How so? The Food and Drug Administration approves tests for diagnosing disease and illness. The Centers for Medicare and Medicaid Services with input from the FDA and the Centers for Disease Control and Prevention ensures those tests are used safely under a 1988 law establishing lab oversight standards.
Labs overseen by the agencies could also help regulate not only FDA-regulated AI, but tools outside the FDA's scope like the AI doctors use to take notes, the authors say.
How it could work for AI: Clinical AI Ops units, as the researchers call them, could validate AI in health systems where they’re deployed, evaluating data quality, modeling performance, running risk assessments and ensuring AI is tailored to specific patient populations.
This method allows flexibility to validate both discrete algorithms and whole platforms, the NPJ Digital Medicine authors write.
That’s important, since some health tech developers sell whole platforms on which they can design custom tools for specific providers.
One way to vet an algorithm, the Journal of the American Medicine Informatics Association paper suggests, would be to send a batch of fake patient cases to multiple sites using a specific AI model and compare the results across sites.
Another bonus of using the lab model for AI: Labs and services would be available to all health systems regardless of size or resources.
What’s next: Federally regulated labs would have standardized performance metrics and testing protocols. Although there isn’t agreement yet on what those standards should be, labs could potentially adapt labs’ existing testing framework.
The lab model isn’t perfect — it failed to root out Theranos’ fraudulent blood tests. Most of the company’s products were lab-developed tests, which are self-validated, bypassing FDA oversight.
But researchers think there’s an opportunity to learn from those lessons and create a new federally regulated AI lab model to ensure local health systems use AI safely.
WELCOME TO FUTURE PULSE
Schuylerville, N.Y. | Richard Schumaker
This is where we explore the ideas and innovators shaping health care.
Former President Jimmy Carter wanted the Carter Center's work to be his legacy. | Getty Images
Diseases that have long plagued humanity can still be wiped from the face of the Earth.
That’s one of the many legacies of former President Jimmy Carter, who died at age 100 on December 29. Ironically, after Carter lost his reelection bid in 1980, he wondered, “What in the world was I going to do?”
With his wife Rosalynn, he founded an eponymous humanitarian organization, the Carter Center, known for its work eradicating diseases.
Among the Carter Center’s most noteworthy achievements:
— Guinea worm defeated. Since the center’s Guinea worm eradication campaign began in 1986, human cases of Guinea worm disease, an infection caused by a parasite in contaminated drinking water, have fallen from roughly 3.5 million cases a year worldwide to seven cases in 2024.
“This is going to be the second disease after smallpox [that] is actually at the brink of eradication,” Dr. Kashef Ijaz, the center’s vice president for health programs, told Erin.
— River blindness success. Colombia, Ecuador, Guatemala and Mexico eliminated the parasitic infection onchocerciasis, or river blindness, an eye and skin disease, with the help of the former president’s center.
— Trachoma elimination. A mass drug distribution effort spearheaded by the Carter Center in Mali to treat trachoma, an eye infection that can cause blindness, has eliminated the disease, officials in the country say.
Tomorrow and beyond: “I’d like to be judged primarily by our work at the Carter Center for the last 32 years,” Carter told “Parade” magazine in 2013.
Its work continues.
FORWARD THINKING
Researchers say there's a connection between kids drinking fruit juice and having higher body-mass indices. | Getty Images
Just one daily serving of 100-percent fruit juice is linked to increased body mass index in children, according to a new review of research published in JAMA Pediatrics.
Many parents see juice as a way to meet their children’s nutritional needs, according to researchers from several institutions, including the University of Toronto and the Harvard T.H. Chan School of Public Health in Boston. But juice contains essentially no fiber and isn’t as filling as whole fruit, factors believed to strengthen the relationship between juice and increased BMI.
Why it matters: Childhood obesity is a significant concern among health policymakers and parents because of its threat to kids’ health and its overall effect on public health in the coming decades with an increase in chronic diseases. And rising obesity rates would likely strain health systems and increase health care costs.
What’s next: With a greater focus from the incoming Trump administration on the relationship between food and health, reviews that offer confident conclusions on diet could be important for crafting new policy.
National and expert guidelines for children consuming juice vary significantly, which could portend changes in the future as more evidence is validated.
