The Medical and Healthcare products Regulatory Agency (MHRA) has greenlit BlueSkeye AI to begin a clinical trial investigating its TrueBlue mental health app for women at various stages of pregnancy.

The trial, which is being conducted in partnership with the UK’s Institute of Mental Health, will establish the safety and efficacy of the app. It is slated to enrol 125 perinatal women through NHS hospitals and will begin in early 2024, lasting for 14 months, according to a 30 November press release.

BlueSkeye AI’s app uses artificial intelligence (AI) to scan the user’s face and analyse their voice to identify and monitor signs of depression. The trial will assess how useable the app is in real life and how well the technology correlates with standard clinical measures of depression.

BlueSkeye AI’s CEO Professor Michael Valstar said: “One in five pregnant women suffer from a mental health problem during their pregnancy and many struggle to access support. The cost of a lack of timely access to good quality perinatal mental health care costs the NHS £1.2bn and wider UK society £8.1bn a year.”

The initial phase of the study will involve 12 participants to establish safety; a follow-up will enrol a further 113 participants for additional data.

The design of the trial includes tasks such as reading or speaking to the app, that patients will complete once each week. The app will monitor the patient’s face and voice during this and will assess depression with added data input from self-report health questionnaires.

The increased prevalence of health apps has meant monitoring symptoms remotely is becoming more common. Technologies such as BlueSkeye AI’s app, which gathers data in-house rather than using a connected sensor device, means patients who do not always have access to support or those living with stigmatised illnesses can access health care more quickly. Big tech players such as Apple have also launched their own mental health tracking platforms.

As with all emerging technologies, apps also come with their issues. Discussions usually centre around cybersecurity due to the wealth of personal data that health apps store. There have been notable data breaches in the healthcare sector this year, including one that affected America’s largest healthcare systems. There was also the unveiling that millions of NHS medical devices in operation across England are unprotected against cybercrime, following a freedom of information request.

BlueSkeye AI encrypts users’ personal information using algorithms and says it is GDPR compliant, according to the company’s website.