BS EN ISO/IEEE 11073-40101:2022 Health informatics. Device interoperability Foundational. Cybersecurity. Processes for vulnerability assessment

Standard number: BS EN ISO/IEEE 11073-40101:2022

Pages: 58

Released: 2022-05-16

ISBN: 978 0 539 18828 8

Name: Health informatics. Device interoperability Foundational. Cybersecurity. Processes for vulnerability assessment

Status: Standard

Overview

In the rapidly evolving field of health informatics, ensuring the security and interoperability of medical devices is paramount. The BS EN ISO/IEEE 11073-40101:2022 standard provides a comprehensive framework for assessing vulnerabilities in health informatics systems. This standard is essential for healthcare providers, device manufacturers, and cybersecurity professionals who are committed to maintaining the highest levels of security and interoperability in their systems.

Key Features

• Comprehensive Coverage: Spanning 58 pages, this standard offers an in-depth look at the processes required for vulnerability assessment in health informatics.
• Up-to-Date Information: Released on May 16, 2022, this standard incorporates the latest advancements and best practices in the field.
• Global Recognition: As a BS EN ISO/IEEE standard, it is recognized and respected worldwide, ensuring that your systems meet international benchmarks.
• ISBN: 978 0 539 18828 8, making it easy to reference and locate in academic and professional settings.

Why This Standard is Essential

The healthcare industry is increasingly reliant on interconnected devices and systems. While this connectivity offers numerous benefits, it also introduces potential vulnerabilities that can compromise patient safety and data integrity. The BS EN ISO/IEEE 11073-40101:2022 standard provides a structured approach to identifying and mitigating these vulnerabilities, ensuring that healthcare providers can deliver safe and effective care.

Interoperability

One of the core focuses of this standard is device interoperability. In a healthcare setting, devices from different manufacturers must work seamlessly together to provide accurate and timely information. This standard outlines the foundational requirements for achieving this interoperability, ensuring that devices can communicate effectively and reliably.

Cybersecurity

Cybersecurity is a critical concern in health informatics. With the increasing prevalence of cyber threats, it is essential to have robust processes in place to protect sensitive patient data and ensure the integrity of medical devices. The BS EN ISO/IEEE 11073-40101:2022 standard provides detailed guidelines for assessing and addressing cybersecurity vulnerabilities, helping organizations to safeguard their systems against potential attacks.

Who Should Use This Standard?

This standard is designed for a wide range of stakeholders in the healthcare industry, including:

• Healthcare Providers: Ensure that your systems and devices are secure and interoperable, providing the best possible care for your patients.
• Device Manufacturers: Develop products that meet international standards for security and interoperability, enhancing your reputation and marketability.
• Cybersecurity Professionals: Gain a comprehensive understanding of the processes required to assess and mitigate vulnerabilities in health informatics systems.
• Regulatory Bodies: Ensure that healthcare providers and device manufacturers comply with the latest standards, promoting a safer and more secure healthcare environment.

Conclusion

The BS EN ISO/IEEE 11073-40101:2022 standard is an invaluable resource for anyone involved in the field of health informatics. By providing a detailed framework for assessing and addressing vulnerabilities, it helps to ensure the security and interoperability of medical devices and systems. Whether you are a healthcare provider, device manufacturer, cybersecurity professional, or regulatory body, this standard will help you to maintain the highest levels of security and efficiency in your operations.

BS EN ISO/IEEE 11073-40101:2022

This standard BS EN ISO/IEEE 11073-40101:2022 Health informatics. Device interoperability is classified in these ICS categories:

• 35.240.80 IT applications in health care technology

Within the context of secure plug-and-play interoperability, cybersecurity is the process and capability of preventing unauthorized access or modification, misuse, denial of use, or the unauthorized use of information that is stored on, accessed from, or transferred to and from a PHD/PoCD. The process part of cybersecurity is risk analysis of use cases specific to a PHD/PoCD. For PHDs/PoCDs, this standard defines an iterative, systematic, scalable, and auditable approach to identification of cybersecurity vulnerabilities and estimation of risk. This iterative vulnerability assessment uses the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme and the embedded Common Vulnerability Scoring System (eCVSS). The assessment includes system context, system decomposition, pre-mitigation scoring, mitigation, and post-mitigation scoring and iterates until the remaining vulnerabilities are reduced to an acceptable level of risk.