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Latest news

Find key updates, announcements and resources to help you stay informed about the evolving AI and digital regulation landscape

  • Supplier Ambient Voice Technology (AVT) Self Certified Registry for the use of AI-Enabled Ambient Scribing Products in Health and Care Settings

    NHS England are seeking to establish a supplier registry for the use of AI-enabled ambient scribing products in health and care settings. Suppliers must hold class 1 Medical Device Accreditation and current DTAC assessment. Published 29 October 2025.

  • AI Airlock Sandbox Pilot Programme Report

    The AI Airlock programme report contains a comprehensive overview of the methodology for establishing the regulatory sandbox, the four pilot case studies and the lessons learned from the independent programme evaluation. This report also summarises the key technical and regulatory insights and recommendations for changes to the regulatory and support framework for AI as a medical device. Published 16 October 2025.

  • AI Airlock Phase 2 Cohort

    Phase 2 of the Airlock will include seven additional technologies spanning AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems. This expansion addresses three fundamental regulatory challenges around managing evolving AI applications, regulating AI-powered diagnostics effectively, and implementing robust post-market surveillance for AI medical devices. Candidates will test in the Airlock until March 2026 when the second phase will be finalised. Published16 October 2025.

  • Call for applications to join the new Knowledge Community on digital mental health technologies regulation

    WHO/Europe and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) are launching a Knowledge Community dedicated to the regulation of digital mental health technologies. The Community is open to all interested parties, including representatives of Member States; intergovernmental, governmental and nongovernmental organizations; the private sector; and academic institutions. Software engineers and service users are also welcome.

  • New Commission to help accelerate NHS use of AI

    New National Commission unites clinical leaders, patient advocates and leading tech firms to make the NHS the most AI-enabled healthcare system in world. Published26 September 2025.

  • Medical devices: post-market surveillance

    Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA. Published 26 January 2015. Last updated 5 September 2025

  • New CQC guidance on use of AI in general practice

    CQC has published guidance on the use of artificial intelligence (AI) in general practice. While AI tools can support safe and effective care, they must meet regulatory standards and be underpinned by good clinical governance. This guidance outlines current uses of AI in GP settings, potential benefits and risks, and highlights regulatory considerations, including a brief overview of what CQC assessments will look at. Published 14 July 2025.

  • AI skin cancer detection system gets green light for conditional NHS use

    An artificial intelligence system for potential skin cancer has been conditionally recommended for use in the NHS for the next three years while further evidence is collected. Published 1 May 2025.

  • Guidance on the use of AI-enabled ambient scribing products in health and care settings

    This guidance offers high-level information to assist those adopting ambient scribing products that feature Generative Artificial Intelligence (AI), for use across health and care settings in England. These products are sometimes referred to as ambient scribes or AI scribes and include advanced ambient voice technologies (AVTs) used for clinical or patient documentation and workflow support. Published 27 April 2025. Date last updated 29 April 2025.

  • Digital mental health technology: qualification and classification

    Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification. Published 3 February 2025.