Saudi to launch world’s largest AI physician clinical trial

Saudi Food and Drug Authority greenlights HUMAIN-Lean AI healthcare trial

The official announcement photo at the Gulf Health Exhibition (Credit; Lean)

#SaudiArabia #healthcare – The Saudi Food and Drug Authority (SFDA) has approved what could be the world’s largest AI Physician Clinical Trial. Soon to be launched by Saudi Arabia’s national AI company HUMAIN and digital health enabler Lean Business Services, working in collaboration with the Ministry of Health, the trial aims to empower individuals with better self-care and effective preventive care. The news was announced at The Global Health Exhibition 2025 in Riyadh last week. Backers hope that the experimental AI trial will enhance citizens’ quality of life through improved sleep, nutrition and physical activity, reducing the prevalence of chronic diseases such as diabetes and hypertension, whilst building a national database to support scientific research and healthcare development.

SO WHAT? – The AI Physician Clinical Trial could be the first large-scale, regulator-approved clinical trial testing AI systems in direct clinical care delivery, albeit for preventative care. The trial also targets national challenges faced by Saudi Arabia, such as diabetes, hypertension and thalassemia. Therefore, preventative care on a national scale could have an enormous impact on healthcare, wellbeing and the functioning of Saudi Arabia’s healthcare system. By focusing on preventative care, rather than therapeutic care, the trial might avoid many of the regulatory barriers to implementing large scale clinical trials.

Here are some key points about the new clinical trial:

• HUMAIN and Lean Business Services received approval from the Saudi Food and Drug Authority (SFDA) to launch the AI Physician Clinical Trial, announced during the Global Health Exhibition 2025 in Riyadh as the world’s largest regulated experiment applying AI to clinical care delivery. Both HUMAIN and Lean are owned by Saudi Arabia’s Public Investment Fund (PIF).

• The Saudi healthcare market is estimated at $38.5 billion in 2025, making it one of the largest in the Middle East, with government spending on health and social development for 2025 reaching SAR 260 billion ($69b), representing 20 per cent of Saudi Arabia’s total national budget.

• The clinical trial aims to empower individuals with better self-care and effective preventive care, enhancing quality of life through improved sleep, nutrition and physical activity. It is hoped that the initiative will help reduce the prevalence of chronic diseases such as diabetes and hypertension, while building a national database to support scientific research.

• HUMAIN has already been developing healthcare applications for its HUMAIN One AI operating system. The new AI system could bring healthcare systems, teams and data into one aligned layer, aiming to improve visibility, accelerate decision-making and support secure, compliant care delivery across hospital workflows and administrative processes.

• Lean Business Services operates as a Public Investment Fund company enabling the healthcare sector with proactive digital innovations that enhance quality of human life and the healthcare ecosystem by leveraging AI and data analytics capabilities.

• The Saudi government is under pressure to increase national access to quality healthcare and tackle endemic healthcare challenges. The Ministry of Health has over 30 new hospitals planned and upgrades to more than 200 healthcare centres, whilst 290 hospitals are transitioning to private operation under privatisation reforms. Meanwhile, the Kingdom aims to recruit 175,000 healthcare professionals by 2030, including 69,000 doctors.

ZOOM OUT – Saudi Arabia faces significant health challenges that require targeted interventions on a national level. Diabetes affects 23.1 per cent of adults aged 20–79, ranking the Kingdom amongst the top ten countries globally for prevalence, with cases projected to reach 9.4 million by 2050 and annual healthcare expenditures exceeding $7.3 billion. Hypertension affects approximately 24.5 per cent of adults aged 18 and older, whilst thalassemia prevalence reaches 0.7 per cent nationally with regional concentrations as high as 3.2 per cent. Meanwhile, nearly half of diabetes cases in the country remain undiagnosed. Without effective targeted interventions, these chronic and hereditary conditions could continue rising.

[Written and edited with the assistance of AI]

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