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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Digital health startup receives FDA clearance for Parkinson’s Disease applications on Apple Watch

The U.S. Food and Drug Administration (FDA) has approved 501(k) marketing clearance for the prescription mobile app Parky for monitoring Parkinson’s Disease.

Lawmakers urge DOJ to act on anti-trans threats at children’s hospitals

Dozens of lawmakers banded together to urge the Department of Justice to act on rising anti-transgender threats made against the nation’s children’s hospitals.

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New signups rise 40% on healthcare marketplace

In the first few weeks of open enrollment, new signups on the healthcare marketplace, healthcare.gov, are up nearly 40%, according to the Department of Health and Human Services (HHS).

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UnitedHealth, AARP team up for hearing aid savings

UnitedHealthcare has teamed up with AARP to administer hearing aid solutions, including prescription and over-the-counter (OTC) hearing aids.

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AMA opposes criminalization of pregnancy loss

The American Medical Association (AMA) released a number of new policy adoptions, including several in reaction to the recently changed reproductive health laws in the United States.

PHE for COVID-19 will continue past January

The public health emergency enacted during the start of the COVID-19 pandemic will continue past January 2023. 

 

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Emergency hospital transfer of STEMI patients might be expedited with a hospital-level 'Call 911 protocol'

The AHA Mission: Lifeline Program was designed to reduce STEMI patient transfer times, but response times still often lag, and new protocols may be needed to expedite STAT transfers.

U.S. Food and Drug Administration Commissioner Robert Califf, MD, who is a cardiologist, spoke at the opening session of the American Heart Association (AHA) last week about the need for doctors and health systems to step up to address two major problems - misinformation and health disparities.

FDA Commissioner Robert Califf calls on cardiology to address health inequities and combat misinformation

FDA Commissioner Robert Califf, MD, who is a cardiologist, spoke at the opening session of the American Heart Association about the need to step up and address two major problems in the American healthcare system. 

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Around the web

Cardiovascular Business
Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

Cardiovascular Business
FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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