IEC 81001-5-1 Vulnerability Assessment & Penetration Testing | Medical Software Security Services in Malaysia

Overview

The adoption of digital health technologies in Malaysia has made medical software and healthcare applications central to patient care, telemedicine, and hospital operations. While enhancing efficiency, these applications face increasing cyber threats that can compromise patient safety, data privacy, and regulatory compliance.

IEC 81001-5-1 provides guidance for cybersecurity risk management in medical software systems, covering secure design, development, testing, and deployment practices. Organizations developing mobile health apps, cloud-based solutions, or device-integrated software must implement robust security measures to meet this standard.

Cyberintelsys, a CREST-accredited cybersecurity company, delivers Vulnerability Assessment (VA) and Penetration Testing (PT) services for IEC 81001-5-1 compliant medical software. These services help identify vulnerabilities, mitigate risks, and strengthen digital health ecosystems.

Importance of VA/PT for IEC 81001-5-1 Compliance

1. Critical Risks

Medical software is highly targeted due to sensitive data and regulatory requirements. Common risks include:

  • Insecure authentication and access control

  • Data leakage in mobile or cloud applications

  • API vulnerabilities and integration flaws

  • Weak encryption or session management

  • Insider threats and misconfigurations

2. Importance of VA/PT

VA/PT is essential to:

  • Identify vulnerabilities early before deployment

  • Align with IEC 81001-5-1 risk management guidelines

  • Protect patient data in compliance with PDPA and other regulations

  • Mitigate operational and reputational risks

  • Demonstrate regulatory diligence to hospitals and partners

Partnering with a CREST-accredited provider like Cyberintelsys ensures thorough and globally recognized assessments.

Cyberintelsys CREST-Accredited VA/PT Approach

1. Scoping & Asset Mapping

  • Identify medical software components: desktop apps, mobile apps, cloud interfaces, APIs, and integrations

  • Map data flows, authentication paths, and sensitive information storage

  • Define risk-based testing boundaries
    Deliverables: Scope document, asset inventory, and risk assessment plan

2. Vulnerability Assessment (VA)

  • Automated scanning for known vulnerabilities in code, APIs, and cloud

  • Manual review: source code, logic, and configuration checks

  • Third-party dependency evaluation

  • Data security checks: encryption, storage, and privacy compliance
    Output: VA report with vulnerabilities, severity ratings, CVSS scores, and remediation recommendations

3. Penetration Testing (PT)

  • Application-layer attacks: SQL Injection, XSS, CSRF, authentication bypass

  • API testing: endpoint exposure, insecure communication

  • Cloud & infrastructure testing: IAM, storage, hosting security

  • Mobile security: Android/iOS storage, session handling, sensitive data exposure
    Deliverable: Exploit demonstration report with proof-of-concept vulnerabilities

4. Risk Analysis & Prioritization

  • Evaluate likelihood, impact, and regulatory significance

  • Prioritize remediation to mitigate high-risk issues

5. Reporting & Compliance Documentation

  • CREST-aligned VA/PT reports suitable for audits or regulatory submission

  • Step-by-step remediation guidance

  • Gap analysis highlighting IEC 81001-5-1 compliance

6. Retesting & Validation

  • Post-remediation retesting to confirm resolution

  • Validate security controls and compliance readiness

Methodology Overview

1. Reconnaissance

Map software architecture, data flows, APIs, cloud interfaces

2. Threat Modeling

Identify attack vectors using STRIDE and MITRE ATT&CK

3. Exploitation

Conduct safe simulations to demonstrate impact

4. Post-Exploitation Analysis

Assess effects on patient safety, data integrity, and operational continuity

5. Reporting

Provide actionable, regulatory-ready documentation

Benefits of Cyberintelsys VA/PT Services

1. Regulatory Compliance

Align with IEC 81001-5-1 and local data protection regulations

2. Patient Safety & Trust

Detect and remediate vulnerabilities in medical software

3. CREST-Accredited Expertise

Ethical, standardized, and globally recognized testing by CREST professionals

4. Operational Resilience

Secure deployment of medical software without disruptions

5. Continuous Security Improvement

Integrate findings into SDLC and perform periodic assessments

Industries & Software Supported

  • Hospitals & Clinics: EMRs, EHRs, patient management systems

  • Telemedicine Platforms: video consultation, remote monitoring apps

  • Medical Device Software: embedded or device management tools

  • Cloud Health Solutions: SaaS platforms, patient portals, analytics

  • Mobile Health Apps: Android/iOS applications

Why Cyberintelsys in Malaysia?

  • CREST-accredited cybersecurity company

  • Expertise in IEC 81001-5-1 compliance

  • Knowledge of Malaysian regulatory frameworks

  • Audit-ready reporting and actionable remediation guidance

  • Trusted partner for hospitals, developers, and medical device manufacturers

Conclusion

Medical software security is vital in Malaysia’s digital healthcare ecosystem. Compliance with IEC 81001-5-1 ensures resilience against cyber threats and protection of sensitive patient information.

Cyberintelsys delivers comprehensive VA/PT services that provide:

  • Ethical vulnerability identification and exploitation

  • Regulatory-aligned documentation and remediation guidance

  • Enhanced patient safety, data security, and operational continuity

  • Confidence in secure deployment of medical software

Partner with Cyberintelsys to secure your medical software, achieve IEC 81001-5-1 compliance, and maintain trust in Malaysia’s healthcare landscape.

Reach out to our professionals

[email protected]