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 Commissioner Robert Califf, MD, explains the U.S. is spending the most on healthcare of any country, but has poorer outcomes than other western nations. He said healthcare reform is needed to change that course. #Healthdisparities #healthequity

FDA commissioner urges health systems to strengthen AI quality oversight

FDA Commissioner Robert Califf, MD, explains the need for hospitals to perform quality assurance checks on clinical artificial intelligence to ensure these technologies don't "drift" from what was originally cleared by the FDA.
 

artificial intelligence AI in healthcare

Stanford HAI lookback: Best-read blog posts of 2024

The year 2023 saw a shift toward open-source AI models, surging investments in generative AI and increasing AI regulation.

RSNA Board member Richard Heller, MD, explains issues with Medicare reinburements and the No Surprises Act and Congressional actions that may fix both.

Key Medicare reimbursement and No Surprises Act updates from RSNA 2024

Richard Heller III, MD, RSNA board member and senior VP of policy at Radiology Partners, offers an overview of policies in Congress that are directly impacting imaging.
 

Artivion, an Atlanta-based medical device company, has received a Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for its AMDS Hybrid Prosthesis designed to treat DeBakey Type 1 dissections when malperfusion occurs. This HDE ensures select patients can be treated with the device before the FDA makes its final approval decision.

First surgical device of its kind granted key FDA exemption

This update helps ensure Artivion's AMDS Hybrid Prosthesis can be used to treat high-risk patients as the FDA makes its final approval decision. The news came as Artivion works to bounce back from a cybersecurity attack that occurred in November.

artificial intelligence AI in healthcare

Providers, payers share actionable experiences involving healthcare AI

A large venture capital firm focused on supporting early-stage healthtech companies has a tip for AI startups targeting the healthcare sector.

Anthem

Anthem BCBS reverses course on anesthesia time limits

After announcing it would place time limits on reimbursement for the time a patient is under anesthesia, Anthem Blue Cross Blue Shield has now denied it ever intended to make the change. 

FDA issues Class I recall on insulin syringes due to risk of death

A line of syringes manufactured by Cardinal Health may fail to properly inject insulin when used with needleless IV connectors. 

Stock image of an illegal bribe.

Operations manager, doctors charged in $70M imaging kickback scheme

The scam took place over a period of seven years, resulting in Medicare being billed for more than $70 million in fraudulent claims for unnecessary scans. 

Around the web

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.