Don’t Worry, Be App-Y – The Government Plans for Regulation of Digital Mental Health Technologies

The government's review of DMHT takes place in the context of a broader project focused on the role played by software (including AI) in health and social care generally – the Software and AI as a Medical Device Change Programme(the Change Programme), which was originally announced in September 2021.

The Change Programme considers, among other things, the interfaces between software products and the regulatory regime for 'medical devices' under the Medical Device Regulations 2002 (as amended).

Its objective is to provide clarity for patients, suppliers, and healthcare providers, as well as ensure that patients are adequately protected.  

Guidance is already available for manufacturers of general health-related technology solutions (including standalone software products such as apps), which may be subject to the medical device regulatory regime if they have what is defined as 'a medical purpose'.    

Software and technologies focused on mental health form a sub-set of such technologies and raised specific considerations which do not fall neatly within existing guidance. 

With that in mind, the MHRA, working in partnership with the National Institute for Health and Care Excellence (NICE) and with funding from the Wellcome Trust, embarked in 2023 on a three-year project to formulate guidance and other sources of information for developers, healthcare professionals, patients and the public, to clarify the regulatory and evaluation requirements for DMHT.  

The output of the first work package in that project is the report titled Digital Mental Health Technology: User and Public Perspectives, which was published in April 2024 and is discussed below.

As its title indicates, the report focuses on 'User and Public Perspectives' on DMHT, and it represents an early phase in the wider project.

As well as reporting current opinion, however, it does give some indications of potential regulatory conclusions, which may be of interest to businesses which may, in due course, be subject to that regulatory regime.  

• The function of the specific technology was naturally viewed as significant to the level and type of regulation that would be required.  
• For example, apps focused on 'care' (i.e. general mental wellbeing) were viewed differently from those which might be held out as a 'cure' for an identified condition (with the latter requiring more stringent regulation).  
• Similarly, an app that replaced a physical item or a process (such as 'a self-help book, journal, yoga class or meditation session') was viewed differently from an app that replaced interaction with a human (e.g. diagnosis, triage, therapy or case management') with the latter again representing a higher risk and greater regulatory concern. 
• The public were also concerned about the need for guidance for those involved in advising in the design or use of DMHT, and considered this 'as much if not more of a priority than guidance for the public'.  
• Regulation could be focused on developers of DMHT, with a requirement to ensure that risks associated with use of such technologies are mitigated by design, for example by ensuring that a user accessing an AI-enabled counselling platform gets access to a health care professional when required.
• Ensuring that users of DMHT are properly informed about the technology was viewed as important, and the obligation to provide this information is a potential regulatory requirement for providers.  
• Such information might include in what circumstances and in what way the product could help the user, any warning signs that might arise from its use, such as anxiety, and how to get help if the product was not providing the care and support they needed, or might be causing harm to the user.

These are initial indicators only, though, and the main message for providers is to continue to monitor developments as the project progresses.