AI Regulation In Healthcare: UK And EU Approaches

By Taylor Wessing, Lexology

At a time of nurses’ strikes, lengthening operation waiting lists and mounting pressure on the NHS, relief for the UK’s current healthcare system is being sought from all angles. In the medium to long term, one possible source of relief is the increased use of artificial intelligence (AI). The inevitable development of this technology and its growing implementation will support staff and offer the potential to drive a revolution in healthcare.

Uses of AI in healthcare

Globally, it has been predicted that the market for AI health technologies will expand at a compound annual growth rate of 38.5% from 2022 to 2030, by which point it will be worth USD208.2 billion.

The excitement surrounding the advancement and uptake of AI derives not only from its ability to maximise efficiency and accuracy but also the wide range of areas in which it can be applied, such as pattern identification and information synthesis. When used correctly, AI can facilitate tasks throughout the healthcare sector, with its current capabilities ranging from the automation of tasks at a basic administrative level, through to assisting with more accurate diagnoses, surgeries, drug development and treatment plans. This support will free healthcare workers to focus on human-orientated tasks that cannot (yet?) be automated, making the overall healthcare system more efficient and productive.

This potential has been recognised by both the EU and UK, who have been preparing their respective regulatory strategies to control and promote the use of AI. For example, in its 2017 Industrial Strategy, the UK government stated its aim to use data and AI to “transform the prevention, early diagnosis and treatment of chronic diseases by 2030”.

UK regulation

There is currently no legislation in place specifically governing the use of AI in the UK. Instead, AI’s use is regulated by a patchwork of more general legislation, such as the UK Medical Device Regulations 2002 or the Data Protection Act 2018, covering certain uses of AI.

However, the UK government hopes that, by directing the regulation of AI, they will drive its evolution and implementation in a way that places the UK at the cutting edge of AI development. To this end, the government published the National AI strategy in September 2021, setting out a plan for the development of AI in the UK over the next ten years.

Given the rapid growth of AI’s multifarious capabilities, predicting upcoming developments in the technology is a continual challenge. Therefore, the UK’s focus is on developing a “proportionate, light-touch and forward-looking” regulatory framework that can respond quickly and effectively to new opportunities and risks. The hope is that such a framework will “drive growth while also protecting our safety, security and fundamental values”. Careful drafting will be required to balance the encouragement of innovative development with the prioritisation of the safety and security of citizens.

The fundamental starting point for any regulation is to define what is being regulated. Therefore, the UK’s approach will be to define the core characteristics of AI to establish the scope of its regulatory framework. Once this base definition has been prepared, individual regulators (such as the Information Commissioner’s Office, Competition and Markets Authority, Ofcom, the Medicine and Healthcare Regulatory Authority (MHRA) and the Equality and Human Rights Commission) will build on the definition as appropriate for the context of their regulatory domain. The government hopes that limiting their definition to the core characteristics of AI will be sufficient to enable the regulators to understand the framework’s scope, whilst permitting them flexibility in each sector. In effect, the framework will be guiding and regulating the application of AI according to its use or sector, rather than regulating the technology itself.

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