MDR Cybersecurity Compliance: Complete EU MDR/IVDR Guide for Medical Devices
Navigating MDR cybersecurity compliance under the EU’s new medical and in vitro diagnostic regulations can be complex. This in-depth guide helps device manufacturers understand and implement the cybersecurity requirements of EU MDR (2017/745) and IVDR (2017/746) — from secure-by-design principles to post-market surveillance and CE certification. If you're building or selling connected medical devices or software in Europe, this is essential reading.
Kristina Romanenko
May 2812 min read
Is Our DNA in Safe Hands? What the Regeneron Acquisition of 23andMe Means for Security and Privacy
When Regeneron announced its $256 million acquisition of 23andMe, most headlines focused on drug discovery potential. But beneath the surface lies a deeper concern: the fate of 15 million genetic profiles. At Sekurno, we unpack the post-acquisition security risks, Regeneron’s breach history, and why compliance alone isn’t enough to protect the world’s most personal data—your DNA.
Sekurno
May 244 min read
Understanding FDA Regulation and Cybersecurity Guidance for Software-Enabled Medical Devices
Learn how FDA regulation and cybersecurity guidance apply to software-enabled medical devices, from classification and submission to lifecycle risk management
Kristina Romanenko
May 2112 min read
Building a Biotech Threat Model: A Practical Step-by-Step Guide & Example Case Study
Explore a real-world threat modeling example for a genomics platform using MITRE’s playbook, C4 diagrams, and STRIDE. A practical guide for healthtech and biotech security teams
Alex Rozn
May 2011 min read
HIPAA Compliance Checklist (Self-Assessment Guide)
Simplify HIPAA compliance with our Self-Assessment Guide. Quickly identify gaps, understand key requirements, and take actionable steps to strengthen your data security and meet regulatory standards. Ideal for startups, biotech, healthtech, and healthcare companies.
Kristina Romanenko
May 26 min read
The 23andMe Breach: Anatomy, Impact, and Lessons for Genomic Security (Deep Dive)
Explore the anatomy of the 23andMe data breach, its impact on genomic privacy, and critical lessons for biotech security. This deep dive reveals how sensitive genetic data was compromised and what organizations must do to strengthen defenses.
Demyd Maiornykov
Apr 711 min read
From Startup to Scale-Up: When Biotech Companies Must Take Security & Compliance Seriously
Discover why scaling biotech companies must prioritize security and compliance. Learn when regulatory triggers like HIPAA, GDPR, and FDA guidelines come into play — and how proactive cybersecurity strengthens growth and partnerships.
Kristina Romanenko
Apr 79 min read
Cloud Security for Biotech: The Biggest Misconfigurations Putting Your Data at Risk
Modern biotech startups  increasingly rely on cloud infrastructure  to power genomic data analysis  and deliver applications to users....
Alex Rozn
Mar 2923 min read
Penetration Testing for Biotech: Simulating a Cyberattack on Your Genomic Data
Discover how biotech and genomics firms can safeguard sensitive data by simulating cyberattacks on cloud systems, DNA databases & AI models
Alex Rozn
Mar 246 min read