By Matt Williams, Senior Programme Manager – Mental Health, Health Innovation Oxford and Thames Valley
If you are developing any new digital mental health technology, you need to know about the new government guidance.
We work with digital health pioneers every day. We recognise the challenges of navigating regulation, and we know how crucial it is to get it right. This guidance helps innovators understand whether their technology qualifies as a medical device and, if so, what that means in practice. But it also raises key questions: How do you assess risk? What evidence do you need? How do you ensure compliance without stalling innovation? Let’s break it down.
What you need to know
- Define your technology’s purpose early – The guidance makes it clear that your product’s intended purpose dictates whether it qualifies as a medical device. Getting this right from the start helps avoid regulatory surprises or frustrations later. Find out more on page 8 of the guidance.
- Does your technology have a ‘medical purpose’? – If your tool is designed to diagnose, prevent, monitor, treat, or alleviate a mental health condition, it likely qualifies as Software as a Medical Device (SaMD). That means specific regulations apply. Find out more on page 9 of the guidance.
- Know your risk classification – Not all digital mental health tools are the same. Your product will be classified as Class I, IIa, IIb, or III depending on its risk level. As you would expect, higher-risk devices require more evidence and oversight. Find out more on page 44 of the guidance.
- Plan your regulatory pathway – The guidance lays out different qualification routes for technologies, from wellbeing apps to AI-driven mental health tools. Knowing where your innovation fits can streamline your journey to market and optimise your chances of success. Find out more on page 44 of the guidance.
- Focus on patient safety – Ensuring your technology meets the right standards is not just a regulatory hurdle to negotiate or a box to tick—it’s about building trust with users and healthcare providers and ensuring your product benefits patients and the wider health system safely.
My take on the guidance
I welcome this timely guidance and view it as an important step forward. The digital mental health space is evolving fast, and clear, consistent regulation is vital to ensuring patient safety while allowing innovation to flourish. But I know from experience that regulation can feel like a barrier—especially for start-ups and scale-ups trying to bring new solutions to market.
That’s where we come in. We work with trusted associates who are experts in regulation and can connect you with the right support. Beyond that, we help shape strategies for adoption, reimbursement, and commercial success—ensuring your innovation aligns with NHS needs and the wider health system.
If you are developing digital mental health technology and want to understand how this new guidance affects you, let’s talk. Get in touch, and let’s work together to bring safe, effective innovations to those who need them most.
Email us at info@healthinnovationoxford.org.
For more details, read the full government guidance on digital mental health technology.