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 clears ultrasound AI tool for accurate delivery-date prediction
The cloud-based software service is able to predict a pregnant woman's delivery date using ultrasound imaging alone.
SCAI celebrates new federal funding for PAD prevention
The group's hope is that these new funds will help address the rising rates of PAD and CLTI throughout the United States.
FDA confirms more recalls for Johnson & Johnson heart pumps due to malfunction risk
The issue, first announced to the public in February, has been linked to 22 serious injuries. Customers are urged to review the updated instructions for use to avoid any potential complications.
Radiology artificial intelligence firm asks FDA to exempt certain devices from premarket review
The petition from Harrison.ai has drawn mixed reactions, with AI vendors lending support while radiologists and patient groups worry the move could erode safety.
AHA: ‘Zero trust’ cybersecurity posture necessary to protect hospital data
The National Security Agency released a two-phase plan for all entities within the U.S. Department of War to follow for no-trust cyber defenses. The American Hospital Association said the protocols could be adopted by hospitals.

Lowest dose gadolinium-based contrast agent to date inches closer to FDA approval

Gadoquatrane is now set to go through the regulatory review process on its trek to earning full FDA approval.

Anders Gilberg, MGA, senior vice president, government affairs at Medical Group Management Association (MGMA) explained the need to renew the Medicare geographic pay adjustments in rural areas to make payments more competitive than urban areas. He said this is vital to help retain physicians in rural areas who otherwise could find higher paying jobs in larger cities.

Looming end of Medicare rural pay adjustment raises concerns about doctor shortages

Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains why Congress needs to renew the Medicare geographic pay adjustments in rural areas—to make payments competitive with urban areas and help retain physicians in those communities.

Report: DOJ investigating business practices of UnitedHealth’s Optum Rx

Bloomberg said the pharmacy benefit manager is being probed as part of a larger look into the “prescription management services” of UnitedHealth. According to sources, this may be related to an ongoing investigation into alleged instances of Medicare Advantage upcoding.

New $6B Eversana looks to bypass PBMs and lower drug prices

A merger between Eversana and Waltz Health will create a new entity that CEO Mark Thierer says will upend the “existing oligopoly that I helped build.”

Dispute between Johns Hopkins and UnitedHealthcare pushes patients out-of-network

The two said they’ve been negotiating terms for eight months. Sticking points include denied claims and coverage disputes, with both the insurer and health system pointing fingers.

FDA announces recall of Boston Scientific interventional radiology devices, citing risk of serious injury or death

Its alert pertains to over 26K carotid artery stents, used by interventional neuroradiologists, vascular surgeons and other docs to prevent strokes.

AI patient portal messages personalized care

Healthcare AI today: $81M acquisition, Illinois says no to AI therapy, AI glucose cleared, more

FDA clears AI-powered glucose monitoring app. The clearance marks a first for an over-the-counter tool in this category.

Data policy research: AI hesitancy remains real, and value-based care models are still an uncertainty

Tech vendor Reveleer and policy analytics firm Mathematica released their 2025 State of Technology in Value-Based Care report, the findings of which show that AI adoption in healthcare is widespread—but integration is spotty.

Policy & Regulations

FDA clears ultrasound AI tool for accurate delivery-date prediction

SCAI celebrates new federal funding for PAD prevention

FDA confirms more recalls for Johnson & Johnson heart pumps due to malfunction risk

Radiology artificial intelligence firm asks FDA to exempt certain devices from premarket review

AHA: ‘Zero trust’ cybersecurity posture necessary to protect hospital data