Unique Cybersecurity Challenges & Compliance Expectations in Biotech

Biotech companies face distinct security challenges — from safeguarding irreversible genomic data to navigating overlapping regulations like HIPAA, FDA, GDPR, and MDR. This guide walks you through the real risks, architectural decisions, and compliance realities that shape modern biotech operations.

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Why Cybersecurity Matters in Biotech

The biotech industry isn’t one-size-fits-all — and neither are its cybersecurity needs. This guide is tailored for platforms operating in key biotech sub-niches, each with its own data types, regulatory exposure, and architectural decisions.

This guide helps you:

Understand the security risks unique to biotech

Navigate frameworks like HIPAA, FDA SPDF, MDR/IVDR, GDPR, and ISO 27001

Explore practical strategies like threat modeling, secure SDLC, and cloud-native protections

Learn about pitfalls in GenAI implementation for your healthcare / biotech platform.

Backed by engineers, auditors, and compliance experts working directly with biotech platforms, this page compiles the must-knows for founders, security leads, and product teams building in the space.

Who This Guide Is For

Biotech is transforming healthcare — from AI-driven diagnostics to personalized medicine and direct-to-consumer testing. But with innovation comes a growing attack surface.

Direct-to-Consumer Genetic, Longevity & Health Analytics Platforms

These platforms combine genetic or biomarker testing with data-driven insights around aging, lifestyle, and preventive health. While they serve consumers directly, many also provide dashboards for clinicians or longevity coaches, blurring the line between wellness and clinical oversight.

GDPR/HIPAA overlap, data re-identification risk, long-term storage, consent management, cross-border data transfers.

Diagnostics-as-a-Service Platforms

Unlike consumer tools, these platforms provide clinically actionable diagnostics, often supported by AI or advanced analytics. Used by healthcare providers or labs, they typically fall under FDA SPDF, EU MDR/IVDR, and CLIA regulations — requiring validated workflows, documentation, and lifecycle security.

third-party access, consent enforcement, data anonymization, HIPAA/GDPR compliance, auditability, research ethics.

Data Marketplaces & Clinical Trial Recruitment Platforms

This includes genomic data marketplaces, research data exchanges, and clinical trial recruitment tools — platforms that manage sensitive patient or genomic data across organizations. Whether enabling data sharing or matching patients with studies, these tools must enforce strict access controls, consent tracking, and vendor risk oversight.

third-party access, consent enforcement, data anonymization, HIPAA/GDPR compliance, auditability.

Data Responsibility

Biotech platforms operate at the intersection of sensitive data and multi-stakeholder demands.

Patients expect privacy and control.

Pharma partners and CROs require auditability, compliance alignment, and trustworthy data governance.

Each stakeholder introduces unique expectations, regulatory pressures, and security risks — all of which shape how data is managed, secured, and audited.

This guide distills the core considerations for founders, security leads, and product teams building in biotech — informed by hands-on experience from engineers, auditors, and compliance experts working directly with platforms in the field.

How We Can Help

Penetration Testing

A hands-on security assessment simulating
real-world attacks on your infrastructure,
application, or cloud setup.

Required under: HIPAA, ISO 27001,
SOC 2, FDA, MDR/IVDR

It’s also a common prerequisite for partnerships with healthcare providers and pharma companies.

How does penetration testing work in biotech — and what does a simulated genomic data breach reveal? →

Threat Modeling

A proactive exercise used to identify how your systems might be attacked, which data flows are most exposed, and where controls should be placed. Threat modeling helps you focus security efforts on what matters most — based on how your product actually works.

Required or expected under:
FDA SPDF, EU MDR

In regulated environments, threat modeling is often used as documentation to demonstrate that you’ve identified your security and safety risks — a critical part of pre-market submissions, audit trails, and CE marking processes.

What is Threat Modeling — and how do you apply it in biotech platforms? →

GenAI Architecture

Integrating GenAI into biotech platforms brings powerful opportunities — and serious risks. Most teams underestimate the security and compliance implications of embedding health data (or even PHI) into vector databases, prompts, or third-party models.

Without proper data sanitization secure-by-design architecture, even “just metadata” can expose you to HIPAA violations and prompt leakage.

AWS or GCP won’t make you compliant by default. You need a signed BAA, proper access controls, and to ensure sensitive data never reaches the model unprotected.

Contact us to discuss GenAI systems in healthcare →

Compliance Landscape

This section isn’t just a list of regulations — it’s a map.

We explain what each standard is, when you become subject to it, what concepts you need to understand (like PHI or SaMD), and where to go to explore it further.

HIPAA – U.S. Health Data Privacy Law

HIPAA applies when your platform handles Protected Health Information (PHI) in the context of U.S. healthcare — typically when working with labs, clinics, hospitals, or insurers, collectively known as Covered Entities.

