The Regulatory Horizons Council (RHC) has published 2
independent reports today (30 November 2022) on the regulation of
neurotechnology and AI as a medical device, to
encourage the safe and rapid development of these 2 key
technologies.
The Business Secretary, , has written to the Regulatory
Horizons Council welcoming the reports, saying:
Technological innovation is fundamental to the government’s plans
for unlocking growth.
I am committed to growing the UK’s global reputation for
regulatory best practice and capitalising our Brexit freedoms.
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.
The work of the Regulatory Horizons Council is a key part of
modernising our approach to regulatory reform.
Neurotechnology is an umbrella term that includes a wide range of
devices that record or alter the activity of the nervous system.
This includes promising medical applications that could improve
the lives of thousands of people in the UK enduring health
conditions such as Parkinson’s, Alzheimer’s, depression,
rheumatoid arthritis and cardiac illnesses.
From mind-controlled drones to devices that improve focus and
reduce fatigue, emerging applications in the non-medical field
could redefine how we interact with one another and leverage the
potential of the human brain in unprecedented ways.
The RHC’s new neurotechnology
report suggests an interactive taxonomy to guide future
conversations on neurotechnology governance and makes 14
regulatory reform recommendations to:
-
establish a proportionate regulatory framework that
encourages the safe commercialisation of medical
neurotechnologies and addresses under-regulation concerns in
the non-medical sector; and
-
build an anticipatory governance framework to address
forward-looking privacy, ethical and security challenges.
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 safe use of AI
in medical devices has the potential to create efficiencies and
cost savings in NHS processes through automation of routine
tasks, and can detect predictors of disease with greater speed
and accuracy than health professionals.
The RHC AIaMD
report outlines the challenges and current gaps in the
regulation of AI as
a medical device and provides recommendations on developing a
regulatory framework that balances the needs for effectiveness,
safety and equity, with the importance of ensuring that
high-quality AIaMDinnovations
are brought to patients.
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.
Requests for more examination (relating to technological
innovation), in areas you would like the Regulatory Horizons
Council to investigate further, can be made by completing
this form.
