Regulations

Regulations in healthcare are critical to care quality and patient safety. The UK is currently reforming its medical device regulations and updating these to account for the rapid pace of technological development and the increase in Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD). It is important for developers of technologies to understand early in development, the relevant regulations and regulatory pathways required for market access and adoption. Utilising close links with the NIHR Incubator we will be able to provide industry with access to a ‘safe space’ to supply direct feedback to regulators, helping the MHRA, NICE, HRA, and CQC to develop regulations and guidance that is fit-for-purpose, accelerating responsible innovation.

Additionally, it is vitally important to address inclusivity and equity by design. The NIHR HRC-DDR will support access to inclusive data resources at regional and national level, helping to ensure that data-driven technologies such as AIaMD are trained and tested on datasets that are diverse and representative of the wider UK population.