Rules and Regulations

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March 2025
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Senate report: Private equity endangers patient care in underserved hospitals

Editor's Note A bipartisan Senate Budget Committee report accuses private equity firms of prioritizing profits over patients, compromising care in underserved communities, CBS News reported January 7. The investigation scrutinized the operations of Leonard Green & Partners and Apollo Global Management, alleging widespread financial mismanagement and underinvestment in hospitals they…

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By: Matt Danford
January 8, 2025
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FDA draft guidance addresses pulse oximeter accuracy, AI devices

Editor's Note The US Food and Drug Administration (FDA) has issued new draft guidance January 6 providing recommendations improving the use of pulse oximeters and supporting the safety of AI-enabled medical devices, among other topics. Released January 6, draft guidance supporting the safety and effectiveness of AI-enabled devices would, if…

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By: Matt Danford
January 7, 2025
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Health system to pilot AI-powered OR cameras; leaders acknowledge privacy challenges

Editor's Note UC San Diego Health plans to pilot artificial intelligence (AI)-enabled camera systems to enhance patient safety, addressing risks like falls and bedsores, but leaders are also acknowledging challenges related to patient consent, compliance, and privacy. The San Diego Union-Tribune reported the news January 5. According to the article,…

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By: Matt Danford
January 6, 2025
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Proposed tariffs, stricter immigration policies threaten healthcare workforce, supply chain

Editor's Note Immigration and trade policies proposed by President-elect Donald Trump could exacerbate challenges with healthcare staff and medical supply chains, according to recent reporting from Modern Healthcare and The Hill. As detailed by Modern Healthcare, stricter immigration policies could impede efforts to recruit skilled international workers, exacerbating gaps in…

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By: Matt Danford
January 2, 2025
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Mastering CMS regulations: How to ensure a finding-free Joint Commission survey

Takeaways • Requirements for improvement and condition level deficiency findings have been trending up in recent The Joint Commission surveys. • The scoring trends and OR hot spots focus on infection control, medication management, national patient safety goals, post-surgical electronic health record tracers, and transplant (tissue) safety. • Federal regulations,…

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By: Uyen Vo, BSN, MBA
January 1, 2025
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Surgical legislation advocacy focuses on safety, access

“Surgeons are the only people trained to provide surgery—life-saving care," says Carrie Zlatos, chief of legislative and political affairs at the American College of Surgeons (ACS). "They are an essential element of a community-based healthcare system. Regardless of where you live, everyone should have access to full quality surgical care.”…

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By: Brita Belli
January 1, 2025
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FDA designates Class 1 recalls for balloon catheters, radiographic markers

Editor's Note Balloon catheters for atrial fibrillation patients and implantable radiographic markers were the subjects of separate US Food and Drug Administration (FDA) Class 1 recalls—the most severe category indicating risk of serious injury or death—announced on December 18. The first recall involves Boston Scientific’s POLARx Cryoablation devices. Higher-than-anticipated reports…

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By: Matt Danford
December 19, 2024
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Antitrust guideline withdrawal could dampen M&A, boost uncertainty for provider joint ventures

Editor's Note In a move that could hinder provider-led joint ventures and increase regulatory uncertainty, the Federal Trade Commission (FTC) and the Justice Department have withdrawn antitrust guidance issued in 2000. Modern Healthcare reported the news on December 16. Passed in a 3-2 vote, the decision eliminates previously relied-upon safe…

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By: Matt Danford
December 18, 2024
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Infusion pump problems prompt early FDA safety warning

Editor's Note Risk of delayed therapy and death related to Ivenix large-volume infusion pumps is prompting supplier Fresenius Kabi USA to pull a subset of the devices from the market, according to an early alert from The US Food and Drug Administration (FDA). Issued December 11, the early alert is…

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By: Matt Danford
December 12, 2024
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Analysis: Guidance from leading medical journals mixed on AI use

JAMA (healthcare publication) Network logo

Editor's Note Leading medical journals vary significantly in guidance addressing the use artificial intelligence (AI) in medical research, according to an analysis published December 3 in JAMA Network Open.   The study categorized journals’ attitudes toward AI-assisted peer review into three groups: prohibition, limited use with conditions, and lack of explicit…

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By: Matt Danford
December 10, 2024
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