UK Seeks AI Rules to Spur Health-Care Overhaul, Protect Patients
(Bloomberg) — The UK is pushing ahead on regulations for artificial intelligence in health care, creating a national commission to help the country attract health-tech investment and make the most of the AI revolution.
The commission, made up of doctors, academics and regulatory experts, will consult with patients and tech companies including Microsoft Corp. and Google to map out recommendations.
“No one yet really has figured out how to update their medical device regulation for the AI era,” Lawrence Tallon, chief executive officer of the Medicines and Healthcare Products Regulatory Agency, said in an interview. “Unless we can update that regulatory framework for AI, we will ultimately be slowing up the potential application.”
Headed by AI health-care expert Alastair Denniston and with Patient Safety Commissioner Henrietta Hughes as deputy chair, the group will feed back to the MHRA and help shape a regulatory framework to be published in 2026.
AI is increasingly ubiquitous in health care. There are scribes that take notes during doctor appointments, tools to help clinicians decipher radiology images, others that trawl large datasets to point toward a diagnosis and even adaptive cardiac devices that adjust to changes in a patient’s heartbeat.
These tools are governed by medical-device rules written more than 20 years ago in the UK, raising concern that regulations lag behind the pace of innovation. The World Health Organization has warned about risks related to AI technology, including unethical data collection, cybersecurity threats and bias.
Other countries have also grappled with how to balance AI’s potential against its risks. The European Union’s answer has been the AI Act, which includes rules around medical devices. The act has drawn criticism from tech companies that argue Europe is overreaching. The MHRA’s Tallon said he doesn’t envisage the UK’s new regulation as a copy of the EU’s.
The UK’s final regulatory framework will be clear and practical, he said.
“The problem we have at the moment is because we have a lack of clarity in the global regulation of AI, it’s quite hard for different parties to know what they need to do and what to expect,” Tallon said. “I want us to bring clarity and confidence to that overall framework.”
Some aspects will likely require legislative changes, meaning that parliament will need to approve it.
Competition for AI investment is increasingly fraught, with the British government’s recent charm offensive resulting in deals worth tens of billions of dollars from the likes of Microsoft and OpenAI. Still, tech companies might balk at the prospect of more rules governing the use of their products in the UK.
But Tallon insisted regulation can be attractive.
“Less regulation isn’t always the right answer because we must make sure that the AI that you use in health care has the confidence and trust of clinicians and patients,” he said, adding firms want predictable and proportionate regulation, rather than none at all. “That’s the sweet spot we are looking to find.”
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