Non-technical summary: Section 2 – Information on how AI is used in Health and the Current Regulatory Frameworks
Published 18 December 2025
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How AI is being used in healthcare
Artificial intelligence (AI) is being used in many ways to help health providers and to assist people with their health. Some examples include:
- Chatbots and Apps: Nearly 1 in 10 people now use AI-powered chatbots to get health advice. Many apps use AI to analyse health data from devices like smartwatches.
- Admin Support: Some hospitals use automated systems to invite patients to appointments or screenings.
- Voice Technology: AI can record and summarise doctor-patient conversations, helping doctors spend less time taking notes. Some services even give patients a summary of their visit and advice based on it.
- Screening and Diagnosis: AI can help spot diseases (like cancer), support doctors in making treatment decisions, and assist with therapies. Some AI tools focus on specific tasks, while others have a broader range of applications
How AI in healthcare is regulated now
To keep people safe, there are existing rules for how AI can be used in healthcare:
- Medical Device Rules: If an AI tool is used for medical purposes, it is treated as a medical device and must meet strict safety and performance standards.
- Approval Process: Low-risk devices can be certified by the manufacturer. Medium-risk and high-risk devices are checked by independent bodies before they are allowed on the market. In Great Britain, the MHRA oversees this process. Northern Ireland follows EU rules.
- Data Privacy: Patient data must be kept safe and used properly. There are laws to protect personal information and make sure everyone involved agrees on how data is shared and protected.
Checking safety after devices are used
Once an AI medical device is being used, the manufacturer must keep checking that it is safe and working well.
New rules from June 2025 mean manufacturers must:
- Have a plan for monitoring their devices
- Report and investigate serious problems
- Take action to fix issues and inform customers
- Regularly review and report on device safety
How new technologies are evaluated
The National Institute for Health and Care Excellence (NICE) looks at new digital health technologies, including AI, to see if they are useful for the NHS. If NICE recommends a technology, it can be funded and used across the country.
Improving regulations for AI in healthcare
The MHRA has a programme to make sure the UK is a safe and innovative place for medical AI. The aim is to protect patients and encourage responsible development of new technologies.
AI tools which do not qualify as a medical advice
Not all healthcare AI tools qualify as medical devices. A future regulatory framework should also consider these tools.