It’s possible that I shall make an ass of myself. But in that case one can always get out of it with a little dialectic. I have, of course, so worded my proposition as to be right either way (K.Marx, Letter to F.Engels on the Indian Mutiny)
Thursday, June 05, 2025
Scientists argue for more FDA oversight of healthcare AI tools
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.
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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.
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 mechanically strong, conduct electricity, and even emit fluorescent light. These properties make them ideal for use in applications like aerospace components, lightweight batteries, and advanced electronics. However, the precision required to manufacture these tiny structures remains a major obstacle to their widespread use. Conventional laboratory techniques struggle with the fine manipulation needed to put these complex molecules together atom by atom, and their defined shapes make it especially difficult to modify them without disrupting their integrity.
“Our team has been conducting research on molecular nanocarbons, but along with that, we've also developed molecules that act on mammals and plants,” says Itami. “Through those experiences, we suddenly wondered — what would happen if we fed nanocarbons to insects?”
As strange as the idea may sound, it’s rooted in biology. Insects, particularly plant-eating insects like grasshoppers and caterpillars, have evolved sophisticated systems in the gut for breaking down foreign substances like plant toxins and pesticides. These metabolic processes rely on enzymes capable of complex chemical transformations. The RIKEN researchers hypothesized that insects could serve as living chemical factories, performing the types of chemical modifications to nanocarbons that are difficult to replicate in the laboratory.
To test their concept, the team fed tobacco cutworm caterpillars—common agricultural pests with well-mapped metabolic pathways—a diet containing a belt-shaped molecular nanocarbon known as [6]MCPP. Two days later, analysis of the caterpillar poo revealed a new molecule, [6]MCPP-oxylene, which is [6]MCPP that has incorporated an oxygen atom. This subtle change caused the molecule to become fluorescent.
Using techniques such as mass spectrometry, NMR, and X-ray crystallography, the researchers determined [6]MCPP-oxylene’s structure. Experiments using molecular biology pinpointed two enzymes, CYP X2 and X3, as being responsible for the transformation. Further genetic analyses confirmed that these enzymes are essential for the reaction to occur.
Computer simulations found that these enzymes could simultaneously bind two [6]MCPP-oxylene molecules and directly insert an oxygen atom into a carbon–carbon bond—a rare and previously unobserved phenomenon. “It is extremely difficult to reproduce the chemical reactions occurring inside insects in a laboratory setting,” Itami explains. “Lab-based attempts at this oxidation reaction failed or had very low yields.”
True to the philosophy of the PRI, this work pioneers a new direction in materials science: making functional molecules using insects. The shift from traditional test tubes to biological systems—enzymes, microbes, or insects—will allow the construction of complex nanomolecules. Beyond glowing molecular nanocarbons, with tools like genome editing and directed evolution, in-insect synthesis could be applied to a wide range of molecules and functions, forging links between organic chemistry and synthetic biology.
“The tobacco cutworm is a notorious agricultural pest because of its rapid life cycle and exceptional ability to metabolize pesticides, earning them a reputation as global villains in the crop protection industry,” says Itami. “And yet, what we find truly fascinating, is that in our project, these very moths took on an unexpected role—not as adversaries, but as unlikely heroes.”
