Earlier this week, we dug into the challenges Americans face while trying to access mental health care.
The pandemic triggered a spike in depression and anxiety and quickly strained our already frail system. As many struggled to find care, the tech world offered a solution: quick and affordable relief via an app.
At the start of the pandemic, companies like Better Help andTalkspacesaw their downloadsnearly double.But some health experts are raising concerns about privacy and quality of care. A recent report from Mozilla found that 28 out of 32 therapy apps are taking advantage of user data. The app Cerebral is currently under investigation forpossible violations of the Controlled Substances Act.
Are mental health apps data pirates with watered-down care or are they a safety net for those in need?
FDA statement on mental health apps:
The FDA understands there is a need for substantive and supportive applications/digital therapeutics for behavioral health, including the prevention and treatment of mental health disorders. We are open to hearing from developers who seek to bring to market evidence-based products that are safe and effective, including consideration of the clinical use context as part of the product’s benefit-risk determination.
The FDA regulates products, including software functions and mobile apps, that meet the statutory definition of “device.” Generally, a product is a “device” if it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or it is intended to affect the structure or any function of the body. However, certain software functions are specifically carved out of the definition of device. Many mobile applications on the market do not meet the statutory definition, and their developers do not submit them for FDA authorization. Consequently, the FDA does not have the opportunity to review the evidence behind them.
If a product is intended for general wellness use only and is low risk, it may not be actively regulated by the FDA. The FDA’s General Wellness guidance applies to these products and lays out how the agency enforces a product’s intended use (e.g., whether there is a medical claim being made about diagnosis or treatment) and whether the product presents a low risk to users. The agency highly encourages developers to gather evidence-based information to support their products.
Those app developers whose products do not fall within FDA’s General Wellness guidance are encouraged to discuss the appropriate medical device authorization process with the FDA. This process requires products to be evidence-based.
Measuring whether products are improving patient health is imperative to assessing safety and effectiveness. When no evidence is provided, regulators, clinicians and developers have limited assessment of whether these products are working, ultimately making it more difficult to learn from and improve upon them to ensure successful patient care.
For the duration of the COVID-19 Public Health Emergency, recognizing that patients would benefit from more options and based on an assessment that the benefits of the approach would outweigh the risks, the FDA established a policy that facilitated patient access to these technologies. The agency has received comments on this policy and is carefully considering that input as we chart a path forward.
Going forward, we are hopeful that more digital health applications/digital therapeutics for behavioral health will be submitted to the agency for review. We remain committed to facilitating the development of additional safe and effective therapies for patients.
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