Charting the Course: Regulating AI in Healthcare – Lessons from the Road

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Artificial intelligence (AI) has exploded onto the scene, capturing headlines and fuelling debates about its transformative potential. While excitement buzzes around its capabilities, the legal and regulatory landscape struggles to keep pace and often highlights risks.

In this blog, HIN Chief Executive Dr Rishi Das Gupta and NHS AI experts Dr Haris Shuaib and Dr Hatim Abdulhussein discuss the parallels between traffic regulation and maintaining oversight of these emerging technologies. 

The House of Lords Communications and Digital Select Committee inquiry into Large Language Models (LLMs) was published on 2nd February, 2024 and highlighted that these models, a powerful subset of AI, showcase not only the immense opportunities AI holds but also the potential “technological turbulence” that may arise as they become more pervasive. Contributions made by Rishi to the evidence can be found here.

Navigating the ethical and regulatory landscape surrounding this powerful technology can be daunting. As we steer towards a future intertwined with AI, it’s crucial to establish guardrails that ensure its safe and responsible use. Here, we might draw inspiration from an unexpected source: traffic regulations. While seemingly disparate, regulating AI in healthcare shares remarkable parallels with regulating driving. A colleague in the field commented recently: “If we were as risk averse in road technology as we are in healthcare AI we’d never have let cars on the roads in the city”. Let’s delve into these similarities and explore how they can inform our approach to AI governance.

Shared Ground: Safety, Evolution, and Responsibility

Both driving and AI regulations share three core objectives:

  1. Prioritising Safety: Both aim to minimize harm, whether on the road or in healthcare delivery. Just as reckless driving endangers lives, poorly designed AI can lead to misdiagnoses, treatment errors, and privacy breaches.
  2. Adapting to Change: Traffic laws have evolved alongside technological advancements, from horse-drawn carriages to self-driving cars. Similarly, AI regulations need to be dynamic, anticipating the ever-evolving nature of AI and its integration into healthcare workflows.
  3. Promoting Responsible Conduct: Drivers, companies employing drivers and vehicle manufacturers are held accountable for their actions, and so should AI developers and users. Fostering a culture of responsibility is essential for ethical and trustworthy AI implementation.

Learning from the Road: A Categorical Framework

Traffic regulations categorise offenses based on severity and consequences. While the laws change infrequently (the Road Traffic Act 1988 is now 35 years old), the guidance is updated often (the highway code was updated in 2022). The categories used in the UK are careless driving and dangerous driving. In addition, we have categories related to consequences, that apply to both individuals (e.g. causing death by dangerous driving) and companies operating fleets of vehicles and manufacturers (corporate manslaughter).

We can adapt this structure to AI in healthcare:

  • Careless / Inconsiderate AI: This covers irresponsible data handling or quality, non-compliance with ethical principles, and failure to meet minimum standards for transparency and explainability. This could include:
    • Using biased datasets without mitigation strategies.
    • Failing to obtain proper informed consent for data collection and use.
    • Developing AI models without adequate documentation and explainability tools.
  • Dangerous AI: This includes biased algorithms, lack of robustness, potential for unintended consequences, and vulnerabilities to manipulation. This could include:
    • AI models perpetuating existing societal biases in healthcare decisions.
    • AI systems susceptible to hacking or manipulation, leading to compromised data or altered outputs.
    • Lack of built-in safety features and safeguards to prevent unintended harm.
  • High-consequence AI: This encompasses situations where AI directly impacts patient outcomes, such as misdiagnoses or inappropriate treatment recommendations. This could include:
    • Clinical decision support systems leading to incorrect diagnoses or treatment plans.
    • AI-powered drug discovery tools generating harmful or ineffective compounds.
    • Algorithmic failures resulting in adverse patient events.

Navigating the Road Ahead: A Proposed Approach

Drawing on the lessons from traffic regulations, we propose a three-pronged approach to governing AI in healthcare:

  1. Establish Clear Principles and Transparency: AI developers and users should adhere to well-defined ethical principles, focusing on aspects like data privacy, fairness, and accountability. Transparency in algorithm development and decision-making is crucial for building trust and more work is needed to understand the level of interpretability and explainability AI developers should adhere to.
  2. Implement Minimum Codes of Conduct: Regularly updated codes can ensure responsible data storage, development practices, and deployment across various AI domains within healthcare. These codes could address:
    • Data governance and privacy standards.
    • Algorithm development and testing protocols.
    • Deployment guidelines and risk mitigation strategies.
  3. Focus on Consequences and Evidence-based Use: Companies and healthcare institutions should be incentivised to provide evidence demonstrating the safety and responsible use of their AI models and ensure there is adequate monitoring of these technologies when deployed in practice. This encourages a proactive approach to risk mitigation and promotes continuous improvement. This could involve:
    • Requiring pre-market approval for high-risk AI applications.
    • Implementing post-deployment monitoring and evaluation systems.
    • Holding developers and users accountable for AI-related harms.

