The introduction of Artificial Intelligence (AI) offers the opportunity to transform healthcare, offering groundbreaking advancements in diagnostics, treatment planning, and medical device functionality.
However, with these innovations comes the responsibility to ensure AI systems meet the highest standards of safety, efficacy, and regulatory compliance.
The Medicines and Healthcare products Regulatory Agency (MHRA) play a crucial role in safeguarding public health by regulating medicines and medical devices in the UK. As AI becomes increasingly integrated into healthcare solutions, it is essential that AI-driven technologies adhere to MHRA guidance to ensure they are safe, effective, and ethically deployed.
As an organisation we also have a legal obligation to carry out adequate due diligence of any processor of personal identifiable data (PID). If this due diligence is not carried out, it can come with legal challenges as well as serious fines.
What do I need to do?
To ensure transparency, governance, and alignment with our digital strategy across the five adult hospitals within the LAASP partnership, we request that all AI-related activities be formally declared and documented. This includes any AI tools, models, automation processes, or experimental initiatives being developed or used within your department.
Please note, this declaration of AI excludes using Microsoft Copilot. However you should never input PID into Copilot. Read more about Copilot guidance here.
Colleagues should submit details of all AI-related projects, implementations, or research using this form to the Digital PMO. This will allow us to maintain oversight, assess compliance, and support integration efforts across the organisation. If you require further clarification or support, please feel free to contact the team.