BS EN IEC 80001-1:2021 - Application of Risk Management for IT-Networks Incorporating Medical Devices

Standard Number: BS EN IEC 80001-1:2021

Pages: 42

Released: 2021-11-01

ISBN: 978 0 580 98363 4

Status: Standard

Overview

The BS EN IEC 80001-1:2021 standard is a comprehensive guide designed to ensure the safety, effectiveness, and security of IT-networks that incorporate medical devices. This standard is essential for healthcare providers, IT professionals, and medical device manufacturers who are involved in the implementation and use of connected medical devices or connected health software.

Key Features

• Comprehensive Risk Management: This standard provides a detailed framework for managing risks associated with IT-networks that incorporate medical devices. It covers all aspects of risk management, including identification, assessment, and mitigation of risks.
• Safety and Effectiveness: Ensures that connected medical devices and health software are safe and effective for use. It provides guidelines for maintaining the highest standards of patient safety and care.
• Security: Addresses the critical aspect of cybersecurity in healthcare IT-networks. It provides best practices for protecting sensitive patient data and ensuring the integrity of medical devices.
• Compliance: Helps organizations comply with regulatory requirements and industry standards. It is aligned with international standards, making it a valuable resource for global healthcare providers.
• Guidance for Implementation: Offers practical guidance for the implementation and use of connected medical devices and health software. It includes case studies and examples to illustrate best practices.

Why Choose BS EN IEC 80001-1:2021?

In today's interconnected world, the integration of medical devices with IT-networks is becoming increasingly common. However, this integration brings with it a range of risks that need to be carefully managed. The BS EN IEC 80001-1:2021 standard is designed to help organizations navigate these challenges and ensure the safe, effective, and secure use of connected medical devices.

By following the guidelines provided in this standard, healthcare providers can:

• Enhance patient safety by minimizing the risks associated with connected medical devices.
• Improve the effectiveness of medical treatments through the use of reliable and secure IT-networks.
• Protect sensitive patient data from cyber threats and ensure compliance with data protection regulations.
• Streamline the implementation process and reduce the time and cost associated with deploying connected medical devices.

Who Should Use This Standard?

The BS EN IEC 80001-1:2021 standard is intended for a wide range of stakeholders in the healthcare industry, including:

• Healthcare Providers: Hospitals, clinics, and other healthcare facilities that use connected medical devices and health software.
• IT Professionals: IT managers, network administrators, and cybersecurity experts responsible for managing healthcare IT-networks.
• Medical Device Manufacturers: Companies that design, develop, and manufacture connected medical devices and health software.
• Regulatory Authorities: Organizations responsible for overseeing the safety and effectiveness of medical devices and healthcare IT-networks.

Content and Structure

The BS EN IEC 80001-1:2021 standard is structured to provide a clear and comprehensive guide to risk management for IT-networks incorporating medical devices. It includes the following sections:

• Introduction: An overview of the standard and its objectives.
• Scope: Defines the scope of the standard and the types of IT-networks and medical devices it covers.
• Normative References: Lists the international standards and guidelines referenced in the document.
• Terms and Definitions: Provides definitions for key terms used in the standard.
• Risk Management Process: Detailed guidance on the risk management process, including risk assessment, risk control, and risk monitoring.
• Implementation Guidance: Practical advice for implementing the standard in healthcare IT-networks.
• Annexes: Additional information and resources, including case studies and examples.

Conclusion

The BS EN IEC 80001-1:2021 standard is an essential resource for anyone involved in the implementation and use of connected medical devices and health software. It provides a comprehensive framework for managing risks, ensuring safety and effectiveness, and protecting against cybersecurity threats. By following the guidelines in this standard, organizations can enhance patient safety, improve the effectiveness of medical treatments, and ensure compliance with regulatory requirements.

Invest in the BS EN IEC 80001-1:2021 standard today and take the first step towards a safer, more effective, and secure healthcare IT-network.

BS EN IEC 80001-1:2021

This standard BS EN IEC 80001-1:2021 Application of risk management for IT-networks incorporating medical devices is classified in these ICS categories:

• 35.240.80 IT applications in health care technology
• 11.040.01 Medical equipment in general

This document specifies general requirements for organizations in the application of risk management before, during and after the connection of a health it system within a health it infrastructure, by addressing the key properties of safety, effectiveness and security whilst engaging appropriate stakeholders.