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 new ‘smart shirt’ for real-time cardiopulmonary monitoring
According to Hexoskin, the newly cleared technology offers significant value for hospitals and health systems as well as researchers conducting clinical trials.
ACLU sues FDA over unanswered Freedom of Information Act request
The agency is accused of failing to respond to a records request related to its upcoming review of the legality of abortion pills and interstate prescribing practices. The ACLU is asking a federal judge to enforce FOIA law.
Trump’s former FDA commissioner joins board of UnitedHealth
Scott Gottlieb, MD, will take on the new position “effective immediately.” UnitedHealth Group did not say what, if any, steering committee the former FDA lead will sit on.
Siemens Healthineers issues correction for MRI systems affected by recent Class 1 recall
On Aug. 28, Siemens alerted customers about safety issues with nine different scanners from its Magnetom series of MRI offerings.
ASTRO releases new radiation therapy guidelines for gastric cancers
Many forms of the disease are identified at later stages, making treatment and management complex and multifaceted.

Neuroradiologists support bipartisan bill that would tap foreign physicians to relieve staffing shortages

The Healthcare Workforce Resilience Act would recapture 15,000 unused immigrant visas, previously authorized by Congress, for overseas medical doctors.

Change Healthcare cyberattack: A recap and update in 10 quotes

“This is what happens when everything merges and you only have one option.”

Some older patients taking aspirin to prevent CVD may be doing more harm than good

“Aspirin is no longer a one-size-fits-all preventive tool for older adults," according to one specialist with Michigan Medicine.

Hospital system accused of inaction after ultrasound technologist allegedly assaults 6 women

Sacramento, California-based Sutter Health and tech Henry Nweke deny the allegations.

FDA announces new Class I recall of drainage systems after 26 injuries

According to the agency, using these devices “may cause serious injuries or death.”

Medicare money payment reimbursement dollar decline george washington

Feds seeking public comment on private equity healthcare spending sprees

A joint announcement from the DOJ, FTC and HHS asks for providers, patients or other industry experts to share their experiences with private equity transactions, including those not typically subject to antitrust review by law.

Industry Watcher’s Digest

Buzzworthy developments of the past few days.

Dexcom, a global healthcare technology company based out of San Diego, has received U.S. Food and Drug Administration (FDA) clearance for Stelo, a wearable glucose biosensor that can be obtained without a prescription.

FDA clears first over-the-counter wearable device for continuous glucose monitoring

The newly cleared device is worn on the back of the arm and sends data directly to the user's smartphone.

Policy & Regulations

FDA clears new ‘smart shirt’ for real-time cardiopulmonary monitoring

ACLU sues FDA over unanswered Freedom of Information Act request

Trump’s former FDA commissioner joins board of UnitedHealth

Siemens Healthineers issues correction for MRI systems affected by recent Class 1 recall

ASTRO releases new radiation therapy guidelines for gastric cancers