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. 

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Fears over affording care overwhelmingly top list of health-related concerns for older Americans

In a national poll, more than half of respondents said they were “very concerned” about the cost of medical care, home care, assisted living and prescription drugs. Those concerns outweighed vaccine hesitancy, crime and loneliness.

The U.S. Food and Drug Administration (FDA) announced that Vyaire Medical has recalled the twin tube samples lines from its Vyntus CPX Metabolic Cart due to ongoing safety concerns. This is a Class I recall, which means the FDA believes using these devices “may cause serious injuries or death.”

FDA announces new Class I recall of CPET devices due to choking hazard

If left unchecked, the devices could put patients at risk of serious injuries or death as they undergo cardiopulmonary evaluations. 

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Radiology groups want clarity from HHS on reporting requirements following Change cyberattack

ACR, the American Society of Neuroradiology and the Society of Interventional Radiology were among over 100 groups asking the feds for further details. 

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‘First federal CIO’ gives 3 reality checks on governmental AI

The White House’s Office of Management and Budget recently released final guidance for the use of AI by executive-branch departments and agencies.

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100+ groups ask OCR for clarification on HIPAA requirements after Change Healthcare hack

In a letter dated May 20, a number of medical associations and physicians groups ask the OCR to force UnitedHealth Group to follow through on notifying patients that their data was taken by hackers.

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Twin doctors plead guilty in $45M insurance fraud scheme

Desi Barroga and Deno Barroga allegedly prescribed opiates to patients in exchange for false statements to insurers.

Hospira, an Illinois-based pharmaceutical and medical device company owned by Pfizer, has issued a voluntary recall of two different drugs due to ongoing safety issues. The recall includes specific lots of labetalol hydrochloride injections and buprenorphine hydrochloride injections. Labetalol hydrochloride injections are used to control blood pressure in patients with severe hypertension.

Pfizer recalls 2 drugs, including 1 for hypertension, over safety concerns

The recall was put in place due to a leak risk that could make the therapies less effective and potentially lead to an infection. 

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Dozens of injuries trigger FDA recall of over 50,000 implantable tissue marking devices

The Class I recall, which is the most serious recall the FDA issues, comes after numerous adverse events and complications linked to the radiographic markers were reported.  

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