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. 

New FDA draft guidance seeks to clarify UDI forms

A new draft guidance from the U.S. Food and Drug Administration (FDA) seeks to clarify how Unique Device Identifiers (UDIs) are included on medical devices.

Stolen laptop costs the University of Mississippi Medical Center $2.75 million

The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has reached a settlement of $2.75 million with the University of Mississippi Medical Center in Jackson concerning the matter of a missing laptop.

CMS star rating system coming "shortly"

Medicare patients who are trying to pick a provider will soon have a more straight-forward, visual way to compare nearly 4,000 hospitals. CMS will assign each hospital an overall rating of between one to five stars, the distribution of which it announced in a statement July 21. 

State news: Ill. requires 3D mammography coverage, Mont. health workers fired for giving data to lawmakers

Here’s a roundup of state healthcare news, including complaints over slow payments in Iowa’s privately managed Medicaid program and California overhauling its cancer database.

Medical groups lobbying for fewer OpenPayments requirements

The American Medical Association and the American College of Radiology are among the groups pushing members of Congress to roll back laws requiring groups to disclose financial ties to doctors in the federal government’s OpenPayments database.

Editorial: Politics pose major threat to healthcare

The healthcare industry is never far from the headlines—and, at least recently, it has not for the best reasons. Hackers are stealing patient data, costs are increasing and the political landscape is always shifting.

Fracking and asthma events could be correlated, says study

The results of a new study published in the Journal of the American Medical Association Internal Medicine contains some bad news for asthmatics living in certain areas. 

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HHS report leaves it to Congress to fill privacy gaps on health data

A report on privacy and security concerns surrounding new technology that collects health data, such as wearable fitness trackers, admitted regulations like HIPAA haven’t kept pace with new developments.

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.