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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Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system

Safety update: Sensor issue with Abbott CGMs ruled a Class I recall

The sensors of certain FreeStyle Libre 3 devices are producing inaccurate glucose readings and should not be used. Two patient injuries have been reported. Abbott first reported the problem in July. 

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Bill to regulate private equity passes California legislature, heads to Newsom’s desk

Governor Gavin Newsom has until Sept. 30 to sign or veto the bill, which gives the attorney general oversight over private equity buyouts in healthcare.

Nationwide chain of mental health centers accused of unlawfully imprisoning patients

A New York Times report said Acadia Healthcare indefinitely detained patients to extract insurance payouts.

Elizabeth Ann Ignacio, MD, FSIR, FACR, the chair of Society of Interventional Radiology (SIR) Small and Rural Practices Committee, president of the Hawaii Medical Association, and a board member of the American College of Radiology, outlines the shortage of IRs outside of major cities and ways to make these positions more attractive.

How to address the shortage of interventional radiologists

Elizabeth Ann Ignacio, MD, FSIR, FACR, chair of SIR Small and Rural Practices Committee, and an ACR board member, outlines ways to make these positions outside of major cities more attractive.

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Healthcare Cybersecurity Act brought to House by bipartisan cosponsors

Initially proposed in 2022, the law was reintroduced to the Senate in July. Now it's being backed by members of the House.

 

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Lawyer: Court decision over website trackers has ‘zero impact on patient privacy’

The U.S. Department of Health and Human Services has opted not to appeal a federal court decision that partially repealed the agency’s ban on website trackers.

abortion law ban pregnancy dobbs

Planned Parenthood sues Missouri over Medicaid defunding

Despite abortions being effectively banned in the state, a law that passed in May banned Medicaid funds from going to any organization that provides abortions in any state.

Insulet Corporation, a Massachusetts-based medical device company focused on diabetes technology, announced that its Omnipod 5 Automated Insulin Delivery System is now cleared by the U.S. Food and Drug Administration (FDA) to manage type 2 diabetes (T2D).

FDA clears first automated insulin pump for type 2 diabetes

Insulet's Omnipod 5 Automated Insulin Delivery System was already cleared to help patients manage type 1 diabetes. 

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Around the web

Cardiovascular Business
Cardiology groups cheer new bill that would improve access to Medicare claims data

If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation. 

Cardiovascular Business
Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

Cardiovascular Business
Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing. 

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