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 accepts previously rejected application for new PET imaging agent
The radiopharma firm hopes to soon begin selling Pixclara (Floretyrosine F 18), an investigational product for glioma, a type of brain cancer.
States’ challenge against HHS staffing cuts, restructuring moves forward
The coalition of plaintiffs—representing 19 states and Washington, D.C.—is challenging many of the changes made by Elon Musk’s Department of Government Efficiency, which has since halted operations. State governments argue that HHS is no longer performing its constitutionally required duties. The agency’s attempt to dismiss the lawsuit was rejected this week.
Healthcare in the midterms: A look ahead to decision day
Will healthcare be the top issue voters take into the polls come November? KFF looks at the odds of the economy falling into second place this year.
FDA denies petition to exempt certain radiology AI devices from premarket review
In October, Harrison.ai submitted a citizen petition seeking greater flexibility in the 520(k) clearance process for certain computer-aided detection devices.
Dying former US senator: ‘Will AI bring heaven or hell? Yes.’
Ben Sasse is showing the effects of the terminal pancreatic cancer he was diagnosed with late last year. Yet he’s still in good spirits and his mental energy remains high.

FDA accepts previously rejected application for new PET imaging agent

The radiopharma firm hopes to soon begin selling Pixclara (Floretyrosine F 18), an investigational product for glioma, a type of brain cancer.

States’ challenge against HHS staffing cuts, restructuring moves forward

The coalition of plaintiffs—representing 19 states and Washington, D.C.—is challenging many of the changes made by Elon Musk’s Department of Government Efficiency, which has since halted operations. State governments argue that HHS is no longer performing its constitutionally required duties. The agency’s attempt to dismiss the lawsuit was rejected this week.

Healthcare in the midterms: A look ahead to decision day

Will healthcare be the top issue voters take into the polls come November? KFF looks at the odds of the economy falling into second place this year.

FDA denies petition to exempt certain radiology AI devices from premarket review

In October, Harrison.ai submitted a citizen petition seeking greater flexibility in the 520(k) clearance process for certain computer-aided detection devices.

Dying former US senator: ‘Will AI bring heaven or hell? Yes.’

Ben Sasse is showing the effects of the terminal pancreatic cancer he was diagnosed with late last year. Yet he’s still in good spirits and his mental energy remains high.

Beacon Tip Centimeter Sizing Catheter FDA alert

FDA warns that certain sizing catheters should not be used due to risk of breaking

These catheters from Cook Medical are associated with an increased risk of device fragmentation or vessel injury. Customers are urged to return them to the manufacturer.

warning safety alert recall healthcare issue

Medline recalls millions of devices due to safety risk—FDA threatens ‘regulatory action’ in warning letter

Millions of angiographic syringes were recalled due to a risk of parts becoming loose or disconnected. The FDA, unhappy with Medline's response to this situation, sent the company a new warning letter.

Pennsylvania health system sues Aetna over alleged ‘downcoding’ of inpatient hospital care

The policy shift by Aetna to reimburse hospital stays of fewer than five days as outpatient observation encounters went into effect in January. The insurer implemented the policy to reduce friction with hospitals that previously had to seek approval for inpatient reimbursement, which was often denied. Jefferson Health is challenging the changes in court.