Overview

With the rapid adoption of digital health technologies across the United States, medical software and applications have become central to patient care, telemedicine, hospital management, and private healthcare delivery. While these solutions improve efficiency, interoperability, and accessibility, they are increasingly exposed to cyber threats that can compromise patient safety, data privacy, and regulatory compliance.

IEC 81001-5-1 provides internationally recognised guidance for cybersecurity risk management in medical software systems, covering secure design, development, testing, deployment, and maintenance practices. Organisations developing medical software, mobile health apps, or cloud-based healthcare platforms must implement robust cybersecurity controls to meet these standards.

Cyberintelsys, a CREST-accredited cybersecurity company, delivers Vulnerability Assessment (VA) and Penetration Testing (PT) services to support IEC 81001-5-1 cybersecurity assessment and compliance readiness for medical software across the United States.

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

Medical software systems are prime targets for cyberattacks due to sensitive healthcare data, regulatory scrutiny, and critical clinical workflows. Common cybersecurity risks include:

• Insecure authentication and access control mechanisms

• Data leakage in web, mobile, or cloud-based medical applications

• API vulnerabilities and insecure system integrations

• Weak encryption, key management, or session handling

• Insider threats and misconfigured environments

Vulnerability Assessment and Penetration Testing are essential to:

• Identify and remediate vulnerabilities before deployment or regulatory review

• Align cybersecurity controls with IEC 81001-5-1 risk management principles

• Protect patient data in compliance with HIPAA and US healthcare regulations

• Reduce operational, financial, and reputational risks

• Demonstrate cybersecurity due diligence to regulators, healthcare providers, and partners

Partnering with a CREST-accredited cybersecurity provider ensures testing is ethical, structured, and globally recognised.

Cyberintelsys CREST-Accredited VA/PT Approach

Cyberintelsys follows a structured, CREST-aligned methodology aligned with IEC 81001-5-1, IEC 60601, and IEC 62443 for medical software cybersecurity requirements.

1. Scoping & Asset Mapping

• Identify medical software components including web applications, mobile apps, cloud services, APIs, and third-party integrations

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

• Define controlled, risk-based testing boundaries to ensure patient safety and system stability

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

2. Vulnerability Assessment (VA)

• Automated vulnerability scanning of applications, APIs, and cloud environments

• Manual security testing including logic flaws, configuration issues, and source code review

• Third-party dependency and open-source component assessment

• Validation of encryption, data protection, and secure storage controls

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

3. Penetration Testing (PT)

• Application-layer testing covering OWASP Top 10 vulnerabilities such as SQL Injection, XSS, CSRF, and authentication bypass

• API penetration testing for data exposure, access control flaws, and insecure communications

• Cloud and infrastructure testing including IAM, storage, and network security

• Mobile application security testing for Android and iOS platforms

Deliverable: Controlled proof-of-concept exploitation report demonstrating real-world risk

4. Risk Analysis & Prioritisation

• Assess findings based on likelihood, impact, and patient safety implications

• Prioritise remediation activities aligned with IEC 81001-5-1 risk management expectations

5. Reporting & Compliance Documentation

• CREST-aligned VA/PT reports suitable for audits, HIPAA assurance, or regulatory submissions

• Clear, actionable remediation guidance and mitigation strategies

• Gap analysis against IEC 81001-5-1 and recognised healthcare cybersecurity best practices

6. Retesting & Validation

• Verification testing after remediation to confirm vulnerabilities are fully resolved

• Validation of security controls supporting ongoing compliance readiness

Methodology Overview

1. Reconnaissance: Understand system architecture, data flows, APIs, and cloud interfaces

2. Threat Modelling: Identify attack vectors using frameworks such as STRIDE and MITRE ATT&CK for ICS

3. Exploitation: Perform safe, controlled attack simulations informed by MITRE ATT&CK for ICS and secure testing practices

4. Post-Exploitation Analysis: Evaluate effects on patient safety, data integrity, and service availability

5. Reporting: Deliver regulatory-ready documentation for remediation and compliance assurance

Benefits of Cyberintelsys VA/PT Services

Regulatory Compliance

• Alignment with IEC 81001-5-1 cybersecurity requirements and recognised standards from ISO and NIST

• Support for HIPAA, FDA 510(k) Cybersecurity, and other US healthcare regulations

Patient Safety & Trust

• Identification of vulnerabilities that could impact patient data or clinical workflows

• Increased confidence among healthcare providers, clinicians, and patients

CREST-Accredited Expertise

• Assessments conducted by CREST-certified cybersecurity professionals

• Ethical, standardised, and internationally recognised testing practices

Operational Resilience

• Secure deployment of medical software without disrupting clinical operations

• Reduced risk of outages, breaches, or system compromise

Continuous Security Improvement

• Integration of findings into secure SDLC and DevSecOps practices

• Ongoing assessments to address emerging threats and regulatory changes

Industries & Medical Software Supported

Cyberintelsys provides VA/PT services for:

• Hospitals and clinics: EHRs, EMRs, patient administration systems

• Telemedicine platforms and remote care solutions

• Medical device software and device management platforms

• Cloud-based healthcare SaaS applications and patient portals

• Mobile health applications for monitoring, diagnostics, and care delivery

Why Cyberintelsys in the United States?

• CREST-accredited cybersecurity company with US healthcare expertise

• Strong understanding of IEC 81001-5-1, ISA/IEC 62443, and medical software risk management

• Knowledge of US regulatory requirements including HIPAA, FDA, and state healthcare regulations

• Audit-ready, evidence-based reporting with clear remediation guidance

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

Conclusion

Cybersecurity is a critical component of modern healthcare delivery in the United States. Achieving IEC 81001-5-1 compliance demonstrates a strong commitment to protecting patient data, ensuring software resilience, and supporting safe clinical outcomes.

Cyberintelsys delivers comprehensive IEC 81001-5-1 Vulnerability Assessment and Penetration Testing services that provide:

• Structured identification and validation of cybersecurity risks

• Compliance-aligned documentation and remediation guidance

• Improved patient safety, data protection, and operational continuity

• Confidence in deploying and maintaining secure medical software systems

Partner with Cyberintelsys to achieve IEC 81001-5-1 cybersecurity assessment and compliance readiness for medical software in the United States.