Governance, risk & compliance

IEC 81001-5-1 Health Software Security Life Cycle 2021

The standard that defines what a secure development life cycle looks like for health software and health IT, published 2021.

It sets requirements for the organization running the process (clause 4), for the software development process itself - security requirements, secure architecture, implementation, verification, release, and the software bill of materials (clause 5) - and for maintenance of the released product: monitoring for security problems, resolving them, distributing updates, and communicating end of support (clause 6). It is the standard both FDA and Health Canada expect a manufacturer to be working from, and unlike the Joint Security Plan it is something a manufacturer declares conformity to.

It governs HOW the software is built and maintained; it does not tell you what goes in a submission, which is section 524B, and it is not a quality management system, which is ISO 13485 and QMSR.

Assessment tiers & levels Lavawall supports

Lavawall assesses IEC 81001-5-1 Health Software Security Life Cycle at every level below, so you can start where you are and step up as your program matures.

How Lavawall® helps you get to IEC 81001-5-1 Health Software Security Life Cycle compliance

Most of IEC 81001-5-1 Health Software Security Life Cycle comes down to technical controls you have to run and prove: keeping systems patched, hardening configuration, detecting breaches early, backing up what matters, controlling access, and keeping evidence that all of it actually happened. Lavawall® runs those controls across Windows, macOS, Linux, and Microsoft 365 / Google Workspace from one console, maps them to IEC 81001-5-1 Health Software Security Life Cycle, and tracks your posture continuously instead of once a year at audit time.

• Assess your current state against IEC 81001-5-1 Health Software Security Life Cycle in the Lavawall GRC module, with the questionnaire and control set built in.
• Remediate the gaps with the same platform — automated patching, configuration fixes, backups, and access review — not a separate project.
• Evidence everything with timestamped, exportable records auditors, insurers, and clients accept.

Related

Lavawall® supports IEC 81001-5-1 Health Software Security Life Cycle as part of a built-in catalogue of compliance frameworks. Framework requirements are summarized for planning purposes; always confirm the current official text before certifying.