The Regulatory Horizons Council (RHC)’s two reports make recommendations to encourage the rapid and safe development of neurotechnology and AI for medical tech devices. 

Neurotechnology 

Neurotechnology is an umbrella term which includes a wide range of devices that record or alter nervous system activity. 

This includes promising medical applications to health conditions such as Parkinson’s, Alzheimer’s, depression, rheumatoid arthritis and cardiac illnesses, which would transform thousands of people’s lives in the UK. 

The report touches on the “thriving research ecosystem” in the UK which places it in a strong position to deliver on neurotechnology’s potential to improve lives. 

With 14 recommendations, the report calls for further funding, more collaboration between researchers and regulators, and an ‘anticipatory and agile governance framework’ to allow continued innovation.

Such recommendations would include the creation of a proportionate regulatory framework that encourages the safe commercialisation of medical neurotechnologies, as well as addressing privacy, ethical, and security challenges. 

The paper also outlines how the UK should look internationally for collaboration and further innovation as it establishes itself as a leader in medical neurotechnology. 

Artificial Intelligence 

Artificial intelligence as a medical device (AIaMD) is another emerging technology with widespread healthcare applications, such as supporting the early detection of cancers, and providing risk estimates of the likelihood a patient will develop a condition such as heart disease.

The potential for AI in the medical industry is huge: it can increase efficiency and save costs across NHS processes through automation of routine tasks, as well as detecting predictors of disease with greater speed and accuracy than health professionals, potentially decreasing costly – and life-threatening – wait times. 

Similar to AI’s application in other industries, there are challenges and gaps in regulation, as pointed out by the report. 

Urgently, there is a need to increase regulatory capacity and capability to address the immediate needs of the growing AIaMD sector to improve patient safety while encouraging innovation. 

A regulatory framework must also consider the whole product life-cycle of the devices to ensure the AIaMD are safe, effective and equitable, the report says. 

The report also recommends the regulatory process be more open and transparent, calling for patients and the public to be more involved. 

Again, the report notes the importance of international collaboration to both demonstrate the UK’s leadership in the field as well as working globally to usher in new innovation. 

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Government Response

The Business Secretary, Grant Shapps, has written to the Regulatory Horizons Council welcoming the reports, saying: “Technological innovation is fundamental to the government’s plans for unlocking growth.

“The work of the Regulatory Horizons Council is a key part of modernising our approach to regulatory reform.”

Shapps noted the regulatory opportunity the UK had now it had separated from the EU, and wanted to grow the UK’s regulatory reputation. 

“Building on plans outlined in the Innovation Strategy and by the Taskforce on Innovation, Growth and Regulatory Reform, I intend to foster a regulatory approach that will promote innovation, growth and inward investment,” Shapps said. 

Future Avenues

The RHC is now undertaking a prioritisation exercise to identify its next programme of work. As part of this, it has accepted BEIS’ commission to undertake a review of the regulation of quantum technologies.

Creating a regulatory environment that promotes innovation and growth of the UK quantum industry will enable the UK to lead the debate in international fora, and ensure that quantum technologies are used for the benefit of UK society – with global productivity gains from quantum anticipated to be worth $100 billion annually within the next few decades.

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