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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FDA releases plan for improving medical device safety

“Although medical devices provide great benefits to patients, they also present risks,” said FDA Commissioner Scott Gottlieb, MD. “And we are focusing equal attention on advancing new frameworks for identifying risks and protecting consumers.”

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Oregon surgeon sued for cancer misdiagnosis after failing to consult radiologist

A surgeon based in Klamath Falls, Oregon, is being sued for $7 million after allegedly misdiagnosing a patient’s colon cancer and failing to consult a radiologist, the Herald and News reports.

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Hospitals have the most to lose from healthcare’s blurring lines

The wave of megamergers involving health insurers could place the greatest pressure on both not-for-profit and for-profit hospitals, according to a report from Moody’s Investors Service, if these new combinations steer patients away from hospital-owned facilities.

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FDA releases new medical device safety action plan

The FDA released, "Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health," on April 17 in an effort to enhance programs and processes to assure the safety of medical devices.

FDA clears use of Tracer-QC at Massachusetts Gen

The FDA approved the first use of Trace-Ability’s Tracer-QC at Massachusetts General Hospital for testing of an imaging agent used in positron emission tomography (PET)-N-13 ammonia for injection.

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Radiology’s morality problem—and how to fix it

As radiologists become increasingly familiar faces on news sites and in police blotters, one Indiana University professor is suggesting the physicians might be prone to law-breaking due to their steep salaries and a professional culture centered around compliance.

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What pharma fears about Trump’s upcoming speech on drug prices

President Donald Trump will deliver a speech on April 26 focused on ways to lower prescription drug prices, but the pharmaceutical industry doesn’t expect it to include the more dramatic reforms Trump espoused on the campaign trail.

Why the ABR’s shift to standardized testing is bad for radiology

The American Board of Radiology (ABR) made significant changes to its certification program for diagnostic radiologists in recent years, removing the oral component of the exam and relying on a standardized format with multiple-choice questions. This shift toward psychometric testing has made the certification program less reliable, according to a new analysis published by the Journal of the American College of Radiology, and the ABR should consider working with various stakeholders and education experts to change it.