The Patients Association response to the MHRA's call for evidence on AI regulation

Artificial Intelligence (AI) is one of the most topical issues in the NHS today. It is being trialled in numerous ways in the NHS today, including in booking appointments, diagnostics testing, improving efficiency for NHS staff and in the creation of new treatments and medicines.

While AI offers numerous opportunities for the improvement of health and care services, evidence from the Health Foundation indicates patients are split on its benefits in making improvements to the NHS.

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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the regulation of medicines and medical devices used in health and care services in the UK. This includes the assessment and regulation of AI tools. They currently oversee AI in healthcare when it has a medical purpose, such as tools that diagnose, monitor or support treatment. These tools are regulated as medical devices, under the UK Medical Devices Regulations 2002. You can view a plain language summary of current regulations here.

The MHRA launched their call for evidence on the Regulation of AI in Healthcare in December 2025. To respond to the call for evidence, we surveyed patients both on the call for evidence itself, and their general views on AI usage in healthcare. Our survey received 243 responses in total, providing a timely snapshot of patient perspectives that builds on our previous work on data governance and patient trust, including our 2023 report “Developing the data pact”. We found that patients are eager to see more transparency, stricter regulation and assurances in the privacy of their personal data in AI usage. A full copy of the survey questions and dataset can be found in the appendices of this document.

In the official consultation document, questions 1, 2.2-2.5, 3 and 6 were multiple choice only questions. To ensure the feedback from patients was fully represented in our consultation response, we added in written explanations for our answers, and submitted this document under question 9, which allowed us to submit additional evidence.

We want to thank everyone who took the time to respond to our survey and support our response to this call for evidence. To run this survey and respond to the call to evidence, the Patients Association was given a charitable grant by EBO.AI. EBO.AI have had no influence on the design or delivery of this project.

Download the report

Download the survey results

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