Our Blog

Most FemTech apps are not covered by HIPAA. Since Dobbs, the FTC has fined Premom, GoodRx, Flo, and BetterHelp for unauthorized health data sharing. Here is what your platform actually needs to get right.

Compliance automation platforms make SOC 2 certification faster and more operationally manageable. But a certification doesn't tell a hospital CISO whether your controls hold up under real conditions. Here's how the three leading platforms compare — and what none of them cover.

42 CFR Part 2 enforcement began February 2026. If your behavioral health or mental health platform handles SUD records, HIPAA compliance is not enough. Here is what your architecture actually needs to pass a security review.

SOC 2 readiness is often misunderstood as a compliance exercise. In reality, it’s what determines whether you pass enterprise security reviews or stall deals. This guide breaks down the real timeline from zero to Type I, including where most teams get blocked.

AI scribes are being adopted quickly across healthtech, and in most cases the product delivers. Very few deals fail at the product level. What stops them is the transition into IT and security review — where the conversation shifts from clinical value to data control, and where most vendors are underprepared.

The EU AI Act, effective since August 2024, introduces the world’s first comprehensive legal framework for artificial intelligence. It defines strict obligations for high-risk AI systems, foundation models, and deployers across sectors like healthcare, finance, and legaltech. This guide breaks down what the Act requires, who it applies to, and how organizations can prepare for compliance — including cybersecurity, documentation, and conformity assessments.

Learn how to build secure GenAI architectures in HealthTech. Avoid HIPAA/GDPR pitfalls with identity, data, and compliance guardrails.

As biotech and healthtech companies scale across borders, they face a central challenge: how to lawfully collect, store, and use ...

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.

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.

Learn how FDA regulation and cybersecurity guidance apply to software-enabled medical devices, from classification and submission to lifecycle risk management

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.

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.

Discover the pros and cons of compliance automation, debunk myths, and see who benefits from more efficient, scalable compliance solutions.

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.