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. 

Guerbet

Imaging manufacturer Guerbet faces financial challenges following recent FDA warning

Regulators recently scolded the France-based pharmaceutical firm for safety issues that occurred at its plant in Raleigh, North Carolina, which produces imaging contrast agents. 

Wisconsin Governor Tony Evers Gail's Law

Wisconsin passes legislation requiring insurers to cover supplemental breast imaging

Dubbed "Gail's Law" after a breast cancer care advocate, the passage follows years of advocacy from radiologists and patients. 

MARS Bioimaging extremity scanner

FDA clears portable photon-counting CT scanner

The system is designed for point-of-care settings such as outpatient offices, sports medicine practices and urgent care clinics.

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CMS leaves the ’80s behind with shift away from snail mail correspondence, fax machines

In a Final Rule revealed last week, the Centers for Medicare & Medicaid Services outlined its plan to exchange medical records, diagnostic images and clinical notes electronically using secure protocols. Once the rule is published in the Federal Register, any HIPAA-covered entity that interacts with Medicare will have two years to follow CMS into the modern age.

U.S. FDA Sign

Drugmaker’s stock tumbles 20% after FDA issues formal warning to executives

ImmunityBio, the developer of bladder cancer treatment Anktiva, is accused by the U.S. Food and Drug Administration of disseminating “false or misleading information” about the drug's efficacy in an advertisement and podcast. The FDA said it’s not the first time it's sent a warning letter to the company’s executives over allegedly inaccurate claims.

consoling crying patient

6 things Medicaid stakeholders can remind the world to always do with healthcare AI

U.S. healthcare will know it’s gotten AI right when the technology demonstrably improves care access, attentiveness and outcomes for the least financially healthy among us. 

heart doctors and surgeons working together. top cardiology hospitals in the United States.

Cardiologists lead push for new cath lab radiation safety standards

Several U.S. medical societies have collaborated on a new report advocating for better safety standards in cardiac catheterization labs. As one cardiologist described it, clinicians have shifted from "accepting risk" to "expecting better."

fax machine doctor

CMS to phase out fax machines and snail mail, saving over $780M annually

Under the final rule, the agency would establish national standards for the electronic exchange of images and other clinical documentation.