Not all digital mental health tools have undergone the same checks and assessments (stock image) (Image: Getty)
The Medicines and Healthcare products Regulatory Agency (MHRA) has released new guidance regarding the use of digital platforms for well-being issues. This is particularly relevant for people using symptom-monitoring apps, virtual reality treatments, and other mental health platforms, especially those without approval from healthcare authorities.
Crucially, the UK Government agency encouraged Brits to consider several important questions about their selected platform, including whether it is trustworthy and safe for use. It also advised people to exercise caution with products making ‘big promises without clear supporting information’.
In a statement today, MHRA Chair and professor of primary care at the University of Oxford, Professor Anthony Harnden, said: « When someone turns to a tool to help with their mental health, they need to know it is safe, effective, and built on reliable evidence.
« Our aim is to give people clear, practical advice they can use in everyday life, so they understand what good looks like and when to speak up if something doesn’t feel right.
« As a GP, I’ve seen how patients can benefit from accessing digital tools alongside traditional forms of care. This guidance supports better conversations between clinicians and patients and helps everyone ask the right questions about whether a tool is right for them.
« Digital mental health technologies are not a replacement for professional healthcare. Anyone experiencing mental health difficulties should seek support from trained professionals. »
Brits are encouraged to ask themselves several questions before using a digital mental health tool (Image: Getty)
Questions to ask yourself before using a digital mental health tool
According to the MHRA, there are five key queries you should consider before making use of a mental health app or online tool. These include the following:
- What is it claiming to do? Does this product provide general well-being support, or does it claim to diagnose, treat or help manage a mental health condition? Any assertions made should be clearly outlined and backed up with evidence.
- Who is the intended user? Check the target age group for the app or tool, as something created for adults may not be suitable for children or teenagers.
- Is there any evidence that it works? Trustworthy tools typically detail their testing or evaluation methods, such as clinical studies. Exercise caution with apps and websites that make substantial claims without providing transparent supporting information.
- What happens to your data? Online mental health tools often gather highly sensitive personal data. The tool should clearly explain where and how this information is stored.
- Is it regulated as a medical device? Some digital mental health tools are classified as medical devices, such as those that claim to diagnose, treat, or manage a mental health condition. Others are not designed as medical devices but are instead categorised as well-being or lifestyle products.
On the fifth point, the MHRA emphasised that well-being and lifestyle products aren’t inherently unsafe, even when not classified as medical devices. However, they may not have undergone the same scrutiny as an officially recognised medical device.
For a product to qualify as a medical device, the MHRA clarified that it must bear a ‘CE or UKCA mark’. The agency’s advice further advised: « People can look for the marking and check whether the product is registered using the MHRA’s online public register.
« This gives you extra reassurance, as it means it meets UK safety standards, is registered with the MHRA and is monitored once in use. » If a regulated digital mental health technology causes harm or distress, you can also raise concerns through the MHRA Yellow Card scheme.
In light of the fresh advice, Chief Scientific Officer at NICE, Dr Nick Crabb, said: « Our role at NICE is to help practitioners and commissioners get the best care to people, fast, while ensuring value for the taxpayer. As digital mental health technologies become more widely used, it’s vital that people can access tools that are safe, effective and built on robust evidence.
« These new resources will help people ask the right questions and make informed choices. This matters now more than ever, as the government’s 10 Year Health Plan expands NICE’s technology appraisal process to cover devices, diagnostics and digital products for the first time.
« Our collaboration with the MHRA and Wellcome is helping to lay the groundwork for this – ensuring that innovation in mental health is matched by rigorous, proportionate evaluation so that the best digital tools can reach those who need them. »
Meanwhile, Head of Information at Mind, Stephen Buckley, said: « It’s really important that people can understand what good support looks like. Digital tools such as these are a useful way for people to access information and help alongside more traditional mental health support. »
Source link
