#vulnerablepopulations — Public Fediverse posts

For #AI-enabled #MedicalDevices, being cleared or approved by the #US #FDA does not mean being tested on #PatientOutcomes:

1,357 AI medical devices cleared, 3 actually tested on patient outcomes
https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0001597

#ArtficialIntelligence
#OpenAccess
@plosdigihealth

"Most studies (62%) employed #observational designs with small, homogenous #cohorts, limited #SubgroupAnalyses, and frequent exclusion of #VulnerablePopulations. Structural barriers (including misaligned financial incentives, reliance on predicate-based regulatory pathways, and logistical challenges of multi-center trials) discourage rigorous #evaluation. Internationally, FDA clearance often functions as a gateway for global #deployment, raising #ethical concerns when under-validated tools are introduced into low- and middle-income countries #LMIC without contextual #validation or #safeguards. Regulatory approval has outpaced clinical validation, creating an ecosystem where innovation advances without accountability."

#Tewa Women United: #Pueblo Infants Endangered by #LANL 's #Radiation Plan

#NativeLedNonprofit #TewaWomenUnited Commissioned Two Reports to Study Impacts. Finding: #LosAlamos National Laboratory Omitted Dose Calculations to Infants and Children in Their Compliance Application

By Tewa Women United, #CensoredNews, November 19, 2024

#EspanolaNewMexico — "The Native-led nonprofit organization Tewa Women United, based in Española, New Mexico, has released two independent scientific technical reports assessing the implications and adherence to regulations concerning Los Alamos National Laboratory’s proposal to release tritium into the open atmosphere from four Flanged #Tritium Waste Containers located in Area G, near #WhiteRockNewMexico.

"These reports found that the concentration of tritium in the most loaded radioactive container, if vented during unfavorable weather conditions, could lead to radiation doses significantly exceeding the annual regulatory limit of 10 millirem established by the Environmental Protection Agency regulatory radiation standards.

"The author of one report, Bernd Franke, stated, 'In the case of tritium, infants and small children get a radiation dose about three times greater than adults, with the same concentrations of tritium in air, water, and food.'

"However, LANL’s application for venting did not include potential impacts of the #TritiumVenting on infants or children; in effect, LANL did not consider them as 'members of the public.' So far during the permitting process, the #EPA has allowed LANL to ignore these #VulnerablePopulations in their proposal.

"Kathy Wan Povi Sanchez, member of #SanIldefonsoPueblo and one of Tewa Women United’s co- founders, said, 'Tritium makes water, our sacred source of life, radioactive. We were shocked to learn that LANL’s compliance calculations did not take infants and other children into account.'"

Read more:
https://bsnorrell.blogspot.com/2024/11/tewa-women-united-pueblo-infants.html

#WaterIsLife #RadioactiveContamination #Genocide #NativeAmericans #ProtectTheSacred
#ReaderSupportedNews #PuebloTribes #NoNukes #TritiumContamination