Choosing a safe and effective mental health application: Understanding what factors should be considered to protect patients from a lack of FDA regulation

FDA Regulation of Medical Mobile Applications

In 2013, the U.S. Food and Drug Administration (FDA) issued a final guidance on the regulation of mobile medical applications.1 Noting that a majority of apps pose a minimal risk to consumers, the FDA stated that it would not enforce requirements under the Federal Drug and Cosmetic Act. The FDA instead is focusing its oversight on mobile medical apps that:

• are intended to be used as an accessory to a regulated medical device, or

• transform a mobile platform into a regulated medical device.

For example, an app used in conjunction with an ultrasound wand would be regulated because it is intended to be used as an accessory to a regulated medical device. However, a mental health app that allows users to track their mood and symptoms would not be regulated by the FDA.

Regulation of Mental Health Applications

Most mental health apps do not change a phone into a medical device, nor are they intended to be used as an accessory to an already regulated medical device. As such, most will avoid FDA regulation. Nevertheless, many psychiatrists believe that mobile apps could be a way to reach populations like teenagers and men, who usually do not seek out mental health treatment on their own. Dr. John Torous, chair of the American Psychiatric Association’s Smartphone App Evaluation Task Force, advises app users to consider all ASPECTS of mental health apps:2

• Actionable To be actionable an app must collect data that can be valuable and clinically useful.

Secure – State and federal laws require that health information be secure. In Illinois, mental health information is protected by the Mental Health and Developmental Disabilities Confidentiality Act as well as HIPAA. However, mental health app providers are not bound by HIPAA, leaving patient information vulnerable to data mining. Apps should be password protected and patient data should be encrypted in case the mobile device is stolen or hacked.

Professional – Mental health apps should follow established professional and ethical standards for clinical use. Apps that do not comply with established professional standards run the risk of negatively affecting a patient’s mental state.

Evidence based – Less than 1 % of mental health apps available for download have been clinically tested for efficacy. Apps that have not been studied could have an adverse effect on a patient’s mental health. Some apps have been found to contain information that is incorrect. For example, a recent study identified an app for users with bipolar disorder that advised users that the disorder was contagious!

Customizable – Patients and clinicians are more likely to become invested in and adhere to something that they created together.

Transparent – Look for apps that openly report how data is collected, stored, analyzed, used and shared. If uncertainty exists as to what is happening with a patient’s health care data, patient data may not be safe and the app may not be dependable.

More information about the regulation of mobile medical apps is available by visiting the FDA’s website.3


Sarah Costa is a 3L at Loyola University Chicago School of Law and an extern at Presence Health.

1. FDA Issues final guidance on mobile medical apps, U.S. Food and Drug Administration (Sept. 23, 2013) <>.

2. Weighing the Pros and Cons of Mental-Health Apps, Science Daily (Apr. 26, 2016) <>.

3. Mobile Medical Applications, U.S. Food and Drug Administration (Sept. 22, 2015) http://<>.

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February 2017Volume 3Number 3PDF icon PDF version (for best printing)