IEC 81001-5-1:2021

IEC 81001-5-1 defines the activities and tasks necessary to maintain the security of health software throughout its lifecycle. It provides a comprehensive framework for health software manufacturers to implement security practices from design through decommissioning, covering threat modeling, secure coding, vulnerability management, and incident response specific to the healthcare domain.

Overview

Background

Published by the International Electrotechnical Commission (IEC), this standard was developed specifically to address the cybersecurity needs of health software and health IT systems. It builds on concepts from IEC 62443-4-1 but is tailored to the unique requirements of the healthcare sector, where cybersecurity failures can directly impact patient safety and data privacy. It has become a key harmonized standard under the EU MDR and IVDR.

Applicability

This standard applies to manufacturers of health software, including software that is a medical device (SaMD), software that is part of a medical device, and other health IT systems. It is particularly relevant for manufacturers seeking conformity with the EU MDR and IVDR cybersecurity requirements and is recognized by regulatory authorities worldwide as a benchmark for health software security lifecycle management.

Core Principles

Security risk management integration

Threat modeling and security architecture

Secure design and coding practices

Security testing and verification

Vulnerability and patch management

Security incident response planning

Post-market security monitoring

Security documentation and transparency