

Building a Secure GenAI Architecture in HealthTech: Avoiding HIPAA & GDPR Pitfalls
Learn how to build secure GenAI architectures in HealthTech. Avoid HIPAA/GDPR pitfalls with identity, data, and compliance guardrails.

Sekurno
Sep 527 min read


GDPR and Cybersecurity in Biotech: How to Protect Genetic & Health Data in the EU
As biotech and healthtech companies scale across borders, they face a central challenge: how to lawfully collect, store, and use ...

Kristina Romanenko
Jul 2912 min read


ISO 27001 Compliance: Checklist & Guide for Biotech & HealthTech Companies
Biotech companies are under pressure to prove strong data security and compliance. This practical ISO 27001 guide and checklist outlines what biotech firms need to know in 2025 — from protecting IP and clinical data to choosing the right auditor and reducing risk.

Kristina Romanenko
Jul 1011 min read


MDR Cybersecurity Compliance: Complete EU MDR/IVDR Compliance Guide & Checklist 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


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


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


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


Compliance Automation: Silver Bullet for Security or Just a Myth?
Discover the pros and cons of compliance automation, debunk myths, and see who benefits from more efficient, scalable compliance solutions.

Sekurno
Nov 6, 202419 min read


Navigating Cybersecurity Compliance: A Definitive Guide
Master the essentials of cybersecurity compliance with our definitive guide. Learn how to navigate complex frameworks like SOC 2, PCI DSS, NIST, HIPAA, CCPA, GDPR, and ISO 27001, avoid common pitfalls, and build a security program that drives trust and resilience.

Kristina Romanenko
Sep 25, 202413 min read