How Mental Health Apps Are Regulated-or Are They?

Are smartphone apps as effective as many companies claim? I will be presenting at APA 2016 in a workshop titled “Smartphones, Sensors, and Mobile Mental Health: Regulations, Research, and Real Life.” The workshop will look at the current state of clinical evidence for the use of digital tools like smartphone apps for schizophrenia and other psychiatric illnesses.

We will also explore strategies that participants can use to identify potentially useful apps and avoid dangerous ones. The goal is to demonstrate that with a little knowledge, clinicians can become savvy about if, how, and when to use (or not use) these digital tools in their practices.

Here are some questions to prepare you to educate your patients on common issues in digital technology.

True or false? Mental health apps are subject to strict regulations (eg, HIPAA) and therefore they safeguard my patients’ private health data.

Answer: False. The majority of health care apps, including those for mental health, actually fall outside of HIPAA. These apps are under no obligation to protect your patients’ health data and many may actually make money by selling or marketing that data.

Always check the privacy policy of any app you are using with patients. To learn more, consider reading this excellent paper about mental health apps and privacy.¹ Of course, some apps do fall under the scope of HIPAA. The privacy policy is again the place to check to learn more.

Be careful to look at any app you are recommending to a patient to ensure it does what it says and is following best standards of care-as many are not.

True or False? Smartphone apps for mental health do not offer my patient easy access to evidenced-based care and are not required to meet rigorous standards for approval on the Apple and Android stores.

Answer: True.

While an app has to meet certain technical standards to be on the Apple or Android stores, there is no clinical testing required for an app to be approved. The vast majority of apps that are available for download directly to patients have never been clinically tested or validated.

One study looked at 700 mindfulness apps on the Apple and Android stores and found only one had been clinically investigated.² Our team recently reviewed all the evidence for smartphones to aid in the care of schizophrenia and found only 7 studies have been published.³

Be careful to look at any app you are recommending to a patient to ensure it does what it says and is following best standards of care-as many are not!

True or False? Some smartphone apps may be ineffective, but at least they cannot cause my patient harm.

Answer: False.

Many apps are poorly designed and never studied; some contain dangerous information; and others offer harmful recommendations.

For example, a recent review paper of bipolar apps provides examples of one app telling users to “take a shot of hard liquor an hour before bed” to help with sleep during a manic episode.⁴ Another app informed users that bipolar disorder is contagious and “can transfer to another relative if they spend too much time with you and listen to your depressive life.”⁴

Apps designed to help users cut back on drinking have been found to actually increase rates of alcohol consumption for some.⁵ Many apps are “zombies”-that is, they are never updated and can contain information that is years out of date. The bottom line Before recommending an app to patients, it is best to try out the app yourself and make sure it is not offering false or dangerous information.

Disclosures:

Dr Torous is a presenter at APA 2016 and the Digital Psychiatry Editor at Psychiatric Times.

References:

1. Glenn T, Monteith S. Privacy in the digital world: medical and health data outside of HIPAA protections. Curr Psychiatry Rep. 2014;16:494. http://www.ncbi.nlm.nih.gov/pubmed/25218603.

2. Mani M, Kavanagh DJ, Hides L, Stoyanov SR. Review and Evaluation of Mindfulness-Based iPhone Apps. JMIR Mhealth Uhealth. 2015;3:e82. http://mhealth.jmir.org/2015/3/e82.

3. Firth J, Torous J. Smartphone Apps for Schizophrenia: A Systematic Review. JMIR Mhealth Uhealth. 2015;3:e102. http://mhealth.jmir.org/2015/4/e102.

4. Nicholas J, Larsen ME, Proudfoot J, Christensen H. Mobile Apps for Bipolar Disorder: A Systematic Review of Features and Content Quality. J Med Internet Res. 2015;17:e198. http://www.jmir.org/2015/8/e198.

5. Gajecki M, Berman AH, Sinadinovic K, et al. Mobile phone brief intervention applications for risky alcohol use among university students: a randomized controlled study. Addict Sci Clin Pract. 2014;9:11. http://www.ncbi.nlm.nih.gov/pubmed/24985342?dopt=Abstract.