ISO 27001 Compliance: Checklist & Guide for Biotech & HealthTech Companies
- Kristina Romanenko
- Jul 10
- 11 min read
Updated: Sep 4
Protecting Innovation with Global Security Standards
Biotech and Healthech companies face intense information security pressures. Cyberattacks increasingly target genetic, clinical, and IP data, like the ransomware breach at Enzo Biochem that exposed 2.4 million patient records, or the massive 23andMe data leak that eroded public trust and preceded its collapse. Meanwhile, global regulators - from GDPR and HIPAA to FDA and EU MDR - are raising the bar on cybersecurity. Investors and enterprise clients now expect ISO/IEC 27001 certification as a baseline.
What is ISO 27001?
ISO/IEC 27001 is the international standard for establishing, implementing, maintaining, and continually improving an Information Security Management System (ISMS). Developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), this standard helps organizations secure three core principles of information security:
Confidentiality – Ensuring only authorized individuals access sensitive data.
Integrity – Maintaining the accuracy and reliability of information.
Availability – Ensuring systems and data are accessible when needed.
The 2022 revision of ISO 27001 Annex A includes 93 controls, grouped into four main categories:
Organizational Controls: Policies, risk management, roles and responsibilities.
People Controls: Background checks, training, disciplinary processes.
Physical Controls: Secure areas, equipment protection, visitor access.
Technological Controls: Access control, encryption, malware defenses, SIEM.
For biotech and healthtech companies handling genomic data, PHI, clinical records, connected device data, or proprietary algorithms, ISO 27001 offers a structured and auditable framework to secure sensitive assets, meet regulatory expectations, and build trust with partners and patients.
🎯 Take our ISO 27001 Self-Assessment Checklist
Assess yourself against Sekurno’s ISO 27001 “Technological Controls” Checklist – a practical guide to review your current security posture, identify control gaps, and benchmark your compliance readiness.
Addressing Biotech & Healthtech Challenges with ISO 27001
1️⃣ Protecting Intellectual Property (IP) and Patient Data
→ Both biotech and healthtech sectors rely heavily on proprietary methods, genomic datasets, clinical trial results, and sensitive patient information. If compromised or altered, these assets can derail research, provoke regulatory penalties, and damage competitive advantage.
✔️ ISO 27001 safeguards these critical assets through comprehensive asset inventory and classification, role-based access controls, encryption of data at rest and in transit, continuous monitoring, incident response, and regular internal audits.
2️⃣ Mitigating Disruptions from Ransomware Attacks
→ Organizations in biotech and healthtech face heightened risk of ransomware that can lock down critical lab instruments, clinical platforms, or patient data systems — leading to halted research, regulatory complications, compromised patient care, and expensive recovery efforts.
✔️ ISO 27001 enforces strict backup strategies, network segmentation, patch management, documented incident response and disaster recovery plans, ongoing monitoring, and regular testing to reduce attack impact, protect patient safety, and ensure swift restoration.
3️⃣ Complexity of Regulatory Compliance
→ Biotech and healthtech companies must comply with overlapping frameworks such as GDPR, HIPAA, FDA regulations, and EU MDR, each demanding stringent data protection, audit trails, and integrity measures. Without a unified security model, compliance risks multiply.
✔️ ISO 27001 serves as an overarching governance model — aligning security controls with diverse regulatory requirements, maintaining documented audit trails, and enabling cross-framework readiness.
4️⃣ Third-Party Risk & Supply Chain Vulnerabilities
→ Both industries rely extensively on third parties — CROs, labs, device manufacturers, cloud service providers — creating potential vulnerabilities from inconsistent controls or unauthorized access that may expose sensitive data or disrupt operations.
✔️ ISO 27001 mandates comprehensive management of supplier-related risks, including thorough risk assessments, binding contractual security requirements, strict access controls, continuous monitoring, and rigorous validation of supplier controls through regular audits and management reviews to ensure the security of the entire supply chain.
When Do You Need to Implement ISO 27001?
The short answer: sooner than you might think.
Whether you're developing diagnostics, managing clinical platforms, or building AI models on sensitive health data, the risks of delay are real — and increasingly costly.
In 2023, Enzo Biochem’s ransomware breach exposed 2.4 million patient records, triggered over $12 million in fines and settlements, and forced the company into costly security overhauls. A single failure in password hygiene unraveled trust, drained resources, and disrupted core R&D operations — a stark reminder of how one breach can derail a trajectory of a biotech or healthtech company.
