This curriculum spans the design and operationalization of an ISO 27799-aligned governance structure across clinical, technical, and compliance functions, comparable in scope to a multi-phase advisory engagement supporting enterprise-wide health information governance in a regulated healthcare environment.
Module 1: Establishing the Governance Framework for Health Information
- Define scope boundaries for health information governance across clinical, administrative, and research systems within a multi-facility organization.
- Select governance roles and responsibilities for data stewards, system custodians, and clinical leads based on regulatory accountability.
- Map existing organizational policies to ISO 27799 control objectives to identify coverage gaps in privacy and security practices.
- Determine reporting lines for information governance decisions between IT, compliance, legal, and clinical leadership.
- Develop escalation protocols for data breaches involving protected health information (PHI) that align with both HIPAA and ISO 27799.
- Integrate risk appetite statements into governance charters to guide decision-making on data access and retention.
- Establish a governance review cycle for periodic evaluation of control effectiveness across electronic health record (EHR) platforms.
- Implement a centralized register of information assets to support classification and ownership assignment.
Module 2: Aligning with Regulatory and Legal Requirements
- Conduct jurisdictional analysis to reconcile conflicting data residency laws when operating across state or national borders.
- Document legal basis for processing sensitive health data under GDPR, HIPAA, or PIPEDA within shared care environments.
- Negotiate data processing agreements with third-party vendors that enforce ISO 27799-aligned security obligations.
- Implement audit trails to demonstrate compliance with mandatory retention periods for clinical records.
- Design data subject access request (DSAR) workflows that balance patient rights with clinical operational continuity.
- Develop policies for handling law enforcement data requests while preserving patient confidentiality.
- Update governance controls in response to new regulatory interpretations, such as OCR guidance on ransomware and PHI.
- Coordinate with legal counsel to assess implications of using AI-generated clinical documentation on data accountability.
Module 3: Risk Assessment and Management Integration
- Perform health-specific risk assessments using ISO 27799 guidance to prioritize threats to patient data confidentiality.
- Assign ownership for risk treatment plans involving legacy clinical systems lacking modern encryption capabilities.
- Integrate clinical safety considerations into information risk evaluations for connected medical devices.
- Quantify residual risk levels for data sharing initiatives with external research partners.
- Define thresholds for risk acceptance based on clinical impact, not just technical exposure.
- Implement risk treatment plans that address insecure default configurations in medical imaging systems.
- Use risk assessment outcomes to justify investment in access control upgrades for EHRs.
- Ensure risk registers are updated following system decommissioning or integration of new health information exchanges.
Module 4: Information Classification and Handling
- Define classification levels for health data (e.g., public, internal, confidential, highly sensitive) based on clinical impact of disclosure.
- Implement automated tagging of clinical documents at point of creation using EHR metadata.
- Configure secure printing policies for documents containing mental health or genetic information.
- Enforce encryption requirements for removable media used in mobile clinical workflows.
- Develop handling rules for de-identified datasets used in population health analytics.
- Train clinical staff on proper handling of screenshots containing PHI during telehealth consultations.
- Restrict email transmission of classified health data using DLP policies integrated with clinical messaging systems.
- Establish procedures for secure destruction of physical health records in decentralized clinics.
Module 5: Access Control Governance
- Define role-based access control (RBAC) models for clinicians, billing staff, and researchers based on minimum necessary principles.
- Implement just-in-time access for third-party contractors supporting EHR maintenance.
- Enforce privileged access management (PAM) for database administrators with access to patient records.
- Conduct quarterly access reviews for users with elevated privileges in clinical systems.
- Integrate identity lifecycle management with HR systems to automate access revocation upon staff termination.
- Configure context-aware access policies that restrict logins from non-trusted locations during off-hours.
- Address override access (e.g., emergency override in EHRs) with mandatory justification and audit logging.
- Manage shared account usage in clinical kiosks while maintaining individual accountability.
Module 6: Third-Party and Vendor Risk Oversight
- Conduct security assessments of cloud service providers hosting patient portals using ISO 27799 criteria.
- Enforce contractual SLAs requiring vendors to report security incidents involving health data within one hour.
- Verify subcontractor controls when a cloud provider uses additional data centers in unapproved jurisdictions.
- Perform on-site audits of medical billing vendors with access to full patient datasets.
- Implement continuous monitoring of vendor access to internal health information systems.
- Require penetration test results from SaaS providers before integrating with EHR infrastructure.
- Establish governance processes for terminating vendor relationships with data transition requirements.
- Manage risks associated with open-source software components used in clinical applications.
Module 7: Incident Management and Breach Response
- Define incident severity levels based on patient impact, such as delayed care due to system unavailability.
- Coordinate response between IT security, legal, communications, and clinical leadership during a ransomware event.
- Preserve forensic evidence from clinical workstations while minimizing disruption to patient care.
- Report breaches to regulatory authorities within 72 hours as required by HIPAA or GDPR.
- Conduct root cause analysis for insider threats involving clinicians accessing unauthorized patient records.
- Implement automated alerting for anomalous data exports from health data warehouses.
- Test incident response plans with realistic scenarios involving loss of backup tapes or cloud misconfigurations.
- Document lessons learned from incidents to update governance policies and access controls.
Module 8: Audit and Compliance Monitoring
- Design audit log specifications for capturing access to sensitive health data in EHRs and PACS systems.
- Configure log retention periods to meet both legal requirements and forensic investigation needs.
- Implement automated log correlation rules to detect suspicious access patterns across multiple systems.
- Conduct unannounced audits of access logs for high-risk clinical departments such as oncology or psychiatry.
- Respond to internal audit findings by updating governance controls for data export functionality.
- Prepare for external certification audits against ISO 27799 by compiling evidence of control implementation.
- Use audit findings to refine user training content on secure data handling practices.
- Integrate compliance dashboards into executive reporting to track control effectiveness over time.
Module 9: Continuous Governance Improvement
- Establish key performance indicators (KPIs) for governance effectiveness, such as time to revoke access after role change.
- Conduct post-implementation reviews after deploying new health information systems to assess control adherence.
- Update governance policies in response to changes in clinical workflows, such as adoption of remote patient monitoring.
- Facilitate governance forums for clinicians to report usability issues with security controls.
- Benchmark governance maturity against ISO 27799 best practices using structured assessment models.
- Integrate governance feedback into system procurement criteria for future technology acquisitions.
- Manage version control of governance policies to ensure all staff reference the current edition.
- Align governance improvement initiatives with organizational strategic objectives in digital health transformation.