Why FDA Rejects the Cybersecurity Content of Regulatory Submissions
Harbor Labs Chief Scientist Dr. Avi Rubin identifies some of the most common reasons why the FDA rejects the cybersecurity content of regulatory submissions.
Thought Leadership
Regulatory Science Meets Cyber Science; Why It’s So Much More than a Pen Test
HarborLabs 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.
Negotiating a Protective Order for Code Reviews
Your Protective Order could set the stage for a successful code review and case or a long, arduous process. How do you ensure your analysts have the best access and avoid hardships as they look to help build your case?
Medical Systems and Third-Party Smart Devices
As more medical devices leverage phones and other consumer devices, are they introducing more risk to patients? We’ll go inside a conceptual hack and explore the impact of the crossover between unregulated third-party devices and smart medical devices.
Why Harbor Labs Supports The CVSS 3.0 Standard For Medical Device Security
The common vulnerability scoring system is a valuable tool, but how strictly should medical organizations rely on it? When assessing medical and healthcare technology, does it bring enough information, or does it fall short?
DIY Diabetics and FDA Policy
Technology is putting more control into patients’ hands and expanding their access to data. But how far is too far? HarborLabs’s Director of Medical Security provides his view of DIY technology regarding diabetes-care technology.
New FDA Guidance On WiFi-Managed Infusion Pumps Is Cybersafe And Cybersecure
HarborLabs’ CEO, Nick Yuran, was recently interviewed about misconceptions and concerns around the FDA’s new policies on wireless management of infusion pumps. Here are his thoughts regarding the interview and the overall risks involved.