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#safeguards — Public Fediverse posts

Live and recent posts from across the Fediverse tagged #safeguards, aggregated by home.social.

  1. 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
    journals.plos.org/digitalhealt

    #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."

  2. 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
    journals.plos.org/digitalhealt

    #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."

  3. 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
    journals.plos.org/digitalhealt

    #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."

  4. 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
    journals.plos.org/digitalhealt

    #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."

  5. 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
    journals.plos.org/digitalhealt

    #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."

  6. HT @rmblaber1956

    #EnvironmentalGroups sue #Trump’s #EPA over repeal of landmark #climate finding

    Lawsuit from #health and #EnvironmentalJustice groups challenges the EPA’s rollback of the ‘endangerment finding’

    Dharna Noor
    Wed 18 Feb 2026 07.10 EST

    "More than a dozen health and environmental justice non-profits have sued the Environmental Protection Agency over its revocation of the legal determination that underpins US federal climate regulations.

    "Filed in Washington DC circuit court, the lawsuit challenges the EPA’s rollback of the '#EndangermentFinding', which states that the buildup of heat-trapping #pollution in the atmosphere endangers #PublicHealth and welfare and has allowed the EPA to limit those emissions from #vehicles, #PowerPlants and other #industrial sources since 2009. The rollback was widely seen as a major setback to US efforts to combat the #ClimateCrisis.

    "The suit was brought by the American Public Health Association [#APHA], #AmericanLungAssociation, the #CenterForBiologicalDiversity, the #EnvironmentalDefenseFund, the #NaturalResourcesDefenseCouncil [#NRDC], the #SierraClub and 11 other public health and environmental organizations. The lawsuit was filed by green legal organizations #CleanAirTaskForce and #Earthjustice and it names the EPA and the agency’s administrator, #LeeZeldin, as defendants.

    " 'EPA’s repeal of the endangerment finding and #safeguards to limit vehicle emissions marks a complete dereliction of the agency’s mission to protect people’s health and its legal obligation under the #CleanAirAct,' said #GretchenGoldman, president and CEO at the #UnionOfConcernedScientists, another one of the groups behind the lawsuit. 'This shameful and dangerous action by the Trump administration and EPA Administrator Zeldin is rooted in falsehoods not facts and is at complete odds with the public interest and the best available science.' "

    Read more:
    theguardian.com/us-news/2026/f

    Archived version:
    archive.ph/kp4pY

    #USPol #ClimateChange #EPAFail #ClimateCrisis #GreenhouseGas #FossilFools #FossilFuelIndustry #BigOilAndGas #CorporateColonialism #Oiligarchy #Oligarchy #CorporatePolluters

  7. #OpenAI reports that over a million #ChatGPT users discuss #suicidalthoughts weekly, highlighting the need for improved #mentalhealthsupport. The company claims its latest #GPT5 model responds more appropriately to #mentalhealth issues, with a 65% improvement in desirable responses and 91% compliance with desired behaviours in #suicidalconversations. OpenAI is also implementing new #evaluations and #safeguards to address emotional reliance. techcrunch.com/2025/10/27/open #tech #media #news

  8. We’ve always needed more than just contracts. Laws, court decisions, treaties too all can work together to make AI more beneficial and less destructive for all.

    sagaftra.org/gov-newsom-signs-

    #ai #AIguardrails #safeguards #laws #generativeAI #safety #AIsafety #UnionStrong #union