Credit: Greater Kruger Environmental Protection Foundation
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, strategies that focus on reducing opportunities for and rewards from poaching may be more effective.” Born of international demand for horns, poaching not only harms rhinos – it also affects countries’ tourism revenue, hurts ecosystems, funds criminal syndicates, and spurs violence. One popular conservation strategy, based on the tenets of behavioral economics, suggests that increasing the probability of being caught and/or the severity of punishment once caught can deter poachers. Yet, these law enforcement measures are largely reactive and take place after poaching has already occurred. Now, Kuiper et al. have compared law enforcement (tracking dogs, camera surveillance, and rangers for judicial punishment) to dehorning. The latter proactively removes incentive, instead of reactively applying a disincentive. From 2017 to 2023, the team recorded poaching of 1,985 rhinos across 11 southern Greater Kruger African reserves. This activity took place even with the equivalent of 74 million US dollars spent on antipoaching law enforcement and despite more than 700 poacher arrests. Kuiper et al. used Bayesian regression models to establish causal pathways between reactive and proactive interventions and their outcomes. Reactive interventions had no statistically significant effect on poaching. However, dehorning – which happened to 2,284 rhinos in 8 of the reserves – yielded a 78% reduction in poaching. Notably, dehorning only cost 1.2% of the entire budget spent within the time period. The authors offer several reasons for why reactive antipoaching interventions were less useful. “Ongoing socioeconomic inequality incentivizes a large pool of vulnerable and motivated people to join, or poach for, criminal syndicates even when the risks are high,” they write, adding that corruption and ineffective justice systems can further thwart reactive approaches. They also warn that poachers will still sometimes target dehorned rhino stumps or regrown horns out of necessity, and caution that dehorning’s long-term impact on rhino biology remains poorly understood.
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 between reserve managers under the banner of the Greater Kruger Environmental Protection Foundation (GKEPF) and scientists from the University of Cape Town (UCT), Nelson Mandela University, University of Stellenbosch and the University of Oxford. Other partners included South African National Parks, the World Wildlife Fund South Africa, and the Rhino Recovery Fund.
Lead author, Dr Tim Kuiper of Nelson Mandela University (George campus) said, “We documented the poaching of 1,985 rhinos (about 6,5% of the population annually) across 11 Greater Kruger reserves over seven years. This landscape is a critical global stronghold that conserves around 25% of all Africa’s rhinos.”
Dr Kuiper added, “Dehorning rhinos to reduce incentives for poaching (2,284 rhinos were dehorned across eight reserves) was found to achieve a 78% reduction in poaching using just 1.2% of the overall rhino protection budget”. This was based on comparison between sites with and without dehorning as well as changes in poaching before and after dehorning.
The study did show, however, that some poaching of dehorned rhinos for horn stumps and regrowth continued, while more recent evidence (2024-2025) since the conclusion of the study in 2023 suggests this is a growing challenge. Dehorning may also shift the focus of poachers to horned populations elsewhere.
Reserves under study invested $74 million (R1 billion) in anti-poaching interventions from 2017-2021. Most of the investment focused on reactive law enforcement — rangers, tracking dogs, helicopters, access controls and detection cameras — helping achieve over 700 poacher arrests. Yet the authors found no statistical evidence that these interventions significantly reduced poaching.
Interventions that work to aid poacher detection and arrest, while a necessary element of the anti-poaching toolkit, are compromised by systemic factors, such as local poverty (driving people to take risks) and corruption (offering a way around interventions, as this recent hard-hitting report highlights).“Finally, ineffective criminal justice systems mean that arrested offenders often escape punishment, with evidence from our study area of multiple repeat offenders”, said Dr Kuiper.
In a shining example of science-policy collaboration, this project was first conceived by reserve managers at the frontline of rhino conservation who recognised the need to critically evaluate their investments into anti-poaching interventions (from tracking dogs to AI cameras). GKEPF led the initiative by convening manager workshops and gathering data for the evaluation.
Sharon Hausmann, CEO of GKEPF, was the intermediary between the managers and scientists. She said, “The true value of this innovative study, conceived by GKEPF operational managers, lies in its collective critical thinking. Ensuring not only that operations are guided by science, but also that science is grounded in real experience from the frontline”.
Dr Markus Hofmeyr, of the Rhino Recovery Fund added, “From a donor perspective this study has given excellent insight where conservation donor funding can be spent and where to avoid funding.”
The research results present an opportunity for government, funders, the private sector and NGOs to re-reassess their strategic approaches to wildlife crime in general and rhino poaching in particular.
Study co-author Professor E.J. Milner-Gulland of the University of Oxford said: “This collaboration is a brilliant example of how the effectiveness of conservation interventions can be assessed quantitatively, even in challenging and complex situations, and how important the participation of on-the-ground practitioners is in initiating, and interpreting, such research.”