Many assume all health data is PHI. It’s not. PHI is health-related data that’s identifiable and processed within a covered entity context.

If your platform is a covered entity or processes data for one, HIPAA likely applies.

PHI = Health Info + Identifier + Covered Entity Context

Key Requirements:

Sign Business Associate Agreements (BAAs)
Implement security safeguards
Conduct risk assessments and prepare for breach notifications

→Learn more about HIPAA, including examples of what counts as PHI, security requirements and access to our free HIPAA Compliance Checklist Guide.

What the FDA Expects from Cybersecurity: SPDF Guidance

When regulation applies, the FDA expects cybersecurity to be integrated into your development lifecycle. The Secure Product Development Framework (SPDF) outlines:

Threat modeling
Software Bill of Materials (SBOM)
Vulnerability handling & patching
Post-market monitoring

→Learn more about FDA & SPDF including examples of diagnostic triggers and a checklist for regulated cybersecurity practices.

FDA – U.S. Regulator for Medical and Diagnostic Products

The FDA regulates platforms that offer tools to diagnose, treat, or manage health conditions — whether through software, lab processes, or expert-reviewed reports.

For example, a company that sells DNA testing kits and provides general wellness insights (e.g., nutrition or sleep advice) is not subject to FDA.

But if the same company starts using that data to diagnose disease or guide treatment decisions, they may require FDA clearance.

If your reports support clinical decision-making, you’re likely offering a regulated diagnostic product.

Trigger = Clinical claim + U.S. market + diagnostic or treatment intent

GDPR – EU Regulation for Personal Data Protection

The General Data Protection Regulation (GDPR) applies when your platform processes personal data of individuals in the EU/EEA — regardless of where your company is located.

Personal data includes anything that can directly or indirectly identify someone — from names and emails to genetic, biometric, or health-related information.

Important: Health and genetic data are considered special category data under GDPR. This means they require explicit legal justification, heightened protection, and stricter control over how they’re accessed, processed, and stored.

What GDPR Expects from You

To process sensitive data lawfully, you must meet strict conditions, including:

A valid legal basis (e.g., explicit consent, public interest, contractual necessity)
Data protection by design and by default
A defined Data Protection Officer (DPO) (in most cases)
A process for Data Subject Rights (access, deletion, correction)
Breach notification within 72 hours

→ Learn more about GDPR and Cybersecurity and how to Protect Genetic and Health Data.

Device Classification Notes:

For low-risk Class I devices, self-declaration may be enough — but even then, some structured QMS documentation is still required.
For Class IIa, IIb, or III devices → this QMS typically needs to be certified by a Notified Body, and ISO 13485 is the most recognized path.

→Learn more about MDR/IVDR including how to determine if your platform qualifies as a regulated device, what classification it falls under, and what security documentation is required for CE marking.

EU MDR & IVDR – Cybersecurity for Medical and Diagnostic Devices in Europe

The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are the European counterparts to FDA oversight — applying to platforms that offer medical or diagnostic functionality in the EU.

If your platform analyzes biological samples or supports clinical decisions for users in Europe, you may fall under MDR or IVDR — even if it’s software-only.

Key Concept:

These regulations now classify many digital diagnostics, genetic testing services, and other non-physical tools as regulated medical or in-vitro diagnostic devices.

Trigger = EU market + medical/diagnostic functionality or data reporting

ISO 27001 & SOC 2 – Proving Your Security Posture

ISO 27001 and SOC 2 are leading security frameworks used by biotech companies to demonstrate mature, auditable security practices — especially when handling sensitive personal, health, or genomic data.

While neither is mandatory, both are often requested by enterprise clients, partners, or investors as a sign of trust and operational maturity.

ISO 27001 is a certifiable international standard focused on building a formal Information Security Management System (ISMS).

PHI = Health ISOC 2 is a U.S.-based attestation report that evaluates how well your security controls meet specific Trust Principles like Security and Availability.nfo + Identifier + Covered Entity Context

Which one should you choose?

If you’re scaling in the EU or globally, ISO 27001 may be preferred.
If you’re focused on U.S. B2B clients, VCs, or HIPAA-covered partners, SOC 2 may be expected.
Some companies pursue both to cover all markets.

→Contact us to discuss ISO 27001 & SOC 2, including what each involves and how to approach them depending on your growth stage and target market.

What Compliance Actually Demands in Practice

Most regulations — HIPAA, ISO 27001, SOC 2, FDA, MDR — don’t prescribe exact tools. But when you break them down, they all point to the same thing: your platform should be able to withstand real threats.

Whether driven by compliance, client expectations, or investor due diligence, biotech companies are expected to adopt a core set of security practices — not just to pass audits, but to genuinely reduce risk.

Below are the disciplines that make that possible.

Next Steps

To strengthen your security posture, contact Sekurno for a security consultation and learn how proactive cybersecurity measures can protect your business.