Evaluate mobile health product effectiveness

Research & Technology
social determinants of health
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Coverage & Standards
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Federal department
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house committees
House Energy and Commerce Committee
senate committees
Senate Health, Education, Labor, and Pensions Committee


Congress should designate a regulatory agency to evaluate mobile health product effectiveness in real-world settings.[1]


Mobile health (mHealth) technologies like smartphone applications (apps), wearable devices, and sensor technologies are expanding to unprecedented levels, including in the mental health and substance use space.[2] More than 10,000 mental health apps are available for patients to download and use.[3] Some apps monitor symptoms and deliver supplemental treatments. For example, they help to track mood symptoms and provide access to therapy-inspired exercises and lessons.[2]

Currently, there is no independent regulatory agency, such as the Food and Drug Administration (FDA), charged with consistently examining all mental and behavioral health apps. While the FDA may review certain apps (e.g. those that may require a prescription or function as a medical device), the agency uses its enforcement discretion with respect to many other mental health and substance use applications. The Federal Trade Commission (FTC) can also investigate potential false claims that an app developer may make.

Without a regulatory body charged with overseeing mental health and substance use health apps, the impact of these new technologies on patient outcomes remains unclear[1]. The American Psychiatric Association (APA) developed its App Evaluation Model to help health care providers determine if a mental health app is appropriate for patient use.[2] While this is a very positive step, there is still a need to ensure an expert regulatory body has the authority to evaluate the viability, risks, and impact of these novel medical technologies and protect patients.


1. Bipartisan Policy Center. Tackling America’s Mental Health and Addiction Crisis Through Primary Care Integration. Last Updated March 2021.

2. American Psychiatric Association. APP Advisory, An American Psychiatric Association Initiative. Last Accessed July 27, 2023.

3. American Psychiatric Association. Thousands of Mental Health Apps Available: Supporting Evidence Not So Plentiful. Last Updated July 22, 2019.