(Press-News.org) An agile, transparent, and ethics-driven oversight system is needed for the U.S. Food and Drug Administration (FDA) to balance innovation with patient safety when it comes to artificial intelligence-driven medical technologies. That is the takeaway from a new report issued to the FDA, published this week in the open-access journal PLOS Medicine by Leo Celi of the Massachusetts Institute of Technology, and colleagues.
Artificial intelligence is becoming a powerful force in healthcare, helping doctors diagnose diseases, monitor patients, and even recommend treatments. Unlike traditional medical devices, many AI tools continue to learn and change after they’ve been approved, meaning their behavior can shift in unpredictable ways once they’re in use.
In the new paper, Celi and his colleagues argue that the FDA’s current system is not set up to keep tabs on these post-approval changes. Their analysis calls for stronger rules around transparency and bias, especially to protect vulnerable populations. If an algorithm is trained mostly on data from one group of people, it may make mistakes when used with others. The authors recommend that developers be required to share information about how their AI models were trained and tested, and that the FDA involve patients and community advocates more directly in decision-making. They also suggest practical fixes, including creating public data repositories to track how AI performs in the real world, offering tax incentives for companies that follow ethical practices, and training medical students to critically evaluate AI tools.
“This work has the potential to drive real-world impact by prompting the FDA to rethink existing oversight mechanisms for AI-enabled medical technologies. We advocate for a patient-centered, risk-aware, and continuously adaptive regulatory approach—one that ensures AI remains an asset to clinical practice without compromising safety or exacerbating healthcare disparities,” the authors say.
#####
In your coverage please use this URL to provide access to the freely available article in PLOS Digital Health: https://plos.io/3HgQkja
Citation: Abulibdeh R, Celi LA, Sejdić E (2025) The illusion of safety: A report to the FDA on AI healthcare product approvals. PLOS Digit Health 4(6): e0000866. https://doi.org/10.1371/journal.pdig.0000866
Author Countries: Canada, United States
Funding: The author(s) received no specific funding for this work.
END
Scientists argue for more FDA oversight of healthcare AI tools
2025-06-05
ELSE PRESS RELEASES FROM THIS DATE:
Study finds dehorning of rhinos drastically reduces poaching
2025-06-05
EMBARGOED UNTIL Thursday, 5 June 2025 at 14:00 (2:00 pm) U.S. Eastern Time (8pm South Africa time, 7pm UK time)
JOINT MEDIA RELEASE
Study finds dehorning of rhinos drastically reduces poaching
More rhino images and video clips available via the link below
An international study published today (5 June 2025) in the prestigious journal Science found that dehorning rhinos resulted in a drastic reduction in poaching of these endangered animals. This is based on the analysis of data across 11 reserves in the Greater Kruger region of South Africa between 2017 and 2023. Poaching for their horn is a major threat to the world’s five rhino species.
The project was a collaboration ...
NIH researchers conclude that taurine is unlikely to be a good aging biomarker
2025-06-05
Scientists at the National Institutes of Health (NIH) have found that levels of circulating taurine, a conditionally essential amino acid involved in multiple important biological functions, is unlikely to serve as a good biomarker for the aging process. In blood samples from humans, monkeys, and mice, scientists found that circulating taurine levels often increased or remained constant with age. Analysis of longitudinal data showed that within individual differences in taurine levels often exceeded age-related changes. Researchers also found that taurine levels were inconsistently associated with ...
Caterpillar factories produce fluorescent nanocarbons
2025-06-05
Researchers led by Kenichiro Itami at the RIKEN Pioneering Research Institute (PRI) / RIKEN Center for Sustainable Resource Science (CSRS) have successfully used insects as mini molecule-making factories, marking a breakthrough in chemical engineering. Referred to as “in-insect synthesis,” this technique offers a new way to create and modify complex molecules, which will generate new opportunities for the discovery, development, and application of non-natural molecules, such as nanocarbons.