UCT Professor Res Altwegg, who supervised the statistical analysis, highlighted the importance of this publication: “It’s important to check that our conservation interventions work as intended, and keep working that way. For me, this project has again highlighted the value of collecting detailed data, both on the interventions that were applied and the outcome. It’s such data that makes robust quantitative analyses possible.”
Black rhino 1-4 - General photos of black rhino in the Greater Kruger region. All dehorned and showing some horn regrowth. (Credit all photos: Tim Kuiper).
Dehorning operation - Greater Kruger region - white rhino being dehorned. Credit: Greater Kruger Environmental Protection Foundation
Dehorned white rhino mother and calf - two photos - Greater Kruger region. Credit both photos: Tim Kuiper
Horned white rhino mother and calf - one photo - Undisclosed South African reserve (Credit all photos: Tim Kuiper).
Horned white rhino - three photos - Undisclosed South African reserve (Credit all photos: Tim Kuiper).
Video - horned white rhino - Greater Kruger reserve (Credit: Tim Kuiper).
ABOUT THE GREATER KRUGER ENVIRONMENTAL PROTECTION FOUNDATION
The Greater Kruger Environmental Protection Foundation (GKEPF) is a registered non-profit organization that was established in 2016 by the private reserves on the Western boundary of Kruger National Park as well as the Kruger National Park. GKEPF was established in direct response to the alarming increase in the number of rhinos killed by poachers in the Greater Kruger, an area which encompasses more than 2.5 million hectares of unfenced wilderness and is home to the largest wild rhino population in the world.
GKEPF has become integrally involved in facilitating effective communication, aligning approaches and anti-poaching strategies, facilitation of co-ordination and co-operation amongst partners in the Greater Kruger open conservation system to address the relentless onslaught on rhinos, in addition to developing and supporting broader wildlife crime mitigation strategies with the objective of ensuring a safer region for people and wildlife. GKEPF supports its members with communication forums, collective data management, operational support, landscape interventions, the Greater Kruger rhino management group, training and research for the benefit of conservation in the region as well as a people centered approach involving the people living on the boundaries of the protected area to create a safe and thriving region for all.
The University of Cape Town (UCT) is Africa’s leading university – ranked the continent’s top university in five major world rankings, and among the world’s top 200 universities. An inclusive, research-intensive university that strives to find solutions for Africa’s problems, UCT is anchored on pillars of excellence, transformation and sustainability. The university not only strives to produce groundbreaking research but to mold well-rounded global leaders who will make an impact not only in their communities but the world at large. UCT continues to produce sought after graduates, placing among the universities with the most employable graduates globally on several rankings.
Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the ninth year running, and number 3 in the QS World Rankings 2024. At the heart of this success are the twin-pillars of our ground-breaking research and innovation and our distinctive educational offer.
Oxford is world-famous for research and teaching excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research alongside our personalised approach to teaching sparks imaginative and inventive insights and solutions.
Through its research commercialisation arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 300 new companies since 1988. Over a third of these companies have been created in the past five years. The university is a catalyst for prosperity in Oxfordshire and the United Kingdom, contributing £15.7 billion to the UK economy in 2018/19, and supports more than 28,000 full time jobs.
Nelson Mandela University is situated in the coastal city of Gqeberha, in the Eastern Cape, South Africa, with a campus in George. The largest university in the southern and eastern Cape; its existence is a result of a merger of the University of Port Elizabeth, Port Elizabeth Technikon and the Port Elizabeth campus of Vista University. It was initially named Nelson Mandela Metropolitan University in 2004, in line with the restructuring of the higher education sector. However, in 2017, it was renamed Nelson Mandela University, the only higher education institution in the world to carry the name of South Africa’s former president, Nelson Rolihlahla Mandela.
Its values are based on respect for diversity, excellence, Ubuntu, social justice and equality, integrity and sustainable stewardship. This comprehensive University offers degree, diploma and certificate courses. Spread over seven campuses; it is home to over 30 000 students. More than 500 study programmes are offered in seven faculties: Business and Economic Sciences; Education; Engineering, the Built Environment and Technology; Health Sciences; Humanities; Law and Science.
