Global Standards for AI in Healthcare: A WHO Initiative

The WHO Launches Major Global Initiative to Set Unified Standards for AI in Healthcare

The World Health Organization (WHO) has announced a landmark effort to create the world’s first globally harmonized governance framework for artificial intelligence (AI) in healthcare, aiming to ensure that AI technologies are safe, ethical, and accessible—especially in low- and middle-income countries (LMICs).

The initiative, known as the Global Initiative on Artificial Intelligence for Health (GI-AI4H), sets out a comprehensive strategy focused on ethics, regulation, implementation, and operations. Details of the program were recently published in Nature, outlining how the WHO plans to support countries in integrating AI into their health systems safely and sustainably.

Building a Foundation for Health AI

AI’s potential to transform healthcare is immense, from improving diagnostics and treatment to boosting system-wide efficiency. Recognizing both the opportunities and the risks, the WHO launched GI-AI4H to create a global framework that ensures AI innovations are developed and used responsibly.

The initiative draws on the WHO’s Global Strategy on Digital Health 2020–2025 and aligns with the broader United Nations Sustainable Development Goals. A major focus is on helping LMICs, which often face structural challenges in adopting new technologies, to safely and effectively integrate AI into their healthcare systems.

Building on earlier efforts such as the WHO-International Telecommunications Union (WHO-ITU) Focus Group on AI for Health (FG-AI4H), the new initiative emphasizes knowledge sharing, standard setting, and capacity building to promote equitable and sustainable use of AI globally.

Ethics: Turning Principles into Practice

Ethical concerns remain central to the conversation around health AI, and the WHO has been proactive in establishing guardrails. Its 2021 report laid out initial principles for ethical AI use, later expanded in 2024 to address emerging technologies like generative AI and large multi-modal models (LMMs).

GI-AI4H is translating these principles into practical action. One example is its global ethics training course, which has already reached over 25,000 stakeholders in 178 countries, helping to build much-needed capacity, especially in low-resource settings.

Still, achieving global consensus is not straightforward. Cultural differences and varying national priorities mean that ethical standards must be harmonized carefully, with flexibility to respect local values. GI-AI4H stresses the need for inclusive governance frameworks that protect marginalized groups—including children, older adults, and digitally excluded populations—and build trust in AI-driven health solutions.

Regulation: Bridging Fragmented Systems

Currently, health AI regulation is piecemeal, with inconsistent laws on privacy, bias, and safety creating barriers to responsible innovation. GI-AI4H aims to bridge these gaps by encouraging international cooperation and harmonization.

Through collaboration with initiatives like the WHO-ITU FG-AI4H Working Group on Regulatory Considerations and the International Medical Device Regulators Forum (IMDRF), GI-AI4H supports the development of consistent regulatory guidelines that ensure AI systems are safe and effective across different jurisdictions.

A major milestone came in 2024, when the 77th World Health Assembly gathered global stakeholders to prioritize ethical, inclusive, and human rights-based AI governance. GI-AI4H continues to push for scalable regulatory solutions that work across countries, recognizing that resource limitations often make compliance more difficult in LMICs.

Implementation: Closing the Deployment Gap

While many health AI models show promise, relatively few make it to real-world deployment, especially in LMICs. GI-AI4H is determined to close this gap by addressing the structural and cultural barriers that often slow or block implementation.

Through regional consultations and hands-on collaboration with local health professionals and IT teams, the initiative tailors AI tools to specific healthcare contexts. One example is the promotion of AI-driven cervical cancer screening in resource-limited areas, where even cost-effective innovations have struggled to scale due to a lack of localized frameworks.

By building local capacity and promoting culturally sensitive approaches, GI-AI4H supports not just the adoption of AI tools but their sustained and responsible use over time. Efforts like partnering with the WHO’s South-East Asia Regional Office further strengthen this localized focus.

Operations: Ensuring Sustainability Beyond Deployment

Long-term success in health AI depends not just on getting technologies into clinics but also on keeping them effective and sustainable over time. GI-AI4H places a strong emphasis on strengthening the operational capacities of health systems to appraise, monitor, and maintain AI tools.

This means investing in local expertise, creating systems for ongoing monitoring and auditing, and fostering cooperative resource sharing, including contributions to global AI data repositories. Sustainability also involves safeguarding data privacy, ensuring environmental responsibility, and establishing clear accountability frameworks.

By supporting countries in building the infrastructure needed to operate health AI sustainably, GI-AI4H aims to protect communities while ensuring that AI continues to evolve in ways that serve public health priorities.

A Global Framework for the Future

With GI-AI4H, the WHO is laying the groundwork for a truly global, sustainable approach to AI governance in healthcare—one that rests on four interconnected pillars: ethics, regulation, implementation, and operations.

In its first year, the initiative has made important strides, from mobilizing resources and training health leaders to strengthening engagement with member states. As it continues to build momentum, GI-AI4H will be critical in ensuring that the benefits of AI in healthcare are distributed fairly, safely, and sustainably across the world.

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