Molecular nanocarbons are super tiny structures made entirely of carbon atoms. Despite their minuscule size, they can be ...
Taurine is not a reliable biomarker for aging, longitudinal study shows
2025-06-05
Research in animals and humans has suggested low levels of taurine may be a driver for aging, which has led to discussions about whether taurine is an aging biomarker. Now, a comprehensive study involving longitudinal data from humans, monkeys, and mice shows that taurine levels in the blood do not consistently decline with age, and that levels of taurine vary more by factors unique to each individual than based on aging. These results lead the study authors – Maria Fernandez and colleagues – to conclude that “the efficacy of taurine supplementation to delay aging ...
Lidar survey reveals expansive precolonial maize farming in Michigan’s Upper Peninsula
2025-06-05
Findings from a new archaeological survey challenge long-held assumptions that intensive agriculture in North America was limited to centralized societies or favorable environments. The findings reveal an extensive precolonial agricultural landscape in Michigan’s Upper Peninsula, suggesting Indigenous American communities cultivated maize intensively between 1000 and 1600 CE, despite a cold climate and marginal growing conditions. Indigenous American communities across what is now the United States increasingly relied on intensive maize cultivation, ...
Dehorning of rhinos reduced poaching by 78% in Greater Kruger African reserves from 2017 to 2023
2025-06-05
Dehorning rhinos proactively removed the incentive for poachers and reduced poaching activity by 78% across 11 Greater Kruger African reserves from 2017 to 2023, a new study has found. Conversely, law enforcement interventions designed to punish poachers retroactively had no statistical effect on poaching. “Our results present a challenge to governments, funders, the private sector, and nongovernmental organizations to reassess their strategic approaches to wildlife crime in general,” Timothy Kuiper and colleagues write. “Although detecting and arresting poachers is essential, ...
Retinal prosthesis bestows artificial vision in blind mice and detects near-infrared in large animals
2025-06-05
A new prosthesis for the retina weaved with nanowires partially restored vision in blind mice and allowed detection of near-infrared light in macaques, according to a new study. The new technology’s feasibility and strong safety profile marks a milestone in the development of artificial vision, which could prove invaluable to patients worldwide who are living with blindness or retinal disease. Currently, there are many approaches to restoring vision in the blind, but almost all of these treatments face obstacles such as electrical interference or a lack of long-term efficacy. At the same time, researchers are also trying ...
Archaeologists uncover massive 1000-year-old Native American fields in Northern Michigan that defy limits of farming
2025-06-05
With its cold climate, short growing season, and dense forests, Michigan's Upper Peninsula is known as a challenging place for farming. But a new Dartmouth-led study provides evidence of intensive farming by ancestral Native Americans at the Sixty Islands archaeological site along the Menominee River, making it the most complete ancient agricultural site in the eastern half of the United States.
The site features a raised ridge field system that dates to around the 10th century to 1600, and much of it is still intact today.
The raised fields are comprised of clustered ...
Advance in creating organoids could aid research, lead to treatment
2025-06-05
For over a decade, scientists have been growing organoids — small clusters of cells that mimic a particular organ — to serve as miniature biological models. Organoids of the brain have been used to study neurodevelopmental disorders; intestinal organoids, to model celiac disease; and lung organoids, to investigate SARS-CoV-2. Heart organoids have even been sent to space to test the effect of microgravity on cardiac muscle. But there’s a tiny problem — the organoids can’t grow ...
Groundbreaking study maps the movements of marine megafauna
2025-06-05
A sweeping new study is helping pinpoint where whales, sharks, turtles, and other ocean giants need the most protection and where current efforts fall short.
Led by Ana Sequeira of Australian National University and supported by the United Nations, the research synthesized data from 12,000 satellite-tracked animals across more than 100 species. It reveals how marine megafauna move globally and where their migratory, feeding, and breeding behaviors intersect with human threats such as fishing, shipping, and pollution.
Virginia ...