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.

CDC considers letting nurse practitioners, physician assistants read X-rays under federal program
The agency's “B Reader Program” trains and certifies physicians to classify chest radiographs of workers participating in federal health surveillance programs.
FDA to hopeful marketers of AI-equipped medical devices: Think beyond your initial approval
Some FDA-approved medical devices age more safely than others. That’s no less true of AI-enabled technologies than of any others. The agency spells out the ramifications in draft guidance issued this week.
FDA issues proposed guidance for improving reliability of pulse oximeters
The devices struggle to accurately read blood-oxygen levels in patients with darker and thicker skin. The FDA hopes that changes in design and improved clinical trials will improve clinical efficacy.
FDA seeking nominations for mammography advisory committee
The National Mammography Quality Assurance Advisory Committee provides guidance and recommendations related to the standards by which facilities are regulated.
Bill to regulate healthcare private equity lands on desk of Mass. governor
Gov. Maura Healey has until Jan. 9 to pass the act into law or use her veto powers. The bill passed the state Senate on Dec. 30.

Cigna sues CVS over executive’s move

According to Cigna, Amy Bricker left her role as an executive with the company just days before joining CVS Health.

February 2, 2023

VIDEO: Who gets sued when radiology AI fails?

Brent Savoie, MD, JD, vice chair for radiology informatics, section chief of cardiovascular imaging, Vanderbilt University, explains who will get sued when there is a misdiagnosis due to artificial intelligence (AI).

February 2, 2023

Fraud in Florida: Feds bust fake nursing diploma scheme

The scheme led to more than 7,600 fake nursing diplomas issued by three South Florida-based nursing schools.

February 1, 2023

Coronary IVL now recommended at all cath labs, even those without surgical backup

The latest SCAI guidance on the safety of PCI procedures included a key change that could expand coronary IVL utilization throughout the United States.

February 1, 2023

GoodRx slapped with $1.5M fine by FTC over patient privacy

According to the FTC, the company failed to notify consumers it had disclosed personal health information to Facebook, Google and other companies.

February 1, 2023

Healthcare industry reacts to PHE ending in May

MGMA and AHA discuss how the end of the PHE will impact healthcare stakeholders.

February 1, 2023

New rule aims to claw back overcharges from MA plans

The move could reclaim overpayments of an estimated $479 million from 2018 and $4.7 billion over 10 years.

January 31, 2023

CardiacSense, an Israel-based healthcare technology company, gained FDA clearance for its CSF-3 medical watch

Regulatory Roundup: FDA clears new medical watch, considers empagliflozin for CKD and much more

Our monthly review of FDA-related news items in the world of cardiology includes updates from CardiacSense, MedAlliance, Lupin, Realize Medical and Eli Lilly and Company.

January 31, 2023

Policy & Regulations

CDC considers letting nurse practitioners, physician assistants read X-rays under federal program

FDA to hopeful marketers of AI-equipped medical devices: Think beyond your initial approval

FDA issues proposed guidance for improving reliability of pulse oximeters

FDA seeking nominations for mammography advisory committee

Bill to regulate healthcare private equity lands on desk of Mass. governor