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. 

Joysticks recalled after power wheelchairs move on their own, injuring a patient

The U.S. Food and Drug Administration announced a recall of Mo-Vis BVBA joysticks after a faulty firmware version was linked to the malfunction. Users will need to have their devices upgraded.

Luigi Mangione Mugshot

Terrorism charges dropped against Mangione in UnitedHealthcare CEO killing

Luigi Mangione still faces nine counts in New York stemming from the alleged murder of Brian Thompson. Additionally, he faces a federal murder indictment that carries the possibility of the death penalty.

MGMA's Anders Gilberg says Congress needs to act soon to preserve access to telemedicine programs.

MGMA: Congress needs to act soon to preserve access to telemedicine programs

Congress needs to act soon to extend telemedicine services that were greatly expanded under COVID provisions, or they will expire by October. Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains concerns raised by doctors and lawmakers.

 

Corstasis Therapeutics bumetanide nasal spray Enbumyst

FDA approves nasal spray for edema associated with congestive heart failure

The newly approved intranasal loop diuretic can also be used to treat edema in patients with liver and kidney disease.

All medical device products in Europe need to obtain the Conformité Européenne mark (European Conformity, or CE mark) regulatory approval. This is based on minimal safety requirements and is needed to be sold in the EU.

Cardiologists lead charge for medical device approvals in Europe to be more rigorous

There is a belief among some clinicians that it is too easy for companies to gain CE mark approval for their medical devices. However, a new proposal from the European Society of Cardiology and other groups could help change that. 

Medline recalls surgical kits due to safety concern with Medtronic catheters

The FDA is warning the public that certain Medline surgical kits may contain catheters that have been linked to 41 customer complaints and three serious injuries. 

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11% of U.S. adults were uninsured in 2024, Census data shows

Newly released data from the U.S. Census Bureau shows most Americans still rely on work for their health coverage, with 53.8% of insured Americans receiving coverage through their employer.

Video interview with Anders Gilberg, MGA, senior vice president, government affairs at Medical Group Management Association (MGMA), explains the issues involved with the Affordable Care Act (ACA) subsidies that are set to end in late 2025 and what the impact will be on hospitals.

MGMA: Ending ACA subsidies could strain health system, leave millions uninsured

Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains the political and patient care issues involved with ending Affordable Care Act subsidies.