AI is entering medicine. It demandstransparency.supervision.accountability.rigorous audits.independent oversight.

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The medical AI oversight gap

900+

AI/ML medical devices currently authorized by the FDA.

~80%

Cleared via pathways that bypass novel clinical trials.

< 10%

Validated using multi-site, prospective clinical data.

Independent Audit Framework
Currently in development
Designing a comprehensive, open-source evaluation criteria to stress-test medical AI models for bias, accuracy, and real-world clinical safety before deployment.
Read our methodology →
Regulatory Alignment
Ongoing coalition building
Partnering with healthcare systems, ethicists, and policymakers to close the loopholes in current FDA 510(k) clearance pathways for machine learning devices.
See our policy goals →
Clinical Validation Registry
Planning phase
Building a secure, multi-site database of prospective clinical trial results to ensure AI tools perform equally well across diverse, real-world patient demographics.
Learn about the registry →