PD ISO/TS 81001-2-1:2025 Health Software and Health IT Systems Safety, Effectiveness and Security Coordination

Standard Number: PD ISO/TS 81001-2-1:2025

Pages: 58

Release Date: January 15, 2025

ISBN: 978 0 539 17684 1

Status: Standard

Overview

In the rapidly evolving world of healthcare technology, ensuring the safety, effectiveness, and security of health software and IT systems is paramount. The PD ISO/TS 81001-2-1:2025 standard provides comprehensive guidance and requirements for the use of assurance cases to achieve these critical objectives. This standard is an essential resource for professionals involved in the development, implementation, and management of health IT systems.

Why Choose PD ISO/TS 81001-2-1:2025?

This standard is meticulously crafted to address the unique challenges faced by health IT systems. It offers a structured approach to demonstrating the safety and security of health software, ensuring that these systems can be trusted by healthcare providers and patients alike. By adhering to the guidelines set forth in this standard, organizations can enhance their compliance with regulatory requirements and improve the overall quality of their health IT solutions.

Key Features

• Comprehensive Guidance: Provides detailed instructions on creating and maintaining assurance cases for health software and IT systems.
• Focus on Safety and Security: Emphasizes the importance of safety and security in health IT systems, offering strategies to mitigate risks.
• Effectiveness Assurance: Ensures that health software not only meets safety and security standards but also delivers effective performance.
• Regulatory Compliance: Helps organizations align with international standards and regulatory requirements, reducing the risk of non-compliance.
• Structured Approach: Offers a clear framework for developing assurance cases, making it easier for organizations to implement and maintain.

Who Can Benefit?

The PD ISO/TS 81001-2-1:2025 standard is designed for a wide range of stakeholders in the healthcare industry, including:

• Healthcare IT Professionals: Gain insights into best practices for ensuring the safety and security of health IT systems.
• Software Developers: Learn how to integrate safety and security considerations into the software development lifecycle.
• Regulatory Bodies: Use the standard as a benchmark for evaluating the compliance of health IT systems.
• Healthcare Providers: Ensure that the IT systems they rely on are safe, secure, and effective.

Enhancing Trust in Health IT Systems

Trust is a cornerstone of effective healthcare delivery. With the PD ISO/TS 81001-2-1:2025 standard, organizations can build and maintain trust by demonstrating their commitment to safety and security. This standard provides a robust framework for developing assurance cases that clearly articulate the safety and security measures in place, giving stakeholders confidence in the systems they use.

Conclusion

The PD ISO/TS 81001-2-1:2025 standard is an invaluable tool for any organization involved in the development or management of health IT systems. By following its guidance, organizations can ensure that their systems are not only compliant with international standards but also capable of delivering safe, secure, and effective healthcare solutions. Embrace this standard to enhance the quality and reliability of your health IT systems, and ultimately, improve patient outcomes.

PD ISO/TS 81001-2-1:2025

This standard PD ISO/TS 81001-2-1:2025 Health software and health IT systems safety, effectiveness and security is classified in these ICS categories:

• 35.240.80 IT applications in health care technology