Charting the Future: The UK’s Potential Leadership

The UK, with its diverse population, centralized healthcare system (NHS), and robust regulatory framework, is well-positioned to play a leading role in shaping the responsible development and governance of AI in healthcare. By leveraging existing structures like accredited AI testing centres and fostering open dialogue with stakeholders, the UK can pave the road to a future where AI empowers healthcare professionals to deliver better, safer care for all. The analogy to traffic regulation holds here too. We should invest in infrastructure and environment where the need is greatest – our cars today travel faster and are safer than three decades ago. This is due to focusing investment in adapting our environment to make this happen, for example, we put traffic lights at junctions where the risk of collisions is highest or where there is a history of accidents occurring. Investing in the environment and monitoring infrastructure will help the UK be the place to come to develop, deploy and build the evidence for safe AI.


The road ahead for AI in healthcare is full of promise, but also potential pitfalls. Humans in healthcare must be in control of its development to ensure it is safe, effective and ethical. By learning from the established framework of traffic regulations and adapting it to the unique context of healthcare, we can develop a comprehensive and flexible approach to governing AI. Let’s work together to ensure that AI becomes a powerful tool for good, shaping a future where technology and ethics go hand-in-hand to improve patient outcomes and advance healthcare for all.

About the Authors:

Dr Rishi Das-Gupta is Chief Executive of the Health Innovation Network (South London), is on the Board of the NIHR Applied Research Collaboration (South London), DigitalHealth.London and NodeNs Medical and is a member of the NHS London Clinical Senate.

Dr Haris Shuaib is Head of Scientific Computing at Guy’s and St. Thomas’ NHS FT and director of the Fellowships in Clinical AI programme he is also the founder of Newton’s Tree a company focussing on using AI in clinical practice.

Dr Hatim Abdulhussein is Medical Director of Health Innovation Kent, Surrey and Sussex and National Clinical Director for AI and Digital Workforce at NHSE.

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Introducing Mindset: a new ecosystem to help immersive technology developers improve the UK’s mental health

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The Health Innovation Network (HIN) South London and UKRI recently announced a multi-year innovator support programme focused on the use of immersive therapeutics for mental health. In this first blog about the programme, HIN Executive Director for Digital and Transformation Dr Amanda Begley discusses the context of the project and why we believe emerging extended reality technologies offer real hope for the millions of people impacted by mental illness in the UK.

I am thrilled to be writing the first blog on our partnership with UKRI for the Mindset-XR Innovator Support Programme.

Stimulating immersive innovations in mental health will require the involvement of a wide range of skills from different sectors, including those who may not have traditionally brought their expertise to health and care challenges. In particular, the creative industries such as gaming, artists and visual production will bring genuinely innovative perspectives and novel solutions.

We were inspired on hearing about some of the Strand 1 Mindset-XR funded projects recently, which cover a range of immersive technology, such as extended and virtual reality using headsets, remote touch, music and sounds, and mobile gaming. These novel solutions will offer support to people with anxiety, autism, bipolar disorder psychosis, and dementia. A further cohort of projects – funded through Stand 2 – will be announced soon.

In our first blog I wanted to share why we are so passionate about supporting the development and acceleration of UKRI’s Mindset-XR programme and to ask you to join us in driving forward new solutions for those in need of support:

The scale of the mental health challenge

The impact of poor mental health set out in the recent Government’s Mental Health and Wellbeing plan discussion paper makes for difficult reading. Approximately one adult in six has a common mental health condition; more than 60% of children and young people who have a diagnosable mental health condition do not currently receive NHS care, and two-thirds of the growing number of people who end their life by suicide are not in contact with NHS mental health services.

There are also huge disparities – people facing social and economic disadvantage have a much higher risk of developing mental health conditions, and there are significant inequalities related to ethnicity, age, sexuality, gender, neurodiversity, and long-term physical health conditions. The Kings Fund recently published a series of Mental Health 360 reports outlining these issues in greater detail.

Merely expanding current services is not a feasible or complete solution. Our Mindset programme aims to co-develop solutions with lived experience partners and bring to market a broader range of accessible innovative technologies – technologies that will help people to live well and support them to recover when they are in need.

At the HIN, we recently engaged over 870 service users and members of the public to explore their experiences and sentiments towards digital health technologies (DHTs) in the context of mental health. We found that overall there was openness toward digital adoption and a recognition that DHTs can help make services more efficient and user experience better. The insights we gathered have informed a set of recommendations to improve acceptability and usage of digital within mental health. We will actively use these recommendations to inform our Mindset Innovation Support .

