Artificial intelligence and innovative technologies

In this resource we answer questions on the use of innovative technologies in healthcare and how doctors should apply our guidance when using them.

How will innovative technologies, like AI, change the way that healthcare is delivered?

It’s hard to anticipate the full extent to which innovative technologies and the advancement of AI will affect healthcare in the future. However, it’s clear their impact will be significant. 

In the past 10 years alone, new technologies have led to big changes in the delivery of healthcare. From the increased use of wearable medical devices to the role of augmented and virtual realities for surgery and a substantial increase in the use of virtual and remote care.

AI can now also support doctors when reading a variety of different imaging types, including X-rays, CT, and MRI scans, including mammograms. And remote monitoring technology has supported the creation of virtual wards, which means patients can be assessed at home rather than in hospital.

We want to support doctors through these changes, so they can continue to provide a high standard of care to their patients.

What role do you have in the development, adoption, and rollout of innovative technologies?

We do not regulate or approve new technologies or medical devices. That is the role of the Medicine and Healthcare products Regulatory Agency (MHRA).

Instead, we set the values, knowledge, skills, and behaviours expected of all doctors working in the UK. And we help them to meet and understand these professional standards by providing guidance and advice. Good medical practice sets out the standards of patient care and professional behaviour expected of all doctors and outlines what doctors must do if an adverse incident happens when using medical devices

We’ll continue to track the changing healthcare landscape as new technologies develop to make sure we can effectively support doctors to maintain the highest standards of care for patients.

What does the new edition of Good medical practice say about innovative technologies?

Good medical practice 2024 includes reference to software, diagnostic tests, and digital tools as examples of medical devices for the purpose of adverse incident reporting for doctors. This would also include software, diagnostic tests, and digital tools that use AI technologies.

In paragraph 73 we say

‘To help keep patients safe you must:

  • report adverse incidents involving medical devices (including software, diagnostic tests, and digital tools) that put the safety of a patient or another person at risk, or have the potential to do so’

Why did you make this change?

As part of our review of Good medical practice, we heard from doctors that our guidance could be clearer when referencing reporting adverse incidents relating to medical devices, including software, apps, and AI technologies.

We examined what we could do to provide greater clarity and how we could better address the challenges involved in delivering healthcare with innovative technologies. We supported our public consultation with a specialist policy workshop on digital technologies with key experts from within the sector. This helped to inform our understanding of innovative technologies, their implications for doctors, patient safety, and our role as a regulator.

How do your professional standards apply when AI is used in healthcare?

As with other medical devices, we expect doctors to use their professional judgment to apply the principles in our guidance to the use of innovative technologies or AI tools. We recognise that not all doctors are involved in the development, procurement and ongoing updating of these new technologies. We expect those who have been involved in the creation, testing and updating of these technologies, whether developers, employers or doctors, to remain responsible for these aspects once they are in use. 

Doctors are responsible for the decisions they take when using new technologies like AI, and the principles in our professional standards continue to apply. For example, it’s important to discuss the use of innovative technologies with patients, what other options may be available and any uncertainties and limitations, so they can make informed decisions. This is in line with the principles set out in Good medical practice, and our guidance on Decision making and consent

If a doctor is concerned that the technology or system they are being asked to use may put patients at risk of harm, they should follow our advice in Raising and acting on concerns about patient safety. We can’t tell doctors what to do in individual situations, but they should put their patients at the heart of their decision making and follow the principles in our guidance.

What if I don’t feel confident using new AI technologies?

We recognise the use of innovative technologies may raise questions for doctors, especially at an early stage of development and adoption.

Doctors are expected to recognise and work within the limits of their competence. As outlined in paragraphs 3 and 13 of Good medical practice. They are also expected to keep up to date with developments that affect their work and take steps to develop and improve their performance. This may include taking part in regular training and continuing professional development. As innovative technologies, including AI, continue to develop and are implemented it is likely doctors will be expected to take part in education and training to understand how to use them in practice.

If you’re concerned that the technology or system you are being asked to use may be putting patients at risk of harm, you should follow our advice in Raising and acting on concerns about patient safety

Are you planning any further work in this area?

We will continue to work with other partners, including the MHRA, our registrants and the other health and care regulators, to support the delivery of the benefits that can come from adopting new technologies, while maintaining patient safety. To see the ethical principles this advice is based on, you can read our Professional standards.

Our guidance provides a high-level framework which doctors and other medical professionals can apply in different settings. This will apply both now and in the future, and as innovative technologies continue to develop.

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