

There are many frameworks that are being used to evaluate digital health apps, including those that focus on mental health apps.^27–31 Several of these frameworks are being used by advocacy agencies and online health resource platforms to recommend apps to interested users. However, most existing frameworks are geared towards evaluating specific aspects of health apps (e.g., usability), and do not adequately reflect concerns around assessment of risks posed by the apps, as well as recent advancements in artificial intelligence, and their use by apps for automating certain diagnostic (e.g., Ada) or counseling protocols (e.g., Woebot, Replika).

Objectives of This Technical Brief

Given the uncertain evidence-base for most mental health apps coupled with potential app safety and privacy concerns in a more vulnerable population of users, the decisional dilemma is “How should consumers, family members and peer supports, and providers and health systems select mental health and wellness mobile apps?” The aim of this Technical Brief is to develop a framework to assess the safety and effectiveness of mental health and wellness apps for users across age groups. This Technical Brief addresses only mobile health apps that can be downloaded on a smartphone and does not include pure text-based apps, wearable devices, or general telehealth and telemedicine apps.

Guiding Questions

This Technical Brief was guided by the following questions:

1. What characteristics and minimal standards of available mental health mobile apps need to be analyzed to assess the appropriateness (to various stakeholders) and effectiveness of available apps, to include but not be limited to:

   • Accessibility, including ease of use, health literacy, 508 compliance, digital equity, cost;
   • App background, including funding source and purpose;
   • Security features and privacy policy, such as data ownership/usage;
   • Clinical foundation and linkage to current evidence-base;
   • Usability, including interoperability across platforms, and stability; and
   • Therapeutic goals, linkage to the provider, and crisis warning notification/alert system?
2. Identify or develop an assessment framework for mental health apps and apply the framework to help consumers, family members and peer supports, and providers and health systems select apps. The framework will take into account current FDA status on the use and classification of risks of apps in healthcare.