Imagine what would happen if the government put Boeing in charge of airline safety, or if fast-food chains set national nutrition standards.
Such an irony took place when then-President Joe Biden allowed an “independent” nonprofit group backed by Big Tech to regulate, and stifle, the development of artificial intelligence.
The Trump administration is choosing a radically different course, empowering us to unleash AI in a manner that better serves the public.
Following President Donald Trump’s executive order on AI, our goal is to “sustain and enhance America’s global AI dominance in order to promote human flourishing, economic competitiveness, and national security.” Practically, this means healthcare AI can be developed and deployed without having to gain approval from a narrow, powerful group of insiders. We’re confident this democratized approach will unleash AI to serve the public better.
TRUMP DIRECTS $50 MILLION TO AI IN CHILDHOOD CANCER RESEARCH
This marks a clear departure from the Biden administration, which had plenty of ideas for slowing AI development but none for accelerating it. The problem went beyond mere overregulation. Biden administration leaders sought to outsource the very duties of a regulator to a private party.
While small startup companies were building AI tools to improve health, legacy technology companies and large hospital systems, perhaps looking to undercut their new competitors, built and funded what they called the Coalition for Health AI. Biden’s Department of Health and Human Services gave CHAI and its Big Tech backers the power to regulate and stifle health-tech startups. This took regulatory capture to a whole new level — one of regulatory outsourcing.
There’s a safety concern here. Why would the government leave such an important matter of regulation up to the companies that profit from it? CHAI should get out of the business of regulating and focus on advising and educating.
CHAI’s ties to the Biden administration render it incapable of impartial regulatory guidance. Even more problematic, CHAI had Biden appointees on its board while HHS Secretary Xavier Becerra was developing plans for third-party audits of healthcare AI developers. Not surprisingly, CHAI was designated as a top candidate.
It’s like a self-licking ice cream cone, a virtual and unethical syndicate.
We’re hitting reset. Under Secretary Robert F. Kennedy Jr., HHS will not allow CHAI — nor any other nonprofit group, think tank, or company — to operate as an implicitly government-backed regulator or policymaker. While we welcome the emergence of a robust consortium of voices offering suggestions for best practices, we will not force taxpayers to fund assurance labs nor any other regulatory model that we cannot hold accountable on their behalf.
Beyond the political implications, we are concerned that CHAI’s influence will result in poorer outcomes for patients. Sound AI policy should encourage the best healthcare technologies through open, participatory processes that include all stakeholders, not just a self-interested group of industry insiders. Whether you’re representing a Silicon Valley giant or a startup, we want to hear from you.
The public sent Trump back to the White House with a clear mandate to restore America’s dominance in healthcare innovation, root out conflicts of interest, and deliver solutions to the chronic disease epidemic. Instead of regulating AI into the ground, we will wield it to improve lives.
Consistent with the president’s vision, HHS has embraced a forward-leaning, pro-innovation, and pro-competition mindset regarding the development and use of AI. Where the previous administration’s accomplishments consisted of publishing lengthy frameworks and socializing at conferences, this administration is putting technology into action — piloting before deploying, learning fast, and constantly iterating.
At the Food and Drug Administration, we’ve already proven this approach works. We brought our best thinkers and talent from across the agency into collaborative working sessions and developed practical solutions. The results speak for themselves: FDA reviewers say that our AI tool enables them to complete certain scientific review tasks in minutes that used to take days. After a very successful and thorough pilot, we set an aggressive goal of implementing the tool agencywide by June 30. We are proud that we beat this deadline, under budget. We know our scientists find the tool helpful because (1) they tell us, and (2) our internal analytics show that thousands of them use it each day.
TRUMP ANNOUNCES DEAL WITH PFIZER TO LOWER DRUG COSTS
This dramatic improvement demonstrates what’s possible when you move beyond talk to action. Many more innovations are in development. We will use AI to predict drug toxicity better, reducing the need for animal testing, improve post-market safety monitoring, and enhance food inspections and safety, just to start.
Artificial intelligence will make the future of healthcare brighter. By guiding innovation toward patient-focused outcomes, this administration has the potential to deliver historic wins for the public — wins that lead to longer, healthier lives.
Jim O’Neill is deputy secretary of health and human services.
Dr. Marty Makary is the commissioner of the U.S. Food and Drug Administration
