The UK’s new approach to regulating artificial intelligence in healthcare

Traditionally, the healthcare industry can be slow to adopt new technologies and modernise given the highly regulated nature of its operations. However, the future looks exciting: artificial intelligence (AI), 5G and cloud technology are driving developments at a never-before-seen rate. In the United Kingdom (UK), we’re already seeing impressive applications of artificial intelligence in healthcare. Investigations are underway to explore how we can fully capitalise on its benefits and use it ethically and safely at scale.

The role of AI in healthcare in the UK

AI offers enormous potential to the NHS. By taking on the tasks that can be automated, it can reduce the burden on the system and free up clinicians’ time so they can focus on the human parts of the job where they add the most value. Crucially, the areas which see the most potential are those currently suffering the most pressure, such as pathology and radiography.

Emerging AI solutions are already helping patients through earlier diagnoses and targeted treatments. AI’s ability to rapidly analyse large quantities of complex information and data helps healthcare services and providers through enhanced efficiencies and effectiveness.

The potential to transform key aspects of the industry is clear, including the opportunity to drive innovation in:

• Data management
• Human intelligence to aid recruitment and source talent
• Remote surgery
• Drug discovery
• Clinical trial design

Regulating AI in the UK

Innovators and developers are already researching and creating AI solutions to benefit the public, healthcare providers and patients. However, they face significant challenges in the path to market due to a lack of clarity around what good levels of evidence for digital health technologies look like. Focusing time and resource in the wrong area or missing important steps in the regulatory process are commonplace.

For patients and practitioners to benefit from these technological advances, it is up to regulators to ensure the right regulatory environment that makes approval pathways easier to follow and expectations clearer, whilst protecting patient data and maintaining quality and safety standards.

Organisations throughout the NHS are determining how these benefits can be realised. So, UK regulators and agencies are partnering to develop a “Multi-Agency Advisory Service for AI and data-driven technology”.

What is the multi-agency advisory service?

The new service aims to give healthcare providers and innovators developing AI technologies a central source for information, guidance and support on regulation and evaluation.

With the first iteration of the service expected to go live in summer 2022, it will give support in clarifying the regulatory pathway for scaling AI technologies in a safe way. The service aims to provide comprehensive and easy to access guidelines for all innovators, helping them meet the robust safety and quality requirements. In tandem, it will support healthcare providers by ensuring they have the knowledge and tools to allow them to adopt and deploy these new technologies.

In addition to advice and support, the service also hopes to streamline and accelerate the currently complex regulatory process. In doing so, it hopes to make a clearer and more robust regulatory framework without compromising the necessarily high patient safety standards.

To do this, HRA is undertaking two projects. One will look at how innovators can take a more efficient approach to review studies that utilise patient data. The other will target creating a more seamless and coordinated application process to reduce the time needed for approval.

This ties into the biggest challenge the service faces: ensuring that regulation does not hinder or slow down development and progress for innovators.

Who is involved?

Many influential, high-profile bodies will make up the service, including:

• The National Institute of Health Excellence (NICE)
• Care Quality Commission (CQC)
• Medicines and Healthcare Products Regulatory Agency (MHRA)
• Health Research Authority (HRA)

The cross-functional, multi-disciplinary nature of the board allows the project to supply the service across two key areas:

• Developers of AI and data-driven technologies use in health and social care; and
• Adopters of AI and data-driven technologies.

Both sectors are focused on understanding the most efficient adoption and deployment of the best data-driven technologies and AI in healthcare, so will benefit from help with regulatory issues.

Next steps

The development of this new multi-agency advisory service is a sign of things to come. AI is set to facilitate incredible progress across the entire healthcare industry in the not-too-distant future, and regulatory boards want to aid this in a safe and quality-driven way.

But AI is not the only disruptor. 5G and cloud technology will all increase in prevalence and drive real improvements for healthcare innovators, providers and patient outcomes.