As the use of artificial intelligence (AI) in healthcare becomes more prevalent, there is a critical need for oversight to prevent potential patient harm. This article proposes the establishment of national AI algorithm assurance laboratories to test and certify AI tools, ensuring they are developed using diverse datasets and demonstrate meaningful clinical outcomes in real-world settings before receiving regulatory approval. The goal is to enhance safety, instill confidence among patients and healthcare professionals, and incentivize developers to prioritize these concerns. Effective, rigorous, and rapid testing and certification shared between developers and users are essential for fulfilling the expectations of various stakeholders in the healthcare sector.
