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.

Six hospital groups urge UnitedHealth to take responsibility for Change Healthcare hack notifications
In a public letter, the groups are urging UnitedHealth Group to announce a timeline for notifying patients about what personal data was stolen in the breach of Change Healthcare's systems.
Ohio doctor gets 7 years in prison for violating Controlled Substances Act
The Department of Justice said Thomas Romando, MD, illegally prescribed over 137,000 pills to nine patients over a five-year period.
UPMC settles $38M whistleblower lawsuit for Medicare fraud
Surgeons at the health system were accused of performing unnecessary procedures and receiving bonuses as kickbacks. UPMC does not admit wrongdoing.
FDA announces new recall of delivery catheters after patient’s death
The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.
FDA warns against use of troubled heart devices, citing ‘continued concerns’ after multiple recalls
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.

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.

November 23, 2022

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.

November 22, 2022

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).

November 21, 2022

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.

November 18, 2022

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.

November 16, 2022

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.

November 15, 2022

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.

November 15, 2022

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.

November 11, 2022

Around the web

Cardiovascular Business

FDA announces new recall of delivery catheters after patient’s death

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

Cardiovascular Business

FDA warns against use of troubled heart devices, citing ‘continued concerns’ after multiple recalls

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.

Cardiovascular Business

The push for an independent cardiology board continues

Jeffrey Kuvin, MD, one of the leading voices behind efforts to create a new Board of Cardiovascular Medicine, spoke with Cardiovascular Business about where things stand today.