This curriculum spans the design and operationalization of health information governance programs comparable in scope to multi-phase advisory engagements, covering policy development, technical implementation, and cross-functional coordination required to align clinical data management with ISO 27799 across complex healthcare environments.
Module 1: Establishing Governance Frameworks Aligned with ISO 27799
- Define scope boundaries for health information governance based on organizational care delivery models and regulatory jurisdictions.
- Select governance roles (e.g., Data Steward, Privacy Officer) with documented accountability for PHI lifecycle management.
- Map ISO 27799 controls to existing enterprise risk frameworks such as NIST CSF or COBIT to avoid duplication.
- Develop escalation protocols for unresolved data governance conflicts between clinical and IT departments.
- Integrate data governance charter into enterprise compliance committee reporting cycles.
- Document exceptions to ISO 27799 recommendations with risk acceptance justification signed by CISO and DPO.
- Establish version control and audit trails for governance policies to support regulatory inspections.
- Implement periodic governance framework maturity assessments using ISO 38500 principles.
Module 2: Health Data Classification and Sensitivity Grading
- Classify data elements (e.g., diagnosis codes, genomic data) using sensitivity tiers defined in ISO 27799 Annex B.
- Implement automated metadata tagging in EHR systems to enforce classification at point of entry.
- Define retention periods for each classification level in alignment with HIPAA and local health regulations.
- Configure access control policies to reflect data sensitivity tiers in identity management systems.
- Conduct classification reviews after system integration events (e.g., new EMR module deployment).
- Establish data declassification procedures with audit logging for data moving to archival status.
- Train clinical staff on manual classification responsibilities for unstructured clinical notes.
- Validate classification accuracy through random sampling audits and automated data profiling.
Module 3: Role-Based Access Control in Clinical Environments
- Define clinical role matrices that map provider types (e.g., radiologist, nurse practitioner) to minimum necessary data access.
- Implement just-in-time access for third-party vendors with automated session termination.
- Negotiate role definitions with medical staff leadership to balance clinical workflow and security.
- Enforce role separation between data entry, review, and billing functions in revenue cycle systems.
- Monitor access patterns for role creep using UEBA tools integrated with HR onboarding data.
- Configure emergency override access with real-time logging and post-event attestation requirements.
- Conduct quarterly access recertification campaigns with automated reminders and escalation paths.
- Integrate role definitions into enterprise IAM systems using SCIM or similar provisioning standards.
Module 4: Consent Management and Patient Rights Enforcement
- Implement granular consent flags in MPI systems for research, marketing, and treatment disclosures.
- Design audit reports that track consent modifications and data disclosures per patient request.
- Integrate consent directives with HIE routing rules to prevent unauthorized data sharing.
- Develop workflows to respond to data access and deletion requests within statutory timeframes.
- Map implied consent scenarios (e.g., emergency care) to documented policy exceptions.
- Validate consent synchronization across affiliated entities in integrated delivery networks.
- Configure system alerts for consent expiration or withdrawal in longitudinal care programs.
- Test consent logic during EHR upgrades to prevent unintended data exposure.
Module 5: Data Sharing and Interoperability Governance
- Negotiate data use agreements (DUAs) that specify permitted uses and re-identification prohibitions.
- Implement FHIR API gateways with OAuth 2.0 scopes aligned to ISO 27799 access principles.
- Configure audit logs to capture payload details for every query in cross-organizational exchanges.
- Establish data minimization rules for queries submitted through national health information networks.
- Conduct privacy impact assessments before enabling new data exchange partnerships.
- Enforce data masking for test environments populated from production HIE feeds.
- Define breach notification thresholds for anomalous data transfer volumes.
- Validate encryption in transit and at rest for all shared data repositories.
Module 6: Audit Logging and Monitoring for Health Data Flows
- Define mandatory audit events (e.g., access to mental health records, prescription overrides) per ISO 27799.
- Centralize logs from EHR, PACS, and pharmacy systems into a SIEM with healthcare-specific correlation rules.
- Implement immutable log storage with write-once-read-many (WORM) configuration.
- Configure real-time alerts for access from unauthorized geographic locations or devices.
- Conduct quarterly log coverage assessments to identify unmonitored critical systems.
- Preserve logs for minimum seven-year period to support litigation and regulatory audits.
- Restrict log access to designated privacy and security personnel with dual controls.
- Perform forensic readiness testing to validate log integrity during breach simulations.
Module 7: Third-Party Risk Management in Health IT
- Require ISO 27799 alignment documentation from cloud EHR and telehealth platform providers.
- Conduct on-site assessments of data centers used by business associates handling PHI.
- Enforce contractual clauses for breach notification timelines and liability allocation.
- Validate subcontractor oversight processes used by third-party vendors.
- Implement continuous monitoring of vendor security posture using automated assessment tools.
- Review penetration test results from third parties annually and after major system changes.
- Define exit strategies for data return or destruction upon contract termination.
- Map vendor access privileges to least privilege principles and review quarterly.
Module 8: Incident Response and Breach Management
- Classify incidents using ISO 27799 severity levels to determine escalation and notification requirements.
- Integrate incident response playbooks with hospital command center operations.
- Preserve forensic evidence from clinical workstations while maintaining care delivery.
- Coordinate legal, PR, and clinical leadership in breach notification decision-making.
- Validate breach reporting timelines against HIPAA, GDPR, and local jurisdictional rules.
- Conduct post-incident reviews to update controls and prevent recurrence.
- Implement automated data loss prevention (DLP) rules to detect exfiltration patterns.
- Test incident response plans annually with simulated insider threat scenarios.
Module 9: Governance of AI and Predictive Analytics in Healthcare
- Require bias assessment reports for AI models trained on historical health data.
- Document data provenance for training datasets used in clinical decision support tools.
- Implement model access controls to prevent unauthorized inference attacks.
- Establish review cycles for model drift detection and retraining triggers.
- Enforce patient notification requirements for AI-assisted diagnosis systems.
- Define audit trails for AI-generated recommendations and clinician overrides.
- Restrict use of AI outputs in automated decision-making without human review.
- Validate anonymization techniques used in research datasets feeding AI models.
Module 10: Continuous Governance Improvement and Regulatory Alignment
- Conduct gap analyses between ISO 27799 and evolving regulations such as the EU Health Data Space.
- Integrate governance KPIs into executive dashboards for board-level reporting.
- Update policies biannually or after significant regulatory changes.
- Perform control effectiveness testing using independent internal audit teams.
- Benchmark governance maturity against peer healthcare organizations.
- Implement feedback loops from privacy officers and clinical end users to refine policies.
- Align governance roadmap with enterprise digital transformation initiatives.
- Document lessons learned from audits, inspections, and incidents in governance repositories.