The emergence of new AI-assisted health tools has been exponential—rapidly changing and disrupting how health services are delivered. Although these innovations promise to enhance access to preventive, diagnostic, curative, rehabilitative, and palliative care, there are consequential risks to an individual’s safety and privacy if these innovations are not appropriately regulated.

To mitigate potential risks, many national and international regulatory agencies have developed initiatives to control this fast-moving and continuously evolving innovation. The quantity and similarities among these initiatives can often be confusing for the developers of AI-assisted health tools, governments, and other partners. As such, PATH developed an overview of the current regulatory landscape for medical devices incorporating AI—key actors, regulatory approaches and steps, best practices, etcetera, are covered.

The overview also provides high-level guidance for AI-assisted health tool developers, governments, and global health donors as they navigate and strengthen regulatory ecosystems.

This work is a foundational step toward ensuring all partners have a shared understanding of the current state of regulations, and how improvements can be made amid an ambiguous and constantly changing environment.