This document defines the life cycle requirements for development and maintenance of health software needed to support conformance to IEC 62443–4–1[11] – taking the specific needs for health software into account. The set of processes, activities, and tasks described in this document establishes a common framework for secure health softwarelife cycleprocesses. An informal overview of activities for health software is shown in Figure 2.

The purpose is to increase the cybersecurity of health software by establishing certain activities and tasks in the health softwarelife cycleprocesses and also by increasing the security of softwarelife cycleprocesses themselves.

It is important to maintain an appropriate balance of the key properties safety, effectiveness and security as discussed in ISO 81001–1[17].

This document excludes specification of accompanying documentation contents.