T/ZMDS 20007-2023 Active

Scope: This document provides principles, concepts, terminology, and definitions for health software and health IT systems, as well as key attributes of safety, effectiveness, and cybersecurity throughout their lifecycle from concept to decommissioning, as shown in Figure 1. It also identifies transition points during the lifecycle where responsibility shifts occur and the types of multilateral communication necessary at these transition points. The document establishes unified concepts and standard terminology for other dedicated standards addressing safety, effectiveness, and cybersecurity (including privacy protection) related to health software and health IT systems. Main technical content: This article takes into account the increasingly complex internal and external environments in the healthcare sector, including people, technology (hardware/software), organizations, processes, and external environments. Managing the safety, effectiveness, and cybersecurity of health software and health IT systems (including medical devices) requires a comprehensive and coordinated approach to optimize these three attributes. It provides principles, concepts, terminology, and definitions for health software and health IT systems, as well as key attributes of safety, effectiveness, and security throughout their lifecycle from concept to decommissioning. This article identifies transition points during the lifecycle where responsibility shifts occur and the types of multilateral communication necessary at these transition points. It establishes consistent concepts and terminology for other standards (ISO 81001 series standards, ISO 80001 series standards) addressing safety, effectiveness, and security (including privacy) related to health software and health IT systems. Many organizations and roles participate in the entire lifecycle of health software and health IT systems. Therefore, a common understanding of concepts, principles, and terminology is essential for standardizi