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W-WATI project: Call for Participants

Horizon’s Workplace Wellbeing and the Internet (W-WATI) project is running focus groups to understand people’s workplace experiences of how the balance between their online and offline activity affects their wellbeing. They are also interested in the steps people take to support their own wellbeing, and the support currently available to them. Findings from this work will inform recommendations and interventions designed to improve wellbeing in the workplace.

The project is looking to recruit people aged 18 or over who work in any sector so long as their job role requires some online work.

Focus groups will take place during May and last for an hour and a half. Each participant will be offered a £25 Amazon voucher as a thank you for their contribution.  Participants must attend and participate for a minimum of 75 minutes to receive the voucher.

Participants can join online or in person at the University of Nottingham, Jubilee campus.

If you are interested in taking part, please complete this form.  We look forward to hearing from you.

 

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Regulating Digital Mental Health Technologies

In February, the Medicines and Healthcare products Regulatory Agency (MHRA) released new guidance [1] aimed at clarifying aspects of regulation for Digital Mental Health Technologies (DMHTs) in the UK. This is the most recent output from a three-year project by the MHRA and NICE (National Institute for Health and Care Excellence), funded by the Wellcome Trust, focusing on the regulation and evaluation of these technologies [2-5]. The guidance provides the latest information and helpful clarification to the questions around the definitions of DMHTs and whether they qualify as a ‘Software as a Medical Device’ (SaMD), requiring compliance with associated regulations.  

In this blog post, we highlight key messages of the new guidance, provide our views on the strengths of the guidance, what we see coming next and how the guidance relates to the HAWT project currently in progress at Horizon Digital Economy Research at the University of Nottingham. 

As noted by Holly Coole, Senior Manager for Digital Mental Health at the MHRA, who leads the Wellcome-funded DMHT project in collaboration with NICE: 

  “We hope the recently published guidance for digital mental health technology characterisation, regulatory qualification and classification will be useful for resources like the HAWT Toolkit. We recognise that mental health support is often provided through third sector organisations like charities and helping them to understand the regulations is crucial to ensure that safe and effective technologies are adopted that have been responsibly developed. We hope that clarification about what qualifies as SaMD, along with clear examples, can support decision making not just within national health services across the UK but across all sectors and we sincerely value the work that the HAWT project is doing to guide potential adopters and raise awareness of the regulations”. 

 Overview of the guidance: Useful, but only for DMHT as SaMD 

In the UK, the MHRA are responsible for regulating medicines and medical devices. Due to the varied nature and recent development of technologies for mental health, stakeholders were keen for clarification on regulatory approaches and requirements [3]. As a result, the new guidance is aimed at manufacturers to help them answer the question of whether their DMHT is classified as a SaMD.  

What is a DMHT? 

According to the guidance, DMHTs are “digital and software products designed to support mental health and wellbeing”. Keeping to a board definition, this includes a wide range of different technologies including internet-based or smartphone-based applications, websites, virtual reality (VR) headsets and AI-driven tools for mental health.  

 Which DMHTs qualify as medical devices? 

Previously, the MHRA had guidance on qualification and classification for SaMDs, but not with examples for mental health [3]. As DMHTs create a grey area for regulators, the guidance aims to systematically unpack the purpose and level of functionality of the DMHT determining whether it qualifies as a SaMD. 

This means that manufacturers must answer the following two questions: 

  1. Does the DMHT have a medical purpose? 
  2. Does the DMHT have sufficient functionality? 

Determining Medical purpose: 

  • To have a medical purpose, the medical devices must perform a clinical task and target clinical conditions and symptoms. 
  •  With reference to the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended), the medical devices are defined as any instrument, software or other material intended to be used for human beings for purposes including: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury; investigation, replacement or modification of the anatomy or of a physiological process. 
  • EU Medical Devices Regulation (2017/745) (EU MDR) covers similar purposes as the above with the additions of prognosis, compensation for an injury or disability, and investigation, replacement or modification of the anatomy a physiological or pathological process or state. 
  • DMHTs are likely to be considered to have a medical purpose if they are intended for one or more of the above purposed or as part of the broad process involved in the management of mental ill health.  

Determining Sufficient functionality: 

  • For DMHTs to be considered SaMD, they need to have a medical purpose and high functionality.  
  • High functionality: If the function performs computational tasks (other than standard tasks*), such as the following, it is considered high functionality: Processes user instruction with an interactive and / or personalised output; Processes data / information with a calculation / algorithm that is not easily verifiable; Processes data / information using AI. 
  • *Standard tasks include a) stores data / information without changes b) Communicates data / information without change or prioritisation c) Processes user instruction to show fixed content in a similar manner to a user choosing a chapter in a digital book, audio book or video d) Processes data / information with an easily verifiable calculation / algorithm. 

