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

Overview

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

IEC 81001-5-1 provides guidance for cybersecurity risk management 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, provides Vulnerability Assessment (VA) and Penetration Testing (PT) services to support IEC 81001-5-1 compliance for health software in the United Kingdom.

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

Health software systems are prime targets due to access to sensitive patient data and integration with NHS and private healthcare networks. Cyber threats can compromise patient safety, disrupt healthcare operations, and result in regulatory non-compliance.

Key cybersecurity risk areas:

  • 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 throughout the software lifecycle

  • Protect patient safety and sensitive data

  • Demonstrate due diligence for GDPR and HIPAA 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 IEC 81001-5-1 compliance and regulatory adherence

  • Mitigate operational, safety, and reputational risks

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

Cyberintelsys follows a structured, CREST-aligned methodology tailored to 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 threats using STRIDE and MITRE ATT&CK

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

Deliverables: Threat model diagrams and detailed cybersecurity risk register

3. Vulnerability Assessment (VA)

  • Automated scanning and manual code review

  • Evaluate third-party libraries and cloud configurations

  • Validate 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 the UK

1. Regulatory & Compliance Readiness

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

  • Supports GDPR, ISO, and NIST compliance

  • Audit-ready reports for healthcare regulators and partners

2. Patient Safety & Trust

  • Protects sensitive patient health data

  • Enhances confidence among NHS providers, private clinics, and patients

3. CREST-Accredited Expertise

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

4. Operational Resilience

  • Secure deployment without disrupting healthcare operations

  • Minimises risk of service outages, breaches, and downtime

5. 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 the UK?

  • CREST-accredited cybersecurity provider

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

  • Evidence-based, audit-ready reporting

  • Trusted partner for NHS, private healthcare providers, and medical software developers

Conclusion

VA/PT and cybersecurity testing aligned with IEC 81001-5-1 are critical to protect patient safety and ensure regulatory compliance in the United Kingdom healthcare sector.

Cyberintelsys delivers comprehensive health software security testing, offering:

  • 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 across the UK healthcare ecosystem.

Reach out to our professionals

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