The UK immersive technology sector has the potential to be world leading in bringing solutions to market.

The opportunity for growth is well documented in the recent UKRI-funded report The Growing Value of XR in Healthcare, citing existing evidence of the effectiveness of immersive technology for neurodevelopmental disorders, psychotic disorders, depression, anxiety disorders, and eating disorders. The report also states that while immersive technologies will never replace face-to-face therapies, there is a positive view towards the use of virtual reality by therapists and the public.

The 2022 Immersive Economy in the UK report highlights that immersive technology in healthcare has experienced the highest growth rate in the number of businesses over the previous five years (88%) of any comparable innovation area. Close to 40% of immersive tech companies are within the health sector. The report also states that private investment in immersive technologies reached £224m in 2021 and investments in the first half of 2022 totalled at nearly 90% of the amount raised in 2021.

We will shortly be hosting a roundtable to discuss how we stimulate investment in immersive technology for mental health, which will be led by HIN’s chair Hitesh Thakrar. Let us know if you’d like to see the output.

Through collaboration – with UK wide reach and a breadth of expertise – we can help to bring immersive tech safely into the hands of patients and staff.

When bidding for the programme, we rapidly formed a brilliant team of collaborators with expertise in areas including:

  • understanding the need for innovation;
  • the immersive and digital technologies market;
  • navigating the NHS for adoption and spread;
  • regulatory, legal and ethical requirements; and
  • clinical study design.

However, we are learning all the time about more individuals and teams across the UK with a passion for – and expertise in – immersive and digital health technologies and mental health.

We want to expand the Mindset innovator support collaboration – bringing our collective skills and networks together with yours to support innovators, enable people to connect and ultimately to help our service users and staff by improving access, experience and outcomes.

Our collaboration includes:

  • The Health Innovation Network provides geographical coverage of health and care organisations and Universities across England, alongside having established relationships across Wales and Scotland through our collaborators: Health Innovation North East and North Cumbria, Health Innovation North West Coast and Health Innovation South West.
  • Health Innovation Research Alliance Northern Ireland (HIRANI) is an alliance of universities, health organisations and other industry bodies, established to drive and support ambitious growth in Northern Ireland’s Life and Health Sciences sector.
  • Hardian Health has an experienced multidisciplinary team which provides significant experience of bringing medical devices to market including regulatory consultants with MHRA and notified body contacts, medical doctors, health economic experts, market strategists and an intellectual property attorney.
  • Hill Dickinson LLP will provide pro bono support with experience and expertise in providing advice, training and materials on regulatory issues, IP, data protection, contracting and market access digital health, mental health, and immersive technology.
  • Kings College London’s Institute of Psychiatry, Psychology & Neuroscience (IoPPN) will lead our clinical study design training. The IoPPN is an internationally-recognised centre of expertise focused on how we understand, prevent and treat mental illness, neurological conditions, and other conditions that affect the brain.
  • MQ Mental Health Research is the UK’s leading mental health research charity with an extensive network across lived experience, clinical, policy, research, industry and investors. MQ will lead on service user involvement and training for grant recipients, alongside bringing in their network to the Mindset community.
  • XR Health Alliance have over 7 years’ experience working to support transdisciplinary collaborations – connecting the creative, XR and healthcare sectors to support the adoption of XR in mental health. Through delivery of the Growing Value of XR in Healthcare Report, and global expert mission to engage key international stakeholders, they have built a network of national and global leaders in immersive technologies.

There will be lots of opportunities to collaborate and contribute to the programme – so if you want to be part of this exciting new immersive tech opportunity, then please sign up to our Mindset Innovator Support Programme newsletter to hear about our events and networking opportunities.

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Virtual wards: developing business cases to unlock patient and system benefits

Virtual wards offer the promise of providing safe, high-quality care at home. Recently, the Health Innovation Network South London and NHS England (London Region) have collaborated on a number of events and projects to help understand the challenges and opportunities related to virtual wards in London.

In this blog Dr Sanjay Gautama, Chief Clinical Informatics Officer for OneLondon and consultant anaesthetist, discusses how well-developed businesses cases are important to help realise the full benefits of virtual wards for patients.

Virtual wards already appear to be delivering a positive impact to patients across London and are playing an important role in giving patients the choice to receive safe and high-quality care at home.

However, with operational and financial pressures on NHS services perhaps more pronounced than they have ever been, justifying investment into the wider spread and implementation of virtual wards requires the development of sustainable and robust business cases.

Developing the business case for an emerging new model of care can be a significant challenge – with issues such as a paucity of evidence, fractured data sets and a rapidly-evolving technological offering all making it difficult for providers or commissioners to pull together comprehensive benefits assessments.

