Why clearer regulation is needed on mental health apps – Med-Tech Innovation

Mental health concept

From catheters to ultrasound scans, medical technologies are found at every stage of the patient pathway, designed with the fundamental purpose of saving and improving lives. Digital mental health tools, such as wellbeing apps including Headspace and Unwind, perform the very same function and are the latest type of medical technology society is embracing to meet the population’s mental health needs. 

These apps are growing in popularity and present an innovative solution to the growing mental health crisis in this country: they are convenient, accessible and in many cases, free to use. Above all, they provide extra capacity to overwhelmed and under-resourced NHS mental health services, helping people access vital support at the touch of a button.

The evidence pointing to a mental health crisis amongst children and young people in particular is considerable. The NHS estimates that 1 in 7 children aged 11-16 have a diagnosable mental health disorder, which is roughly five children in every classroom. According to a survey conducted earlier this year, Child and Adolescent Mental Health Services (CAMHS) are turning away many children and young people with mental health issues due to immense demand for their services, which has been exacerbated by the pandemic. 

With services experiencing unprecedented demand, interest in mental health apps is booming. According to a 2021 report by the Organisation for the Review of Care and Health Apps (ORCHA), searches for apps for critical mental health needs, such as depression and OCD, rose by 156% and 422% respectively during the pandemic. The lack of face-to-face appointments also resulted in a growing number of healthcare professionals recommending digital technologies to their patients. 

In 2021, Germany became the first country in the world to approve a new digital mental health app for prescription and reimbursement. Deprexis, an app intended to provide therapies and exercises for patients with depression, became the 11th app to be approved under a new fast-track regulatory process created by the German Government through the 2019 Digital Healthcare Act. The fast-track route expedites the approval, testing, piloting, and evaluation of these apps in Germany.

By contrast, the regulatory framework to approve such apps in the UK is weak. A plethora of mental health apps exist, but questions remain over whether they are medical devices and if so, which risk classification they would fall under. Under Regulation 7 of the Medical Devices Regulations 2002, medical devices deemed ‘high risk’, e.g., devices in Class III, need to be assessed by an Approved Body, which can often be a lengthy process. 

To address these regulatory challenges, the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) were recently awarded £1.8 million by the charitable foundation, Wellcome, to explore and produce risk-appropriate guidance on regulating digital mental health tools. 

The guidance will be used to establish when these products should be regulated and what evidence they must have to demonstrate their safety and effectiveness. According to the programme director for Information Services at NICE, the guidance ultimately will help both the MHRA and NICE to “simplify” and “streamline” the approval process, bringing this into line with other European countries.  

Once the guidance has been published, the challenge will be ensuring that app innovators have a solid grasp of what is required of their apps. For digital health technologies to be considered for use by the NHS, they must also be assessed at the point of commissioning against the NHS’ Digital Technology Assessment Criteria.

With around 21,000 mental health apps currently available, tighter regulation will likely lead to a fall in this number, so patients will have access to the best and safest tools on the market and can be confident they’re avoiding any which may cause harm. Whether they are used while waiting for a real-life therapy session, or on their own to support our mental wellbeing, these apps have real potential to transform mental health provision in the UK. 

The MHRA and NICE, with the backing of Wellcome, are determined to get their regulatory approach right.

Questions about or comments upon this article can be addressed to the author at [email protected].