Category: Standards

Standards

HHS, FDA Want to Slash Health Care Rules in 10-to-1 Deregulation Plan

The agencies are asking stakeholders to weigh in on a sweeping deregulatory initiative that will eliminate 10 regulations for every one introduced.

Standards

Opinion: Right to Repair Must Stop Where Patient Safety Starts

A former FDA official argues that medical device repair needs stricter oversight to protect patient safety amid growing right to repair efforts.

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

Washington State Legislature Passes Right to Repair Bills

Washington is expected to become the eighth state in the country to pass Right to Repair legislation, pending the signature of Gov Bob Ferguson.

FDA Updates

AI-Driven Coronary Physiology Software Gains FDA Clearance

The software, powered by artificial intelligence and deep learning, assesses angiography-derived coronary physiology in patients with ischemic coronary artery disease.

Government Regulations

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.

Cybersecurity

Most Phishing Attacks in Healthcare Go Unreported, Survey Finds

A new Paubox IT Survey Report examining the state of email security in healthcare reveals that 95% of phishing attacks go unreported to security teams.