Considerations for the regulation of artificial intelligence in healthcare settings

With the increasing availability of healthcare data and the rapid progress in analytic techniques – whether machine learning, logic-based or statistical – AI tools could transform the health sector. WHO recognises the potential of AI in enhancing health outcomes by strengthening clinical trials; improving medical diagnosis, treatment, self-care and person-centred care; and supplementing healthcare professionals’ knowledge, skills and competencies. For example, AI could be beneficial in settings with a lack of medical specialists, e.g. in interpreting retinal scans and radiology images among many others.

However, AI technologies – including large language models – are being rapidly deployed, sometimes without a full understanding of how they may perform. This could either benefit or harm end-users, including healthcare professionals and patients. When using health data, AI systems could have access to sensitive personal information, necessitating robust legal and regulatory frameworks for safeguarding privacy, security, and integrity, which this publication aims to help set up and maintain.