Major AI Regulation Anticipated by Mid-2026, According to MHRA Chief

Key Takeaways

  • The MHRA plans to introduce a regulatory framework for AI in healthcare by mid-2026.
  • The Department of Health is updating the AI Buyer’s Guide to support informed AI purchasing decisions.
  • A national self-certified registry for ambient voice technologies will be launched to ensure supplier compliance.

Regulatory Framework and AI in Healthcare

Lawrence Tallon, CEO of the Medicines and Healthcare products Regulatory Agency (MHRA), announced a new regulatory framework for artificial intelligence (AI) in healthcare, set to be outlined by mid-2026. Speaking at The Health Foundation’s AI in the NHS event, Tallon mentioned the establishment of a UK National Commission on the Regulation of AI in Healthcare aimed at redesigning regulations to align with the country’s ten-year health plan. While ambitious, Tallon acknowledged the challenges posed by the slow pace of legislative processes.

Health minister Zubir Ahmed emphasized the importance of national value-based procurement but acknowledged that AI solutions must be tailored to local needs. He stressed the necessity of creating clearer and more consistent processes that will instill confidence in the industry while ensuring local systems maintain autonomy and cost-effectiveness.

To support this transition, the Department of Health and Social Care and NHS England are collaborating to refresh the AI Buyer’s Guide, first published in 2020. This guide is designed to prompt critical considerations for organizations looking to invest in AI technologies.

Ahmed underscored the role of leaders in championing innovation, detailing the importance of understanding both the potential and limitations of AI applications in the clinical environment. He stated, “Ultimately, AI is not the ubiquitous hammer for every single nail,” indicating that a careful and planned approach is essential.

Clinicians and healthcare staff will be involved in shaping AI systems to ensure that they are effective support tools. Ahmed committed to ensuring that their voices are heard and empowered throughout the process.

Dr. Alec Price-Forbes, Chief Clinical Information Officer for England, discussed the upcoming NHS AI strategic roadmap, expected to be published in autumn. He promised that the roadmap would offer a practical direction rather than just a high-level overview. It will detail priorities, necessary actions, and the conditions needed for measuring success in AI integration.

In another notable development, Price-Forbes announced the launch of a national ambient voice technologies self-certified registry for suppliers. This initiative will require vendors to demonstrate compliance, furthering accountability and standardization in the use of AI technologies in the NHS.

As the UK moves toward integrating AI more comprehensively in healthcare, these initiatives represent significant steps in ensuring that both regulatory and practical frameworks support its successful implementation. The collaboration between government bodies and healthcare professionals aims to create a future where AI enhances clinical practice while remaining controlled and effective.

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