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.

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.
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.
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.
Radiologists urge specialty to ‘speak up’ on reimbursement-related issues
Three radiologists presented on hot topics in imaging economics Sunday during the opening day of RSNA 2025 in Chicago.
FDA announces full recall of Baxter Life2000 ventilators over cybersecurity flaw
All models and lot numbers of the units are subject to the recall. The security vulnerability could allow an unauthorized person to access and control the pumps, posing a serious health risk to patients.

FDA grants fast track designation to Bayer’s new drug for preventing stroke in AFib patients

The new drug, asundexian, is currently the subject of two multicenter Phase III studies—the OCEANIC-AF trial and OCEANIC-STROKE trial—focused on its safety and efficacy.

Industry Watcher’s Digest

Buzzworthy developments of the past few days.

framework for regulating healthcare artificial intelligence

A framework for regulating healthcare AI at the federal level has begun taking shape

America’s two major political parties agree on very little of late, but they have a mutual interest in working together toward overseeing AI.

'Bureaucratic and monetary hurdles' hinder international medical graduates' pursuit of radiology

Radiology trainee programs must overcome several barriers to offer J-1 and/or H-1B visas to trainees, with more difficulties associated with the latter.

Alzheimer’s drug could spur upward of $500M in new Medicare spending on imaging

Lecanemab requires a baseline PET scan and follow-up MRIs after infusions, spelling heavy demand for radiology services, experts wrote in JAMA.

Envision bankruptcy could be 1st canary in the physician services coal mine, MD writer contends

The private equity-backed multispecialty group's failure could have "significant ripple effects" on radiology and other specialties, N. Adam Brown, MD, MBA, wrote recently.

Philips will pay $62M to settle allegations of corruption

The accusations pertain to the Amsterdam-based corporation’s sales of diagnostic imaging equipment in China, the SEC announced May 11.

Amit Trivedi, HIMSS director of informatics and health IT standards explains the human factor in interoperability is often overlooked. #HIMSS #HIMSS23

Health IT needs to develop its workforce and become more involved in setting informatics standards

Amit Trivedi, HIMSS director of informatics and health IT standards, explains the importance of the human role in interoperability.

Policy & Regulations

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

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

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

Radiologists urge specialty to ‘speak up’ on reimbursement-related issues

FDA announces full recall of Baxter Life2000 ventilators over cybersecurity flaw