Mental health apps encompass a range of mobile technology applications offering support for mental well-being. These apps can be broadly categorized into three types:

1. Medical Devices: These apps, like ReSET, are FDA-approved computerized behavioral therapy devices requiring a prescription. They provide virtual therapy sessions outside of live sessions with a clinician.
2. Telehealth Apps: Examples include TalkSpace and Lyra, offering therapy sessions with licensed providers via live video or audio communication. They may also provide consultations and prescription drugs from licensed psychiatric providers, alongside general wellness features.
3. Mental Health "Wellness" Products: Apps like Happify and PTSD Coach App focus on general wellness and symptom management through journaling, motivational quotes, chatbot therapy, and meditation. While some may offer clinician-endorsed treatments, distinguishing between medical and non-medical care can be challenging for users.

Consumers may encounter mental health apps through various channels, such as health insurance coverage providers or employers. These apps may be provided directly or marketed at low or no cost to younger audiences through social media.

1. Federal COVID Waivers: During the pandemic, federal agencies suspended certain policies to increase access to digital behavioral health services, including mental health apps. These waivers facilitated the use of telehealth and mental health apps by easing restrictions on telehealth coverage, privacy standards, and prescription protocols.
2. Types of Mental Health Apps: Mental health apps offer a variety of services, including clinical therapy, telehealth features, and general wellness tools. The range of available apps varies from FDA-approved medical devices to non-medical wellness products.
3. Policy Implications: The end of the Public Health Emergency (PHE) has shifted the focus to the permanency of COVID waivers and new concerns such as privacy and access to prescription drugs via telehealth. Efforts are underway to extend some waivers to ensure continued access to digital behavioral health tools.
4. Employer Plan Telehealth Flexibilities: There are proposals to make pre-deductible coverage of telehealth services permanent, aiming to expand access to virtual behavioral health beyond those with Health Savings Accounts. Stakeholders are considering design alternatives for employer coverage incorporating telehealth.
5. Access to Controlled Medications: The PHE changes facilitated easier access to psychiatric medications via telehealth, but also contributed to shortages. The DEA has issued temporary rules allowing virtual prescribing of controlled substances to continue, while evaluating long-term policy options.
6. Privacy Risks: Despite HIPAA protections, concerns persist regarding the privacy practices of mental health apps, including the sale of patient data to third parties. Regulatory agencies like the FTC are scrutinizing app vendors' privacy policies and data handling practices, with potential legal repercussions for non-compliance.
7. Congressional Action: Congress is considering legislation to increase protections for personal health data stored in apps, reflecting growing concerns about data privacy and security in the mental health app industry.