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.

Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries
Safety concerns with certain Boston Scientific leads have resulted in multiple Class I recalls, the FDA has announced. The agency first shared a warning about this issue in August.
AI for opportunistic osteoporosis screening inks FDA clearance
The tool analyzes routine hip and pelvis X-rays for signs of low bone mineral density.
Radiology groups voice ‘enthusiastic support’ for proposal to add 14,000 more Medicare-funded residency slots
The Society of Interventional Radiology and American College of Radiology are thanking lawmakers for reintroducing the Resident Physician Shortage Reduction Act.
Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately
The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.
Why all heart patients should be vaccinated against the flu, COVID-19, RSV
The American College of Cardiology has shared new recommendations highlighting the protective benefits of a variety of vaccines. The new guidance also examines how to speak with patients who are hesitant to be vaccinated.

Most consumers are not shopping around for better healthcare prices

While the Biden administration and federal agencies have made price transparency a long-term goal for the U.S. healthcare industry, a recent study revealed Americans aren’t actually shopping around very often for better healthcare prices.

‘Radiology failures, misdiagnosed fractures’ blamed in 2 wrongful assumptions of child battery

In the U.K., two instances of evidently inept work by radiologists are inadvertently spotlighting the value of subspecialized image interpretation in socially sensitive patient cases.

Cardiologist says COVID-19 vaccinations ‘must stop’ due to the risk of adverse events—scientists and doctors push back

A well-known cardiologist who once fully supported COVID-19 vaccines is now saying he thinks they have done more harm than good. Online, as one might expect, people on both sides of this particular debate have been quick to respond.

Example of the four types of breast tissue density. The density of fibroglandular tissue inside the breast impacts the ability to easily see cancers. Cancers are very easy to spot in fatty breasts, but are almost impossible to find in extremely dense breasts. These examples show craniocaudal mammogram findings characterized as almost entirely fatty (far left), scattered areas of fibroglandular density (second from left), heterogeneously dense (second from right), and extremely dense (far right). RSNA

Breast density notification laws blanket 90% of U.S. women, yet still no national reporting standard is at hand. Why is that?

Dense breast experts Wendie Berg, MD, and JoAnn Pushkin, executive director of DenseBreast-info Inc., explain the current status of breast density patient inform laws, reimbursement and new technologies to aid cancer detection.

Female Medical Research Scientist Working with Brain Scans

FDA approves AI analysis of high-grade gliomas

An AI startup in the neuro-oncology space has received the government’s go-ahead to market software for analyzing certain fast-growing brain tumors on MRI.

Current LDCT eligibility criteria leave women and minorities behind

Compared to USPSTF 2013, modified eligibility criteria could increase cancer detection by 37%.

CMS aims to create centralized directory

According to the agency, directories can serve as important resources for patients who need to locate providers or compare health plan networks.

Patient access to radiology reports: 2 angles

Should patients read their radiology reports ahead of the doctor who ordered the exam? That’s not a new question. It was supposed to have been settled in the affirmative by the 21st Century Cures Act.

Policy & Regulations

Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries

AI for opportunistic osteoporosis screening inks FDA clearance

Radiology groups voice ‘enthusiastic support’ for proposal to add 14,000 more Medicare-funded residency slots

Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately

Why all heart patients should be vaccinated against the flu, COVID-19, RSV