#subgroupanalyses — 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."

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."

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."

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."

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."