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. 

During the 2022 State of the Union address, President Biden outlined a new plan to combat COVID-19 by testing and immediate treatment, plans to reduce drug costs, the need for more mental health coverage, and a call for more cancer research under an NIH program.

President Biden declares COVID-19 pandemic is ‘over’

President Joe Biden said the COVID-19 “pandemic is over” during an interview with 60 Minutes.

September 19, 2022
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District Court ruling in Texas calls ACA preventive care requirement ‘unconstitutional’

The federally-appointed judge expressed concerns that volunteer experts on the U.S. Preventive Services Task Force have the power to make binding recommendations.

September 9, 2022

Monkeypox update: FDA focuses on testing as cases continue to rise

The new guidance offers a validation template that can assist test developers in submitting an Emergency Use Authorization (EUA) request. 

September 8, 2022
vaccine

FDA authorizes COVID-19 variant booster shots

The Federal Food and Drug Administration (FDA) has amended its emergency use authorizations (EUAs) to include updated booster shots targeting the BA.4 and BA.5 COVID-19 subvariants.

August 31, 2022
insurance payer payment insurer

HHS investing nearly $100M in health navigators for open enrollment

The funding, which is through the Centers for Medicare and Medicaid Services (CMS), includes $98.9 million that will help ensure consumers can navigate health insurance enrollment through the Marketplace, Medicaid and the Children’s Health Insurance Program (CHIP).

 

August 30, 2022
Researcher

White House says all federally-funded research must be available to the public

The Biden administration has mandated that all federally-funded research become available to the public––for free.

August 26, 2022
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UnitedHealth CFO sued in retirement plan case

The suit alleges the company’s 401(k) retirement plan invested in low-performing target-date funds in favor of its business relationship with Wells Fargo.

August 25, 2022
Echo:Prio represents the latest addition to Dyad Medical's cloud-based Libby platform. Image courtesy of Dyad Medical.

Regulatory Roundup: FDA approves new-look self-expanding stent, clears 2 advanced AI models

The FDA has had a busy month, overseeing the recall of nearly 88,000 implantable cardiac devices, juggling the continued rise of monkeypox cases in the United States and maintaining an active Breakthrough Devices program. This rundown covers some of the agency's biggest moves during that time. 

August 24, 2022

Around the web

This week Washington took a major step toward nailing down a solid game plan on federal AI spending for everything outside of defense.

The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.

The agency is urging healthcare providers to transition away from these devices and seek out alternatives. It is even working with other manufacturers to try and get similar products on the market as quickly as possible. 

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