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

Overview

The healthcare industry in the United States is increasingly adopting connected health software, Software as a Medical Device (SaMD), cloud-based platforms, and telemedicine solutions. While these digital solutions enhance patient care and operational efficiency, they also introduce complex cybersecurity risks that can affect patient safety, data confidentiality, and regulatory compliance.

IEC 81001-5-1 offers comprehensive guidance for cybersecurity risk management across the lifecycle of medical device and health software. It covers secure design, development, verification, deployment, operation, and post-market maintenance to ensure the resilience of health software systems.

Cyberintelsys, a CREST-accredited cybersecurity company, provides specialised Vulnerability Assessment (VA) and Penetration Testing (PT) services to support IEC 81001-5-1 compliance for health software in the United States.

Why IEC 81001-5-1 Compliance Matters in the US?

Health software systems are critical targets due to their access to sensitive patient data and integration with hospital networks. Cyberattacks can compromise patient safety, disrupt healthcare operations, and lead to regulatory penalties.

Common risk areas include:

  • Weak authentication and access controls

  • Insecure APIs and cloud integrations

  • Insufficient encryption and session management

  • Mobile application vulnerabilities

  • Third-party software and supply chain risks

IEC 81001-5-1 enables organisations to:

  • Establish a structured cybersecurity risk management program

  • Embed security across the software lifecycle

  • Protect patient safety and sensitive data

  • Demonstrate due diligence for FDA and HIPAA compliance

  • Enhance trust among healthcare providers and partners

Importance of VA/PT for Health Software

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

Key Objectives

  • Identify vulnerabilities before deployment

  • Assess cloud, API, and mobile application security

  • Ensure compliance with IEC 81001-5-1, HIPAA, and FDA requirements

  • Mitigate operational and reputational risks

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

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

1. Scoping & Asset Mapping

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

  • Map data flows and authentication paths

  • Define safe testing boundaries

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

2. Threat Modelling & Risk Analysis

  • Identify potential attack vectors using STRIDE and MITRE ATT&CK

  • Evaluate potential impact on patient safety and data integrity

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 and secure data handling

Output: VA report with CVSS scores and remediation guidance

4. Penetration Testing (PT)

  • Application-layer testing (OWASP Top 10)

  • API and cloud infrastructure testing

  • Mobile application security testing for Android and iOS

Deliverables: Controlled proof-of-concept exploitation report

5. Risk Prioritisation & Remediation

  • Prioritize findings based on severity, likelihood, and regulatory relevance

  • Provide actionable mitigation recommendations

6. Compliance Reporting & Documentation

7. Retesting & Continuous Improvement

  • Confirm remediation effectiveness through retesting

  • Continuous security monitoring and lifecycle improvements

Benefits of Cyberintelsys VA/PT Services in the US

Regulatory & Compliance Readiness

Patient Safety & Trust

  • Protects sensitive health data

  • Enhances confidence among healthcare providers, patients, and stakeholders

CREST-Accredited Expertise

  • Certified professionals performing ethical, standardised, and recognised testing

Operational Resilience

  • Secure deployment without disrupting healthcare operations

  • Minimises risk of service outages and data breaches

Continuous Security Improvement

  • Integrates findings into secure SDLC practices

  • Periodic assessments to maintain compliance and security posture

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 solutions and patient portals

  • Mobile health applications for patient care and monitoring

Why Choose Cyberintelsys in the United States?

  • CREST-accredited cybersecurity provider

  • Expertise in IEC 81001-5-1, FDA 510(k), and healthcare cybersecurity

  • Evidence-based, audit-ready reporting

  • Trusted partner for healthcare providers, medical software developers, and device manufacturers

Conclusion

Effective cybersecurity testing and VA/PT for IEC 81001-5-1 compliance is essential to protect patient safety and maintain regulatory compliance in the US healthcare industry.

Cyberintelsys delivers comprehensive health software security assessments, providing:

  • Ethical, structured identification of vulnerabilities

  • Regulatory-aligned documentation and remediation guidance

  • Enhanced patient safety, data security, and operational continuity

Partner with Cyberintelsys to secure your health software, achieve IEC 81001-5-1 compliance, and maintain trust and resilience in the US healthcare ecosystem.

Reach out to our professionals

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