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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Psychiatric hospital sued for $150M over ‘encouraging’ fight between juveniles

A new lawsuit claims a 15-year-old girl was used as an enforcer of bad behavior at a psychiatric facility in Michigan, resulting in her severely beating a 10-year-old boy.

Biden Administration itemizes AI accomplishments to date

Half a year after President Biden officially directed federal agencies in the executive branch’s bailiwick to “seize the promise and manage the risks” of AI, the White House has posted a status report.

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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.

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Around the web

Cardiovascular Business
Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

Cardiovascular Business
FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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