Description

This curriculum spans the breadth of a multi-workshop governance initiative, addressing the same scope and complexity as an internal healthcare organization’s program to align clinical operations, IT systems, and third-party relationships with ISO 27799’s security requirements.

Module 1: Establishing the Scope and Boundaries of Healthcare Information Security Governance

Define which clinical and administrative systems fall under the scope of ISO 27799, including EHRs, PACS, and laboratory information systems.
Determine whether third-party hosted applications (e.g., cloud-based telehealth platforms) are included in the governance framework.
Map data flows across departments to identify where personal health information (PHI) is created, stored, processed, or transmitted.
Decide whether research data containing de-identified patient information requires the same controls as identifiable health records.
Establish jurisdictional boundaries for compliance when operating across multiple regulatory regimes (e.g., HIPAA, GDPR, PIPEDA).
Document exceptions for legacy systems that cannot meet current encryption or access control standards.
Obtain formal sign-off from clinical leadership on the inclusion or exclusion of point-of-care devices (e.g., infusion pumps, monitors).
Integrate scope decisions with enterprise risk assessment processes to ensure alignment with organizational risk appetite.

Module 2: Leadership Commitment and Governance Structure Design

Assign accountability for information security outcomes to specific executive roles, such as Chief Medical Information Officer or Chief Privacy Officer.
Establish a clinical-inclusive security steering committee with representation from nursing, IT, compliance, and risk management.
Define escalation paths for security incidents that involve clinical operations disruption.
Allocate budget for security controls that require clinical workflow adjustments, such as two-factor authentication at nursing stations.
Implement governance mechanisms to resolve conflicts between clinical efficiency and security requirements (e.g., login timeouts in emergency departments).
Develop performance indicators for security governance that are reported to the board on a quarterly basis.
Define authority levels for overriding access controls during medical emergencies, including audit logging requirements.
Ensure that security policies are co-reviewed by legal counsel and clinical leadership before implementation.

Module 3: Risk Assessment Methodology Tailored to Healthcare Environments

Select risk assessment methodologies (e.g., OCTAVE, NIST SP 800-30) that account for patient safety implications of system outages or data corruption.
Classify health data assets based on sensitivity, criticality, and availability requirements, including life-supporting device data.
Assess risks associated with Bring Your Own Device (BYOD) policies in clinical settings, including personal smartphones used for care coordination.
Quantify the impact of ransomware on clinical operations using downtime scenarios and patient throughput models.
Conduct threat modeling for medical IoT devices that lack patching capabilities or default credentials.
Document residual risks that cannot be mitigated due to vendor limitations or clinical workflow constraints.
Integrate findings from internal audit and incident response into the risk register on a recurring basis.
Validate risk treatment plans with department heads to ensure operational feasibility.

Module 4: Access Control Policies for Clinical and Administrative Roles

Define role-based access control (RBAC) models that reflect dynamic care teams, including temporary staff and locum physicians.
Implement just-in-time access for specialists who require temporary access to patient records during consultations.
Configure automatic session termination on clinical workstations based on department-specific usage patterns (e.g., longer timeouts in radiology).
Enforce multi-factor authentication for remote access to EHR systems without disrupting telemedicine workflows.
Establish procedures for deactivating access upon staff termination, including locum and contractor roles.
Monitor and review access logs for anomalous behavior, such as after-hours record access by non-clinical staff.
Address the challenge of shared workstations in nursing units while maintaining individual accountability.
Design emergency override mechanisms that allow access during crises while triggering real-time alerts and audit trails.

Module 5: Asset Management in a Heterogeneous Healthcare IT Environment

Maintain an inventory of all devices that process or store PHI, including mobile carts, wearable monitors, and diagnostic equipment.
Classify medical devices based on security criticality and patchability, prioritizing those connected to hospital networks.
Implement asset tagging and tracking for portable devices used across multiple departments (e.g., ultrasound machines).
Establish ownership accountability for each system, assigning responsibility to clinical or administrative leads.
Integrate asset data with vulnerability management tools to prioritize patching efforts.
Manage end-of-life systems that no longer receive security updates but remain in clinical use due to procurement cycles.
Enforce encryption on all portable media, including USB drives used for transferring imaging studies.
Develop procedures for securely decommissioning devices that contain residual PHI in onboard storage.

Module 6: Secure System Acquisition, Development, and Maintenance

Include ISO 27799 compliance requirements in RFPs for new clinical information systems and medical devices.
Conduct security reviews of software updates from vendors before deployment in production environments.
Define change control procedures that require joint approval from IT security and clinical operations.
Implement secure coding standards for in-house applications that interface with EHRs or medical devices.
Verify that third-party APIs used for health data exchange comply with authentication and encryption standards.
Test disaster recovery procedures for clinical systems with actual clinical staff participation.
Ensure that software development lifecycles for health apps include privacy-by-design and security-by-default principles.
Address the risks of shadow IT by providing approved alternatives for clinical workflow automation tools.

Module 7: Incident Management and Response in Clinical Contexts

Develop incident response playbooks specific to healthcare threats, such as ransomware targeting imaging systems.
Define thresholds for declaring a security incident that also triggers clinical continuity protocols.
Integrate the incident response team with hospital command centers during major disruptions.
Preserve forensic evidence from medical devices while minimizing patient care impact.
Coordinate breach notification timelines with legal, PR, and clinical leadership to meet regulatory deadlines.
Conduct tabletop exercises involving clinical staff to test response effectiveness under stress.
Implement real-time monitoring for indicators of compromise on critical care systems (e.g., ventilators, dialysis machines).
Establish post-incident review processes that result in updated controls and policy changes.

Module 8: Business Continuity and Availability of Clinical Systems

Define recovery time objectives (RTOs) for critical systems based on clinical impact, such as pharmacy or lab systems.
Test failover procedures for EHR systems during off-peak hours to minimize patient care disruption.
Maintain paper-based fallback procedures for medication ordering and patient identification during outages.
Store backup data in geographically separate locations to protect against regional disasters.
Validate that backup restoration processes preserve data integrity for longitudinal patient records.
Coordinate with external partners (e.g., reference labs, radiology groups) on mutual continuity expectations.
Ensure that emergency generators and UPS systems support critical IT infrastructure during power failures.
Review and update business continuity plans annually with input from clinical department heads.

Module 9: Compliance Monitoring, Audit, and Continuous Improvement

Conduct internal audits of access control logs in high-risk departments such as oncology and psychiatry.
Align ISO 27799 controls with HIPAA Security Rule requirements for joint compliance reporting.
Use automated compliance tools to continuously monitor configuration settings on clinical workstations.
Respond to audit findings with remediation plans that include timelines and responsible parties.
Perform periodic reviews of third-party vendor compliance with contractual security obligations.
Track key security metrics such as patch latency, incident response times, and access review completion rates.
Integrate audit outcomes into staff performance evaluations for IT and clinical leadership roles.
Update policies and controls based on emerging threats, regulatory changes, and post-incident reviews.

Module 10: Third-Party and Supply Chain Risk Management

Assess security practices of medical device vendors during procurement, including patch management and incident response support.
Negotiate contractual terms that require vendors to report security vulnerabilities within defined timeframes.
Monitor third-party access to hospital networks, especially for remote maintenance of imaging equipment.
Validate that cloud service providers hosting health data comply with ISO 27799 and regional privacy laws.
Conduct on-site security assessments of business associates that process large volumes of PHI.
Implement network segmentation to isolate third-party systems from core clinical networks.
Require evidence of penetration testing and vulnerability management from software vendors.
Establish exit strategies for terminating relationships with non-compliant or high-risk vendors.