Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle

This document defines the life cycle requirements for development and maintenance of health software needed to support conformance to IEC 62443-4-1, which concerns security for industrial automation and control systems.

The set of processes, activities and tasks described in this document establishes a common framework for secure health software life cycle processes and end products. The balance between safety, effectiveness and security, as set out in ISO 81001-1, is considered.

Main sections:

· Structure

· Field of application

· Conformance

· Scope

· Normative references

· General requirements

· Software development process

· Security risk management process

· Software configuration management

· Software problem resolution process