Healthcare organizations are subject to strict data privacy regulations, such as the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA), which protect patient privacy and data. Since the end of the year 2024, the European Union’s Network and Information Security Directive 2 (NIS 2) adds an additional layer of cybersecurity regulations which Ethical is committed to comply with. Here’s why and how.
As the cyber threat landscape continues to evolve, so do regulatory expectations — and the European Union’s Network and Information Security Directive 2 (NIS 2) marks a major shift. This updated directive seeks to strengthen the collective cybersecurity and cyber resilience level of EU member states.
With the potential for fatal real-life consequences in case of a successful cyberattack, the health sector is deemed “essential” under the NIS2 Directive, subjecting it to the Directive’s toughest requirements and obligations.
What Is the NIS 2 Directive?
The Network and Information Security Directive 2 (NIS 2) is the EU’s strengthened cybersecurity legislation that replaces the original NIS Directive from 2016. It expands coverage from the original 7 sectors, adding 8 more for a total of 15 sectors and introduces stricter requirements, and higher penalties for non-compliance.
The official deadline for EU Member States to transpose NIS 2 into national legislation was October 17, 2024. However, implementation has been uneven, with not all countries completing transposition on time. Despite this fragmentation, proactive organizations have already aligned with its expectations.
Core Requirements
Entities covered by NIS 2 are expected to implement robust measures including:
- Cybersecurity risk management policies
- 24-hour incident detection and reporting protocols
- Business continuity and disaster recovery strategies
- Strong access control and secure supply chain management
NIS2 also requires corporate management to oversee, approve, and be trained on the entity's cybersecurity measures and to address cyber risks.
For organizations falling under the category of “essential entities”, such as organizations in the health sector, penalties for non-compliance can reach up to €10 million or 2% of global annual turnover, whichever is higher.
Why It Matters for Clinical Trials
Clinical research generates and handles highly sensitive data, from intellectual property to patient-level health information and trial results. A breach doesn’t just threaten data privacy, it could derail an entire trial or compromise the regulatory submission process.
Risks include:
- Cyberattacks on trial data systems or EDC platforms
- Disruption of trial continuity due to ransomware
- Exposure of patient-identifying information
- Delays in approval processes due to non-compliant infrastructure
For companies governed by GxP standards, failure to comply with NIS 2 may also raise flags with regulators like the EMA or FDA, especially if data integrity or audit trails are compromised.
What About US-Based Sponsors and CROs?
Even if your company is based in the United States, NIS 2 may still affect you. If your organization operates within the EU, or relies on EU-based vendors (like EDC providers, CTMS platforms, Clinical Committee software platforms, or trial sites), you could fall under the regulation’s reach through your European footprint or supply chain.
Aligning your cybersecurity posture with both US regulations (e.g., HIPAA, 21 CFR Part 11) and NIS 2 ensures not only regulatory harmonization but also builds partner and patient trust across markets.
How Ethical Helps You Meet NIS 2 Expectations
In this high-stakes environment, compliance is not optional, it’s strategic. At Ethical, we are committed to providing clinical trial platforms that are secure, compliant, and audit-ready. Ethical’s leadership actively oversees information security and risk management programs, ensuring board-level awareness and engagement as required under NIS2. Furthermore, our software and processes are aligned with recognized international standards and best practices:
- Information Security Management certified to ISO 27001
- Software development and validation aligned with EU-GMP Annex 11 and GAMP 5 guidelines
- Compliance with 21 CFR Part 11 requirements for electronic records and signatures
- Built-in role-based access control, encryption, audit trail, and digital signature capabilities
- Support for incident response protocols and disaster recovery planning
In conclusion, with the right systems in place, compliance can become a differentiator, signaling that your organization is trustworthy, forward-looking, and prepared for the future of clinical development. Start by engaging with technology partners that understand your needs!
📍 Learn how the NIS2 directive affects organizations in the health sector: https://nis2directive.eu/health/
At Ethical, we are committed to helping you navigate cybersecurity with confidence, wherever your trials run. Want to find out more? Please contact us through the form below.
