ISO 81001-5-1 – Health Software Cybersecurity – Development Life Cycle Requirements

ISO 81001-5-1:2021 is an international standard that defines cybersecurity requirements for the development and maintenance of health software. It applies throughout the software life cycle and ensures secure design, development, testing, and support for health IT systems. It complements other standards like ISO/IEC 27001, IEC 62304, and ISO 14971.

Why ISO 81001-5-1 Matters

• Protects patient safety by ensuring health software is developed with cybersecurity in mind.
• Reduces the risk of data breaches, system compromises, and service interruptions in digital health environments.
• Supports compliance with regulatory frameworks such as MDR, IVDR, and GDPR.

Scope of Application

• Applies to health software developers, including medical device software (SaMD), EHR systems, mobile health apps, and clinical decision support tools.
• Covers all software life cycle stages, including planning, development, validation, release, maintenance, and decommissioning.

Key Requirements

• Security Risk Management: Integrate cybersecurity risk assessments into the software development process.
• Secure Design Principles: Apply concepts like least privilege, data minimization, and secure default settings.
• Threat Modeling & Risk Control: Identify and address potential attack vectors.
• Vulnerability Management: Establish processes to detect and resolve security flaws.
• Documentation & Traceability: Ensure clear traceability between risks, requirements, and controls.
• Testing & Verification: Perform security-focused validation and penetration testing.

Benefits of Implementing ISO 81001-5-1

• Ensures cyber resilience of software used in clinical environments.
• Enhances patient trust and market access by aligning with international best practices.
• Reduces product recalls and post-market cybersecurity incidents.

Relation to Other Standards

Works in tandem with:

• IEC 62304 – Software lifecycle processes.
• ISO 14971 – Risk management for medical devices.
• ISO/IEC 27001 – Information security management systems.

Our Services

• Gap analysis and implementation roadmap.
• Secure SDLC process development.
• Cybersecurity risk analysis – Threat modelling.
• Cybersecurity risk workshops tailored to health software teams.
• ISO 81001-5-1 training for developers and QA professionals.

Contact information

For help with 81001-5-1 Health Software Cybersecurity compliance, email us at steven@clauwaert.dk or use the contact form.