What are Mental Mobile Health Apps and How Are These Apps Regulated? Part One

Mobile mental health apps provide a lot of services to patients. Many of these services focus on monitoring behavior and helping consumers understand and think about their behaviors.

The companies that manufacture these products need to understand when the design and sale of these products might violate FDA medical device rules, FTC rules on truthful advertising, state laws on the practice of medicine, and other regulations.

Medical practitioners need to understand when these mobile apps might be considered telemedicine, when doctors can recommend these apps, and what financial relationships with any manufacturers might violate Stark Law, the AKS, or other laws. Psychologists and other mental health professionals need to understand when professionals need to speak with a patient directly and when emergency medical care may be required.

What are mobile mental health apps?

Mental health mobile apps are now being used by many different people for many different types of mental health issues. As the applications expand, many different questions need to be reviewed, with experienced healthcare professionals, by the manufacturers who design and make the products that carry the apps, the software developers who create the apps, and physicians and other healthcare providers who recommend and use the apps.

• What are the different types of mobile mental health apps?
• What federal and state telemedicine laws apply?
• Does the FDA regulate the devices?
• Are mental health apps considered mobile health (mHealth), electronic health (eHealth), or a combination of the two?
• What other laws govern mental mobile health apps?

What are the different types of mobile mental health apps?

Most mental health apps are now available on desktops, laptops, and smartphones. The apps are used for many different purposes from sending reminders, collecting information, providing advice, and being used to help the apps themselves learn through artificial intelligence. While mobile mental health apps have their benefits, mental health apps are not designed to supplement an appointment with an experienced licensed mental health professional.

Mental health apps are generally categorized in the following six ways:

• Self-management. Self-management apps enable the consumer to enter information into the software such as medication reminders to provide reminders about when the consumers need to take their medications. Some apps can track a user’s heart rate, blood pressure, breathing patterns, and other physical factors that affect sleep, anxiety, and stress problems. The apps can help record the data and provide feedback about the user’s health.
• Apps for Improving Thinking Skills. Some software helps patients with a serious mental illness improve their thinking – their cognitive abilities.
• Skill-Training Apps. These apps help users learn to cope. For example, the NIH states that a user might watch educational videos about the need for social support or a whole range of other strategies. In addition to educational help, the apps may provide ways to track how the user is using any skills he/she learns.
• Illness Management, Supported Care. This software helps users interact with other humans. Some users may be connected to peer support groups. Other users may be directed to trained health care providers who can recommend approved therapy options. “Researchers are working to learn how much human interaction people need for app-based treatments to be effective.
• Passive Symptom Tracking.  Here, smartphones have sensors that collect data such as “movement patterns, social interactions (such as the number of texts and phone calls), behavior at different times of the day, vocal tone and speed, and more.” Some apps may, in the future, be designed to analyze the data in real-time to assess behavioral changes that indicate a user is experiencing depression, psychosis, mania, or other mood disorders. The app may then be able to alert a health professional or caregiver that the user needs immediate medical attention.
• Data Collection. These apps “gather data without any help from the user.” The data, collected from numerous users, not just an individual can help researchers learn more about mental health and possible interventions.

Mobile mental health apps are used for the different stages of care including “clinical care provision, including immediate crisis intervention, prevention, diagnosis, primary treatment, supplement to in-person therapy, and post-treatment condition management.”

Some of the factors that make mental health apps effective, according to Delve Insight include:

• High-patient engagement through real-time and gaming interactions.
• Easy to use through a simple user interface.
• “Transdiagnostic capabilities (reduction in interaction with multiple apps for comorbid disorders)”
• Self-monitoring features including regularly monitoring of a person’s thoughts actions, and behaviors.
• They’re cost effective.

Delve Insight states expectations of the sale of mobile mental health apps to increase 42 percent in 2021 from 2019 when there were 730 million installs. Some of the most used apps include Calm, Headspace, and Meditopia. The leading mobile mental health companies include CVS Health, 7 cups of Tea, Aurora Health Care, Talkspace Network, Addicaid, Calm, NOCD Inc, Sanvello, Headspace Inc, and Happify Inc.

Delve Insight predicts that healthcare professionals will be expanding their adoption of mental health apps in the coming years.

What mental health diseases and disorders do mental health apps focus on?

