Earlier this week, we delve into the challenges facing Americans while trying to access mental health care.
The pandemic triggered a spike in depression and anxiety and quickly strained our already fragile system. While many were struggling to find care, the world of technology offered a solution: fast, affordable relief through an app.
At the start of the pandemic, companies like Better Help and Talkspace saw their downloads nearly double. But some health experts are raising concerns about privacy and quality of care. A recent report from Mozilla found that 28 of 32 therapy applications they are taking advantage of user data. The Cerebral app is currently under investigation. for possible violations of the Controlled Substances Act.
Are mental health apps data hackers with diluted care or are they a safety net for those who need it?
FDA Statement on Mental Health Apps:
The FDA understands that there is a need for substantive and supportive digital applications/therapies for behavioral health, including the prevention and treatment of mental health disorders. We are open to hearing from developers seeking to bring evidence-based products to market that are safe and effective, including consideration of the context of clinical use as part of the product risk-benefit determination.
The FDA regulates products, including software features and mobile applications, that meet the legal definition of “device.” In general, 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 if it is intended to affect the structure or any function of the body. However, certain software features are specifically excluded from the definition of a device. Many mobile apps on the market do not meet the legal definition and their developers do not submit them for FDA clearance. Consequently, the FDA does not have the opportunity to review the evidence behind them.
If a product is intended for general wellness only and is low risk, the FDA may not actively regulate it. fda General Wellness Guide applies to these products and states how the agency enforces a product’s intended use (for example, whether a medical claim is made about diagnosis or treatment) and whether the product presents low risk to users. The agency strongly encourages developers to collect evidence-based information to support their products.
App developers whose products do not fall within the FDA’s General Wellness guidance are encouraged to discuss the appropriate medical device authorization process with the FDA. This process requires that the products be evidence-based.
Measuring whether products are improving patient health is imperative to assessing safety and efficacy. 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 them to ensure successful patient care.
For the duration of the COVID-19 Public Health EmergencyRecognizing 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 politics that facilitated patient access to these technologies. The agency has received feedback on this policy and is carefully considering that information as we chart a path forward.
In the future, it is our hope that more digital health applications/digital therapies 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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