Follow That Trail: New Guidance For Manufacturers Of Digital Mental Health Technologies

Follow That Trail: New Guidance For Manufacturers Of Digital Mental Health Technologies

On February 3, 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidance for manufacturers of medical devices. The guidance is intended to help these manufacturers comply with new regulations and ensure that the technologies they create to monitor mental health are dependable, productive and safe for use. The guidance specifically explains how to define a digital mental health technology, when it qualifies as a medical device under UK law, and how to classify its risk to ensure proper regulation. 

The rise of digital technologies has coincided with changing societal attitudes to mental health. There is a growing recognition that poor mental health can lead to issues such as anxiety and stress, harming an employee's ability to work. This has resulted in the introduction of frameworks such as Total Worker Health, launched by NIOSH (the US National Institute for Occupational Safety and Health) in 2011, to integrate workplace safety measures with worker wellbeing across all aspects of health, both physical and mental. This approach aims to create an environment that not only protects employees from workplace hazards, but enables their health and wellbeing to prosper. In the latest Verdantix global corporate EHS survey, 77% of respondents considered integrating total worker health and wellness programmes into EHS initiatives to be a ‘high’ or the ‘highest’ priority over the next two years.

Technology vendors recognize the demand for digital solutions that can monitor the mental health of workforces. In particular, they have explored the use of dedicated mobile applications, which are accessible to all employees. Through regular app engagement, senior leaders can assess employees' mental wellbeing and identify issues requiring further investigation. 

EHS software vendors also understand the importance of mental health in the workplace. Some have introduced personal wellness assessments, whilst others have launched partnerships with mobile app providers. Take Cority, which instigated a strategic partnership in 2022 with mental health solution provider Highmark Interactive. Highmark Interactive provides an app called ‘EQ At Work’, which uses gamified neurological mini-assessments to ensure that staff are both cognitively and emotionally fit for work. Cority's integration allows customers to monitor results through its own business intelligence (BI) tools, while guiding users to health or online training resources.  

Digital mental health technologies must comply with medical device regulations to ensure they are both safe and effective. The new guidelines help firms with the difficult task of applying these regulations to software, providing more trust and confidence in these applications. To read more about employee mental health, click here.