All 44 recommendations accepted on 6 October

The UK government published its response to the National Commission into the Regulation of AI in Healthcare on 6 October 2026. It accepts all 44 of the Commission's recommendations.

The MHRA set up the Commission in September 2025 as an independent, non-statutory advisory body. Its recommendations came out on 10 September 2026, after evidence gathering that the government release says involved more than 12,000 people.

The same day, the MHRA opened applications for Phase 3 of AI Airlock, its regulatory sandbox for AI-enabled medical devices.

MHRA, DHSC and NHS England carry the work

The 42-page response names the bodies responsible for each step:

  • By our count, the MHRA leads 32 of the 44 entries and DHSC leads 10.
  • DHSC and NHS England will build an AI Readiness Toolbox with the devolved health departments, to help healthcare organizations prepare for AI.
  • DHSC, the MHRA, the CQC, NHS Resolution, the Professional Standards Authority and professional regulators will form a working group on responsibilities.
  • DHSC will work with the Patient Safety Commissioner so that patients have access to redress.

A cross-system Programme Board will meet quarterly. It will report progress to the Life Sciences Delivery Board each quarter.

Change control plans, staged authorisation and Airlock Phase 3

The response sets ten priority areas for the next year. Dated commitments include:

  • The MHRA intends to issue draft guidance on Predetermined Change Control Plans for public comment by December 2026. The proposed approach would let manufacturers define the scope of allowable change, including for adaptive AI devices, while keeping a device's intended use.
  • The MHRA intends to consult on classifying software and AI-enabled devices by Spring 2027. It would then use secondary legislation to bring in a new approach.
  • An implementation plan and roadmap will follow by Spring 2027, with annual progress updates after that.

The MHRA will also explore staged authorisation pathways. These would allow earlier use of promising tools under close supervision while real-world evidence builds, the release says.

AI Airlock Phase 3 focuses on post-market surveillance and oversight across a device's working life. The MHRA says the programme has three more years of government funding and is funded until April 2029. The first wave of innovators will be chosen in November 2026.

Most dates point to Spring 2027

By our count, 42 of the 44 entries say further details will be shared by Spring 2027. Several refer to legislative reform that the response says is being considered.

The response sets out plans and the bodies that will carry them out. By our reading, it does not itself amend any regulation.

Scotland's Health Secretary said Scotland will set out its own response in due course. The response notes an earlier government commitment of up to £10 billion over three years for technology, digital and data initiatives.

Device makers can apply to Airlock before 31 October

  1. Developers of AI-enabled medical devices can apply to AI Airlock now. The MHRA asks applicants who want the current review wave to apply before 31 October.
  2. Manufacturers that update models after approval should prepare to comment on the draft change control guidance, due by December 2026.
  3. Prospective Airlock applicants can join the MHRA webinar on 22 October.
  4. NHS organizations can watch for the AI Readiness Toolbox from DHSC and NHS England.

For earlier UK pressure for AI legislation, see UK human rights committee asks for an AI Bill and mandatory model testing by AISI.

For a clinical benchmark from a model developer, see OpenAI releases MentalHealthBench: 1,215 expert-rubric chats, with GPT-6 Astra top at 57.3.