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.
FDA
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.
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.