(Non accredited or referenced on the 27001 certificate as add-on) 

ISO 27799 is the international standard for information security in the healthcare sector. Its objective is to ensure the confidentiality, integrity, and availability of health information by protecting patient data throughout its lifecycle. The standard builds upon and extends ISO/IEC 27002, providing sector-specific guidance for healthcare organizations seeking to implement an effective and auditable information security framework. 

What ISO 27799 Is and Its Scope 

ISO 27799 is a technology-neutral health informatics standard that provides guidance for managing the security of all types of health information, regardless of storage or transmission medium (paper, digital, or in transit). 

It complements and specializes the controls of ISO/IEC 27002 within healthcare environments without mandating specific technologies or solutions. Instead, it defines control objectives and guidelines that can be adapted to the size, complexity, and risk profile of each organization. 

It applies to hospitals, clinics, diagnostic centers, laboratories, e-health providers, and third parties processing health data on their behalf (e.g., data centers, cloud providers, telemedicine platforms). 

Why It Is Important for Healthcare Organizations 

The healthcare sector is increasingly targeted by cyber threats and data breaches. Loss or exposure of sensitive patient information can lead to severe consequences, including risks to patient care, legal and regulatory exposure, financial losses, and reputational damage. 

ISO 27799 helps ensure that only authorized personnel have access to health data, supports structured risk assessment, and introduces processes that reduce both the likelihood and impact of incidents. It also strengthens compliance with regulatory requirements such as GDPR and supports justified investments in cybersecurity through measurable quality and safety improvements. 

Relationship with ISO 27001 and ISO/IEC 27002 

ISO 27001 provides the overall framework for an Information Security Management System (ISMS). ISO/IEC 27002 defines practical security controls. ISO 27799 acts as a sector-specific extension for healthcare, interpreting and enhancing ISO 27002 controls with examples, roles, and processes tailored to health data environments. 

Certification to ISO 27799 typically requires a valid ISO/IEC 27001 certification (or a combined certification), ensuring that ISO 27799 guidance is embedded within an operational ISMS that is monitored and continually improved. 

ISO 27799 Certification Requirements and Process 

The path toward certification typically includes: 

  1. Scope definition & gap analysis: Mapping services, departments, PHI/PII data flows, systems, and third parties; identifying gaps against ISO 27799 and ISO/IEC 27002. 
  1. Risk management: Identifying threats and vulnerabilities, assessing impact on care and information security, and selecting appropriate controls. 
  1. Policies & procedures: Role-based access control, data classification and minimization, encryption and logging, incident management, supplier management, and physical security. 
  1. Staff training: Role-based awareness for clinical, administrative, IT/biomedical, and privacy personnel. 
  1. Internal audit & management review: Demonstrating effectiveness, KPIs, and corrective actions. 
  1. Certification audit by an independent certification body: 
    Stage 1 – readiness of ISMS and ISO 27799 implementation 
    Stage 2 – implementation and effectiveness through sampling 

Prerequisite: Active ISO/IEC 27001 certification. 
Cycle: Three-year certification cycle with annual surveillance audits and recertification at year three. 

Benefits for Healthcare Organizations 

  • Improved care quality and safety: Reduces risks affecting clinical decisions and patient outcomes. 
  • Trust of patients and partners: Demonstrates documented responsibility in handling sensitive data. 
  • Compliance and due diligence: Supports alignment with GDPR and supplier/partner requirements. 
  • International recognition: Provides a common language for telemedicine, interoperability, and clinical cloud projects. 
  • Competitive advantage: Strengthens participation in tenders and collaborations with regulated entities. 

GDPR and ISO 27799: Compatibility and Complementarity 

ISO 27799 provides a structured framework of risk management and technical/organizational measures supporting GDPR implementation in healthcare, particularly regarding lawful processing, minimization, data subject rights, security of processing, transfers, and documentation. 

It does not replace GDPR but offers a practical and auditable approach to implementing and demonstrating compliance during audits and assessments. 

Audit Preparation and Best Practices 

  • Mapping health data flows (process maps and ROPA): sources, purposes, systems, and third parties. 
  • Access governance: RBAC/ABAC, MFA, least privilege, and regular access reviews. 
  • Encryption and key management: data at rest and in transit, HSM/KMS, secure media disposal. 
  • Logging and monitoring: clinical and administrative system logs, SIEM integration, anomaly detection, alerting. 
  • Incident response and breach handling: defined runbooks, notification SLAs, post-incident reviews. 
  • Supplier and third-party management: contracts, DPAs, cloud/telemedicine vendor assessment. 
  • Enhanced safeguards for sensitive data categories and privacy-by-design in new projects. 
  • Continuous staff training and awareness by role. 
  • Use of compliance tools (GRC platforms, ticketing systems, asset and risk registers) to support audits and recertification. 

Cost, Duration and Certification Challenges 

Cost: Depends on organization size, number of locations, variety of clinical systems, data sensitivity, third-party integrations, and whether combined with other standards (e.g., ISO 27001, ISO 22301). 
Duration: Typically 2–4 months depending on ISMS maturity and healthcare process readiness. 
Challenges: System heterogeneity (HIS, LIS, RIS, PACS), legacy equipment, staff shift patterns and training, and multiple external integrations. These can be addressed through risk-based phased implementation, strong management support, and clear governance (RACI). 

Conclusion and Future Outlook 

As cyber threats and digital healthcare services (telemedicine, remote monitoring, clinical cloud) continue to expand, the importance of ISO 27799 is increasing. The standard is periodically updated to remain aligned with technological and regulatory developments and will continue to serve as a key reference for protecting patient data and strengthening healthcare organizational resilience. 

Frequently Asked Questions (FAQs) 

Not necessarily. However, it is a strong competitive advantage for diagnostic centers, laboratories, and clinics that want to demonstrate responsibility and maturity in managing sensitive health data. 

Costs vary depending on the number of personnel, facilities, and the scope of systems involved. For small organizations, certification may start from a few thousand euros, while for large hospitals the cost is significantly higher.

Certification is renewed every three years, with annual surveillance audits to ensure ongoing compliance and continual improvement. 

Yes. GRC platforms, risk assessment tools, incident management systems, and compliance monitoring solutions can make implementation and maintenance significantly more efficient.

Yes. ISO 27799 is often combined with ISO/IEC 27001, ISO 22301 (business continuity), and ISO 9001 (quality management) to support integrated governance, security, and operational resilience.

Why Q-CERT for ISO 27799 Certification 

ISO 27799 certification strengthens information security, compliance, and credibility for healthcare organizations that manage sensitive patient and medical data. If you are considering adopting the standard, request a scope, audit-day, and cost estimation, along with a realistic implementation and certification plan tailored to the specific needs and complexity of your organization. 

You may contact Q-CERT for ISO 27001/27799 certification to receive clear guidance throughout the audit process and benefit from a value-added approach focused on the effective protection of health data and genuine regulatory compliance.