Health informatics — Guidance on standards for enabling safety in health software

Health informatics and associated eHealth systems have significant potential to eliminate, reduce or mitigate documented threats to patient safety and quality of care. But they can also introduce safety risks.

This document provides guidance to National Member Bodies and readers by identifying a coherent set of international standards relevant to the development, implementation and use of safer health software. It provides guidance on the applicability of these standards towards enabling optimal safety in health software within overall risk management and quality management approaches, as well as within the lifecycle steps and processes of health-software development. It also addresses the health-software safety issues that remain as gaps or overlaps between or among the identified standards and discusses how those gaps and overlaps could be addressed by revising current standards or developing new ones.

Included is a framework (with mapped standards) to illustrate relevant standards and how they can be optimally applied. The mapping serves to demonstrate where gaps and overlaps in standards exist.

Main sections:

· Scope

· Health software safety

· Standards assessment and guidance

· Annex A: Patient safety benefits arising from eHealth investments

· Annex B: Standards analysis from a software lifecycle perspective

· Annex C: Scope information of safety-relevant JTC 1 standards