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. 

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Breached Change Healthcare server lacked multifactor authentication, UnitedHealth CEO admits

UnitedHealth CEO Andrew Witty told the Senate Finance Committee that systems have been rebuilt “from scratch” in light of the oversight.

FDA announces recall of SonarMed airway monitors after injury

Medtronic brand SonarMed airway monitors and acoustic sensors are being recalled due to a risk of breathing obstruction and lung tissue damage.

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‘Concerning’ data connect industry payments to cardiologists with medical device use

U.S. physicians often receive payments from medical device manufacturers and pharmaceutical companies. New research in JAMA found a connection between receiving such payments and using specific devices—should the industry be concerned? 

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Philips settles cases over faulty sleep apnea machines for $1.1B

The litigation stems from a 2023 recall of CPAP machines and ventilators that caused users to inhale pieces of foam during use. The faulty units were linked to at least 561 deaths.

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AMGA condemns FTC ban on noncompetes in healthcare

The healthcare employers’ trade group said a nationwide ban on noncompete contracts will stifle investment in new technologies.

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Kaiser Permanente exposed data on 13.4 million members to tech companies

Tracking technologies sent patient information to advertisers such as Microsoft, Google and Meta.

FDA announces recall of infusion pumps after thousands of complaints, 1 death

InfuTronix has received 3,698 complaints related to device failures of its Halo Ambulatory Infusion system and other Nimbus pumps.

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Cardiology groups share key update: ABMS seeking feedback on proposed Board of Cardiovascular Medicine

Five of the largest U.S. medical societies focused on cardiovascular health are one step closer to seeing their paradigm-shifting proposal become a reality.

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Around the web

Cardiovascular Business
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

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.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

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. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

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.