Implement ISO 27001 when you:
Handle sensitive data such as PHI, genomic sequences, diagnostic results, or clinical trial records
Plan to enter regulated markets like the EU or U.S., where GDPR, HIPAA, FDA, or MDR requirements apply
Pursue Series B+ funding, enterprise clients, or pharma partnerships that demand demonstrable security practices
Experience a breach or near miss that exposes weak points in data protection or incident response
Receive ISO 27001 inquiries in due diligence, vendor assessments, or RFPs
BioAgilytix Labs – This bioanalytical laboratory pursued ISO 27001 in response to customer demand. As a “trusted partner to many top pharma and biotech companies..." - BioAgilytix was frequently asked to prove its security controls. Gaining certification in 2022 helped the lab satisfy client audits and demonstrate robust protection for the sensitive biologic data it handles.
Adopting ISO 27001 early helps reduce risk, streamline compliance efforts, and establish a security-first culture — all of which become strategic advantages as your company scales.
Case Study: See how RAKwireless achieved ISO 27001 to satisfy enterprise client audits and accelerate global expansion.
How to Define the Scope of Your ISMS
Your ISO 27001 scope defines the boundaries of your Information Security Management System (ISMS). For biotech and healthtech companies, it’s crucial to include all sensitive data, core operations, and supporting infrastructure — especially those tied to patient care, clinical research, diagnostics, or proprietary technology.
Here’s how to scope effectively:
Identify Critical Assets → Include all systems and processes handling intellectual property, patient health records, clinical trial data, connected devices, or R&D platforms.
Set Organizational Boundaries → For startups and smaller firms, scoping the entire company is often simplest. Larger organizations may limit scope to specific divisions, products, or regions based on structure and maturity.
Account for Infrastructure & Vendors → Include cloud environments, data centers, and key third-party services — especially CROs, SaaS platforms, or hosting providers that process or store regulated or sensitive data.
Atara Biotherapeutics faced a major setback in 2025 when the FDA placed a clinical hold on its key cell therapy trials due to serious violations at a third-party manufacturing facility. Days earlier, the agency had also refused approval of its lead therapy, citing the same compliance lapses. The outcome: halted patient enrollment, shaken investor confidence (stock dropped 4% pre-market), and costly remediation.
Exclude Only If Justified → Components should only be left out if they’re demonstrably isolated and have no impact on the systems, data, or processes within the ISMS scope.
Write a Clear Scope Statement → Clearly summarize what’s in scope (e.g., “clinical platform, lab IT, AWS infrastructure for Product X”) and what’s out of scope (e.g., HR, finance systems — if fully separate).
Your scope isn’t permanent — it can (and should) evolve as your business grows or changes. But getting it right from the start ensures a smoother audit process and better long-term risk management.
How to Choose the Right Certification Body
Your auditor isn’t just certifying compliance — they’ll be your long-term partner through the initial audit and annual reviews. Choose one who is accredited, experienced, and a strong fit for your team.
Use Accredited Bodies (e.g., ANAB, UKAS) to ensure global recognition and trust.
Prioritize Biotech or Healthcare Expertise so they understand your systems, data, and regulatory landscape.
Check Reputation through references and peer feedback.
Test the Fit via intro calls to assess clarity, audit style, and communication.
Validate Scope & Cost to avoid lowball quotes that skip essential work. The proposed audit days should match your size and complexity.
A good auditor strengthens your program, not just your paperwork.
💡 Trusted ISO 27001 auditors with experience in biotech and healthtech: BSI Group, NQA, Schellman, and Bureau Veritas. These accredited bodies are known for their work in regulated industries and are well-equipped to audit organizations handling sensitive health and research data.
Essential Technologies for Biotech & Healthtech Compliance
ISO 27001 compliance goes far beyond written policies — it requires strong technical controls to protect sensitive data such as genomic sequences, patient records, connected device outputs, and research IP. Core technologies include:
1️⃣ Identity & Access Management (IAM): Enforce role-based access, multi-factor authentication (MFA), and single sign-on (SSO) to restrict access based on job function.
→ E.g., CROs and clinical teams only access relevant trial data; developers can’t view PHI or raw genomic files.
Change Healthcare (2024) suffered a major ransomware attack after hackers accessed a Citrix remote desktop portal that lacked multi-factor authentication (MFA). The AlphV group used stolen credentials to infiltrate the network, exfiltrate data, and deploy ransomware, halting claims processing nationwide. The breach exposed critical IAM weaknesses and caused widespread healthcare disruptions across the U.S. healthcare system.
