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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Moon

Moon Surgical gets FDA approval for mission launch of surgery robot

The Maestro robot aids surgeons by holding tools and providing real-time analysis of a surgery.

June 5, 2024
Product Recall

FDA announces recall of Medtronic brain surgery support systems

Medtronic has issued a recall affecting several versions of its StealthStation S8 due to a software error that puts patients at risk of serious injury or death.

June 5, 2024
Heart Rhythm Society (HRS) President Kenneth Ellenbogen, MD, FHRS, director of clinical cardiac electrophysiology and pacing, Virginia Commonwealth University, discussed two key initiatives for 2024-25 with Cardiovascular Business. These include helping create a new, independent cardiovascular medicine board, and supporting the movement toward more outpatient procedures being performed in office-based labs (OBL) and ambulatory surgical centers (ASC). #EPeeps #HRS #HRS24 #HRS2024

Heart Rhythm Society shows support for new cardiovascular board, outpatient EP centers

Cardiovascular Business spoke with HRS President Kenneth Ellenbogen, MD, about two key initiatives the group is focused on this year.

June 5, 2024
UnitedHealthcare UHC UnitedHealth

Q&A: Healthcare cybersecurity advocate fears damage from Change Healthcare breach has only begun

Richard Staynings says the breach of Change Healthcare’s systems stems from consolidation, and the impact may devastate independent providers.

June 4, 2024
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HHS: ‘Who is responsible for ensuring that individuals affected by the Change Healthcare breach receive notification?’

HHS’s Office for Civil Rights (OCR) has confirmed UnitedHealth Group can send out HIPAA-required notifications about the breach but stopped short of saying the company will be responsible for doing so.

June 3, 2024
Closed

Rural New Mexico hospital may close its doors after $100M malpractice judgment

Rehoboth McKinley Medical Center lost a 2019 malpractice case involving a botched hernia surgery. The hospital was already operating at a loss before the case went to court.

May 31, 2024
Recall

FDA announces recall of Optum infusion pumps over risk of serious malfunctions

The Nimbus II Plus infusion pumps are being recalled due to multiple malfunctions that could put patients at risk.

May 30, 2024
wallet purse broke bankrupt

Rising cost of private insurance unsustainable for 180 million families, study finds

The average cost of care for families covered by private insurance increased from $3,920 to $4,907 between 2007 and 2019.

May 29, 2024
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Around the web

Cardiovascular Business
Private equity-backed cardiology group puts cloud-based technology in hands of its cardiologists

Cardiovascular Associates of America, backed by Webster Equity Partners, currently includes practices in eight different states. Its partner cardiologists now have preferred access to multiple cloud-based services provided by Athenahealth. 

Cardiovascular Business
ASNC supports AMA effort to limit use of AI in prior authorization decisions

The American Society of Nuclear Cardiology (ASNC) supports an AMA policy that condemns the use AI to make prior authorization decisions rather than a doctor or clinician.

AI in Healthcare
US healthcare is flush with venture investments in AI: Silicon Valley Bank report

The past five years have been boom times for AI startups courting venture investors in healthcare, and the good times just keep rolling.

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