IEC 81001-5-1 Cybersecurity Gap Analysis & Compliance Evaluation | Health Software Testing in Turkey

Overview

Turkey’s healthcare sector is rapidly adopting connected health software, Software as a Medical Device (SaMD), telemedicine platforms, and cloud-based healthcare solutions. While these digital systems enhance patient care, clinical efficiency, and operational workflows, they also introduce cybersecurity risks that can compromise patient safety, data privacy, and regulatory compliance.

IEC 81001-5-1 provides internationally recognized guidance for managing cybersecurity risks throughout 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, delivers comprehensive gap analysis and compliance evaluation services to help organizations align with IEC 81001-5-1 for health software in Turkey.

Importance of IEC 81001-5-1 Gap Analysis

A cybersecurity gap analysis ensures that health software and SaMD solutions meet IEC 81001-5-1 standards, regulatory requirements, and industry best practices.

Key benefits include:

  • Identify missing or inadequate security controls

  • Prioritize remediation efforts based on risk and impact

  • Reduce the likelihood of patient data breaches or operational disruptions

  • Support compliance with HIPAA, ISO, and NIST standards

  • Build confidence with healthcare providers, regulators, and patients

Cyberintelsys IEC 81001-5-1 Gap Analysis Approach

Cyberintelsys follows a structured, CREST-aligned methodology to evaluate cybersecurity compliance gaps in health software.

1. Initial Assessment & Scoping

  • Identify software components: desktop apps, cloud platforms, APIs, mobile applications

  • Map patient data flows and system integrations

  • Define scope aligned with IEC 81001-5-1

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

2. Control & Compliance Mapping

  • Evaluate existing security controls against IEC 81001-5-1 requirements

  • Map controls to applicable regulations including HIPAA, ISO 27799, and NIST

  • Identify gaps in policies, procedures, and technical implementations

Deliverables: Compliance matrix and gap identification report

3. Risk Analysis & Prioritization

  • Assess likelihood and impact of identified gaps

  • Prioritize based on patient safety, data sensitivity, and regulatory relevance

  • Provide actionable remediation guidance

4. Remediation Planning & Recommendations

  • Detailed recommendations to address compliance gaps

  • Align with secure software development lifecycle (SDLC) practices

  • Integrate with VA/PT results for comprehensive security posture

Deliverables: Gap remediation plan with risk-based prioritization

5. Reporting & Documentation

  • Comprehensive report suitable for management, auditors, and regulatory review

  • CREST-aligned reporting ensures structured and ethical evaluation

  • Maps gaps to IEC 81001-5-1, IEC 60601, and IEC 62443 standards

Benefits of Cyberintelsys Gap Analysis Services

Regulatory & Compliance Readiness

Patient Safety & Trust

  • Identifies and mitigates risks affecting patient care and data integrity

  • Builds trust with healthcare providers, patients, and regulators

CREST-Accredited Expertise

  • Assessments performed by CREST certified professionals

  • Ethical, standardised, and globally recognised methodologies

Operational & Security Resilience

  • Proactively addresses vulnerabilities

  • Reduces risk of service outages and operational disruptions

Continuous Security Improvement

  • Integrates findings into SDLC and DevSecOps practices

  • Periodic re-evaluations to maintain compliance and resilience

Supported Health Software & Industries

Cyberintelsys provides gap analysis and compliance evaluation for:

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

  • Telemedicine and remote monitoring platforms

  • Software as a Medical Device (SaMD)

  • Cloud-based healthcare platforms and patient portals

  • Mobile health applications

Why Choose Cyberintelsys in Turkey?

  • CREST-accredited cybersecurity provider

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

  • Evidence-based, audit-ready documentation

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

Conclusion

IEC 81001-5-1 gap analysis and compliance evaluation are crucial for ensuring patient safety, data security, and regulatory adherence in Turkey.

Cyberintelsys delivers structured, ethical, and comprehensive gap analysis services enabling organizations to:

  • Identify and remediate cybersecurity gaps

  • Strengthen software resilience and patient safety

  • Maintain regulatory and audit readiness

  • Deploy health software securely and confidently

Reach out to our professionals

[email protected]