Leveraging the Use of Technology in Behavioral Health

This article discusses the current terminology for technology in behavioral health as well as research findings on the effectiveness of such technology.

Mobile Applications

In 2022, the U.S. Department of Health and Human Services, Food and Drug Administration (FDA) announced guidance (PDF) for technology in behavioral health and defined the following five categories:

Mobile Platforms. Commercial, off-the-shelf handheld computing platforms, with or without wireless connectivity;

Mobile application or “mobile app.” Software application that can be used on either a mobile platform, as previously defined, or a web-based software application that is tailored to a mobile platform but run on a server.

Mobile medical app. Mobile app that incorporates device software functionality that meets the definition of a device in section 201(h) of the federal Food, Drug, and Cosmetic (FD&C) Act; and either is intended:

• To be used as an accessory to a regulated medical device; or
• To transform a mobile platform into a regulated medical device.

The FDA noted: “In general, if a software function is intended for use in performing a medical device function (i.e., for diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease), it is a medical device, regardless of the platform on which it is run.”

Regulated medical device. A product that meets the definition of device in section 201(h) of the FD&C Act and that has been cleared or approved by the FDA. Novel devices can be included.

Mobile medical app manufacturer. Any person or entity that manufactures mobile medical apps in accordance with the definitions of manufacturer in 21 CFR Parts 803, 806, 807, and 820. A mobile medical app manufacturer may include anyone who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components but does not include any individual or entity who exclusively distributes mobile medical apps.

Digital Health Interventions

In July 2023, the Substance Abuse and Mental Health Services Administration (SAMHSA) provided the following definitions in their advisory for digital health resources:

Digital Health Interventions. Discrete digital functionalities of technology used to achieve health sector objectives. These may encompass evidence-based Digital Therapeutics (DTx) but may also include interventions that do not have an evidence base to support their use, such as many wellness apps.

Digital Therapeutics (Dtx). Health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health. DTx are used independently or in concert with medications, devices, or other therapies. DTx may or may not require a prescription and are generally considered medical devices subject to regulatory oversight by the FDA.

Prescription Digital Therapeutics (PDTs). DTx in the United States that are cleared or approved for prescription use by the FDA as software-based medical devices intended to prevent, manage, or treat a medical condition. A clinical provider prescribes PDTs, typically to support health claim payment.

SAMHSA noted that there are currently six Dtxs that meet the FDA requirements for PDTs.

Mobile Health Effectiveness

The research available on the effectiveness of mobile health varies and depends on the type of technology being used. In February 2022, a blog posting by Harvard Health concluded: “Research on the mental health effects of mobile apps is still in its infancy, and we will have more to guide us in the next few years. Low-touch interventions like mobile apps may help get you through a rough time, or at least help increase your symptom awareness. Will it treat your depression? Probably not, but it may help if you believe in it.” The author also expressed concerns about privacy when using a mobile app.

SAMHSA identified the benefits of DTx stating: “DTx have demonstrated benefits in improving access to care, client engagement, and health outcomes while reducing costs for care. They also reduce barriers to behavioral health care for hard-to-treat conditions and hard-to-reach populations, such as youth and those living in rural areas. In addition, the White House’s strategy to address the national mental health crisis specifically notes the importance of bridging the gaps between available services and access for individuals. DTx have the potential to profoundly reduce these gaps, by providing complementary services that may reduce the burden of an already strained behavioral health workforce.”