WHO provides guidelines for regulating AI in healthcare

The World Health Organization (WHO) has released a new publication outlining crucial regulatory considerations for Artificial Intelligence (AI) in the field of health. The publication underscores the significance of ensuring the safety and effectiveness of AI systems, swiftly making them accessible to those in need, and promoting dialogue among various stakeholders, including developers, regulators, manufacturers, health professionals, and patients.

Given the increasing availability of healthcare data and the rapid advancements in analytical techniques, such as machine learning, logic-based approaches, and statistical methods, AI tools have the potential to revolutionise the healthcare sector. WHO acknowledges AI’s capacity to enhance health outcomes by strengthening clinical trials, improving medical diagnoses, treatments, self-care, and personalised care, as well as augmenting the knowledge, skills, and capabilities of healthcare professionals.

However, the rapid deployment of AI technologies, including large language models, sometimes occurs without a comprehensive understanding of their potential performance, which could lead to either benefit or harm for end-users, including healthcare practitioners and patients. When utilising health data, AI systems may access sensitive personal information, necessitating robust legal and regulatory frameworks to safeguard privacy, security, and integrity. This publication aims to provide guidance in establishing and upholding these frameworks.

Dr Tedros Adhanom Ghebreyesus, WHO Director-General, remarked that AI holds great promise for health, but 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.