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.

White House to end civil service protections for 50,000 federal workers
President Donald Trump's administration said an executive order to implement Schedule F, to make it easier to fire federal works that don't align with its agenda of "draining the swamp," is forthcoming.
Proposed HHS budget would close NINR, cut nursing programs
The American Nurses Association is warning that eliminating support for the training and research offered by the National Institute of Nursing Research could be devastating to the public, as many programs support specialties such as maternal and mental health.
FDA warns that certain coronary imaging catheters are being removed from market over safety concerns
A catheter sheath detached during use and was left in the patient’s body. It was successfully removed, but the FDA said it is now evaluating the potential risk to others going forward. There is no official recall at this time.
FDA clears new cold cathode tomosynthesis system
Cold cathode tubes make for smaller systems that are lighter in weight and require less energy to operate, also resulting in decreased costs.
Arkansas the 30th state to pass legislation bolstering coverage for breast imaging
Gov. Sarah Huckabee Sanders signed Senate Bill 123 into law on April 14 following its passage by the state legislature, weeks after Virginia passed a similar bill.

$3.3B merger of UnitedHealth and Amedisys delayed by DOJ lawsuit

The new deadline for the deal to be finalized is Dec. 31, 2025. However, the ultimate fate of UnitedHealth's acquisition of Amedisys will be decided in a federal court.

Alleviant Medical, a Texas-based medical device company, has received the FDA’s breakthrough device designation and an investigational device exemption (IDE) for its new atrial shunt that treats heart failure without leaving a permanent implant in the body.

FDA sees value in no-implant heart failure device

The new atrial shunt from Alleviant Medical was designed to treat heart failure without leaving a permanent implant behind. The FDA granted the technology its breakthrough device designation and approved additional research.

CDC considers letting nurse practitioners, physician assistants read X-rays under federal program

The agency's “B Reader Program” trains and certifies physicians to classify chest radiographs of workers participating in federal health surveillance programs.

artificial intelligence AI infrastructure

Industry Watcher’s Digest

New Year’s Day brought the go-live for California’s new law forbidding the use of AI to deny health insurance claims.

FDA AI enabled medical devices approval clearance

FDA to hopeful marketers of AI-equipped medical devices: Think beyond your initial approval

Some FDA-approved medical devices age more safely than others. That’s no less true of AI-enabled technologies than of any others. The agency spells out the ramifications in draft guidance issued this week.

FDA issues proposed guidance for improving reliability of pulse oximeters

The devices struggle to accurately read blood-oxygen levels in patients with darker and thicker skin. The FDA hopes that changes in design and improved clinical trials will improve clinical efficacy.

FDA seeking nominations for mammography advisory committee

The National Mammography Quality Assurance Advisory Committee provides guidance and recommendations related to the standards by which facilities are regulated.

Bill to regulate healthcare private equity lands on desk of Mass. governor

Gov. Maura Healey has until Jan. 9 to pass the act into law or use her veto powers. The bill passed the state Senate on Dec. 30.

Policy & Regulations

White House to end civil service protections for 50,000 federal workers

Proposed HHS budget would close NINR, cut nursing programs

FDA warns that certain coronary imaging catheters are being removed from market over safety concerns

FDA clears new cold cathode tomosynthesis system

Arkansas the 30th state to pass legislation bolstering coverage for breast imaging