 What does this mean for regulation?  

If the product classes as a SaMD then further legal requirements need to be considered from evidence generation to risk assessment to certifications to post-market surveillance. The requirements are based on device classification Class I or Class IIa/b or Class III. It is important to note that when placing products in the UK market, there are some differences in regulatory requirements between Great Britain (UK MDR & EU MDD) and Northern Ireland (EU MDR).  

Our analysis – The strengths and areas to improve on the guidance and why? 

While the new guidance is aimed at clarifying the regulation and evaluation of DMHTs, the guidelines only focus on technologies that may qualify as ‘software as a medical device’ (SaMD) in the UK. The guidance provides a helpful starting point for manufacturers to understand whether their technology is a SaMD and if so, the next steps for regulation and evaluation, but does not focus on non-SaMD technologies thereafter.  

 Strengths  

  • There are various examples to help illustrate different applications where DMHTs could be classified SaMD (e.g., see Table 3. MHRA DMHT examples of functions, computational tasks and low / high functionality). 
  • The distinction between low and high functionality paradigms attempts to detect risks especially related with AI technologies.  Additional safeguards are needed when DMHTs attempt personalised recommendations as the human rights’ risks for individuals increase (manipulation and bias).  
  • There appears to be a broader scope of DMHTs with an increased emphasis on wellbeing focused application as well as general diagnosed mental health issues.  The guidance includes DMHTs that target wellbeing and sub-clinical levels as well as other technologies involved with managing mental health for those with other conditions.  
  • The guidance has many practical elements including the easy-to-digest decision maps and the MHRA DMHT characterisation form to help manufacturers define and communicate their device characterisation to the MHRA (and other stakeholders). 
  • The guidance is generally helpful in the mission to ensuring safe and effective digital mental health interventions.  

 Next steps?  

  • Because the MHRA is only meant to regulate medicines and medical devices, there are many DMHTs that this guidance might not be applied to (i.e. those that are not SaMD). This means that there are still gaps in the regulation of DMHTs which must be filled by other regulators like NICE and the NHS [3]. 
  • There is not much discussion on the determination for ‘medical device’ classification. It mentions “this guidance explains how to determine this and how UKCA / CE certification shows compliance with these regulations”, but this is not clear about what actions to follow if the DMHT is classified as a medical advice but does not satisfy SaMD requirements – in other words what do we do following the flowchart from Figure 2 if we land on ‘not SaMD’? 
  • ‘Medical purpose’ has a very broad definition, so it is likely that most of the DMHTs will fall under this definition, but identifying ‘sufficient functionality’ may not be that straight forward. Especially the distinction between processing data / information with an easily verifiable calculation / algorithm and processing data / information with a calculation / algorithm that is not easily verifiable.  Although the paradigms are well drafted, there might be more borderline cases. 
  • While the guidance is helpful, the title and overview are slightly misleading. The guidance can be better described to reach the audience with a different title and a disclaimer that this is only a piece of a puzzle (i.e., DMHT as SaMD), this is not the guidance for DMHTs as a whole. There are technologies that will sit at the “borderline,” requiring further advice. Furthermore, it could be noted that manufactures have additional regulatory obligations such as data protection regulation. 
  • Finally, more explanation about what legal principles are to be protected in each occasion and more connection with specific rights (privacy, informational self-determination, non-discrimination, freedom of thought etc) should be considered to better inform the general audience and the manufactures about potential risks and adequate measures.  

Horizon Adoption of Wellbeing Technology toolkit 

So how does this relate to our project? 

Horizon launched the Horizon Adoption for Wellbeing Technologies (HAWT) project to co-develop a comprehensive toolkit to guide the evaluation and adoption of immersive and emerging technologies for mental health support; so that community and voluntary sector (CVS) organisations can make informed decisions about which technologies to adopt.  

So far, the project has conducted a review of the current regulations and guidance for DMHTs from different sources and is in the process of conducting workshops to begin co-developing the toolkit with experts and key stakeholders.  

Our toolkit will provide CVS organisations with practical resources to assess different aspects of DMHTs such as relevant legislation, standards and regulations. Therefore, this new guidance from the MHRA will be included to inform the decisions process for adopters of these technologies about considerations for DMHTs that classify as medical devices, instead of the manufacturers. However, the HAWT toolkit will also bring together other guidance and standards for technologies that are not medical devices, such as the NHS Digital Technology Assessment Criteria (DTAC) and NICE Evidence Standards Framework (ESF). This toolkit will bridge gaps in knowledge of DMHTs by providing a comprehensive toolkit of relevant topics, compliance and considerations to allow CVS organisations to check if the DMHTs are right for them.  

