ISO 81001-1:2021 Health Software And Health IT Systems Safety, Effectiveness And Security
ISO 81001-1:2021 is a standard developed by the International Organization for Standardization (ISO) titled “Health software and health IT systems – Part 1: Fundamental concepts, principles and requirements.” It addresses the safety, effectiveness, and security of health software and health information technology (IT) systems.
Here’s a breakdown of what this standard entails:
1. **Scope**: The standard outlines fundamental concepts, principles, and requirements related to health software and health IT systems. It provides guidance on ensuring the safety, effectiveness, and security of these systems within the healthcare domain.
2. **Definitions**: It establishes clear definitions of terms relevant to health software and health IT systems to ensure common understanding among stakeholders.
3. **Fundamental Concepts**: ISO 81001-1:2021 discusses fundamental concepts related to health software and health IT systems, such as risk management, usability, interoperability, and lifecycle management.
4. **Principles**: The standard lays out principles that should guide the development, implementation, and maintenance of health software and health IT systems. These principles typically include considerations for patient safety, data security, regulatory compliance, and continuous improvement.
5. **Requirements**: It specifies requirements that organizations involved in the development, deployment, and management of health software and health IT systems should adhere to. These requirements may encompass aspects such as risk assessment, validation and verification, documentation, and user training.
6. **Safety**: ISO 81001-1:2021 emphasizes the importance of ensuring the safety of health software and health IT systems to minimize the risk of adverse events or harm to patients, healthcare providers, and other stakeholders.
7. **Effectiveness**: The standard addresses the effectiveness of health software and health IT systems in meeting their intended purpose and delivering expected outcomes within healthcare settings.
8. **Security**: Security considerations are integral to ISO 81001-1:2021, with provisions for safeguarding health data, protecting against unauthorized access or malicious activities, and ensuring the integrity and confidentiality of information processed by these systems.
Overall, ISO 81001-1:2021 provides a comprehensive framework for addressing the unique challenges and requirements associated with health software and health IT systems, aiming to promote their safe, effective, and secure use in healthcare delivery and management. Organizations involved in the development, deployment, or use of such systems can use this standard to guide their practices and ensure compliance with industry best practices and regulatory requirements.
This document provides the principles, concepts, terms and definitions for health software and health IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to decommissioning, as represented in Figure 1. It also identifies the transition points in the life cycle where transfers of responsibility occur, and the types of multi-lateral communication that are necessary at these transition points. This document also establishes a coherent concepts and terminology for other standards that address specific aspects of the safety, effectiveness, and security (including privacy) of health software and health IT systems.
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