Medicines agency sets out its approach to AI

The Medicines and Healthcare products Regulatory Agency (MHRA) has set out its strategic approach to artificial intelligence (AI), with the aim both of protecting patient safety and enabling industry to innovate.

Last year, the government published a white paper on the regulation of AI, and in the past 12 months the MHRA has been taking steps to implement the recommendations set out in that white paper.

The hope is that the resulting efficiencies will both allow patients earlier access to safe medical products, and also enable the MHRA to cast a wider focus on innovation and patient engagement. The agency hopes to cement the UK’s reputation as a science and technology superpower by 2030.

The work the MHRA is doing is based on a set of principles:

• Safety, security and robustness
• Appropriate transparency and explainability
• Fairness
• Accountability and governance
• Contestability and redress

The strategy document says: “To ensure that any efficiency gain is not at the expense of the quality of the decisions made, and that the reason for those decisions can be explained at a future date should that become necessary, the five principles of the AI White Paper will also be adhered to as we develop our approaches.”

AI brings potential benefits – but also possible harm

To ensure safety, security and robustness, the document adds, “requires investment in getting the basics right. Data structures, classification, security and sharing rules which are fit for purpose, will be essential for the successful expansion of AI into new use-cases.”

It also says that the MHRA “is fully committed to ensuring equitable access to safe, effective, and high-quality medical devices for all individuals who use them.” It adds: “As Dame Margaret Whitehead notes, the advance of AI brings with it not only great potential benefits to society but also possible harm through inherent bias against certain groups in the population, notably women, ethnic minorities and disadvantaged socio-economic groups.”

The MHRA is considering the opportunities and risks of AI from three perspectives:

• As a regulator of AI products
• As a public service organisation delivering time-critical decisions
• As an organisation that makes evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties

The document notes that the MHRA was one of the first regulators to use AI to increase the efficiency and effectiveness of its vigilance systems, adding: “This was initially for COVID-19 vaccine suspected adverse reaction reports as an additional quality assurance step to ensure that information in free text is coded to the structured fields used for signal detection. In excess of 100,000 previous vaccine reports were used for training and validation, with rules applied over the top of the technology to ensure adequate control of the system.”

Dr Laura Squire, the MHRA’s chief quality and access officer, said: “AI offers us the opportunity to improve the efficiency of the services we provide across all our regulatory functions from regulatory science, through enabling safe access for medicines and medical devices, to post market surveillance and enforcement.”

She added: “Increasingly, we expect AI to feature in how those we regulate undertake their activities and generate evidence and we therefore need to ensure we understand the impact of that in order to continue to regulate effectively.”

The agency expects its processes and protocols – including submission consideration, premise inspections and data examination  – to evolve in line with innovative AI.

The MHRA is also in the process of implementing its own reform through The Regulation of Artificial Intelligence as a Medical Device programme.

The MHRA says that its partnerships with other organisations, including the International Medical Devices Regulators Forum, and in particular the US Food and Administration, and Health Canada, will keep the agency at the forefront of international best practice.