AI healthcare regulation report highlights need for professional standards and clear accountability

The publication of the UK Government’s National Commission into the Regulation of AI in Healthcare: Recommendations for a Future Regulatory Framework has placed professional regulation, accountability and public trust at the centre of the debate on how artificial intelligence should be deployed across health and care services.

The independent commission, established by the Medicines and Healthcare products Regulatory Agency (MHRA), argues that healthcare regulation must evolve to reflect the distinctive characteristics of AI technologies, particularly systems that continue to learn, adapt and change after deployment. The report proposes a future regulatory framework based on lifecycle oversight, system-wide responsibility and greater transparency for patients and professionals.

While much of the report focuses on medical device regulation, its recommendations have significant implications for professional standards and fitness to practise across the health and care workforce.

The commission emphasises that public support for AI depends on maintaining strong safety standards, meaningful human oversight and accountability for decisions involving AI-enabled technologies. It concludes that healthcare professionals must remain able to exercise independent judgement and challenge AI-generated outputs where appropriate, rather than becoming passive users of automated systems.

A key theme running through the report is the need for clearer allocation of responsibility when AI is used in clinical settings. The commission recommends a system that distinguishes the responsibilities of developers, manufacturers, healthcare providers and individual practitioners, helping to avoid situations where frontline clinicians become the default focus of accountability when technological failures occur.

The recommendations also highlight the importance of training and professional competence. The commission states that healthcare professionals should be supported with guidance, education and escalation pathways that enable them to identify risks, raise concerns and use AI technologies safely. It argues that clinicians have a responsibility to become competent in technologies that form part of their role, mirroring expectations associated with the adoption of other healthcare innovations.

For professional regulators, the report raises questions about how existing standards of conduct, competence and fitness to practise should be applied in increasingly AI-enabled environments. As AI tools become embedded in decision-making, diagnosis and patient management, regulators may need to consider how professional accountability is balanced with organisational responsibilities and technological safeguards.

The Professional Standards Authority for Health and Social Care (PSA), which oversees the UK’s statutory health and care regulators and reviews fitness to practise decisions, welcomed the report and its focus on collaboration across the regulatory landscape.

In a statement, the PSA said the recommendations recognise the importance of maximising the benefits of AI while maintaining professional standards and public confidence. The organisation noted that it has been bringing together professional regulators and accredited registers to explore the opportunities and challenges created by AI, drawing on research into patient and public expectations of the technology’s use in health and care.

Melanie Venables, Director of Policy and Communications at the PSA, said effective regulation cannot be developed in isolation and that confidence in AI depends on appropriate safeguards, accountability and consistency in expectations about how the technology is used. She stressed that collaboration across the regulatory system will be essential to support innovation while maintaining professional standards.

The PSA’s response reflects wider regulatory concerns that AI adoption should not compromise public protection. As the oversight body for healthcare regulation, the PSA audits regulators’ performance and reviews their fitness to practise decisions, giving it a particular interest in how professional accountability is defined when AI-supported care goes wrong.

The commission’s recommendations stop short of proposing immediate legislative change. However, they signal a future direction of travel in which professional regulation, organisational governance and technology regulation operate together as part of a coordinated framework.

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