The Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light for BlueSkeye AI to begin a clinical trial investigating its TrueBlue mental health app for women at different stages of pregnancy.
The trial is being carried out in collaboration with the UK Institute of Mental Health and will establish the app’s safety and effectiveness. According to a November 30 press release, the trial will enroll 125 perinatal women through NHS hospitals and will begin in early 2024 and continue for 14 months.
BlueSkeye AI’s app uses artificial intelligence (AI) to scan your face and analyze your voice to identify and monitor signs of depression. The trial will assess how easy the app is to use in real life and how well the technology correlates with standard clinical measures of depression.
Professor Michael Valster, CEO of BlueSkeye AI, said: “One in five pregnant women suffers from a mental health problem during pregnancy, and many struggle to access support. The cost of not having access to Leigh is £1.2 billion a year to the NHS and £8.1 billion to British society as a whole.”
The initial phase of the study will involve 12 participants to establish safety. A follow-up study will enroll an additional 113 participants to obtain additional data.
The study design includes reading and speaking tasks on the app that patients complete once a week. The app meanwhile monitors the patient’s face and voice and adds data input from self-reported health questionnaires to assess depression.
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With the increasing prevalence of healthcare apps, monitoring symptoms remotely has become more common. Technologies like the BlueSkeye AI app, which collects data in-house rather than using connected sensor devices, can help patients who don’t always have access to support or who are living with a stigmatized disease more quickly. means access to medical care. Big tech companies like Apple are also launching their own mental health tracking platforms.
Like all emerging technologies, apps come with challenges. Healthcare apps store large amounts of personal data, so discussions usually center around cybersecurity. This year has seen some notable data breaches in the healthcare sector, including one that affected the largest healthcare system in the United States. Freedom of Information requests have also revealed that millions of NHS medical devices in operation across the UK are left unprotected from cybercrime.
According to the company’s website, BlueSkeye AI uses algorithms to encrypt users’ personal information and is GDPR compliant.