Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

Coalition for Health AI

Coalition acts to ensure credible, fair, transparent AI in healthcare

Having identified an “urgent” need for guardrails to keep healthcare AI from veering into an avoidable ditch, the Coalition for Health AI has put together a 24-page guide applicable to numerous groups of stakeholders.

the words "FDA recall" on a board

FDA announces recall of 4.2M Abbott devices after hundreds of incidents, including multiple fires

Abbott previously issued a voluntary medical device correction about this problem, but no recall had been announced at that time. The recall includes devices distributed from November 2017 to February 2023.

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Industry groups applaud bill connecting Medicare payments to inflation

Healthcare groups are applauding a bill in the House of Representatives that would ensure Medicare payments are tied to inflation.

board room table trustee directors

Cano Health leadership team in disarray after directors resign

Billionaire Barry Sternlicht, founder and CEO of Starwood Capital Group, was one of the board members who resigned.

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Johnson & Johnson offers nearly $9B to settle talc lawsuits

Johnson & Johnson has offered to pony up $8.9 billion over 25 years to settle all current and future claims that its talc baby powder contained asbestos and caused cancer to some consumers. It is one of the largest consumer liability settlements in history.

artificial intelligence AI deep learning ChatGPT OpenAI Microsoft Google

Too much too soon? Elon Musk, other tech leaders pause AI development to review ethics

Healthcare is one of the biggest areas of opportunity for AI, with more than 500 health AI algorithms cleared by the FDA over the last several years.

Point of Care Ultrasound POCUS Lungs

Specialized lung AI tool cleared for U.S. sales

A popular marketer of handheld ultrasound devices has won FDA approval for an AI-enabled B-line quantification tool for use with patients suspected of having compromised lung function.

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Illumina ordered to divest Grail

The agency, which is charged with preventing fraud, deception and unfair business practices, said Illumina’s acquisition of Grail would stifle competition and innovation in the U.S. market for life-saving cancer tests.

Around the web

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.