The MHRA has identified ten conclusions from its report on regulation of AI in healthcare, from a lifecycle-based approach to regulation to the need for greater training. 

The Medicines and Healthcare products Regulatory Agency (MHRA) has identified ten conclusions from its report on regulation of AI in healthcare.

Following a call for evidence late last year, the MHRA has published Information on how AI is used in Health and the Current Regulatory Frameworks, collecting its findings to provide an evidence base on how AI is used in practice and its regulatory challenges.

From the report, the MHRA has identified ten findings, including that there is a clear call for a proportionate, lifecycle-based approach to regulation and, crucially, that there is strong consensus for significant regulatory reform. 

It also found that there was broad consensus that AI systems will increasingly require continuous post-market surveillance and monitoring, and that that responsibility should be shared across the system, with each individual and institution understanding their essential role and responsibilities. 

Healthcare providers want a robust and clear governance structure/organisational responsibility, while the patient/public wants the current gaps addressed. There is greater clarity and consistency in liability needed. 

Above all, human oversight and responsibility for clinical judgment should be retained, and transparency and explainability will be key for the ongoing deployment of AI systems. Data access and use are central to the role of AI in healthcare moving forward. 

To make sure that it all works and that patient and public trust is maintained, there is a need for robust training and improved AI literacy and, at the same time, that there is a need to improve incident reporting and learning mechanisms. 

“The increasing AI in healthcare will affect all of us,” said Alastair Denniston, chair of the National Commission into the Regulation of AI in Healthcare. 

“These views consistently highlight the potential to bring many benefits, enhancing quality, speed, convenience and increasing safety, but also highlight that this is a change that the regulators and wider health system need to actively engage with, including ensuring that our regulations and governance systems match the risks and benefits of these new technologies.”