Framework
IECIEC 82304-1:2016
IEC 82304-1 defines the requirements for the lifecycle of health software products, covering software that is not part of a medical device but is intended for use in healthcare. It addresses the full lifecycle from design and development through maintenance and decommissioning, establishing quality and safety requirements for standalone health software.
Overview
Background
Published by the International Electrotechnical Commission (IEC), this standard was created to address the growing prevalence of standalone health software products that fall outside the scope of traditional medical device software standards like IEC 62304. It provides a comprehensive framework that references IEC 62304 for development processes while adding product-level lifecycle requirements.
Applicability
This standard applies to the safety and security of health software products intended to operate on general computing platforms such as mobile devices, desktop computers, and cloud infrastructure. It covers health software products used by healthcare professionals, patients, and consumers, including clinical decision support tools, health monitoring applications, and wellness software that meets the definition of health software.