Health Transformation Alliance Teams up With Cognoa for Autism Diagnostic Device

Health Transformation Alliance Teams up With Cognoa for Autism Diagnostic Device

The Health Transformation Alliance (HTA), a group of nearly 60 large employers, announced Thursday it is partnering with pediatric behavioral health company Cognoa for its diagnostic device for autism.
HTA is a cooperative of self-insured employers, including Walgreens, CocaCola, Verizon and American Express. Palo Alto, California-based Cognoa, meanwhile, is a developer of AI-based technologies for early diagnosis of children with developmental and behavioral health conditions. Its Canvas Dx product is authorized by the Food and Drug Administration and assists healthcare providers in diagnosing autism spectrum disorder for children ages 18 months through 72 months. The product is the first of its sort…

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CDS Coalition requests FDA rescind final decision support guidance

CDS Coalition requests FDA rescind final decision support guidance

The CDS Coalition is asking the U.S. Food and Drug Administration to pull back on its clinical decision support guidance in order to ensure that the agency better balances its regulatory oversight with the healthcare sector’s need for innovation, while comporting with the statutory language of the 21st Century Cures Act. ‘Flagrant’ disregard for Congressional law and intent
The coalition’s stakeholders – clinical decision support software developers, patient advocacy organizations, clinical societies, healthcare providers and healthcare payers – say the FDA’s guidance exceeds Congress’s statutory definitions of what is considered CDS and threatens to undermine lawmakers’ goals.
“The Office of the National Coordinator for…

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