Category: Standards

Standards

Semiconductor Tariffs Would Threaten US Medical Device Industry Growth, says GlobalData

With around half of all medical devices relying on semiconductors, analysts say proposed tariffs could lead to price hikes and supply chain strain.

Standards

HSCC Proposes Collaborative Cybersecurity Framework Over HIPAA Rule Update

The council calls for a one-year consultation with federal officials to align cybersecurity goals with healthcare delivery realities.

Standards

Right to Repair Legislation Now Filed in All 50 States

With Wisconsin filing its first Right to Repair bill, all 50 states have now considered the legislation over the past eight years.

Servicing Legislation

Terumo Ends Servicing Certification Classes for System 1

Terumo Cardiovascular announced it is discontinuing certification classes for the maintenance of its Advanced Perfusion System 1 Heart Lung Machine, a decision that adds to ongoing debates about right-to-repair in healthcare technology.

FDA Updates

BD Issues Correction for Infusion Pump Software

BD is correcting software for its Alaris Systems Manager and CCE Infusion Adapter after identifying a risk that outdated infusion parameters could be uploaded, potentially leading to incorrect dosing.

Government Regulations

ECRI Names Top 10 Patient Safety Threats for 2025

ECRI’s 2025 report outlines the top 10 threats affecting patient safety, with recommendations for system-wide improvements.

Cybersecurity

Advisory Warns of Medusa Ransomware Activity

Federal agencies released a joint cybersecurity advisory warning of activity by Medusa ransomware observed as recently as February.