Overview

The Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a call for evidence regarding the regulation of artificial intelligence (AI) in healthcare. This effort aims to gather insights from various stakeholders, including:

• Members of the public
• Clinicians
• Industry representatives
• Healthcare providers

Purpose of the Call for Evidence

The feedback collected will support the work of the National Commission into the Regulation of AI in Healthcare, established in September to facilitate quicker access to AI tools, such as ambient voice technologies.

Commission Leadership

The commission is chaired by Professor Alastair Denniston, who leads the Centre of Excellence in Regulatory Science in AI and Digital Health. It comprises AI experts, clinicians, regulators, and patient advocates, all working together to advise the MHRA on future AI regulations in healthcare.

Statements from MHRA Leadership

Lawrence Tallon, chief executive of the MHRA, emphasized the importance of ensuring that AI’s integration into healthcare is safe and fosters public trust:

“AI is already revolutionising our lives, and as we continue into this new world, we must ensure that its use in healthcare is safe, risk-proportionate, and engenders public trust and confidence.”

Key Themes for Discussion

The call for evidence will explore several critical themes, including:

1. Modernizing regulations for AI in healthcare
2. Ensuring patient safety as AI technology evolves
3. Clarifying responsibilities among regulators, companies, healthcare organizations, and individuals

Importance of Patient Perspectives

Professor Henrietta Hughes, deputy chair of the commission and patient safety commissioner for England, highlighted the significance of patient experiences in shaping AI regulations:

“The lived experience and views of patients and the public are vital in identifying potential risks and opportunities that technologists and clinicians may miss.”

Call for Participation

The call for evidence is open from 18 December 2025 until 2 February 2026. Stakeholders are encouraged to share their thoughts and experiences to help shape the future of AI in healthcare.

Click here to participate.