A Candid Perspective on Hospital IT Teams and Medical Device Cybersecurity
A look at how hospital IT teams evaluate medical device cybersecurity, including MDS2, SBOMs, vendor risk, and real-world security challenges.
Projects
The Evolution of eSTAR: Cybersecurity Edition
A comprehensive overview of FDA cybersecurity updates and their implications for premarket submissions.
Harbor Labs Supports DOJ False Claims Act Litigation in Healthcare
Harbor Labs supports the U.S. Department of Justice in False Claims Act litigation involving healthcare IT and cybersecurity investigations.
The 2015 FDA Cybersecurity Alert That Shaped the Medical Device Industry
The FDA’s 2015 cybersecurity alert on the Hospira Symbiq infusion pump marked a turning point in medical device safety and launched a new era of regulatory oversight.
Dr. Mike Rushanan Teaches Groundbreaking Course on Medical Device Cybersecurity at Johns Hopkins University
In a new course, students prepare for the FDA's ramped up security requirements for insulin pumps, pacemakers, and other wearables.
Compliance v. Completeness: Rethinking SBOMs Under FDA Premarket Cybersecurity Guidance
Dr. Mike Rushanan explores how an FDA-compliant SBOM may still omit critical software and hardware dependencies, exposing hidden cybersecurity risks in medical devices.
Regulatory Science Meets Cyber Science; Why It’s So Much More than a Pen Test
Harbor Labs CEO Nick Yuran distinguishes cybersecurity from cyberscience, and explains why understanding the shared scientific disciplines of regulators and security professionals are important in achieving positive regulatory outcomes.
SBOM Transparency v. Exposure: Evaluating Adversarial Risk in Healthcare
A new case study explores the risks of public SBOM transparency in healthcare, evaluating how adversarial access may reduce exploitation effort and introduce unintended exposure.
Why FDA Rejects the Cybersecurity Content of Regulatory Submissions
Harbor Labs' Dr. Avi Rubin identifies some of the most common reasons why the FDA rejects the cybersecurity content of regulatory submissions.
Medical Device Manufacturer Must Do’s for Cybersecurity
Harbor Labs Director of Medical Security Dr. Mike Rushanan provides a comprehensive outline of the cybersecurity must-do’s necessary to meet regulatory approval. Based on years of experience working with the FDA and other regulatory bodies, Dr. Rushanan’s blog provides insights into the common pitfalls that can disqualify or delay regulatory approvals.