Description

This curriculum spans the breadth of a multi-workshop privacy governance program, addressing the same regulatory analysis, risk alignment, and system-specific controls required in real-world healthcare compliance initiatives.

Module 1: Establishing the Regulatory Foundation for Health Information Governance

Decide which jurisdictional privacy regulations apply when health data crosses national borders, such as GDPR for EU patients and HIPAA for US data handling.
Map overlapping regulatory requirements between ISO 27799, HIPAA, PIPEDA, and NHRIS to avoid redundant controls while ensuring compliance.
Assess whether legacy health information systems were designed with auditability in mind, and determine remediation paths for regulatory gaps.
Define the scope of “protected health information” (PHI) within the organization, including derived data such as analytics and pseudonymized records.
Implement a regulatory change monitoring process to track amendments in laws like the UK Data Protection Act or Australia’s My Health Records Act.
Establish a formal process for documenting regulatory exceptions, such as research exemptions under HIPAA’s IRB waiver.
Integrate legal counsel into the governance lifecycle to validate interpretations of ambiguous clauses, such as “minimum necessary” data disclosure.
Develop a risk-based prioritization framework for addressing non-compliant systems based on data exposure and enforcement history.

Module 2: Aligning ISO 27799 Controls with Organizational Risk Appetite

Select appropriate risk assessment methodologies (e.g., OCTAVE, NIST SP 800-30) that reflect healthcare-specific threat models and asset criticality.
Customize ISO 27799 control objectives to match organizational size, such as adjusting access review frequency for a 50-bed clinic vs. a national hospital network.
Determine thresholds for acceptable residual risk in clinical systems where availability may outweigh confidentiality during emergencies.
Balance encryption mandates against system performance requirements in real-time patient monitoring environments.
Negotiate control implementation timelines with clinical departments to avoid disruption during peak operational periods.
Document deviations from ISO 27799 recommendations with justification, such as delayed patching due to medical device certification constraints.
Integrate third-party risk assessments into the control selection process, particularly for cloud-based EHR providers.
Define escalation paths for unresolved control gaps that exceed the organization’s risk tolerance.

Module 3: Designing Data Governance Structures for Health Information Systems

Assign data stewardship roles to clinical and administrative staff, specifying accountability for data accuracy and access oversight.
Implement metadata tagging standards to track data lineage, especially for datasets used in AI/ML training pipelines.
Establish data classification levels (e.g., public, internal, PHI, genetic) and enforce handling rules per classification.
Design data retention schedules that comply with legal mandates while minimizing storage of obsolete records.
Implement automated data disposition workflows with audit trails to prevent unauthorized deletion.
Create data sharing agreements that specify permissible use, re-identification risks, and breach notification timelines.
Enforce data minimization by configuring EHR systems to suppress non-essential fields in routine queries.
Monitor data sprawl across shadow IT systems, such as departmental spreadsheets containing patient identifiers.

Module 4: Implementing Access Control and Authentication Frameworks

Design role-based access control (RBAC) models that reflect clinical workflows, such as emergency override privileges.
Enforce multi-factor authentication for remote access to EHR systems, including exceptions for legacy medical devices.
Implement just-in-time (JIT) access for third-party vendors performing system maintenance.
Conduct quarterly access reviews with department heads to validate active user permissions.
Integrate privileged access management (PAM) for administrative accounts on clinical databases.
Configure session timeouts on shared workstations in high-traffic areas like emergency departments.
Log and analyze failed access attempts to detect potential insider threats or compromised credentials.
Restrict cross-departmental access based on need-to-know, such as limiting billing staff from viewing psychotherapy notes.

Module 5: Securing Health Data Across Hybrid IT Environments

Apply encryption at rest and in transit for databases hosting PHI, including configuration of TLS 1.2+ for internal APIs.
Segment clinical networks from corporate IT to limit lateral movement during cyber incidents.
Enforce device compliance policies for BYOD used in telehealth consultations, including mandatory MDM enrollment.
Configure firewall rules to restrict outbound data flows from imaging systems to unauthorized external IPs.
Implement DLP solutions to detect and block unauthorized transmission of patient data via email or USB.
Audit cloud storage configurations (e.g., AWS S3 buckets) to prevent public exposure of health records.
Validate the security posture of IoT medical devices through firmware analysis and network behavior monitoring.
Establish secure data exchange protocols for HIE participation, such as using IHE XCA or FHIR with OAuth 2.0.

