After a report criticised the NHS for still not learning from mental health inpatient deaths, the MHRA issues new guidance for digital mental health technologies.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance to help manufacturers meet medical device regulations and ensure digital mental health technologies are effective, reliable and safe.
Digital mental health technologies that diagnose, prevent, or treat conditions using complex software must meet medical device standards to ensure they are effective and acceptably safe, just like any other medical device.
“With millions of people around the world held back by mental health problems, digital mental health therapies have huge potential to be scalable and accessible,” said Miranda Wolpert, director of mental health at Wellcome, which funded the project.
But, she added, “it is not easy to navigate between over and under regulation in this area”.
This new guidance explains how to define and communicate the intended purpose of a digital mental health technology; when a digital mental health technology is considered a medical device under UK law; and how risk classification is determined, ensuring proportionate regulation for different types of technologies.
The guidance is one of the outputs from a three-year Wellcome-funded project, launched in 2023, to explore the regulation of digital mental health products. Developed by the MHRA, with input from the National Institute for Health and Care Excellence (NICE), NHS experts, researchers, healthcare professionals, and people with lived experience, it aims to meet both clinical and real-world needs.
Fear of safety investigations
The focus on mental health technologies is timely and comes in the aftermath of a report from the Health Services Safety Investigations Body (HSSIB) that concludes that the NHS is still not learning from mental health inpatient deaths.
The investigation reviewed local, regional and national oversight frameworks, as well as data collection mechanisms and examined how providers conduct investigations into deaths of patients receiving care in inpatient units or within 30 days of discharge.
A key finding in the investigation was that there is a culture of blame where individuals, including patients and families, and organisations fear safety investigation processes.
There are, said Nichola Crust, senior safety investigator at HSSIB, “significant systemic issues, gaps and poor cultures that serve to undermine patient safety in mental health care. In short: the system is still not learning effectively from deaths”.
The report emphasises the need for a systemic approach to safety investigations and learning for improvement with a focus on collaboration, transparency, and oversight, with a shift from procedural practices to a culture rooted in empathy.
But, as always, the problem is money.
“There must be an opportunity to effectively learn from patient safety incidents, however, a long-term lack of investment in services is preventing this from happening,” said Roman Raczka, president of the British Psychological Society.
“The government must properly fund mental health services and grow the workforce while embedding a greater focus on prevention. Only then will mental health patients, and their families, get the expert support they need,” he added.
