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. 

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State Supreme Court ruling holds hospitals accountable for mistakes made by independently contracted radiologists

Washington becomes one of a select few where attorneys can also go after a hospital that hired outside physicians, joining South Carolina, Michigan, Maryland and Iowa

Study ranks US health system dead last among wealthy nations

Low rankings for accessibility and outcomes earned the country the overall lowest ranking in an analysis of healthcare systems across 10 nations.

pain pills opioids

Landmark opioid trial in Baltimore set to begin; Johnson & Johnson settles to avoid jury

Six companies have settled with the city for as total of over $402M. Two remaining defendants, McKesson and AmerisourceBergen, will test their luck in court.

District of Columbia DC congress capitol hill

American College of Radiology issues ‘call to action’ on key federal funding issue

ACR noted that Congress is returning from its August recess, with one of the “most critical” considerations pertaining to government funding for fiscal 2025. 

Coalition of 86 healthcare groups calls for change to Affordable Care Act rule

In a letter to Congress, the groups are urging lawmakers to support HR 9001 and lift the ban on physician-run hospitals.

FDA issues recall on infusion pump parts due to risk of uncontrollable drug flow

Due to a risk of fatal overdose, the recall is labeled as the most serious of its type. While no patients have died, two have reportedly been injured. 

Shockwave Medical, a Johnson & Johnson MedTech company, has officially launched its Shockwave E8 Peripheral IVL Catheter in the United States. Shockwave’s E8 catheter was designed specifically to treat patients with calcified femoropopliteal and below-the-knee (BTK) peripheral artery disease (PAD), including those diagnosed with complex chronic limb-threatening ischemia (CLTI).

Shockwave Medical launches new FDA-approved IVL catheter for PAD, CLTI

The new device, already cleared by the FDA, was designed to treat femoropopliteal and below-the-knee PAD. 

Biotronik has received U.S. Food and Drug Administration (FDA) approval to make its Solia S lead and Selectra 3D catheter available for a new indication: left bundle branch area pacing (LBBAP).

FDA approves Biotronik lead, catheter for left bundle branch area pacing

LBBAP is a relatively new alternative to biventricular pacing. The FDA's decision was based largely on data from the BIO-CONDUCT clinical trial.