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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FDA announces recall of more than 2 million catheter parts, citing serious health risks

Fresenius Medical Care is issuing a recall on 2,192,535 catheter extensions and adapters used in patients with acute and chronic kidney disease.

noncompete contract clause employment pen sign

Cardiologists, thoracic surgeons applaud FTC’s ban of most noncompete clauses

The Society for Cardiovascular Angiography & Interventions and Society of Thoracic Surgeons have both shared statements in support of the ban, which is already being challenged in court. The American Hospital Association, meanwhile, opposes the policy shift, saying it “errs by seeking to create a one-size-fits-all rule”

Which healthcare entities will be affected by ban on noncompetes? Look to business practices, not tax status

The new rule will give healthcare workers more options, but are non-profit hospitals exempt from the law?

Alison Bailey, MD, FACC, chief of cardiology, Centennial Heart at Parkridge Medical Center, and a physician director of cardiovascular disease for HCA Healthcare. She was the co-chair of a four-part series on the business of cardiology sessions at ACC 2024. She explains why ACC chose to concentrate on business. #ACC #ACC24 #ACC2024 #Cardiologybusiness

Why the business side of cardiology was a key focus at ACC.24

Alison Bailey, MD, co-chair of the business of cardiology sessions at ACC.24, emphasized that reimbursement cuts can have a long-term negative impact on patient. 

Hackers were inside Change Healthcare’s systems 9 days before attack

UnitedHealth Group confirms hackers have personal data on “a substantial proportion of people in America."

Joint replacements recalled after FDA safety warning

The FDA initially made the complaint in January. Exactech has agreed to recall products at risk of chemical oxidation as a result of faulty packaging.

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Mental health platform fined $7M by FTC for sharing data with advertisers

Cerebral has admitted to improperly sharing data with social media platforms for the purpose of targeted advertising. The company also made it difficult to cancel the service, costing its members millions.

Healthcare worker sentenced to 10 years for abusing disabled patients

Tyler Smith and co-defendant Zachary Dinell confessed to assaulting more than a dozen patients, expressing hatred for them simply because they’re disabled.

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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.