London — The Global Health AI Foundation today announced the launch of the Open Clinical AI Certification Programme (OCACP), a globally accessible framework designed to establish a consistent, transparent, and enforceable standard for the independent verification of artificial intelligence tools used in clinical healthcare settings.
The programme, developed over three years in collaboration with clinicians, ethicists, AI researchers, and patient advocacy groups across 19 countries, provides healthcare institutions, regulatory authorities, and AI developers with a structured certification pathway that evaluates clinical AI systems across five core domains: technical performance, algorithmic fairness, data governance, clinical workflow integration, and post-market surveillance readiness.
Programme Design and Certification Tiers
The OCACP defines four certification tiers corresponding to the clinical risk profile of the AI application. Tier 1 applies to low-risk informational and administrative AI tools. Tier 4 applies to autonomous or semi-autonomous diagnostic and therapeutic decision systems operating in high-acuity clinical environments. Higher-tier certifications require progressively more rigorous independent validation, including multi-site prospective trials and structured human factors studies.
Critically, the programme is designed to be accessible to developers in low and middle-income countries. Certification fees are scaled to the economic context of the deploying institution, and the GHAI Foundation is establishing a network of regional audit partners in sub-Saharan Africa, South Asia, and Latin America to ensure that geographic access does not determine which clinical AI tools receive rigorous independent verification.
The goal of the OCACP is not to create another certification burden — it is to build the shared infrastructure of trust that will allow healthcare systems everywhere to deploy AI tools with confidence and patients to receive care from AI tools with protection.
The Open Clinical AI Certification Programme is open for applications from developers and health systems. More information, including the full framework documentation and application portal, is available at ghai.foundation.
