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 fragile system. When many struggled to find care, the tech world came up with a solution: fast, affordable relief via an app.
Early in the pandemic, companies like Better Help and Talkspace saw their downloads nearly double, but some health experts are concerned about privacy and quality of care. A recent report from Mozilla found that 28 out of 32 therapy apps take advantage of user data. The Cerebral application is currently under study for possible 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 Applications:
The FDA understands that there is a need for substantial digital applications/therapeutics and support 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 determining the benefits and risks of product.
The FDA regulates products, including software features and mobile applications, that meet the legal 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 if it is intended to affect the structure or any function of the body. However, some software functions are specifically cut out of the device definition. Many mobile apps on the market do not meet the legal definition, and their developers do not submit them for FDA clearance. Therefore, the FDA does not have the opportunity to review the evidence supporting them.
If a product is intended for general wellness use only and poses a low risk, it may not be actively regulated by the FDA. The FDA General wellness tips applies to these products and indicates how the agency applies the intended use of a product (for example, whether there is a medical claim regarding diagnosis or treatment) and whether the product poses a low risk to users. The agency strongly encourages developers to gather factual information to support their products.
App developers whose products fall outside of the FDA’s general wellness guidelines are encouraged to discuss the appropriate medical device authorization process with the FDA. This process requires products to be evidence-based.
Measuring whether products improve patient health is imperative to assess safety and efficacy. When no evidence is provided, regulators, clinicians and developers have limited evaluation of the effectiveness of these products, ultimately making it more difficult to learn and improve 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 have facilitated patient access to these technologies. The agency has received feedback on this policy and is carefully considering this feedback as we chart the way forward.
In the future, we hope that more digital health applications/digital behavioral health therapies will be submitted to the agency for review. We remain committed to facilitating the development of safe and effective additional therapies for patients.
Copyright 2022 WAMU 88.5
0 Comments