The rapid integration of artificial intelligence (AI) into UK healthcare is driving a critical debate among clinicians, ethicists, and patient advocates. There is a growing, unified call for AI regulation that places patient rights, safety, and trust at the forefront, rather than merely focusing on innovation and efficiency. This push for a robust framework is intensifying as regulators, including the Medicines and Healthcare products Regulatory Agency (MHRA), work to keep pace with technological change.
Embedding Patient Rights in AI Healthcare Regulation
A core argument is that risk-based frameworks alone are insufficient. Commentary in the Journal of the Royal Society of Medicine (2025) suggests that traditional regulatory approaches protect system-level safety but fail to safeguard individual patient autonomy, consent, and fairness in AI-driven diagnosis and treatment. Experts are urging policymakers to embed specific patient rights into the regulatory design, such as the right to explanation, consent withdrawal, and a second opinion.
Patients across England are already engaging with AI in their routine care, with surveys indicating that nearly one in four UK patients uses AI tools for health information, and many would consult AI rather than wait for a clinician. While helpful for general queries, clinicians and regulators warn that unregulated use poses risks if guidance on reliability and transparency is unclear for both patients and healthcare providers. Critically, experts have also highlighted the danger of misleading impressions of AI empathy in clinical settings, which could foster unwarranted trust and confusion, underscoring that transparency about AI's functions and limitations is vital for regulation.
The UK government and MHRA have responded with concrete steps. In September 2025, the Department of Health and Social Care announced a National Commission on the Regulation of AI in Healthcare. This commission, which will include clinicians, tech leaders, and patient safety experts, aims to advise on a comprehensive rulebook that balances innovation, patient safety, and equitable access, ensuring patient perspectives shape the outcomes.
Proactive work also includes the MHRA’s AI Airlock scheme. This pilot creates a regulated "sandbox" environment to rapidly and safely test new AI-enabled medical devices, accelerating NHS access while gathering crucial evidence on performance and risk. This highlights the importance of data quality, safety evidence, and transparent evaluation before widespread adoption. The Royal College of Physicians has also weighed in, urging the government to strengthen NHS digital foundations and ensure AI solutions address genuine clinical problems while protecting patient safety.
The Global and Domestic Imperative for Patient-Centred AI Regulation
The challenge is both domestic and international, with the World Health Organization (WHO) outlining regulatory considerations that emphasise safety, effectiveness, equitable access, and patient dialogue, signalling a shared global priority for patient-centred AI. Domestically, the use of AI tools, including diagnostic aids and predictive models, risks perpetuating bias and inequity if they rely on unrepresentative data. Without safeguards that explicitly protect vulnerable groups, AI may reinforce existing health disparities.
The UK’s regulatory evolution is actively seeking public input. The MHRA has a public call for evidence open through February 2026, inviting contributions on pre- and post-market regulation, liability, and patient rights. This participatory dimension is key to creating genuinely patient-centred regulation.
Ultimately, this movement seeks to ensure that technological advances benefit patients without compromising safety, autonomy, or trust. As the UK strives to be a global leader in AI healthcare, its regulatory design will be tested not just on speed, but on its capacity to uphold ethical standards and patient rights. Achieving patient-centred regulation will require sustained dialogue with patients and their groups, enabling the NHS to adopt AI responsibly, equitably, and with patients at the centre of decision-making.
