Geneva and London — The Global Health AI Foundation and the World Health Organization today announced the establishment of a joint technical working group to develop internationally applicable minimum safety standards for the deployment of artificial intelligence in health systems worldwide. The initiative, funded through a multi-donor programme, will run for four years and is designed to address the significant gap between the sophistication of clinical AI deployment and the maturity of governance frameworks in most national health systems.
The Governance Gap in Clinical AI
Despite significant regulatory activity in the European Union, United States, United Kingdom, and a small number of other jurisdictions, the majority of the world's health systems are deploying AI tools in the absence of any jurisdiction-specific regulatory framework governing their clinical use. A 2025 WHO survey found that of 135 member states with documented clinical AI deployment, 94 had no national regulatory guidance specific to AI medical devices. This means that in most of the world, clinical AI operates in a regulatory vacuum.
The joint initiative will develop a tiered standards framework applicable across diverse regulatory environments, from mature national medical device regulatory agencies to contexts where regulatory capacity is still being developed. The framework will be designed for adoption either as standalone national policy or as a supplement to existing medical device regulation.
Health AI should not be the exclusive preserve of well-resourced health systems. Global standards are the foundation of equitable access to safe AI-enabled care.
