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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FDA approves AI ultrasound application for musculoskeletal imaging

FDA approves AI ultrasound application for musculoskeletal imaging

Clarius Mobile Health, which first introduced wireless handheld imaging for medical specialties in 2016, says its third-generation device, HD3, which was approved by the U.S. Food and Drug Administration this week, will also help improve MSK ultrasound training.WHY IT MATTERS
With clearance from the FDA, the new MSK AI model will be available with the Clarius L7 HD3 and Clarius L15 HD3 ultrasound scanners introduced last year, according to the announcement.
“AI automation is the new frontier and we’re excited to be the world’s first to receive FDA clearance to use AI for musculoskeletal ultrasound,” said Ohad Arazi, president and CEO, in the statement.
Upon…

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Episode 10: A Look at the  Proposed HIPAA Changes

Episode 10: A Look at the Proposed HIPAA Changes

In this episode of Health+Tech, Andrea Lee Linna and Jonathan Ishee are joined by fellow McGuireWoods digital health team member Michael Paluzzi to discuss proposed HIPAA changes that may require covered entities and business associates to overhaul their HIPAA policies and procedures in 2022.After providing a high-level overview of the proposed changes, the podcast turns to a live recording of Andrea and Jonathan’s recent webinar, “Preparing for Major HIPAA Changes in 2022,” offering in-depth details about the proposed changes and how to prepare for them in the new year….

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Episode 9: Digital Health Trends and Issues for Life Sciences Companies

Episode 9: Digital Health Trends and Issues for Life Sciences Companies

In this episode of Health+Tech, McGuireWoods healthcare attorneys Janice Suchyta, Kate Hardey, Kae Gruner and Royce DuBiner discuss the latest digital health updates from the Food and Drug Administration and Federal Trade Commission. Join the conversation as we wrap up Cybersecurity Awareness Month and discuss the following topics:• FDA draft guidance on electronic health records and medical claims data• FDA new resource for approved artificial intelligence/machine learning medical devices• FDA Digital Health Center of Excellence• FTC rules for health apps outside of HIPAA…

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