Additionally, members of our HAWT team were involved in the organising, planning and facilitating of an MHRA event earlier this year which focused on bringing together experts to discuss AI for Mental Health. Dr Aislinn Gomez Bergin, Professor Elvira Perez Vallejos and Lucy Hitcham presented their research findings on digital mental health technologies and facilitated workshops with those in attendance on what should be considered when regulating and evaluating these technologies. We hope to carry on this work with the development of the HAWT toolkit. Stay tuned! 

References  

[1] Digital mental health technology: Qualification and classification. (2025, February 13). GOV.UK. https://www.gov.uk/government/publications/digital-mental-health-technology-qualification-and-classification 

 [2] Digital mental health technology. (2024, May 3). GOV.UK. https://www.gov.uk/government/collections/digital-mental-health-technology 

 [3] Hopkin, G., Branson, R., Campbell, P., Coole, H., Cooper, S., Edelmann, F., Gatera, G., Morgan, J., & Salmon, M. (2025). Building robust, proportionate, and timely approaches to regulation and evaluation of digital mental health technologies. The Lancet Digital Health, 7(1), e89–e93. https://doi.org/10.1016/S2589-7500(24)00215-2 

 [4] Hopkin, G., Coole, H., Edelmann, F., Ayiku, L., Branson, R., Campbell, P., Cooper, S., & Salmon, M. (2025). Toward a New Conceptual Framework for Digital Mental Health Technologies: Scoping Review. JMIR Mental Health, 12(1), e63484. https://doi.org/10.2196/63484 

 [5] Hopkin, G., Branson, R., Campbell, P., Coole, H., Cooper, S., Edelmann, F., & Salmon, M. (2024). Considerations for regulation and evaluation of digital mental health technologies. DIGITAL HEALTH, 10, 20552076241293313. https://doi.org/10.1177/20552076241293313 

 

 

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Workplace Wellbeing and the Internet -W-WATI reaches mid point

The first 6 months of W-WATI have been busy and very productive!

The first stage of our study exploring workplace wellbeing and the internet was to define workplace wellbeing. To this end, we conducted a literature review (Workpackage 1), which showed that wellbeing can be defined in myriad ways that are impacted by factors such as time-period, gender, age, culture, and individuality.

As a team, we discussed the literature and settled on the following definitions of wellbeing:

  • An overall/general subjective feeling of satisfaction, optimism, or happiness about life
  • Functioning well and with a sense of purpose
  • Feeling content about activities engaged in

Once we had our definitions, we returned to the literature to understand specific factors that went into workplace wellbeing. Across the literature we saw metrics that aimed to capture job satisfaction, job demands, workplace values, home life, personal and professional goals, personal and professional opportunities, individual autonomy, and social support. Common ways of capturing these metrics included, but are not limited to, sense of purpose, optimism, anxiety, loneliness, happiness, satisfaction, and time for activities.

This understanding of workplace wellbeing subsequently allowed us to seek more information about ways that being online might impact workers. These impacts were broadly negative, and common impacts were noted to be: feeling unable to ‘switch off’; suffering from information overload; feeling pressured to multitask beyond what is comfortable; and increased negative emotions such as anxiety, stress, and alienation.

 How do people feel about workplace wellbeing and the Internet?

In the next stage of the project, Workpackage 2, we ran on online questionnaire to elicit perspectives on how using the Internet and Internet-based technologies can affect wellbeing in the workplace. Our questionnaire aimed to capture details of respondents’ workplace experiences, time spent online at work and feelings about being online at work. We particularly focused on the topic areas that will be addressed later in the project in Workpackages 3,4 and 5. We circulated the questionnaire across our networks and the Prolific platform – a business that puts researchers in touch with participants. We received 248 responses. Respondents’ ages ranged from 18 to 71, with an average of 38 years old. Just over half of the participants (56.9%) were female.

Alongside questions about how people spend their work time online, we had several measures of aspects of wellbeing: ratings of current wellbeing in relation to work, how stressful their job is, technostress (the psychological impact of technology use at work), and general wellbeing. On average, participants rated their workplace wellbeing fairly high (3.54/5) with 52.4% feeling it was ‘somewhat good’; job stress was lower (2.71/5) with 41.5% stating ‘a little stressful’ and 28.2% ‘fairly stressful’, technostress was low medium (3.10/6), and overall wellbeing was moderate (3.9/6).

