The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has called for new regulations governing the use of artificial intelligence (AI) in healthcare settings, including the National Health Service (NHS). This recommendation comes as the agency published 44 proposals aimed at updating its policies to accommodate the increasing integration of AI technologies in medical care, as reported by the BBC.
The MHRA, which oversees the regulation of medical devices and the licensing of treatment drugs in the UK, emphasised the need for these changes as AI is expected to become a routine part of healthcare delivery. Lawrence Tallon, the agency’s chief, indicated that patients will increasingly encounter AI in their healthcare experiences, and it is crucial that they maintain trust in these technologies.
The report, developed by an independent commission, incorporated feedback from over 12,000 stakeholders, including patients and healthcare professionals. Among the key recommendations are measures to continuously monitor AI products, ensuring they are removed from regulatory approval if they malfunction or lose effectiveness over time.
Additionally, the proposals advocate for patients to be informed about the involvement of AI in their care and to have easy access to information regarding the AI products used. The MHRA also suggested implementing a system that would allow for penalties against developers whose AI products fail to meet established standards.
Another notable recommendation is the introduction of an AI “L plate” system, which would facilitate the trial of new AI models by healthcare professionals under close supervision. Tallon pointed out that the existing medical devices regulatory framework is outdated, primarily designed for traditional medical devices like hip replacements and stethoscopes.
He noted that while current guidelines may suffice for simpler AI applications, they do not adequately address the complexities of more advanced models. Unlike conventional medical products, AI systems evolve post-authorization as they learn from new data, which presents unique regulatory challenges.
Tallon acknowledged that regulating AI is a global issue, stating that no single country has yet developed a comprehensive regulatory framework that effectively addresses the challenges posed by AI in healthcare.
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