World Health Organization Releases Guidelines for AI Regulation in Health Care

The World Health Organization (WHO) released a new publication Oct. 19 outlining key regulatory considerations for the use of artificial intelligence (AI) in health care. The publication emphasizes the importance of establishing AI systems’ safety and effectiveness, rapidly making appropriate systems available to those who need them, and fostering dialogue among stakeholders, including developers, regulators, manufacturers, health care workers and patients.

In an accompanying news release, WHO recognized the potential of AI in enhancing health outcomes. At the same time, the organization noted that AI technologies are being rapidly deployed, “sometimes without a full understanding of how they may perform,” which could either benefit or harm end-users.

In response to growing country needs to responsibly manage the rapid rise of AI health technologies, the publication outlines six areas for regulation of AI for health. These areas include the importance of transparency and documentation to build trust, comprehensive risk management, ensuring data quality, navigating complex regulations such as GDPR and HIPAA, and fostering collaboration among various stakeholders. Additionally, the publication underscores the importance of addressing AI's role in amplifying biases in training data, such as gender, race and ethnicity, to ensure inclusivity and fairness.

Through the publication, WHO aims to outline key principles that governments and regulatory authorities can follow to develop new guidance or adapt existing guidance on AI at national or regional levels.