World Health Organisation publishes key principles on the regulation of AI for health

The World Health Organisation has published new guidance on the regulation of artificial intelligence for health, highlighting the need for “establishing AI systems’ safety and effectiveness, rapidly making appropriate systems available to those who need them, and fostering dialogue among stakeholders”.

The new guidance is released alongside the WHO’s recognition for “the potential of AI in enhancing health outcomes”, including in strengthening clinical trials, improving diagnosis and treatment, and supplementing clinician’s knowledge and competencies. It is intended to help respond to challenges such as the rapid deployment of AI technologies such as large language models, “sometimes without a full understanding of how they may perform”, and to regulate access for AI systems to sensitive personal information.

Key areas for regulation of AI in health are outlined by the publication, including the external validation of data and clarity on the intended use of AI, to help “assure safety and facilitate regulation”, as well as the need to commit to data quality to ensure that biases or errors are not amplified. Other areas include transparency and documentation, for example documenting the entire product lifecycle and tracking development processes; risk management; privacy and data protection; and the need to foster collaboration between regulatory bodies, patients, healthcare professionals, industry representatives and government partners.

Dr Tedros Adhanom Ghebreyesus, WHO director-general, is quoted as saying: “Artificial intelligence holds great promise for health, but also comes with serious challenges, including unethical data collection, cybersecurity threats and amplifying biases or misinformation. This new guidance will support countries to regulate AI effectively, to harness its potential, whether in treating cancer or detecting tuberculosis, while minimising the risks.”

The WHO intends the new guidance to be used by governments and regulatory authorities in the development of their own guidance on AI at national or regional levels.

Click here for access to the guidance.

Back in March, we covered the launch of NHS England’s AI and digital regulations service for health and social care, which supports adopters and developers with guidance on the implementation of these technologies in health and social care.

In June, NICE announced a new one-stop-shop and advice service, intended to support the wider health and care system “adopt and make use of new digital and artificial intelligence”, to provide guidance on AI and other digital technologies to facilitate their deployment and rollout.