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. 

artificial intelligence AI in healthcare

Healthcare-specific AI: How to multiply successes and head off accidents

Given the rapid proliferation of AI-equipped medical devices across U.S. healthcare, unintended effects should surprise no one. 

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Private-equity watchdog warns against nominating Marc Rowan as Treasury Secretary

The Private Equity Stakeholder Project likens Rowan to a fox guarding the hen-house, due to his position as CEO of Apollo Global Management. Rowan is being considered for a cabinet role in the incoming Trump administration. 

the words "FDA recall" on a board

FDA issues Class I recall on insertion tubes after manufacturing error

Specific FHC-branded insertion tubes used in brain surgery are 20mm longer than expected and could pose a serious risk to patients. 

FDA recalls brain biopsy needles due to stainless steel debris

There have been no reported injuries. However, due to the risk of death or paralysis associated with metal debris entering brain tissue, the recall is designated Class I, the most serious of its type. 

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Michigan doctor claims he was fired for reporting unnecessary pacemaker surgeries

Daniel West, MD, is suing Trinity Health Muskegon and seeking whistleblower protection after reporting alleged malpractice and being summarily terminated.

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UnitedHealth successfully sues CMS over disputed phone call

The Centers for Medicare & Medicaid Services violated the Administrative Procedure Act by allowing a single phone call made by a contractor to determine a Medicare Advantage star rating, a federal judge ruled. 

FDA Digital Health Advisory Committee

FDA taking the long view of generative AI in healthcare

The FDA’s fledgling Digital Health Advisory Committee (DHAC) only held its first meeting last week, but it has already committed its thinking to writing. 

medical debt

Report: 44% of adults in the U.S. are uninsured or underinsured

According to an analysis from the Commonwealth Fund, millions of patients are skipping necessary care and struggling to pay mounting medical debt. 

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.