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Digital technology has transformed mental healthcare, increasing accessibility, flexibility, and reducing stigma. However, this shift can create new barriers if manufacturers and organisations don’t address risks leading to digital exclusion for those most vulnerable. All healthcare technology stakeholders must ensure their products and services are accessible to everyone, especially those at risk of exclusion. This article emphasises designing for digital inclusion and offers solutions for manufacturers to create more equitable solutions.
The Scale of the Digital Exclusion
While high rates of internet and smartphone use suggest widespread access, these numbers don’t tell the full story. Millions of households struggle to afford their mobile contracts and millions more adults lack basic digital skills. This disproportionately affects vulnerable groups such as people with severe mental illness, who are twice as likely to lack these skills (NIHR, 2022), as well as those aged 65+ and people with a disability or health condition (UK Consumer Digital Index 2023). This shows that access is not the same as inclusion.
Double Jeopardy
For digital mental health, this can create a ‘double jeopardy’. Groups who face both mental health inequalities and digital barriers experience a particular disadvantage, where they may struggle to access the very resources designed to help them
The Good Things Foundation, the UK’s leading digital inclusion charity, outlines the key barriers to digital inclusion in health systems, summarised below:
- Access & Connectivity: Not everyone has a reliable internet connection or a suitable device
- Digital Literacy & Confidence: Many people lack the skills and confidence to use digital tools for health
- Motivation: Patients may be unwilling to use digital services, often fearing they will replace traditional care
- Trust: Concerns about data privacy and cybersecurity can stop people from engaging
- Physical Space: A private, safe, and confidential space isn’t guaranteed for everyone
- Support: Some people, especially older or disabled individuals, lack the help needed to get online
- Independence, Choice & Control: Not all users can or want to use digital tools, and they want to maintain control over their data
For manufacturers building digital mental health products, the foundation of inclusive design is the right risk management team. This team should include an expert Clinical Safety Officer (CSO), to manage digital mental health risks and representation from clinical experts who understand the user’s perspective.
This team is essential to achieve the following:
User-Centred Design & Testing
Inclusive design starts with user research, especially with underserved groups. A patient’s perspective on things like language and design is very different from a developer’s. By bringing end-users into the process earlier, at the scoping stages, manufacturers can use ongoing feedback to promote a more inclusive product through continuous refinement.
Formal Standards and Foundational Accessibility
Manufacturers should adhere to the Digital Technology Assessment Criteria (DTAC) for NHS products and the Web Content Accessibility Guidelines (WCAG) as a baseline. This commitment ensures solutions are accessible to users with diverse needs. This includes compatibility with assistive technologies like screen readers, full keyboard navigation, and sufficient colour contrast.
Beyond these formal standards, a great user experience is key. Products should be intuitive, using clear visual cues, and simple, built-in tutorials can also help reduce the learning curve and build user confidence from the start.
Augmentation, Not a Replacement
The most effective digital mental health tools serve to enhance existing services, not replace them entirely. When a traditional care pathway is digitised, it should be offered as a flexible alternative. This approach ensures that patients who can benefit from technology have a new, accessible option, while the original pathway remains a safe and reliable option for all.
Low Bandwidth and Limited Data
To address the anxiety and reluctance caused by limited internet access or data plans, manufacturers can design for low bandwidth from the start. This involves optimising products to consume minimal data, offering Wi-Fi-only downloads, and enabling core features to work offline.
Device Compatibility and Technical Support
It is important to consider device compatibility and ongoing technical support, as many users have older operating systems or devices that may not run newer applications. Since patients are likely to go back to their healthcare professional for help with tech problems, manufacturers should provide a clear way to resolve issues, whether through their own support team or by providing clear guidance to staff in deploying organisations.
Trust Through Responsible Data Handling
Trust is everything when dealing with sensitive mental health data. Manufacturers should build this trust through transparency and robust cybersecurity, providing clear, plain-language information on how data is collected, used, stored, and shared. This transparency encourages engagement and helps patients feel secure using digital tools.
Human Connection and Support
Even the best digital tools can’t replace human connection. Products should make it easy for users to get help from a person when they need it, for example, through an in-app phone option. Additionally, the service itself should feel personal and caring. Using empathetic language in notifications and throughout the interface can build trust and help the user feel supported, not simply managed by an automated system.
The Role of AI in Trust and Connection
While AI offers powerful tools for scalability and personalisation, it must be handled with care. A lack of transparency about how AI models are built and used may cause anxiety or paranoia about use, especially for individuals with pre-existing mental health conditions. Similarly, over-reliance on AI chatbots can undermine trust and replace the human connection that is so important in mental health care.
It’s also important to note that the use of AI for a medical purpose, such as diagnosis or treatment, can mean a solution is classed as a Medical Device by the MHRA, which requires a different regulatory pathway beyond DCB0129 and DCB0160. If you need help defining whether your digital mental health tool may be entering Software as a Medical Device (SaMD) territory, get in touch with us about a Regulatory Review and Strategy.
Crisis Signposting
When a digital intervention replaces a face-to-face interaction, it’s a critical safety control to ensure users are clearly signposted to appropriate human support, including crisis pathways. This topic, and how manufacturers should approach it, is explored in more detail here.
Inclusion for All
The transformative potential of digital mental health is clear, but it depends on inclusion for everyone. An equitable future requires both manufacturers to build products that are inclusive by design and meet DCB0129 standards, and deploying organisations to implement them under DCB0160 with a focus on patient needs.
Through this shared responsibility, we can ensure these powerful tools benefit everyone, especially those who need them most.
As a team of Clinical Safety Officers, we do our utmost to guide organisations through these requirements, ensuring clinically safe solutions are deployed to the market and an inclusive approach is taken to digital health transformation.
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