Rules and Regulations

Latest Issue of OR Manager
July 2025
Home Regulations/Legal > Rules and Regulations

FDA designates Class 1 recalls for intraoperative positioning guidewires, infusion pumps, dialysate

Editor's Note Centerline Biomedical’s recall of IOPS Guidewire ATW-2,  Zyno Medical’s recall of Z-800 series infusion pumps, and Nipro’s recall of MedicaLyte Liquid Bycarbonate Concentrate have been designated by the US Food and Drug Administration (FDA) as Class 1, the most serious designation indicating risk of severe injury or death.…

Read More

By: Matt Danford
June 17, 2025
Share

The Joint Commission, CHAI collaborate on scalable health AI standards

Editor's Note The Joint Commission and the Coalition for Health AI (CHAI) are partnering to set national standards for responsible artificial intelligence (AI) use in healthcare, according to a June 11 announcement from the organizations. This effort will deliver AI implementation guidance, tools, and a certification program to over 80%…

Read More

By: Matt Danford
June 17, 2025
Share

Low-income patients face uphill battle overturning insurance claim denials, study shows

Editor's Note Patients earning less than $50,000 annually are significantly less likely to have denied insurance claims reversed compared to wealthier individuals, according to a new study published in Health Affairs and reported by Fierce Healthcare on June 5. Researchers from the University of Massachusetts Amherst and the University of…

Read More

By: Matt Danford
June 16, 2025
Share

Medicaid data shared with DHS to aid immigration enforcement

Editor's Note The Trump administration ordered federal health officials this week to share personal data from Medicaid enrollees with deportation authorities, the Associated Press (AP) reported June 14. According to the report, the Centers for Medicare and Medicaid Services (CMS) was given just 54 minutes on Tuesday to transfer enrollee…

Read More

By: Matt Danford
June 16, 2025
Share

Sponsored Message

Significant CMS moves include withdrawal of emergency abortion care guidance

Editor's Note CMS has rescinded a 2022 guidance that protected clinicians providing emergency abortion care under the Emergency Medical Treatment & Labor Act (EMTALA), removing a key federal safeguard for providers in states with abortion restrictions, according to a June 2 article in Becker’s Hospital Review. The guidance, originally issued…

Read More

By: Matt Danford
June 5, 2025
Share

Proposed HHS, NIH budget cuts reveal administration priorities

Editor's Note The Trump administration’s proposed fiscal year 2026 budget calls for slashing the Department of Health and Human Services (HHS) discretionary budget by $32 billion, a nearly 25% cut that brings the total to $95 billion. Fierce Healthcare reported the news June 2.  Although many of the proposed cuts…

Read More

By: Matt Danford
June 3, 2025
Share

Sponsored Message

CMS updates hospital price transparency guidelines

Centers for Medicare & Medicaid Services

Editor's Note The Centers for Medicare & Medicaid Services (CMS) has updated hospital price transparency guidelines to require publishing real, calculated dollar amounts rather than placeholders and estimates. As detailed in the agency’s May 22 announcement, the revision complies with President Trump’s February 25 Executive Order 14221, “Making America Healthy…

Read More

By: Matt Danford
May 23, 2025
Share

AHA urges HHS to cut regulations that burden hospitals and staff

Editor's Note The American Hospital Association (AHA) has called on the Department of Health and Human Services (HHS) to eliminate or ease a variety of federal regulations, arguing that excessive administrative rules drive up costs, reduce patient access, and hinder innovation, Modern Healthcare reported May 13. According to the article,…

Read More

By: Matt Danford
May 16, 2025
Share

FDA launches effort to identify, slash outdated healthcare regulations under 10-to-1 rule

Editor's Note The US Food and Drug Administration (FDA) and US Department of Health and Human Services (HHS) have launched a public Request for Information (RFI) to identify and eliminate outdated healthcare regulations, according to a May 13 press release from the FDA. The move supports a broader federal deregulatory…

Read More

By: Matt Danford
May 14, 2025
Share

FDA fast-tracks generative AI rollout amid growing safety concerns

Editor's Note The US Food and Drug Administration (FDA) is deploying generative AI across all its centers by June 30, aiming to accelerate drug reviews and reduce bureaucratic workload even as experts and critics express worries about data security, reliability, and other safety concerns. Medical Design & Outsourcing reported the…

Read More

By: Matt Danford
May 12, 2025
Share

Join our community

Learn More
Video Spotlight
Live chat by BoldChat