Nelson Mandela University is reputed for its excellence in, among others, art and design, building, chartered accounting, engineering, health and environmental sciences and information technology. Its state-of-the-art Ocean Sciences campus is one of its kind in the country. This campus’s range of marine and maritime education and training, research, innovation and engagement programmes is aimed at supporting the continent’s blue (ocean) economy.
The University is home to the country’s 10th Medical School, unique in South Africa as its comprehensive primary healthcare approach focuses on the four pillars of medicine: disease prevention, health promotion, treatment and rehabilitative medicine.
In a recent paper published in the Bulletin of the American Meteorological Society, the researchers document substantially higher risk of extreme temperatures and flooding in the Southeast U.S.
The researchers' work, which was supported by a NASA cooperative grant, also includes a proposed framework to help these communities better prepare for disasters they have not yet experienced but are likely to encounter.
“Disaster planning based on historical events is like driving forward while only looking in the rearview mirror,” says principal investigator Erin Coughlan de Perez, research director at Feinstein and Friedman School associate professor. “Many communities are planning for what they have seen in the past, only slightly worse. They need to be preparing for things they haven’t seen at all.”
While the entire region is at risk for extreme weather events, some communities also have a “high potential for surprise,” say the researchers, who include The Fletcher School graduate students Bethany Tietjen, F20, and Jenna Clark, A21, as well as Amy Jaffe, a non-resident senior fellow at the Climate Policy Lab.
“These are communities where the overall risk has increased over time, but the community hasn’t experienced one of these severe weather events in recent memory,” says Coughlan de Perez. This makes them potentially poorly prepared for future disasters, or “sitting ducks,” according to the researchers’ framework.
Analyzing five counties, researchers found them all to be “sitting ducks” when it comes to an extreme heat event. According to the study, Montgomery County, AL, Yazoo County, MS, Madison Country, TN, Warren County, KY, and Terrebonne Parish, LA, have gotten lucky in recent years and not had significant heatwaves.
“What our models showed is that temperatures have been rising gradually over the years, with one year maybe being really hot, but because the risk has been changing slowly, people living in these communities may not have noticed it,” Coughlan de Perez says.
When it comes to flooding, researchers concluded that Yazoo County is also a “sitting duck.” The other four communities fall into what the researchers call the “living memory” category, meaning there is a recent flooding event that people can remember, which can encourage people to stay prepared for future events. “Flooding events have also increased in frequency during the rainiest months of the year, but not every community has experienced catastrophic flooding,” Coughlan de Perez says.
In what the researchers categorize as “fading memory” communities, a particular weather event has become less frequent, and people barely remember it. “Boston used to have frequent extreme cold snaps in the winter, for example, but that happens less often now,” Coughlan de Perez says. Similarly, in “recent rarity” communities, people might remember a particular weather event—but the likelihood of it happening again is also relatively low.
In their analysis, the authors used large weather models of historical weather events between 1981-2021 to examine the five Southeastern U.S. counties, which were a combination of urban and rural communities. “It’s a roll of the die whether they have experienced extreme weather events yet or not. Extreme heat and flooding are in their futures,” Coughlan de Perez says.
Preparation may include identifying those at greatest risk; setting up accessible cooling centers for those who are homeless or don’t have air conditioning; educating the public about evacuation plans and potential shelters for floods; putting state or local heat protections in place for outdoor workers; establishing communication systems to alert residents to the dangers of high daytime and overnight temperatures or impending floods; and other measures.
The Tufts team is working with the American Red Cross in multiple locations to improve disaster planning, but Coughlan de Perez notes that state and local policies addressing extreme heat and flooding are often limited and need to be developed further.
In the meantime, Coughlan de Perez says, “Our ultimate goal is to provide a framework to help all communities prepare for weather events they may not have experienced before but have a high likelihood of facing in the future.”
This work was supported by a NASA cooperative grant titled “Today’s Risk of Extreme Events” (Agreement 80NSSC22K1706). Complete information on authors, methodology and conflicts of interest is available in the published paper. The content is the sole responsibility of the authors and does not necessarily represent the official views of the funder.
