Maps to
IEC 81001-5-1: §5.2.1
Requirement text
The manufacturer shall establish an activity (or activities) for ensuring that security requirements are documented for the health software, including requirements for security capabilities related to installation, operation, maintenance, and decommissioning.
What changed
IEC 81001-5-1:2021 is the first standalone cybersecurity standard purpose-built for health software and medical device software. Published in December 2021, it was adapted from IEC 62443-4-1 (industrial control systems security) to address the unique safety and regulatory context of medical devices — adding 64 health-specific requirements that account for patient safety, clinical workflows, and the manufacturer-HDO relationship.
The standard mirrors IEC 62304's lifecycle structure but adds security-specific activities at every phase — planning, development, testing, release, and maintenance. It requires security risk management to be integrated with ISO 14971 safety risk management, not treated as a separate IT concern. FDA formally recognized it as Consensus Standard #13-112 in December 2022 and references it as providing a framework for the Secure Product Development Framework (SPDF) required by Section 524B.
EU MDR harmonization was originally targeted for May 2024 but postponed to May 2028. Despite this delay, Notified Bodies and Competent Authorities universally recognize it as "state of the art" for health software cybersecurity under MDR GSPR Annex I, Section 17.2. Missing or inadequate cybersecurity documentation is already a top cause of Notified Body major non-conformities for SaMD. A December 2025 Interpretation Sheet (ISH1:2025) clarified software item classification into maintained, supported, and required software categories, affecting risk transfer and post-market obligations.
Atomic constraints
- •Security requirements must be documented for the health software.
- •Requirements must cover security capabilities for installation.
- •Requirements must cover security capabilities for operation.
- •Requirements must cover security capabilities for maintenance.
- •Requirements must cover security capabilities for decommissioning.
Common gaps
Security requirements derived from checklists rather than threat models
majorSecurity requirements are copied from generic compliance checklists rather than derived from the product-specific threat model and security risk assessment. Functional requirements exist (e.g., 'Device shall connect to Wi-Fi') but security requirements (e.g., 'Device shall use WPA3 and certificate-based auth') are missing or not traceable.
Evidence signals
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FILE_EXISTS
Security.*Requirements|Cybersecurity.*Requirements|Software.*Requirements.*Specification
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CONTENT_MATCH
Does this document specify security requirements for the health software covering installation, operation, maintenance, and decommissioning phases?
Audit defense
The Security Requirements Specification for [your product] (Doc ID: [your document ID]) documents security capabilities for all life cycle phases from installation through decommissioning, providing the foundation for security design and verification activities.