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.

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.
Medicare on solid ground for now but headed for fiscal quicksand
Medicare’s Hospital Insurance (HI) Trust Fund has the wherewithal to pay the full bill for beneficiaries’ stays in hospitals, hospice sites and skilled nursing facilities for the next 12 years. But what then?
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.
Steward Health Care files for bankruptcy, citing rising labor costs and reduced reimbursement
The health system employs 40,000 people and cares for more than 12 million patients in eight states.
AMA says Change Healthcare breach is crippling independent practices
A survey of physicians by the American Medical Association reveals that many practices are still losing revenue and struggling to make payroll as a result of the Change Healthcare hack.

The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.

FDA panel votes in favor of Recor Medical renal denervation system

A few members of the panel did question the device's efficacy and long-term durability. The FDA will now use these findings to make its final decision related to the system's approval.

August 23, 2023

Lab owner gets 27 years in prison for $463M Medicare fraud scheme

According to the U.S. Department of Justice, LabSolutions took advantage of patients using a telemarketing scheme, with its owner personally pocketing millions in kickbacks.

August 21, 2023

FDA warning letter details quality concerns, violations at Integra facility

The facility in question is responsible for producing collagen-based medical devices primarily used in wound care, soft tissue repair and complex reconstruction surgeries.

August 18, 2023

GE Healthcare's Portrait Mobile wireless and wearable monitoring solution

GE HealthCare earns FDA clearance for new remote patient monitoring device

The newly cleared device was designed with patient freedom and flexibility in mind.

August 18, 2023

Race for AI dominance: 5 points to ponder about US v. China

AI that’s intended to let cars drive themselves can be repurposed to let tanks level cities. And AI can just as easily weaponize a virus as diagnose it. These are not secrets.

August 17, 2023

Biden administration invests $100M in strengthening nursing workforce

The funding is a response to the escalating demand for registered nurses, nurse practitioners, certified nurse midwives and nurse faculty throughout the United States.

August 15, 2023

FDA warns public not to use certain pregnancy tests due to safety, accuracy issues

The agency shared a list of 15 diagnostic tests that should not be used by patients going forward.

August 15, 2023

The Society for Cardiovascular Angiography and Interventions (SCAI) has issued a new statement urging the American Board of Internal Medicine (ABIM) to rethink its maintenance of certification (MOC) policies. The organization, home to more than 4,500 interventional cardiologists, says some of its members have seen their privileges “threatened and even revoked” despite passing the necessary exams and reporting procedural volumes as required. Stamp | Certification

Interventional cardiologists call out ABIM for ‘unfair and unjustified’ certification policies

“This situation unacceptably exacerbates the interventional cardiology workforce shortage and threatens to directly impact the care of patients," SCAI wrote in a new statement.

August 11, 2023

Around the web

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.

AI in Healthcare

Biden Administration itemizes AI accomplishments to date

Half a year after President Biden officially directed federal agencies in the executive branch’s bailiwick to “seize the promise and manage the risks” of AI, the White House has posted a status report.