Module 6: Managing Third-Party and Vendor Risk in Healthcare Ecosystems

Conduct security assessments of business associates using standardized questionnaires like HITRUST CSF.
Negotiate BAAs that explicitly assign liability for breaches caused by vendor negligence.
Verify subcontractor compliance when vendors outsource data processing to offshore providers.
Monitor vendor patch management timelines, especially for critical vulnerabilities in EHR platforms.
Enforce right-to-audit clauses in contracts to validate security controls during renewal cycles.
Require vendors to provide evidence of certifications such as SOC 2 Type II or ISO 27001.
Implement centralized vendor risk scoring to prioritize remediation efforts based on data access level.
Establish incident response coordination protocols with key vendors for joint breach investigations.

Module 7: Auditing and Monitoring for Regulatory Compliance

Configure SIEM rules to detect anomalous access patterns, such as after-hours record reviews by non-clinical staff.
Preserve audit logs for a minimum of six years to meet HIPAA and ISO 27799 retention requirements.
Conduct unannounced audits of high-risk departments, such as radiology or pharmacy, to validate access controls.
Use automated tools to verify that audit trails cannot be altered by system administrators.
Generate compliance reports for regulatory submissions, including evidence of access reviews and training completion.
Integrate audit findings into the organization’s risk register for tracking remediation progress.
Perform log correlation across systems to reconstruct data access timelines during breach investigations.
Limit log access to designated compliance and security personnel to prevent evidence tampering.

Module 8: Incident Response and Breach Notification Protocols

Classify incidents using a standardized severity matrix that accounts for data type, volume, and exposure method.
Activate incident response teams within one hour of detecting unauthorized access to unencrypted PHI.
Preserve forensic evidence from affected systems while minimizing disruption to clinical operations.
Determine whether a breach requires notification under HIPAA, GDPR, or other applicable laws based on risk of harm.
Coordinate legal and PR teams to draft breach notifications that meet regulatory timelines and content requirements.
Report breaches to supervisory authorities within 72 hours for GDPR-covered data, with documented justification for delays.
Conduct post-incident reviews to update controls and prevent recurrence, such as tightening access policies.
Maintain a centralized breach log for regulatory reporting and internal trend analysis.

Module 9: Sustaining Compliance Through Training and Culture

Develop role-specific privacy training modules for clinicians, IT staff, and administrative personnel.
Deliver annual refresher training with updated scenarios reflecting current threats, such as phishing targeting telehealth platforms.
Measure training effectiveness through post-test scores and simulated phishing campaign results.
Assign accountability for privacy compliance to department managers with performance incentives.
Establish anonymous reporting channels for staff to report privacy violations without retaliation.
Disseminate lessons learned from internal incidents to reinforce behavioral expectations.
Engage clinical champions to model compliant behavior and influence peer practices.
Track policy acknowledgment rates and enforce access revocation for non-completion.

Module 10: Strategic Alignment of Privacy Governance with Organizational Goals

Integrate privacy governance into enterprise risk management reporting for board-level review.
Align ISO 27799 implementation roadmaps with digital transformation initiatives, such as EHR upgrades.
Quantify the cost of non-compliance using historical breach data and regulatory fine trends.
Balance innovation in data analytics with privacy-preserving techniques like differential privacy.
Engage patients in governance through transparency portals that explain data usage and consent options.
Conduct maturity assessments to benchmark privacy practices against peer healthcare organizations.
Adjust governance priorities based on audit findings, enforcement actions, and emerging technologies.
Ensure continuity of governance during mergers or acquisitions by harmonizing policies and systems.

Privacy Regulations in ISO 27799