UK launches national commission to regulate AI in healthcare

The UK government has announced the launch of a new National Commission on the Regulation of AI in Healthcare aimed at accelerating the safe and effective adoption of AI technologies within the National Health Service (NHS). 

The UK plans to make the most of the AI revolution and is now finding ways to better integrate the sector with the medical industry. For that to happen, it has to first fix the outdated regulatory environment, which seems to be more of a hindrance. The creation of the commission is a move in that direction. 

The commission, chaired by Professor Alastair Denniston, a regulatory science expert from the University of Birmingham and executive director of the UK’s Centre of Excellence for Regulatory Science in AI & Digital HealthTech (CERSI-AI), is made up of a diverse group of members, such as clinicians, academics, patient safety advocates, and representatives from tech firms like Google and Microsoft.

The UK plans to make the most of the AI revolution 

Lawrence Tallon, chief executive officer of the Medicines and Healthcare Products Regulatory Agency, has acknowledged that the medical device regulation for the AI era is an area that has barely been touched. Unless that regulatory framework for AI is updated, potential applications will remain held back. 

As competition for AI investment continues to grow, officials are hoping that creating transparent regulation will enhance the UK’s reputation as a favorable market for health technology while giving patients and clinicians confidence in new tools. 

In this way, the UK’s health sector can benefit from the AI revolution without putting the millions of patients in the system at risk. 

The UK’s new regulation won’t be a replica of the EU’s 

The commission is expected to report to the MHRA and play a role in shaping a regulatory framework expected to be published in 2026. That is just a few months away, even though the medical industry has already integrated with AI to an extent. 

Right now, there are scribes in charge of taking notes during doctor appointments, tools that help clinicians better understand radiology images, and those that trawl large datasets to point toward a diagnosis, as well as adaptive cardiac devices with the ability to adjust to changes in a patient’s heartbeat.

Unfortunately, these tools are still governed by medical-device rules drafted more than 20 years ago in the UK, raising concerns that regulations lag behind the pace of innovation. 

One reason for the reluctance to update these regulations could be the excessive concerns from entities like the WHO, which have sounded the alarm about risks related to AI technology, including unethical data collection, cybersecurity threats, and bias. 

The European Union’s answer to those concerns has been the AI Act, and it includes rules related to medical devices. The act has drawn criticism from tech companies like Apple, arguing that it is excessive and an overreach. 

However, MHRA’s Tallon has confirmed the UK’s new regulation won’t be a copy of the EU’s. Instead, it will deliver a framework that is supposed to be clear, practical, and proportionate. While some companies may feel cautious about any new requirements, regulators are convinced that predictable and proportionate rules will encourage long-term investment.

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