The Medicines and Healthcare products Regulatory Agency’s (‘MHRA’) Call for Evidence, published on 18 December 2025, aims to shape a future regulatory framework that ensures AI technologies in healthcare are safe, effective, and support innovation. The Association of Personal Injury Lawyers (APIL) responded by raising concerns about the adequacy of existing legal frameworks, particularly product liability law as it applies to AI-driven healthcare tools.
APIL is of the view that traditional consumer protection laws struggle to accommodate the complexities of AI, especially when dealing with international manufacturers and opaque software-based systems. They suggest that injured individuals may face significant barriers when trying to bring claims involving AI-driven products, particularly standalone software systems.
While APIL raises some potentially valid points regarding the challenges of litigating AI-related harms, their response focuses primarily on claimant difficulties and does not fully acknowledge the broader regulatory ecosystem. New and enhanced safeguards, including the MHRA’s ‘Software and AI as a Medical Device Change Programme’ along with strengthened post‑market surveillance requirements are already reshaping the landscape.
Moreover, APIL’s response does not fully account for the need to balance patient’s legal protection with sustainable innovation - an operational necessity given the pressures in NHS and private-sector capacity, outdated systems, rising patient demand and the growing need for faster and potentially more effective diagnostics. Not all AI systems pose equal risk, and regulation must be proportionate. The Commission’s work is designed to take a broader, system‑wide view that integrates medical device regulation, professional standards, and service‑level oversight.
Ultimately, APIL’s submission identifies issues around legal redress and the need for coherent liability reforms, but it represents only one perspective. A balanced approach requires consideration of both the challenges of securing justice for injured individuals and the societal benefits of encouraging responsible AI development in healthcare.
As the National Commission develops its recommendations, the key will be striking the right balance: a regulatory system that is safe, fast, and trusted, whilst enabling the NHS and private healthcare sector to harness the transformational potential of AI.
David Burn, Rehab and Care SIG Lead
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