The UK government has launched a Regulatory Innovation Office to help bring new technologies to the public faster by reducing the time it takes to achieve regulatory approval.
The government says that the Regulatory Innovation Office (RIO) will support regulators across all sectors to implement reform, work together and identify barriers to innovation. The aim is that this will help to speed up approvals. Exactly how the RIO will do this in practice is not yet clear.
When discussing the RIO, Science, Innovation and Technology Secretary Peter Kyle referred to the COVID vaccine approvals as an example of expedited regulatory approvals. While these have often been held up as a different way of government, regulators and industry working together to deliver innovation, the detail of how those working practices during the pandemic might be fed into regulatory approvals in a business-as-usual setting, will be a challenge for the RIO.
The government state that the RIO will support the healthcare sector to deploy AI innovations safely. This could cover a huge range of activities, for example, supporting existing workstreams such as the MHRA roadmap for regulatory reform, NICE early value and health technology assessments or work to develop a framework for assessing real-world evidence. It will be interesting to see what such “support” looks like in practice, for example how it might address resource and capacity constraints, or whether the RIO will simply act as a regulator of the regulators by holding them to account.
The scope of the RIO has been set broadly, with the government flagging the cross-sector nature of certain innovations, for example the use of AI-systems to deliver a variety of technologies. Initially, the RIO will support four areas:
- Engineering biology – the use of synthetic biology and biotechnology to create new products and services derived from organic sources. Innovations in this field can lead to new health treatments, cleaner fuels and more sustainable food production.
- Space – regulatory reform to encourage market access and competition in the UK space industry, supporting technology from GPS to disaster response systems.
- AI and digital in healthcare – the government has made clear it sees AI and digital solutions as critical tools for addressing the pressures on the NHS, including through faster diagnosis and increased hospital efficiency.
- Connected and autonomous technology – the use of autonomous vehicles such as drones to deliver emergency supplies to remote areas quickly. Work to approve this technology could play a key part in supporting emergency services and enhancing business services.
Various government departments such as Transport and Health and Social Care will work closely with the new RIO.
If you have any questions about the regulation of novel Healthcare technology, please contact our Healthcare team.
This article was written by Rory Trust and Amelia Hartley-Baker.