Online/offline balance

The focus of Workpackage 3 is on online/offline balance. This means the optimal balance of time spent online and offline for a person’s wellbeing in relation to work. Initial analysis of the questionnaire results revealed no significant differences in reported wellbeing in relation to work; across different work sectors or role types (i.e., whether respondents worked in full time, part time, self-employed, volunteer or multiple roles), gender and age of respondents, level of control over internet use at work, or confidence in using internet technology . Finally, there is no relationship between wellbeing and time spent on the internet, whether this is for work or for leisure, or background (time spent online indirectly) or active internet use.

We hoped that the questionnaire results would help us to narrow down the focus of our investigations. This is not the case, but they do chime with the ‘assumptions’ we made at the beginning of our project. From the outset, we have been careful not to assume that an online/offline imbalance will negatively or positively impact someone’s wellbeing. For example, one person may find that a small amount of time spent online is detrimental to their wellbeing, whilst someone else may find that being hyperconnected (the focus of Workpackage 4) supports their wellbeing. The questionnaire results indicate that wellbeing is very individual experience and not related to wider identities including age, gender or job sector.

Next, we will hold focus groups with workers of different ages, genders, and role types, working across a range of industries. We aim to uncover barriers and facilitators to achieving optimal online/offline balance that can be shared with others across job sectors to support wellbeing in the workplace. We originally planned to group participants by industry or role type but the questionnaire results suggest that mixed groups will be appropriate and that ‘optimal’ online/offline balance for wellbeing is down to individual preference and experience. This means that the guidance we go on to produce will likely be tailored more towards individual needs, for example, to support anyone who recognises that an imbalance in their online/offline activities is negatively affecting their wellbeing in the workplace.

Hyperconnectivity

Hyperconnectivity, the pressure to always be available and the blurring of work-life boundaries caused by constant digital connectivity, is the focus of Workpackage 4. The questionnaire results show that 10.9% of participants considered themselves to be hyperconnected ‘a great deal’ or ‘an extreme amount’, whilst 21.8% did not consider themselves to be hyperconnected at all. Looking at correlations between factors, it appears that the more hyperconnected someone considers themselves to be, the lower they rate their work wellbeing and overall wellbeing, and the higher they rate the stress levels of their job and their technostress.  Our next steps are to carry out a series of interviews with people who consider themselves hyperconnected, and those who do not, to understand their different perceptions of how the internet affects their workplace wellbeing. Some people who find themselves hyperconnected may see this as a positive thing, whilst some may experience it negatively, so these interviews will help us to get at these nuances.

Dealing with negative online content in the workplace

Just over 34% of our participants stated that they deal with online content posted by others as part of their work. Of those, 16.5% of participants stated that their job involves dealing with excessively negative online content every day and 14% stated that their job requires them to deal with this kind of content a few times a week. Only 5% answered that they never have to deal with excessively negative online content in their job. In Workpackage 6 we are particularly interested in what workplaces do to support their staff when they are faced with excessively negative or even hostile online content as part of their work. Of the participants who told us that their work involves dealing with online content posted by others,  35% stated that their workplaces do provide some form of support for dealing with excessively negative or hostile online content. Of these respondents, 80% said they were either completely or mostly satisfied that the support their workplace provides is sufficient; the remainder said they were either somewhat or a little bit satisfied that it is sufficient.  We intend to find out more about workplaces that do (and do not) currently provide support for staff when dealing with excessively negative or hostile online content and what best practices workplaces can adopt to prevent their staff from being harmed by coming into contact with this content.

Questionnaire reflections

The questionnaire produced some interesting and perhaps unexpected findings about how wellbeing, the Internet and the workplace interact.  For example, it was pleasing to see that the survey reached people from a broad range of occupations, who use the internet in varied and different ways – which promises to provide fascinating insights into areas of work that we are not familiar with. Also interestingly, a first impression is that overall, judgements of the effect of the internet on wellbeing appeared to be more positive than perhaps we had expected. Many respondents reported seeing the benefits to wellbeing that the Internet brings. Having said this, a range of responses were captured. Given the variety of workplaces and roles represented and the range of positive and negative views, our next task is to explore the data in more detail, to identify potential patterns to see if and where these first impressions are supported and build on the responses and qualitative explanations given. In Workpackages 3, 4 and 5 we will identify issues and themes from the data to explore these in more detail through interviews and focus groups to build on this broad survey. This will lay the groundwork for a richer exploration of workplace wellbeing and the internet.

