The expanding role of artificial intelligence in medical care in the United States has raised concerns, even as the Trump administration said it is taking a “responsible, evidence-based approach” that maintains safeguards for patients.
The New York Times reported Monday that the Department of Health and Human Services is moving forward with projects that could expand the role of AI in diagnosing patients, providing therapy, and eventually prescribing and managing medications.
Some officials involved in discussions have questioned whether the technology is being deployed too quickly without sufficient evidence of its safety and effectiveness, according to the Times.
HHS spokeswoman Grace Davis Jamison rejected suggestions that the department is rushing the technology into medical care, telling the Times that HHS is “expanding its use as the evidence demonstrates value.”
“HHS is embracing cutting-edge American innovation, including AI as a practical tool, to better serve patients, families, and clinicians as we work to make America healthy again,” Jamison said.
The administration’s efforts include the Centers for Medicare & Medicaid Services’ ACCESS program, a 10-year voluntary model that began in July and allows Medicare-enrolled organizations to provide technology-supported care for chronic conditions including high blood pressure, diabetes, chronic pain, and depression.
CMS said participating organizations must comply with applicable state licensing, privacy, and Food and Drug Administration requirements and designate a physician clinical director responsible for oversight. Payments are tied in part to measurable improvements in patients’ health rather than simply the services provided.
More than 150 organizations have been accepted to participate in the model, according to CMS.
The Food and Drug Administration, meanwhile, is considering how its regulatory framework should address generative AI systems capable of performing increasingly complex medical functions.
The agency last month sought public input on risk assessment, premarket evaluation, and postmarket monitoring of generative AI-enabled medical devices.
“Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly,” acting FDA Commissioner Kyle Diamantas said when the initiative was announced.
The Times reported, however, that concerns have emerged within the government and medical community about allowing AI systems to assume responsibilities traditionally performed by physicians.
Dr. John Whyte, chief executive of the American Medical Association, told the Times that AI systems designed to independently provide medical care “are not ready for prime time.”
“AI in health should not be driven by the tech industry,” Whyte said. “It should be driven by the clinical community. And right now, what we have going on is that tech is the tail wagging the dog.”
The Times also focused on the involvement of Silicon Valley investors, particularly billionaire venture capitalist Vinod Khosla, whose son Neal founded the AI health company Curai Health. Vinod Khosla, an investor in the company, has argued that AI will ultimately outperform human physicians.
Curai is among the companies selected for a Medicare pilot and has an application pending with the FDA, according to the Times.
Health and Human Services Secretary Robert F. Kennedy Jr. has acknowledged the potential risks of AI while arguing that the technology could transform healthcare.
“AI is going to revolutionize medicine,” Kennedy told Congress in April. “It may at some point make the FDA irrelevant. It’s going to give us the capacity to develop new drugs, personalized medicine for every citizen.
“I was just reading about a dog that had cancer. His owner used AI to develop a personalized treatment to cure the cancer.
“We’re going to see that now across medicine. We’re very excited about it. AI is very dangerous potentially but also has the capacity to bring really great things to humanity, particularly in the realm of human health.”
One HHS research project cited by the Times ultimately seeks to use autonomous AI to help manage heart failure patients, including monitoring their conditions and adjusting medications. Under current law and regulations, however, a physician will oversee the AI system, according to the report.