The development of AI is reaching a critical stage, with developers leaving high-paying jobs at major companies to start health tech companies. As a result, there is a need for regulatory frameworks that prioritize trustworthiness and patient-centricity in AI applications. However, not all regulatory frameworks are conducive to revolutionary advancements. The proposed third-party review process by the Coalition for Health AI, which is led by representatives from big tech companies such as Google and Microsoft, has raised concerns about potential regulatory capture and uneven market entry control. This approach could hinder innovation from smaller, newer companies that have the potential to bring about positive changes in patients' and clinicians' lives. An alternative framework, known as localized quality assurance, emphasizes decentralized decision-making in incorporating health AI.

This approach allows participating organizations to validate AI models on their own datasets, empowering them to determine which technologies are most effective for the populations they serve. Democratized AI access and localized assurance are gaining traction, with initiatives like the Health AI Partnership and Epic's open source tool. However, additional support is needed to ensure that all clinics can participate in the AI review process. An open and competitive market is crucial for technological development in healthcare, and efforts should be made to prevent regulatory capture by big corporations that could stifle innovation and drive away talent and investment. The potential of AI to improve healthcare, reduce clinicians' workload, and address healthcare disparities can only be realized if innovators have the opportunity to test and validate their ideas rapidly, while health systems and providers can select solutions tailored to their unique needs.