2️⃣ Encryption: Apply strong encryption (TLS, disk, and database-level) to safeguard data both at rest and in transit.
→ E.g., encrypt genomic datasets, diagnostic results, and patient health records on cloud platforms, lab systems, and mobile apps.
3️⃣ Network Security & Monitoring: segment lab, production, and clinical environments; apply firewalls and monitor activity using SIEM systems.
→ E.g., detect unusual data flows from IoT-enabled devices or unauthorized exports from isolated lab VLANs.
4️⃣ Endpoint Protection & Vulnerability Management: Use EDR, anti-malware tools, and regular patch cycles to secure workstations and medical endpoints.
→ E.g., protect lab equipment PCs and clinician tablets from exploitation through outdated software or malware.
5️⃣ Data Loss Prevention (DLP): Monitor and block unauthorized data transfers, and redact or mask sensitive information in test environments.
→ E.g., prevent staff from uploading clinical datasets or IP to personal cloud accounts; mask PHI in development sandboxes.
Pfizer (2021) sued a former employee in 2021 for allegedly stealing over 12,000 confidential files, including COVID-19 vaccine research and internal strategies, via personal cloud storage. The breach highlighted weaknesses in data loss prevention (DLP) controls. While no immediate operational shutdown occurred, the theft posed a significant threat to Pfizer’s intellectual property and competitive position, leading to federal litigation under trade secret laws.
6️⃣ Backup & Recovery: Implement automated, encrypted backups and conduct routine restore testing.
→ E.g., replicate health records and lab results to secure cloud backups to ensure continuity in case of outages or ransomware attacks.
These technologies are essential — but only effective when backed by strong policies, regular audits, and operational oversight. ISO 27001 auditors will look for documented evidence that these controls are active, enforced, and monitored consistently.
Core Criteria for ISO 27001 Certification
ISO 27001 certification isn’t just about having the right tools; it’s about proving that security is deeply embedded across your operations, from leadership strategy to everyday workflows.
For biotech and healthtech companies, this means aligning documentation, behaviors, and controls around how sensitive data — such as genomic sequences, patient health records, connected device outputs, or proprietary algorithms — is collected, stored, and protected.
To achieve and maintain certification, organizations must integrate security into governance, operations, and culture:
Management Commitment: Leadership must actively own the information security program by allocating resources, setting clear objectives, and aligning ISMS performance with strategic goals, whether scaling a digital health platform or expanding clinical research. Executive support is essential for adoption and accountability at all levels.
Risk Assessment: Biotech and healthtech firms must conduct structured risk assessments of critical assets — including PHI, genomic data, diagnostic platforms, and cloud environments — to identify vulnerabilities, assess impact, and apply appropriate controls to reduce exposure.
Information Security Policies: Organizations must define policies governing how sensitive data — such as IP, patient records, lab results, or AI training datasets — is handled and secured. These policies, aligned with ISO 27001 Annex A, should clearly define access control, data classification, incident response, and staff responsibilities, and be enforced across technical and operational teams.
Employee Awareness and Training: All staff — from lab scientists to app developers to clinical coordinators — must understand their role in protecting sensitive data. Targeted training and ongoing awareness help foster a culture of security and reduce risks like accidental disclosures or improper access.
Ongoing Monitoring and Review: The ISMS must be continuously assessed through audits, incident reviews, and performance monitoring. In dynamic environments where tools, partners, and regulations evolve quickly, this ensures controls remain effective and relevant.
Continuous Improvement: ISO 27001 is a long-term commitment. Biotech and healthtech companies must continually refine their controls, respond to audits and security events, and adapt to new technologies, threats, and compliance demands — protecting innovation while building stakeholder trust.
Case Study: See how MGID, a global AdTech leader, used ISO 27001 to align with GDPR - strengthening security controls and building trust with enterprise partners.
What are the ISO 27001 Costs & Timeline
Implementation cost and duration depend on company size, scope, complexity, and existing security maturity. Firms handling sensitive health data face closer audit scrutiny and higher costs.
Typical timeline for small to medium biotech or healthtech firms is approximately 6-8 months, with up to 12 months for larger or complex organizations.
Key Phases:
Scope Definition & Gap Analysis: 2–4 weeks
ISMS Development & Control Implementation: 2–6 months
Internal Audit & Remediation: 1-2 months
Certification Audit (Stage 1 & 2): 1–2 months
Post-certification, organizations undergo annual surveillance audits and a recertification audit every three years to maintain compliance.
