The Trump administration is ramping up its campaign against the Coalition for Health AI (CHAI), a nonprofit backed by tech giants and major health systems that vets AI tools for clinical use. Health Secretary Robert F. Kennedy Jr. and other senior officials have publicly denounced CHAI as a “regulatory cartel” that could stifle startups and entrench big‑tech influence in healthcare policy. Their criticism follows a recent editorial by Deputy Secretary Jim O’Neill and FDA Commissioner Marty Makary, which warned that CHAI’s guidelines might become de‑facto regulation, favoring established corporations over emerging innovators .
The dispute centers on CHAI’s role in shaping AI safety standards, data interoperability, and bias mitigation. Founded by companies such as Google, OpenAI, Microsoft, and Mayo Clinic, the coalition aims to develop a common framework for responsible AI deployment, promote secure data sharing, and address algorithmic bias. Critics argue that this private‑sector‑led effort could amount to “regulatory capture,” allowing industry insiders to dictate policy without proper government oversight. Supporters, including CHAI CEO Brian Anderson, stress that the group’s work is purely voluntary and meant to inform—not replace—formal regulation .
Adding to the pressure, Amazon recently withdrew from CHAI, citing a desire to focus on internal initiatives, though analysts suspect the move reflects broader concerns about the coalition’s direction and potential regulatory fallout. The administration’s skepticism has also prompted the FDA to seek public comment on post‑market surveillance of AI‑enabled medical devices, signaling a shift toward more direct federal oversight rather than relying on CHAI’s vetting processes .
The clash highlights a larger debate over how to balance innovation with accountability in health AI. While CHAI’s proponents argue that industry collaboration is essential for rapid, responsible adoption, opponents see a risk of monopolistic control that could limit competition and patient access to cutting‑edge solutions. As the Trump administration pushes for tighter government scrutiny, the future of health AI governance may hinge on whether policymakers can craft regulations that foster innovation without ceding authority to private coalitions .