Some of the diseases that mobile mental health apps target includes addressing depression.

“Mental health mobile apps that use cognitive behavioral therapy (CBT), mood monitoring, mindfulness training and cognitive skills training to treat observed depressive symptoms are gaining much momentum.” The apps generally target people with mild to moderate cases of depression. Patients should work with experienced healthcare professionals if there is any level of depression.

Mental health mobile apps are also being designed to treat anxiety, schizophrenia, and bipolar disorders. Apps may also help manage medications, teach coping skills, and predict when direct intervention by a skilled healthcare provider may be necessary. Ideally, intervention apps can help people stop smoking, with insomnia, and with post-traumatic stress disorder (PTSD).

What are the advantages of mobile mental health technology?

The US NIMH (National Institutes of Mental Health) states that:

“Mobile mental health support can be very simple but effective. For example, anyone with the ability to send a text message can contact a crisis center. New technology can also be packaged into an extremely sophisticated app for smartphones or tablets. Such apps might use the device’s built-in sensors to collect information on a user’s typical behavior patterns. If the app detects a change in behavior, the app may provide a signal that help is needed before a crisis occurs. Some apps are stand-alone programs that promise to improve memory or thinking skills. Others help the user connect to a peer counselor or to a health care professional.”

Some of the advantages of mental health mobile apps, according to the NIH, include:

• Convenience. A user can access an app anywhere (home, on the way to work, in the park, etc.) at any time of day. The ease of access can be ideal for patients who don’t have the time or money to see a psychologist – or who are uncomfortable with in-person discussions.
• Anonymity. The users don’t have to identify themselves to anyone.
• A first step. Some patients are frightened to admit mental health problems or see a professional. An app can be an easy way for someone to get started thinking about mental health.
• Less expensive. Traditional mental health care can be very expensive even if a patient has insurance.
• Helps many more people. Technology is very helpful for patients who live in remote areas or who need help during emergencies such as natural disasters.
• Access. Apps are available 24/ while traditional support is available only part of the day and week.
• Consistency. Apps provide “the same treatment program to all users.”
• Support. Apps may work well to complement traditional therapy instead of replacing it.
• Objective data collection. Apps can record essential information in case of an emergency such as the user’s location, phone number, movement, and other information.

What are the concerns about mobile mental health apps?

The NIH states that the mental health community and software developers do have a number of concerns about mental health mobile apps. There are concerns about what scientific evidence can be used to test and monitor the effectiveness of the apps. There are concerns about whether the apps “work for all people and for all mental health conditions.” There are serious privacy concerns especially because many mental health patients don’t anyone to know about their difficulties and because their private information is very sensitive.

Currently, there are no industry-wide standards to help educate consumers about the effectiveness and reliability of mental health apps. There are numerous challenges ahead involving who will regulate mental health technology and the data that is collected. Consumers with mental health challenges need apps that work and that can be trusted – or consumers may be afraid to try personal therapies.

A recent study, BRIGHTEN study, showed that technology can be used to pilot test treatments that may hold promise for helping patients. “Behavioral health apps will need to combine the engineers’ skills for making an app easy to use and entertaining with the clinician’s skills for providing effective treatment options.”

A lot of work is still necessary to review the effectiveness of different mental health mobile apps. Currently, there are no widely accepted national standards. There’s not much evidence of peer-review research. Consumers should begin the decision-making process (about buying or using a mental health mobile app) by speaking with their healthcare provider. The app should have recommendations if more serious problems arise. Some apps are complete. Other apps require that the user works with a trained professional. Other recommendations include being aware that logos and promotions may be misleading and checking to see if any tests have been done on the app.

Mobile mental health apps in conjunction with experienced psychologists and other mental health professionals may be of value. In this first article, we discussed the various types of mental health apps funded by the NIH, the benefits, and some of the concerns. In our second article, we’ll discuss what regulations and laws may govern the manufacture, recommendation, and use of mental health apps by manufacturers and healthcare professionals.

The manufacturers of mental health mobile apps and the doctors who recommend them should contact Cohen Healthcare Law Group, PC to review the federal and state laws apply to the design, sale, and use of these apps. Our experienced healthcare attorneys advise medical health companies and physicians about healthcare compliance laws and regulations.