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WYSA: The AI Bot Backed by the FDA

The shortage of mental health care practitioners and a significant increase in need since the pandemic has created a void, one that many companies are vying to fill. The APA has estimated that there are now more than 10,000 mental health apps currently available in app stores. Of these available apps, nearly all are not FDA approved and most have little to no research on their effectiveness. ORCHA reviewed over 500 mental health apps and found that almost 70% didn’t meet quality standards including privacy policies. ORCHA reports that this number is higher for applications geared toward crisis management, including suicide assessment and addiction. This is a major concern for consumers, healthcare professionals, and ethicists alike.

While many have concerns about AI in mental health, its integration has the potential to be beneficial. AI-motored mental health apps come with certain advantages including low cost, immediacy of treatment, and 24 hour accessibility. As the need for mental health care increases, the FDA has fast-tracked a mental health AI application (WYSA), granting it FDA Breakthrough Device designation. According to the FDA, this breakthrough designation was given due to a clinical trial that “found Wysa to be more effective than standard orthopedic care and comparable to in-person psychological counseling.”.

How it Works: WYSA uses a “AI emotionally intelligent coach” to respond to users stated emotions and uses evidence based practices including CBT, DBT, meditation, yoga, behavioral strategies, and yoga to promote resilience and recovery. WYSA also has a “human” component where mental health professionals are there for additional listening, encouragement, and guidance. This feature is only accessible for premium members and is not included in the free version. 

Target Population: WYSA claims to help people who are experiencing low mood, stress or anxiety. They cater to individuals who are interested in improving their emotional resilience. It further provides support for people suffering from musculoskeletal pain.

Risk Populations: WYSA clearly states on its website that it is not equipped to assist individuals experiencing abuse, severe mental health disorders, suicidal thoughts or emergency medical situation. Additionally, it states that is not meant to be used to give a diagnosis or cure any disorder or disease.

Overall Impressions: WYSA has taken many steps to address many of the major concerns being raised by the mental health community. They instituted strict privacy settings to reduce concerns about leaking health information. They have integrated mental health professionals to provide additional “human” support. What’s more, WYSA has more than 15 peer-reviewed publications in partnership with major reputable institutions that corroborate its effectiveness. Even with these safeguards in place, The question still understandably arises for many mental health professionals “Is this something I would confidently refer an individual or client to?” This issue continues to be an important question of taste and clinical judgment.

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