Health Software Security Testing & VA/PT for IEC 81001-5-1 Compliance | Cyber Risk Experts in Canada

Overview

Canada’s healthcare sector is rapidly adopting connected health software, Software as a Medical Device (SaMD), cloud-based healthcare platforms, and telemedicine solutions. These digital systems improve patient care, operational efficiency, and clinical workflows but also introduce cybersecurity risks that can impact patient safety, data confidentiality, and regulatory compliance.

IEC 81001-5-1 provides comprehensive guidance for managing cybersecurity risks across the lifecycle of medical device and health software systems. It covers secure design, development, verification, deployment, operation, and post-market maintenance.

Cyberintelsys, a CREST-accredited cybersecurity company, offers Vulnerability Assessment (VA) and Penetration Testing (PT) services to help organisations achieve IEC 81001-5-1 compliance for health software in Canada.

Why IEC 81001-5-1 Compliance Matters in Canada?

Health software systems are highly targeted due to access to sensitive patient data and integration with hospitals and healthcare networks. Cyber threats can compromise patient safety, disrupt healthcare operations, and lead to regulatory non-compliance.

Key cybersecurity risk areas include:

  • Weak authentication and access control

  • Insecure APIs and cloud integrations

  • Insufficient encryption and session management

  • Vulnerable mobile and telemedicine applications

  • Third-party software and supply chain risks

IEC 81001-5-1 ensures organisations:

  • Implement structured cybersecurity risk management

  • Embed security across the software lifecycle

  • Protect patient safety and sensitive data

  • Demonstrate due diligence for HIPAA and PIPEDA compliance

  • Enhance trust among healthcare providers and patients

Importance of VA/PT for Health Software

VA/PT ensures health software is secure, compliant, and resilient against real-world cyber threats.

Key Objectives

  • Identify vulnerabilities during design and development

  • Validate cloud, API, and mobile application security

  • Ensure compliance with IEC 81001-5-1 and Canadian healthcare regulations

  • Mitigate operational, safety, and reputational risks

Cyberintelsys Approach to VA/PT for IEC 81001-5-1

Cyberintelsys follows a structured, CREST-aligned methodology tailored for health software.

1. Scoping & Asset Mapping

  • Identify software components: desktop, cloud, APIs, and mobile

  • Map patient data flows and authentication paths

  • Define controlled testing boundaries

Deliverables: Scope document, asset inventory, and risk assessment plan

2. Threat Modelling & Risk Analysis

  • Identify potential threats using STRIDE and MITRE ATT&CK

  • Assess potential impact on patient safety, data integrity, and system availability

Deliverables: Threat model diagrams and cybersecurity risk register

3. Vulnerability Assessment (VA)

  • Automated scanning and manual code review

  • Assessment of third-party libraries and cloud configurations

  • Validation of encryption, secure storage, and data handling

Output: VA report with severity ratings, CVSS scores, and remediation recommendations

4. Penetration Testing (PT)

  • Application-layer testing (OWASP Top 10)

  • API testing focusing on authentication, authorisation, and data exposure

  • Cloud and infrastructure security assessments

  • Mobile application security testing for Android and iOS

Deliverables: Proof-of-concept exploitation report

5. Risk Prioritisation & Remediation

  • Prioritise findings based on severity, likelihood, and patient safety relevance

  • Provide actionable mitigation guidance

6. Compliance Reporting & Documentation

7. Retesting & Continuous Improvement

  • Verify remediation effectiveness through retesting

  • Continuous security monitoring and lifecycle improvements

Benefits of Cyberintelsys VA/PT Services in Canada

Regulatory & Compliance Readiness

  • Aligns testing with IEC 81001-5-1 and Canadian healthcare regulations

  • Supports HIPAA, ISO, and NIST compliance

  • Audit-ready documentation for healthcare regulators and partners

Patient Safety & Trust

  • Protects sensitive patient health data

  • Enhances confidence among hospitals, clinics, and patients

CREST-Accredited Expertise

  • Certified CREST professionals performing ethical, standardised, and globally recognised testing

Operational Resilience

  • Secure deployment without disrupting healthcare operations

  • Minimises risk of service outages, breaches, and downtime

Continuous Security Improvement

  • Integrates findings into SDLC and DevSecOps practices

  • Periodic VA/PT assessments for ongoing compliance and protection

Industries & Software Supported

Cyberintelsys provides VA/PT for:

  • Hospitals and clinics: EMR/EHR systems, patient management software

  • Telemedicine and remote monitoring platforms

  • Software as a Medical Device (SaMD)

  • Cloud-based health platforms and patient portals

  • Mobile health applications

Why Choose Cyberintelsys in Canada?

  • CREST-accredited cybersecurity provider

  • Expertise in IEC 81001-5-1 and health software security

  • Evidence-based, audit-ready reporting

  • Trusted partner for hospitals, healthcare providers, and medical software developers

Conclusion

VA/PT and cybersecurity testing aligned with IEC 81001-5-1 are essential to protect patient safety and ensure regulatory compliance in Canada.

Cyberintelsys delivers comprehensive health software security testing, providing:

  • Ethical, structured identification of vulnerabilities

  • Regulatory-aligned documentation and remediation guidance

  • Enhanced patient safety, data security, and operational continuity

Partner with Cyberintelsys to achieve IEC 81001-5-1 compliance and secure your health software in Canada’s healthcare ecosystem.

Reach out to our professionals

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