Digital healthcare

Capsticks has advised on a range of claims and indemnity issues within the digital healthcare and AI sphere. Such claims require a clear understanding of who the appropriate defendant may be via contractual liabilities and experience of handling multi-party litigation. The issues can also overlap with the law on product liability claims. Our team has vast experience of handling such issues when they arise and also advising both public and private healthcare organisations on measures that can be put in place contractually at the outset to minimise liability risk. With the growth of AI use in medicine it is more important than ever to consider liability risk in digital health.

Examples of the work we have done include.

• Product liability: As more medtech and AI based products enter the health market to improve care and efficiency, the legal implications around what happens if there is a fault in the AI algorithm , or the product/ implant, become more complex. Our expertise in medical malpractice complements our work in product liability claims involving not only the doctor or clinic but also the supplier or manufacturer of a particular product. We have been involved in PIP implant litigation, Isologen cosmetic claims, metal on metal hip litigation and the surgical mesh claims as well as others.
• Telemedicine: Remote consultation and diagnosis is increasingly common in both primary and secondary care. We have advised on cases ranging from liability for remote GP consultations to tele radiology and tele dermatology claims amongst others. Understanding the relationship between various parties- whether that is the NHS , an independent provider or the individual clinician using specific software – means we not only know where to look for a contractual matrix when a claim is made but we also appreciate the practicalities and complexities associated with telemedicine. It means our clients are reassured that we will have seen their situation before.
• Robotic surgery : the increased use of robotics in surgery has allowed greater precision in surgical treatment. On occasion however error can occur. Our team have experience not only of handling claims relating to malfunctioning robots but also apportioning liability where this overlaps with systems failures or human error.
• Clinical trials: Pharma and biotech companies are routinely making use of AI in a range of applications from clinical trials design to recruitment of participants. Our team has been advising insurers, sponsors and hospitals on clinical trials claims for a number of years and we are well placed to look at complex issues around the extent of the injury caused by the clinical trial itself and the liability of the various parties.

Our Corporate and Commercial teams specialise in providing comprehensive legal advice on contracts, disputes, and regulations across the healthcare sector. We have extensive experience in:

• Procuring solutions: Assisting with the procurement of Electronic Patient Records and other digital healthcare solutions.
• Procurement disputes: Resolving disputes related to software and IT systems.
• Software licensing: Managing the licensing of software applications developed or co-developed by our clients.
• NHS data licensing: Facilitating the licensing of NHS data for AI development.
• AI co-development: Supporting AI co-development projects between universities, NHS Trusts, and other entities.
• Start-up incubators: Advising on digital product-focused start-up incubator projects.

Our expertise 

We are experts in information technology law, data protection, and privacy. The use of artificial intelligence (AI) in healthcare, while potentially high-risk, offers significant rewards. Its application requires careful consideration of medical device law, information governance, and other legal aspects. 

Navigating regulatory changes 

The regulatory landscape is evolving as governments and regulators assess whether existing legal frameworks adequately oversee emerging technologies and changes in healthcare delivery. In the UK, the Health Secretary advocates for a tech- and data-driven NHS reform, and the government is contemplating further AI regulations. In Europe, the new EU Artificial Intelligence Act, effective from August 2, 2026, introduces rules with some extra-territorial application, similar to the EU GDPR. We assist clients in understanding and complying with these new regulations. 

Protecting intellectual property 

Our specialist legal team can guide you through the complexities of intellectual property law, ensuring the NHS safeguards its IP and data value. We advise on collaborative innovation projects between the NHS and the private sector, helping clients to capture value and utilise clinical trial data effectively. Our legal teams can guide NHS clients through negotiations with co-developers and medical device manufacturers to maximise the benefits of their IP. 

Case studies 

We advised Moorfields Eye Hospital NHS Foundation Trust on its collaboration agreement with research partner, University College London, and the setting up of a Biomedical Research Centre funded by the NIHR. 

Capsticks acted for West Suffolk NHS Foundation Trust in its EPR software licence negotiations. 

We acted for Rotherham Doncaster & South Humber NHS Foundation Trust on the licensing out of its eClinic app, an app for instant messaging and appointment booking.  

The efficiency and adaptability of staff and processes are crucial to success. Staying ahead of technological advancements not only ensures compliance with legal obligations but also enhances the management of employees and employment-related issues. 

Embracing artificial intelligence (AI) 

Artificial Intelligence (AI) is being used to transform the healthcare sector by assisting in improvements across operations and service delivery. Unlike other technologies, AI is set to fundamentally change how we live and work. AI is already making a difference to patient care and medical advancements in healthcare 

AI in employment management 

AI is also making significant advancements in the employment space improving efficiency reducing the burden of HR administrative tasks, freeing up resources, cutting costs, and improving staff satisfaction and wellbeing: 

• Staff management and employee experience: Enhancing the management of staff through effective AI tools, e.g. chat-bots and virtual assistants, wellness and productivity tracking, real-time performance metrics 
• Recruitment processes: application and CV screening, predictive analytics, and automated workflows for employee onboarding are all streamlining and speeding up recruitment and other employment processes. 
• HR administrative tasks: automated payroll processing and policy production. 
• Workforce Planning: AI forecast hiring needs, turnover rates and skills shortages 

Navigating employment law with AI 

While AI offers numerous benefits, it also brings significant employment law-related risks in terms of fairness, privacy and bias.  

AI-driven recruitment tools can reinforce historical biases. AI can unintentionally discriminate on the basis of protected characteristics and employers.  

AI decision-making is often hard to decipher or explain, making it difficult for employers to provide the necessary justification for decisions in defence of claims of discrimination. It’s essential for organisations to be aware of these risks and manage them effectively, in particular: 

• AI should assist, not replace human decision making 

• Systems should be monitored and updated to remove biases  

• The use of AI should be clearly communicated to employees 

Expertise 

We are experts in employment and discrimination laws, and we can advice, in collaboration with our commercial and data lawyers, on the effective use of AI in employment.