As medical innovation accelerates, Professor Henrietta Hughes, England’s Patient Safety Commissioner, says patient safety must remain the foundation of all regulatory decisions — a commitment guided by her Patient Safety Principles.
In a recent foreword from the Medicines and Healthcare products Regulatory Agency (MHRA), she stressed that the most valuable insights into safety come not from data or algorithms alone, but from the lived experiences of patients. “When patients are listened to, harm can be prevented and genuine improvement achieved,” she said.
As the MHRA develops its new corporate strategy, Hughes argues that patient and public perspectives should inform every stage of decision-making. Patients, she noted, provide vital real-world evidence on how medicines and devices perform over time and across diverse populations—information that traditional trials may overlook.
Her Patient Safety Principles, published last year, outline how regulators can embed safety, transparency, and equity in all decisions. They promote genuine partnerships with patients rather than token consultation.
Hughes also pointed to new challenges created by artificial intelligence in healthcare. AI systems that evolve after approval, she warned, require constant vigilance and clearer accountability for potential harm. As co-chair of the National Commission on the Regulation of AI in Healthcare, she is helping to shape how technology can improve care without compromising safety.
She further cautioned against misinformation, noting that as patients increasingly turn to AI tools for health advice, credible information must guide algorithms. Hughes commended the MHRA’s swift, evidence-based response to recent concerns about paracetamol-based products as an example of effective regulatory communication.
“The future of medical regulation,” she concluded, “lies not in choosing between innovation and safety, but in ensuring that innovation truly serves patients through trust, accountability, and collaboration.”
