Why IEC 81001-5-1:2021 is Necessary

Relationship with IEC 62304

IEC 81001-5-1:2021 defines additional cybersecurity-specific activities and tasks that build upon the processes specified in IEC 62304 “Medical device software – Software life cycle processes.” This approach enables effective implementation of security measures while maintaining consistency with established software life cycle processes.

The standard was developed by adapting IEC 62443-4-1, which was originally designed for Industrial Automation and Control Systems (IACS), to address the specific needs of health software and medical devices. This adaptation ensures that cybersecurity requirements are appropriately tailored to the healthcare context while leveraging proven industrial security frameworks.

For proper implementation of cybersecurity measures, it is essential to appropriately map security-related terminology to existing processes and add necessary security-related activities. Of particular importance, manufacturers are required to establish and continuously maintain a security risk management process for health software as part of their product risk management approach (Section 7.1.1).

Necessity of the Standard

Foundation in IEC 62443-4-1 and ISO 14971

IEC 81001-5-1:2021 provides a comprehensive framework by combining two fundamental approaches: it adapts the secure product development requirements from IEC 62443-4-1 specifically for health software, and it aligns cybersecurity risk management with the established ISO 14971 “Application of risk management to medical devices” process framework.

When implementing cybersecurity risk management for medical devices, manufacturers must follow the ISO 14971 process framework while appropriately addressing cybersecurity-specific concepts and terminology. In other words, IEC 81001-5-1:2021 manages cybersecurity risks according to the ISO 14971 process, using cybersecurity-aligned terminology.

The following table illustrates the conceptual mapping between traditional safety risk management and cybersecurity risk management:

ISO 14971 Concept	IEC 81001-5-1 Cybersecurity Equivalent
Hazard	Security vulnerability (weakness in system)
Hazardous situation	Threat (potential exploitation of vulnerability)
Harm	Security incident / Cyber attack impact

By establishing these conceptual correspondences, manufacturers can appropriately manage cybersecurity risks within their existing risk management frameworks.

It should be noted that while IEC 81001-5-1 focuses on process requirements for secure software development life cycle activities, the complementary technical report IEC TR 60601-4-5 provides specific technical security requirements. IEC TR 60601-4-5 introduces Security Levels (SL 0-4) that classify devices based on their risk profile and Security Capabilities (SC) that define the technical functions devices must implement. Together, these documents provide both the “how to” (process requirements) and the “what” (technical requirements) for medical device cybersecurity.

Integration with Existing Processes

Medical device manufacturers are typically already implementing software life cycle processes and risk management processes in accordance with standards such as IEC 62304 and ISO 14971. Recognizing this reality, IEC 81001-5-1:2021 adopts an approach of adding cybersecurity-related activities to existing process frameworks rather than specifying an entirely new security life cycle process from scratch. This enables manufacturers to efficiently implement cybersecurity measures while leveraging their existing processes and quality management systems.

The standard is designed to complement and extend existing processes, allowing manufacturers to integrate security activities into their established IEC 62304 software development activities, ISO 13485 quality management system requirements, and ISO 14971 risk management procedures. This integrated approach reduces duplication, maintains consistency across documentation, and enables more efficient resource allocation.

Concrete Examples and Analysis of Threats

Major threats to medical devices include the following examples:

First, there is unauthorized access that involves improper intrusion into medical devices or systems, which can lead to patient data breaches or device malfunctions. Next, Distributed Denial of Service (DDoS) attacks can cause medical devices or systems to stop functioning, potentially resulting in serious disruptions to medical service delivery. Additionally, threats exist from malware attacks, infections, and propagation that can affect entire medical networks, as well as ransomware that encrypts or destroys data.

These threats must be analyzed using a systematic approach called threat modeling. Threat modeling comprehensively evaluates assumed attackers, attack methods, assets that could be affected, and feasible countermeasures. This analysis enables prioritization of effective security measures and construction of optimal defense strategies within limited resources.

When conducting threat modeling, manufacturers should consider multiple factors including the device’s intended use environment, network connectivity characteristics, data sensitivity levels, and potential impact on patient safety. The analysis should account for both intentional malicious attacks and unintentional security compromises due to human error or system failures.

Continuous Improvement of Security Measures

Because cybersecurity threats are constantly evolving, periodic evaluation and updates are essential. Security measures need to be continuously reviewed and improved in response to new vulnerability discoveries, evolution of attack methods, and advances in medical technology.

Therefore, risk management based on IEC 81001-5-1:2021 should be implemented not as a one-time response but as a continuous process throughout the product life cycle. This includes pre-market development activities as well as critical post-market surveillance activities such as vulnerability monitoring, security patch management, incident response planning, and continuous threat intelligence gathering.

Current Regulatory Landscape

The adoption and implementation timeline for IEC 81001-5-1:2021 varies by region:

Japan: The standard has been enforced since 2024 for medical device approvals through the Pharmaceuticals and Medical Devices Agency (PMDA), making it mandatory for market access.

European Union: While the standard is on track for harmonization under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), the process has experienced delays. The current target date for harmonization is May 2028. However, Notified Bodies are already advising manufacturers to implement IEC 81001-5-1 as representing the “state of the art” in cybersecurity practices.

United States: The FDA strongly encourages the use of IEC 81001-5-1 and cross-references it in multiple cybersecurity guidance documents. While not yet mandatory, the FDA has signaled its intention to require manufacturers to integrate cybersecurity documentation into regulatory submissions. The FDA’s recognition of related standards such as IEC 62443-4-1 and AAMI TIR57:2016 demonstrates the regulatory alignment with these cybersecurity frameworks.

Given this regulatory landscape, early adoption of IEC 81001-5-1:2021 is recommended for manufacturers seeking global market access. Proactive implementation not only prevents future compliance gaps but also demonstrates commitment to patient safety and product security, which is increasingly important for procurement decisions by healthcare facilities and payers.

Practical Implementation Considerations

Implementing IEC 81001-5-1:2021 requires manufacturers to integrate security activities across multiple domains:

Security Risk Management: Establish processes to identify, analyze, evaluate, control, and monitor security risks throughout the product life cycle, integrated with the overall ISO 14971 risk management process.

Secure Development Practices: Implement secure coding standards (such as MISRA C or CERT C/C++), conduct security-focused code reviews, utilize automated static analysis tools, and maintain software composition analysis for third-party components.

Verification and Validation: Perform security testing including vulnerability assessments and penetration testing, ideally conducted by independent evaluators to ensure objectivity and thoroughness.

Documentation: Maintain comprehensive documentation including the intended product security context, security risk management files, security architecture specifications, and security verification and validation records.

Post-Market Activities: Establish robust processes for vulnerability monitoring, coordinated vulnerability disclosure, security patch management, and incident response planning.

The standard emphasizes that these security activities must be proportionate to the identified security risks and integrated seamlessly with existing quality management and software development processes. Manufacturers should assess their current practices against the standard’s requirements, conduct gap analyses, and develop phased implementation plans that align with their product roadmaps and regulatory timelines.

Conclusion

IEC 81001-5-1:2021 represents a significant advancement in medical device cybersecurity by providing a structured, healthcare-specific framework that builds upon established industrial security practices and integrates with existing medical device standards. By adopting this standard, manufacturers can systematically address cybersecurity risks while maintaining the critical balance between safety, effectiveness, and security that is essential for modern medical devices. As connected healthcare continues to expand, implementation of comprehensive cybersecurity practices based on IEC 81001-5-1:2021 is becoming not just a regulatory requirement but a fundamental responsibility for protecting patient safety and maintaining trust in medical technologies.