The Life-or-Death Stakes of Medical Device Cybersecurity

Connected medical devices improve patient care but introduce severe cybersecurity risks that require stringent regulatory ...
MobiHealthNews

FDA unveils cybersecurity attack response playbook for medical devices

FDA Commissioner Dr. Scott Gottlieb released a statement today unveiling the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook — a document co-authored with the ...
Medical Device and Diagnostic Industry (MD+DI)

Cybersecurity Threats to Medical Devices: Navigating the Evolving Threat Landscape

The healthcare industry faces an unprecedented cybersecurity crisis as connected medical devices proliferate at an alarming ...
MD&M East

Why Small Medtech Companies May Struggle with FDA's New Cybersecurity Rules

In 2022, Section 524B was added to the Federal Food, Drug and Cosmetic Act through a spending bill, granting FDA new authority over medical device cybersecurity regulation. Now that Section 524B is ...
Forbes

The Case For Generally Accepted Principles For Cybersecurity

Ed Gaudet is the CEO and Founder of Censinet, a healthcare risk management platform, and member of the Health Sector Coordinating Council. Cybersecurity has become as essential to a company’s ...
Hosted on MSN

FDA could intensify focus on medtech cybersecurity in 2026

The US Food and Drug Administration’s (FDA) scrutiny around medical device cybersecurity will “intensify significantly” as we move into 2026, an expert has forecast. In June 2025, the agency published ...