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.

Call gets louder to license medical GenAI like any human healthcare professional
A growing chorus of academic physicians, policy experts and public health specialists is harmonizing behind the idea of licensing medical GenAI models like they’re doctors or nurses.
Radiologists continue to dominate in No Surprises Act payment disputes
The federal government recently released new data pertaining to the landmark legislation, meant to protect patients from receiving unexpected medical bills.
Briefly: Democrats winning on healthcare | Hospital pharmacies blinded by bustle | Gambling boys | Obesity rises | more
If all American voters were single-issue deciders and the cost of healthcare were their issue, Democrat candidates would win the mid-term elections handily. But loyalists of the donkey party shouldn’t be smug around their elephant counterparts.
ASTRO launches new training program to expand radiopharmaceutical therapy access
The program creates a network of accredited sites where radiation oncologists can complete the final regulatory requirements needed to become authorized users for RPT.
FDA issues recalls for interventional systems from 2 big-name vendors
Both recalls are categorized as Class 2, which the FDA designates for issues that have the potential to “cause temporary or medically reversible adverse health consequences."

$V-Wave has gained considerable attention or its Ventura Interatrial Shunt System, a small implantable device designed to reduce pressure on the left atrium and the lungs in patients with heart failure with reduced ejection fraction (HFrEF). The Ventura device includes a nitinol hourglass-shaped frame that anchors to the patient’s fossa ovalis in a way that prevents migration or embolization. It is implanted via an interventional procedure with fluoroscopy and echocardiography guidance.$

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.

Drug discounts for safety-net hospitals up in the air and into the courts

HHS’s 340B drug discount program is set to shift to a rebate model on New Year’s Day. But a lawsuit and temporary restraining order filed by the AHA and others may block the change from going live on time.

FDA issues warning about Olympus ligating devices after 113 injuries

The nylon loop on some devices can fail to release while removing polyps. Because of the severe risk to patient health, the FDA has designated this recall a Class I.

FDA recall medical device recall product recall

FDA announces Class I recall of patches used for heart surgery

There is a risk of certain pericardial patches not being as strong or durable as needed. Customers are urged to identify, quarantine and replace these devices.

AI news & views in brief: State regulation ban or none, AI in healthcare advertising, more

Will there or won’t there be a federal moratorium on state-level regulation of AI? That’s only one question healthcare stakeholders are asking as 2025’s time begins running out.

CVS Health announces $10.6B acquisition of Oak Street Health

CVS agrees to pay $38M to resolve insulin over-distribution allegations, DOJ says

Authorities allege the pharmacy chain gave patients more insulin than prescribed and then billed Medicare and Medicaid for the full amounts. This allegedly occurred for more than a decade.

The BI-RADS 2025 Manual is now live—here are a few of its key updates

During an education session at RSNA 2025, several experts who contributed to the manual spoke on what has changed and how these revisions will affect providers.

warning safety alert recall healthcare issue

Damaged Alaris infusion pumps linked to two serious injuries as FDA updates safety instructions

The infusion system modules can malfunction if dropped or jarred without the user noticing. Manufacturer Becton Dickinson is asking owners to inspect the devices to ensure they are safe to use.

Policy & Regulations

Call gets louder to license medical GenAI like any human healthcare professional

Radiologists continue to dominate in No Surprises Act payment disputes

Briefly: Democrats winning on healthcare | Hospital pharmacies blinded by bustle | Gambling boys | Obesity rises | more

ASTRO launches new training program to expand radiopharmaceutical therapy access

FDA issues recalls for interventional systems from 2 big-name vendors