Cost Breakdown:
Certification Audit - $10K–$30K+
Security Tools (SIEM, EDR, DLP, etc.): $5K–$25K
Consulting Support (Gaps, Docs, Controls): $20K–$50K+
Annual surveillance audits - $5K–$10K/year
Most early-stage teams lack internal InfoSec capacity. Consultants or vCISOs help fast-track readiness and prevent audit delays. Just ensure they’re independent from your auditor and fees are clearly scoped.
ISO 27001 Roadmap for Biotech & Healthtech Companies
ISO 27001 provides a clear, phased path to building a security program that scales with your data, your team, and your regulatory obligations.
Whether you're preparing for funding, expanding into new markets, or responding to client demands, the roadmap below outlines how to turn ISO 27001 from a requirement into a strategic asset:
Phased Approach:
Initiate → Appoint an internal lead, define the ISMS scope, and conduct a risk and gap assessment to baseline your current state.
Document → Develop core policies, procedures, and security documentation aligned with ISO 27001 Annex A — including controls for access, encryption, incident response, and supplier risk.
Implement → Roll out technical and operational controls, train personnel, assign roles and responsibilities, and ensure key processes are working day-to-day.
Internal Audit → Test ISMS effectiveness, identify nonconformities, and resolve gaps before the certification audit.
Management Review → Leadership formally evaluates ISMS performance, sets measurable objectives, and aligns the program with business priorities.
Certification Audit → Undergo Stage 1 and Stage 2 audits by an accredited certification body. Expect evidence-based validation and a report outlining any findings.
Maintain & Improve → Conduct annual surveillance audits, review risk assessments regularly, and keep evolving the ISMS to address new threats, technologies, and compliance needs.
Final Thoughts
For biotech and healthtech companies, protecting sensitive data isn’t optional; it’s foundational to patient safety, scientific credibility, and business success. ISO/IEC 27001 provides the structure, discipline, and global recognition needed to manage growing cybersecurity risks, meet the expectations of regulators and enterprise partners, and confidently scale into new markets.
Whether you’re managing clinical trials, processing genomic data, or building AI-driven diagnostics, a well-implemented ISMS helps unify your security efforts, reduce business risk, and demonstrate operational maturity to investors, clients, and regulators alike.
Companies that treat ISO 27001 as a strategic investment (not a reactive fix) position themselves to lead with trust, resilience, and long-term growth.
Take our ISO 27001 Self-Assessment Checklist
Assess yourself against Sekurno’s ISO 27001 “Technological Controls” Checklist – a practical guide to review your current security posture, identify control gaps, and benchmark your compliance readiness.
About Sekurno & The Author
Kristina Romanenko is an Information Security Account Manager at Sekurno and a certified ISO/IEC 27001 Implementer (PECB). With over 6 years of experience in IT and cybersecurity, Kristina helps organizations confidently navigate regulatory frameworks such as GDPR, CCPA, HIPAA, and ISO 27001. She supports clients in meeting compliance requirements, reducing risk exposure, and building long-term trust with customers and partners.
Sekurno is a globally recognised cybersecurity company specializing in Penetration Testing, Application Security, and Cybersecurity Compliance. At Sekurno, we are dedicated to reducing risks to the highest extent, ensuring high-risk industries like HealthTech and FinTech stand resilient against any threat.
You can contact us by submitting a request or booking a call here.
Additional Resources: Supporting ISO 27001 Implementation
While ISO/IEC 27001 sets the foundation for building an effective Information Security Management System (ISMS), these companion standards offer actionable guidance to ensure your controls are practical, measurable, and audit-ready.
ISO/IEC 27001:2022— Information security management systems — Requirements. The core certification standard. Outlines the requirements for establishing, implementing, maintaining, and continually improving an ISMS.
ISO/IEC 27002:2022— Code of Practice for Information Security Controls
A detailed companion to Annex A of ISO 27001. Provides implementation guidance and examples for each of the 93 security controls.
ISO/IEC 27003:2017— ISMS Implementation Guidance
Offers structured advice for planning and rolling out an ISMS — including project scoping, governance, and stakeholder engagement.
ISO/IEC 27005:2022 — Guidelines for Information Security Risk Management
A comprehensive framework for identifying, analyzing, and treating information security risks as part of your ISMS.
ISO/IEC 27004:2016 — Monitoring, Measurement, Analysis and Evaluation
Explains how to assess the effectiveness of your ISMS using KPIs, metrics, and performance indicators — key for internal reviews and audits.
