The Saudi Food and Drug Authority (SFDA) has approved a landmark initiative that will see the launch of the world’s largest AI Physician Clinical Trial. The trial is being rolled out by Saudi Arabia’s national AI company, HUMAIN, and digital health enabler Lean Business Services, in collaboration with the Ministry of Health, aiming to pioneer a new era of preventive healthcare for the Kingdom’s citizens.
The announcement was made at The Global Health Exhibition 2025 in Riyadh, marking a significant milestone in the application of artificial intelligence in direct clinical care delivery.
A Landmark Initiative in Digital Health
This experimental trial represents one of the first large-scale, regulator-approved studies testing AI systems directly in a clinical setting. By strategically focusing on preventive care—enhancing quality of life through improved sleep, nutrition, and physical activity—the initiative aims to circumvent many of the regulatory complexities associated with therapeutic trials while addressing pressing national health concerns.
The move comes as Saudi Arabia’s healthcare market is projected to reach $38.5 billion in 2025, with the government allocating SAR 260 billion ($69 billion), or 20% of its total budget, to health and social development for the year. This substantial investment underscores the Kingdom’s commitment to leveraging technology to upgrade its healthcare infrastructure.
Tackling National Health Challenges with AI
Saudi Arabia faces significant health challenges that the AI trial is designed to address directly. The Kingdom has one of the world’s highest prevalence rates for diabetes, affecting 23.1% of adults, with cases projected to hit 9.4 million by 2050. Similarly, hypertension affects approximately 24.5% of the adult population.
By empowering individuals with AI-driven tools for better self-care, the trial aims to reduce the incidence of these chronic diseases. A key objective is also to build a comprehensive national database that will support future scientific research and the ongoing development of Saudi Arabia’s healthcare ecosystem.
The Powerhouse Duo Behind the Trial
Both HUMAIN and Lean Business Services are owned by Saudi Arabia’s Public Investment Fund (PIF), positioning them at the forefront of the Kingdom’s strategic technology initiatives.
HUMAIN has been developing advanced healthcare applications for its HUMAIN One AI operating system, designed to unify healthcare systems, teams, and data. This integrated approach aims to improve visibility, accelerate decision-making, and ensure secure and compliant care delivery across hospital workflows. Lean Business Services operates as a key enabler for the healthcare sector, deploying proactive digital innovations that leverage AI and data analytics to enhance the entire healthcare ecosystem.
About HUMAIN
HUMAIN is Saudi Arabia’s national AI company, owned by the Public Investment Fund (PIF). It is developing the HUMAIN One AI operating system to bring healthcare systems, teams, and data into a single, aligned layer. The company focuses on improving visibility, accelerating decision-making, and supporting secure, compliant care delivery across various healthcare processes.
About Lean Business Services
Lean Business Services is a PIF-owned company dedicated to enabling the healthcare sector with proactive digital innovations. It leverages AI and data analytics capabilities to enhance the quality of human life and the broader healthcare ecosystem, driving efficiency and progress in digital health.
Source: Middle East AI News
