Navigating IEC 81001-5-1 Requirements for Health Software

Connected medical devices, software as a medical device (SaMD), health IT applications and cloud-connected clinical systems can introduce cybersecurity risks that affect software confidentiality, integrity and availability. These risks may ultimately affect patient safety and clinical effectiveness.

To help mitigate this risk, the IEC 81001-5-1 standard establishes cybersecurity life cycle requirements for health software and health IT systems. IEC 81001-5-1 draws on principles from IEC 62443-4-1 and aligns with established medical device software processes, including IEC 62304 and ISO 14971.

Our white paper examines the standard’s key requirements and details how the IECEE CB Scheme, a global system for the mutual recognition of test reports and certificates. Under the scheme, manufacturers can use a single conformity assessment as part of the certification and approval processes in multiple participating markets.

Find out more about IEC 81001-5-1 and the IECEE CB Scheme

Our white paper explores key areas of the standard, including:

• Governance and quality management – Cybersecurity responsibilities, training and vulnerability disclosure
• Security risk management – Threat modeling, vulnerability identification and risk assessment
• Secure development life cycle – Secure design, coding and software analysis practices
• Security verification and validation – Security, vulnerability and attack surface testing
• Post-market cybersecurity – Vulnerability monitoring, security updates and maintenance

Explore the whitepaper to learn more and feel free to reach out to our team for more information.