Cheerbot deployment

In another part of the project, we have been making excellent progress with Cheerbot, our prototype workplace wellbeing aid. Cheerbot takes the form of bespoke interactive software developed for a temi© 3 mobile telepresence robot. Cheerbot encourages staff members to engage in fun activities such as playing games, hearing jokes and facts, creating a mood board and communal collage, and sharing movie and song recommendations with colleagues. It can also walk and talk alongside staff members and facilitate telepresence meetings.

MHR, a Nottingham-based HR, finance and payroll software company agreed to host Cheerbot over a two-week period and Cheerbot began its deployment on 31st March. On set up, Cheerbot’s deployment met with a couple of hurdles relating to wifi coverage of the office space, and the difficulty in getting to robot to move around AND be receptive to interacting. But Cheerbot was set up fairly successfully and left in an office seating about 100 people. People’s reactions to Cheerbot ranged from highly interested and excited, to disinterested, but the predominant reaction seemed to be curiosity. We are confident that Cheerbot with gather useful data over its deployment.

Wellbeing walk!

An important output of this project is an enhanced awareness of our own workplace wellbeing. So, to get offline, enhance our peer relationships, and reduce stress we took a project team walk around Colwick Country Park. We did this on March 11th, to coincide with MHFA England’s ‘My Whole Self’ day. To ensure we were truly embracing ‘offline-ness’, we also did a pen and paper scavenger hunt, spending time climbing on cool rocks, looking under logs for insects, and fussing all the dogs we saw. This outing was a fantastic way to connect with each other and markedly improved our own moods and workplace effectiveness for the rest of the week!

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Gendernet: Call for Participants

Netflix’s ‘Adolescence’ has become the first ever streaming show to top the weekly UK television ratings. Everyone’s talking about the dangers posed by toxic online culture, for both women and men.

We’re looking for volunteers to explore how VR and immersive spaces can be more inclusive and safer for everyone. You’re invited to join a participatory workshop involving playful, creative, hands-on activities to imagine alternative scenarios. 

WHEN:  23rd April 2025, 9.30am – 17.00pm​

WHERE: Virtual and Immersive Production (VIP)Studio, King’s Meadow Campus, University of Nottingham.

This is an opportunity to meet other volunteers, creatives and researchers, to reflect on and engage with these challenging topical issues. This is also an incredible opportunity for you to try out immersive technologies and see first-hand how they can be used to produce short films using digital worlds and characters.​

Please keep in mind that VR headsets will be used for activities in this workshop. ​

Participants will receive a £35 shopping voucher as a thank you for taking part.

Please complete this form to express interest. ​

For further information contact: anna-maria.piskopani@nottingham.ac.uk ​

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Help us develop a toolkit to support the adoption of wellbeing technologies!

WHEN: 3rd April 2025, 11an – 1pm

WHERE: Institute of Mental Health, Jubilee Campus, University of Nottingham

Join us for a workshop on the future of mental health technologies, where you will be joined by multidisciplinary experts to discuss the safe and effective adoption of tools like AI and VR by wellbeing providers, particularly charity and third sector organisations.

We welcome people with all different kinds of expertise:

Mental health and psychology

AI and emerging technologies

Law, ethics, and policy

Healthcare and medicine

Human-computer interaction

Social and community work

Creative media and arts

Please join us for an interactive workshop and sandwich lunch on the 3rd April 11:00-13:00 to help us to scope what should be included in a multidisciplinary toolkit. You will be reimbursed with an Amazon voucher for your time (one per participant). Please sign up here by March 27th:  and we will forward you a calendar invite with more details. If you have any questions, please contact aislinn.bergin, natalie.leesakul or anna-maria.piskopani directly.

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Help us develop a toolkit to support the adoption of wellbeing technologies!

Call for participants to join an online workshop on the 20th March, 12 – 1.30pm

Our Horizon Adoption of Wellbeing Technologies Toolkit Project (HAWT) team are keen to engage with people from the following sectors to discuss the safe and effective adoption of tools like Artificial Intelligence (AI) and Virtual Reality (VR) by wellbeing providers, particularly charity and third sector organisations:

·        Mental health and psychology

·        AI and emerging technologies

·        Law, ethics, and policy

·        Healthcare and medicine

·        Human-computer interaction

·        Social and community work

·        Creative media and arts

If you would like to be involved in this interactive workshop to help us scope what should be included in a multidisciplinary toolkit, please sign up here.

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W-WATI: Tell us about your experiences of wellbeing in the workplace!

We are running a questionnaire to find out about people’s experiences of wellbeing in the workplace as it relates to the Internet. It is open to everyone in the UK in some form of employment (including volunteering). The survey should take no longer than 25 minutes and will be a combination of optional multiple-choice and open-ended questions. You do not need to give your name or any other personal details. If you are interested, you can find more information and the questionnaire here. 

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