The MHRA has formally opened a public consultation on the future regulation of artificial intelligence (AI) in healthcare, inviting patients, NHS staff, innovators, and the wider public to contribute evidence and perspectives. The call for evidence will support the work of the newly created National Commission into the Regulation of AI in Healthcare, which advises the MHRA on how best to regulate health AI amid rapid technological change.

The Commission brings together a broad coalition of expertise including global AI leaders, clinicians, regulators, academics, patient advocates, and representatives from across government—to address the most pressing regulatory questions surrounding AI’s growing role in healthcare. Its remit includes ensuring patient safety, fostering innovation, and maintaining public trust as AI systems become increasingly capable and adaptive.

Lawrence Tallon, Chief Executive of the MHRA, underscored the significance of the moment, noting that AI is already transforming daily life and healthcare delivery. He emphasized the need for regulation that is safe, risk-proportionate, and confidence-building, stating that the MHRA is asking the public to share experiences and opinions to help shape the next phase of AI-enabled healthcare.

Key themes of the consultation include modernising rules for AI in healthcare, keeping patients safe as AI systems evolve, and clarifying responsibility and accountability particularly important for AI tools that learn and change over time. The MHRA is keen to understand whether existing regulatory approaches remain fit for purpose or require updates to keep pace with innovation.

The Agency is seeking input from a wide spectrum of contributors, including those unfamiliar with AI in healthcare, recognising that lived experience is critical to identifying risks and opportunities that technical experts alone may overlook. The consultation also explores who should be responsible for AI use in clinical settings and how emerging issues should be addressed swiftly and transparently.

Henrietta Hughes, Patient Safety Commissioner for England and Deputy Chair of the new Commission, highlighted the importance of patient voices. She noted that patients live with the direct consequences of AI-driven healthcare decisions and that public input is essential to shaping AI’s role for current and future generations.

The consultation builds on a series of MHRA initiatives launched in 2024, including an AI sandbox to test regulatory challenges for standalone AI medical devices, an AI regulatory strategy focused on balancing safety with innovation, and a medical technologies regulatory roadmap outlining a new framework for existing and future technologies. This framework will cover AI, software, implantable devices, and diagnostics used for early detection and disease prevention.

The call for evidence will remain open until 2 February 2026, with findings feeding into the Commission’s recommendations to the MHRA later in the year marking a pivotal step in defining how AI is governed within the NHS and across UK healthcare.