The rapid pace of AI development has left government regulators struggling to keep up. This challenge has opened the door for industry-led initiatives such as the Coalition for Health AI (CHAI), led by Brian Anderson, MD, Politico reported Jan. 1.
CHAI, an alliance of major healthcare systems and technology companies — including Rochester, Minn.-based Mayo Clinic, Microsoft, Amazon and Google — proposes creating quality assurance labs to evaluate AI tools. These labs aim to address regulatory gaps by providing a framework for testing and certifying AI technology. The initiative has received bipartisan interest and cautious support from Biden administration officials, but its future hinges on the stance of President-elect Donald Trump.
Dr. Anderson sees industry-led oversight as an opportunity to advance innovation without the delays of government bureaucracy.
"AI is moving incredibly fast," Dr. Anderson told Politico. "We need to develop these frameworks at the pace of this kind of innovation."
However, critics warn that private-sector control could favor established players over startups and risk prioritizing industry interests over patient safety.
Regulatory challenges remain significant. FDA Commissioner Robert Califf, MD, has acknowledged the agency’s limited capacity to oversee advanced AI tools, citing the need for substantial staff increases that Congress has yet to fund. Meanwhile, CHAI's efforts, including "model cards" to enhance AI transparency and its upcoming assurance labs, aim to complement federal rules set by HHS.
The Trump administration's approach to AI regulation could set the tone for years to come, according to Politico. While Trump's campaign rhetoric promises a hands-off approach aligned with free-market principles, he also consults tech leaders like Elon Musk, who has supported stricter AI regulations in other contexts.
Industry leaders and lawmakers, including members of Trump's transition team and bipartisan congressional task forces, are weighing the implications of outsourcing oversight to CHAI. Critics such as Rep. Jay Obernolte, R-Calif., and Rep. Brett Guthrie, R-Ky., have expressed concerns about potential regulatory capture and its impact on competition and healthcare costs.
As CHAI moves to certify its first assurance labs in early 2025, the Trump administration's decision on whether to endorse the initiative or pursue government-led oversight will be pivotal in shaping the future of AI in healthcare.