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.

Noteworthy AI news: Prez Trump vs. state regulators, HHS’s AI strategy 1 week out, imperfect AI, more
State-level regulation of AI: President Trump has turned his thinking into action.
More interventional procedures may be coming to an ambulatory surgical center near you
ASCs have their limitations, but they are also associated with several benefits for cardiologists and patients alike.
New recalls announced for troubled heart devices—FDA previously urged customers to seek alternatives
These most recent recalls focus on a series of maintenance issues. In 2024, the FDA advised customers to transition away from the two devices and find alternative treatment options.
White House executive order aims to curb ‘excessive’ state regulation of AI
President Donald Trump wants to establish an AI Litigation Task Force to challenge any AI laws that may “harm innovation.”
News gems: Hospital price caps, costly drinking water, child-unready hospitals, more
A U.S. state is enjoying $50 million in annual savings after imposing price caps on its hospitals. OK—but what good things (or workers) got sacrificed?

FDA warns public not to use certain pregnancy tests due to safety, accuracy issues

The agency shared a list of 15 diagnostic tests that should not be used by patients going forward.

Medical malpractice gavel diagnostic error mistake stethoscope

Referrer fails to order CT that could have caught man’s deadly lung cancer weeks earlier

An octogenarian visited the emergency department three times in August 2019 complaining of chest pain, with doctors instead diagnosing angina via X-ray.

CMS officially drops fee for independent dispute resolution back to $50

The agency has not yet announced the reopening of the Federal IDR portal to submit new disputes, with the feds hoping to do so "soon."

Google Health, radiology vendor seek regulatory approval of AI as independent mammography reader

"We hope to not only alleviate the increasing burdens on radiologists worldwide but also reduce disparities in healthcare," one Google AI leader said.

Interventional cardiologists call out ABIM for ‘unfair and unjustified’ certification policies

“This situation unacceptably exacerbates the interventional cardiology workforce shortage and threatens to directly impact the care of patients," SCAI wrote in a new statement.

‘Unstoppable’ radiologist keeps practicing despite millions in fines, mounting investigations

James McGuckin, MD, most recently made the news in May when the DOJ filed suit against him and his affiliated practices.

FDA announces fourth recall of 2023 for troubled heart devices

This latest recall was brought on by electrical failures and includes more than 4,500 devices. There have been 26 complaints due to the issue but no reported injuries or deaths.

FDA highlights importance of including heart rhythm risks on drug labels

The agency has shared a new draft guidance focused on the inclusion of information related to QTc interval prolongation.

Policy & Regulations

Noteworthy AI news: Prez Trump vs. state regulators, HHS’s AI strategy 1 week out, imperfect AI, more

More interventional procedures may be coming to an ambulatory surgical center near you

New recalls announced for troubled heart devices—FDA previously urged customers to seek alternatives

White House executive order aims to curb ‘excessive’ state regulation of AI

News gems: Hospital price caps, costly drinking water, child-unready hospitals, more