Given these issues, NHS England (London region) and the Health Innovation Network South London recently brought together key stakeholders from across the capital to understand the most critical considerations for virtual wards business cases and to review the evidence at hand.

Key findings from the subsequent report included reflections on operational priorities, such as the potential for virtual wards to provide admission avoidance rather than only step-down care, and the importance of near-seamless integration into existing services.

The report also summarises evidence from four key areas of benefit identified so far in real-world virtual ward implementations:

The report provides practical, experience-based information about the challenges of optimising virtual wards, as well as guidance on structuring business cases and appropriate measurement and evaluation.

We hope that our newly-published report will prove useful for anyone working in this space across health and social care.

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View our full paper for detailed information about the benefits and considerations for virtual wards business cases.

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Patients are on board with digital tools in primary care: now it’s time for us to make the most of their potential

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In 2023, NHS England (London) commissioned the Health Innovation Network South London to undertake a significant research project looking at Londoners’ experiences of using digital tools to access primary care services.

Following the publication of a report entitled Patient Perspectives on Digital Access to Primary Care, which summarises the research, we hear from Matthew Nye, Director for the Digital First Programme at NHS England (London), about where the digitisation of primary care stands in 2024.

Through early pilots we identified digital tools have an important role in improving patient experiences and outcomes in primary care; when we expanded the programme across London in 2019, one of our key ambitions for using digital technology was to improve access to the right care at the right time, as well as increase personalisation and efficiency of care.

Nearly five years later, the patient voice captured in our Patient Perspectives report demonstrates that we are realising more of those ambitions across London.

It is very positive to see that three quarters of the Londoners we spoke to are now using digital tools to interact with their GP surgery.

We know from this survey, and other work that has taken place locally and nationally, that digital tools such as consultation forms, the NHS App and GP practice websites can really help patients access the right kind of help more quickly for their specific need.

These tools can often help to triage patients more efficiently than relying on busy telephone lines. For patients, that means less time wasted and faster access to appropriate support – whether that is seeing a GP in person, getting advice from a practice nurse, physiotherapist or pharmacist or being able to complete a task such as ordering a repeat prescription online.

Capturing the patient voice

The unexpected Covid-19 pandemic forced an unprecedented change to how patients could access and interact with health care services, and the implementation of “digital first” was accelerated, resulting in the rapid rollout of many digital technologies into primary care.

Feedback from GP practices suggested that, for some patients, the digital tools  and new processes implemented at a practice or local level worked well, but the pace of change made it difficult for us to get a truly comprehensive view of what patients thought about these digital tools.  A key recommendation from the report included improved communication with patients to build awareness and understanding of the digital tools available in primary care, facilitate signposting and better manage patients’ expectations.

More than 3,000 patients shared their views with the Health Innovation Network South London for this report. This has meant that we’ve been able to get a really good idea of what is and isn’t working for patients. Using the results of the survey and themes captured from the focus groups, we can work with colleagues at every level of primary care across London to continue to improve the use of digital tools and effectively embed this with implementation resource.

The case for investing in change

We know that primary care services across London are very stretched and busy. Finding the time to improve GP websites, optimise online services and integrate the NHS App might seem like a tough ask.

However, the survey and focus groups have demonstrated the value that patients see in using digital tools, as well as highlighting some clear recommendations for improvement.

Patients want to use these channels to manage their own health in a more convenient way, but sometimes they are running into frustrating issues with poorly designed forms and websites, consultation forms only being available for part of the day, or not being able to access a full range of online services via the NHS App.

We are confident now that practices have the right digital tools and the objective is to improve the balance between what patients want and the processes/pathways provided by primary care to achieve improved outcomes, greater efficiency and a good user experience.

This report plays an important role in building the case for primary care to invest in supporting GP practices to improve the use of digital tools, and proactively encourage patients to sign up to and use digital tools where appropriate. If you can enable the majority of patients to quickly and easily complete tasks online, it is likely they will engage. That, in turn, reduces pressure on clinical and administrative staff and frees up time for the interactions that require a face-to-face or a phone call, including supporting digitally excluded patients who might not feel confident or are unable to use digital tools.

One of the key recommendations from the report is driving up quality, standardisation and compliance with usability and accessibility standards, whilst ensuring that there is consistency with digital tools and they are available all day.  A focus on this will have a direct positive impact on addressing digital exclusion, through making sure that more people can make use of digital tools if they choose to.

Patients suggested that GP surgeries build in mechanisms to capture timely feedback to enable continuous improvement of digital tools and pathways. It is clear that the need and use for digital tools in primary care is very much in the present, rather than the future. This is an exciting place to be – and more reason than ever to listen, embrace and deliver in line with the expectations and recommendations of patients.

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