"take Two Mobas and Call Me in the Morning"—video Games May Soon Be Prescribed to Treat Medical Conditions

• Jurisdiction: United States,Federal
• Citation: Vol. 6 No. 4
• Publication year: 2023

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Stuart Irvin, Rujul Desai, Olivia Dworkin, and Beth Braiterman ^*

In this article, the authors explain that video games can be used to treat medical conditions and the Food and Drug Administration has demonstrated a willingness to authorize a video game as safe and effective for medical uses in appropriate circumstances.

Video games, and the industry that develops and distributes them, have long been criticized (whether fairly or unfairly) for causing physical and psychological harm to those who play them.

The physical injuries attributed by some to video games include various repetitive stress disorders, including carpal tunnel syndrome, tennis elbow, and "gamer's thumb." There have been various attempts to link video games to obesity, although a recent review of clinical studies found ¹ ambiguous evidence on the extent to which video game play is significantly associated with obesity. There is also a reported risk of seizures in some individuals who play video games, as the full-screen warning on some console games explains.

The psychological harm that is alleged to be associated with video games has been harder to study and quantify. While the World Health Organization (WHO) included ² "gaming disorder" as a behavioral addiction in its diagnostic system, the International Classification of Diseases, in 2018, also noted ³ that studies suggest that this gaming disorder affects only a small proportion of people who engage in video-gaming activities. The approach of the WHO to gaming issues has been controversial. The UK's Chief Medical Officer conducted a comprehensive review of the research on screen-based activities and mental health in children in 2019 and concluded that the "research does not present evidence of a causal relationship between screen-based activities and mental health problems." ⁴ Against this backdrop of allegations aimed at video games, it is somewhat surprising to many when they learn

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that video games are being specifically developed to be prescribed by health care professionals to help treat patients with a variety of medical conditions, including patients with attention deficient hyperactivity disorder, or ADHD. Some early successes in using video games to treat ADHD suggest that video games have the potential to become an important tool for practitioners dealing with many different medical conditions, and there is increasing evidence of safety and efficacy.

Do I Need an Rx for My Controller?

When developed for medical purposes, video games may be medical devices, which in the United States are subject to the authority of the Food and Drug Administration (FDA). Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a "medical device" to include an instrument, apparatus, implement, machine, contrivance, implant, or in vitro reagent that is intended to diagnose, cure, mitigate, treat, or prevent disease in man. ⁵ That definition does not expressly include (or exclude) software, but over many years the FDA has established a regulatory approach for software intended to be used for one or more medical purpos-es. ⁶ In fact, FDA has authorized non-gaming prescription digital therapeutics, or PDTs, which use software to treat or manage a wide array of diseases and conditions. So, while it might at first seem that the regulatory processes of the FDA are better suited for more traditional medical device products—like heart stents or MRIs—the FDA has demonstrated a willingness to authorize a video game as safe and effective for medical uses in appropriate circumstances.

For example, in June 2020, the FDA authorized ⁷ EndeavorRx the first game-based PDT to improve...