How Safe And Effective Are Mental Health Apps? (Rebroadcast)

Earlier this week, we explored the challenges Americans face when trying to access mental health care.

The pandemic has created waves of depression and anxiety, quickly straining our already fragile systems. While many struggle to get help, the tech world has come up with a solution: quick and affordable help through an app

At the start of the pandemic, companies like BetterHelp and Talkspace nearly doubled their downloads. But some health experts have raised concerns about privacy and quality of care. A recent Mozilla report found that 28 out of 32 medical apps use user data. Cerebral App is currently being investigated for possible violations of the Controlled Substances Act.

Are mental health app data hacks pirates' care or a safety net for those who need it?

FDA Statement on Mental Health Applications.

FDA understands the need for substantial and supportive digital applications/therapies for behavioral health, including the prevention and treatment of mental disorders. We welcome collaboration with developers who seek to bring evidence-based products to market that are safe and effective, including the context of clinical use as part of the benefit-risk assessment of the product.

The FDA regulates products with software features and mobile applications that meet the legal definition of a "device." In general, an article is a "device" if it is intended for the diagnosis of a disease or other condition, or for the treatment, mitigation, treatment or prevention of a disease, or if it is intended to improve structure or affect function. the body. However, some software features are specifically excluded from the device definition. Many mobile apps on the market do not meet the legal definition, and their developers do not submit them for FDA approval. Therefore, the FDA is unable to review the evidence that supports them.

If a product is intended only for general health purposes and has a low level of risk, it may not be regulated by the FDA. These products are subject to the FDA's general fitness guidelines, which indicate how the agency ensures that the product is used as intended (for example, is there a medical claim to diagnose or treat a disease) and whether the product is low risk for users. for. . The agency strongly encourages developers to collect real data to support their products.

For app developers whose products fall outside the FDA's general healthy lifestyle guidelines, it is recommended that they discuss the appropriate medical device approval process with the FDA. This process requires products to be evidence-based.

Evaluating safety and efficacy requires measuring whether a product improves a patient's health. When evidence is not provided, regulators, clinicians, and developers make limited judgments about the effectiveness of these products, ultimately making it difficult to study and improve them to ensure successful patient care.

During the COVID-19 public health emergency, recognizing that patients would benefit from more options, and based on an assessment that the benefits of these procedures outweigh the risks, the FDA developed policies to allow patient access to these technologies facilitated. The agency has received feedback on this policy and is considering it carefully as we develop a pathway.

In the future, we expect more digital health/behavioral health digital therapy applications to be submitted for agency consideration. We are committed to contributing to the development of additional safe and effective treatments for patients.

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