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.

FDA commissioner claims Biden administration hid heart risks of COVID-19 vaccines from public
The allegation came days after an internal FDA memo linked the vaccines to the deaths of multiple children. A group of former FDA commissioners pushed back against the content of that memo.
Kaiser Permanente agrees to $46M settlement over data incident affecting 13.4M people
The managed care company does not admit to doing anything wrong. The data breach constituted its use of third-party tracking technology on its website, which shared data with Google, Microsoft, Twitter, Meta and others.
Plan to extend ACA tax credits finds bipartisan support in the House
The new proposal to extend expanded subsidies for health plans sold through the Affordable Care Act is being backed by 35 Republicans and Democrats—but as the New York Times points out, it will be hard for the bill to get a floor vote.
FDA clears new left-heart access system from Atraverse Medical
The Hotwire Transseptal Access System includes the Hotwire RF Generator and Hotwire RF Guidewire, giving electrophysiologists the tools they need for left-heart access.
$V-Wave has gained considerable attention or its Ventura Interatrial Shunt System, a small implantable device designed to reduce pressure on the left atrium and the lungs in patients with heart failure with reduced ejection fraction (HFrEF). The Ventura device includes a nitinol hourglass-shaped frame that anchors to the patient’s fossa ovalis in a way that prevents migration or embolization. It is implanted via an interventional procedure with fluoroscopy and echocardiography guidance.$
FDA panel votes against approving first-of-its-kind heart failure device
All 15 members of the FDA's Circulatory System Devices Panel agreed that more data is required to confirm the new device from Johnson & Johnson MedTech is effective. Will the agency agree with these recommendations? Only time will tell.

CVS sued over alleged ‘political manipulation’ through mass text messages

A class-action lawsuit claims CVS Health sent text messages to customers and patients, inciting fear over a PBM regulation up for vote in Louisiana. Plaintiffs allege the incident violates state data privacy and political communication laws.

OCR investigating Michigan health system over possible violation of 'Church Amendments'

The HHS Office for Civil Rights said it is investigating a "major" health system in Michigan that may have fired an employee for refusing to use a patient's preferred pronouns—meaning those that align with gender identity rather than biological sex. The agency contends that such compelled speech may violate federal laws protecting religious freedom.

PHOTO GALLERY: AMA House of Delegates meeting

These images were taken at the 2025 American Medical Association (AMA) House of Delegates (HOD) meeting in Chicago. This annual meeting brings together representatives from across the House of Medicine to propose, debate and vote on resolutions that shape AMA policy. Once adopted, these resolutions guide the group's advocacy efforts on healthcare issues—whether in Congress, state legislatures or in formal recommendations to regulatory agencies.

American College of Radiology joins legal fight against NIH cuts

ACR and 10 other medical societies filed a “friend of the court” brief in an ongoing lawsuit against the National Institutes of Health, HHS and their leaders.

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

American College of Cardiology now supports early use of medication to treat obesity

The group highlighted the proven effectiveness of these drugs, especially semaglutide and tirzepatide, while noting that eligibility, affordability and availability will still play key roles in any treatment decisions.

Dana Smetherman, MD, MPH, MBA, FACR, chief executive officer of the American College of Radiology, explains an American Medical Association (AMA) resolution ACR is supporting to expand low-dose CT lung cancer screenings and coronary calcium scoring.

AMA resolution backs expanded low-dose CT screenings for lung cancer, heart risk

Dana Smetherman, MD, CEO of the American College of Radiology, discusses the policy, which urges for more robust promotion of low-dose CT as a public health tool.

Papers discussing ‘gender’ have been restored to government website

The information was deleted to comply with an executive order from President Trump that censored content related to “gender ideology.” However, a federal judge has ordered the content restored as a court battle looms.

Cook Medical angiographic catheter recall

Angiographic catheters recalled due to safety risk

The new Class I recall includes nearly 27,000 devices that could potentially experience a harmful defect during use.

Policy & Regulations

FDA commissioner claims Biden administration hid heart risks of COVID-19 vaccines from public

Kaiser Permanente agrees to $46M settlement over data incident affecting 13.4M people

Plan to extend ACA tax credits finds bipartisan support in the House

FDA clears new left-heart access system from Atraverse Medical

FDA panel votes against approving first-of-its-kind heart failure device