Duration: 2 hours Prerequisites: Healthcare regulations knowledge Session Type: Risk Management and Compliance

• Assess cybersecurity risks specific to digital health initiatives
• Ensure compliance with healthcare regulations and standards
• Implement governance frameworks for healthcare technology projects
• Develop incident response strategies for security breaches

• 725 healthcare breaches reported in 2024 alone
• 275 million patient records exposed through security incidents
• Average breach cost: $10.93 million for healthcare organizations
• Primary attack vectors: Ransomware, phishing, insider threats, third-party vulnerabilities

• Ransomware Attacks: System encryption demanding payment for restoration
• Phishing Campaigns: Targeted emails stealing credentials and personal information
• Insider Threats: Malicious or negligent employee actions
• Third-Party Vulnerabilities: Vendor systems and business associate risks
• IoT Device Exploitation: Unsecured medical devices and network endpoints

• Administrative Safeguards: Security management processes and assigned responsibilities
• Physical Safeguards: Access controls to facilities, workstations, and media
• Technical Safeguards: Access controls, audit controls, integrity, transmission security
• Business Associate Agreements: Third-party vendor compliance requirements

• HITECH Act: Enhanced HIPAA enforcement and breach notification requirements
• FDA Cybersecurity Guidelines: Medical device security throughout lifecycle
• State Privacy Laws: California Consumer Privacy Act (CCPA) and similar regulations
• International Standards: GDPR for global operations, ISO 27001 for security management

• Risk Assessment: Regular evaluation of security vulnerabilities
• Policy Development: Comprehensive security policies and procedures
• Training Programs: Security awareness and incident response training
• Audit and Monitoring: Regular compliance assessments and remediation

• Asset Inventory: Cataloging all systems, applications, and data types
• Threat Modeling: Identifying potential attack vectors and vulnerabilities
• Impact Analysis: Assessing potential damage from security incidents
• Likelihood Assessment: Evaluating probability of various threat scenarios

• Data Transmission: Unsecured APIs and data exchange protocols
• Mobile Applications: Insecure mobile app development practices
• Cloud Services: Misconfigured cloud security settings
• Integration Points: Vulnerable interfaces between systems
• User Authentication: Weak password policies and access controls

• Defense in Depth: Multiple layers of security controls
• Zero Trust Architecture: Never trust, always verify approach
• Encryption: Data protection at rest and in transit
• Access Controls: Role-based permissions and least privilege principles
• Network Segmentation: Isolating critical systems and data

• Executive Oversight: C-suite involvement and accountability
• Security Committee: Cross-functional team for security decisions
• Risk Management: Enterprise risk assessment and mitigation
• Incident Response: Coordinated response to security events
• Vendor Management: Third-party risk assessment and monitoring

• Data Classification: Identifying and categorizing sensitive information
• Access Management: Controlling who can access what data
• Data Lifecycle: Managing data from creation to destruction
• Privacy Controls: Ensuring patient privacy protection
• Audit and Monitoring: Tracking data access and usage

• Security by Design: Incorporating security from project inception
• Risk Assessment: Evaluating security implications of project decisions
• Security Requirements: Defining and documenting security needs
• Testing and Validation: Security testing throughout project lifecycle
• Deployment Security: Secure implementation and configuration

• Preparation: Establishing incident response team and procedures
• Detection and Analysis: Identifying and assessing security incidents
• Containment: Limiting damage and preventing further compromise
• Eradication and Recovery: Removing threats and restoring systems
• Post-Incident Analysis: Learning from incidents and improving response

• Patient Safety: Ensuring continued patient care during incidents
• Regulatory Notification: HIPAA breach notification requirements
• Media Management: Public relations and reputation management
• Business Continuity: Maintaining critical healthcare operations
• Legal Considerations: Evidence preservation and law enforcement cooperation

• Business Impact Assessment: Evaluating operational and financial impacts
• Stakeholder Communication: Coordinating with clinical and administrative staff
• Recovery Planning: Designing business process restoration strategies
• Lessons Learned: Documenting findings and improvement opportunities
• Risk Assessment Updates: Revising risk profiles based on incident learnings

• Behavioral Analytics: Detecting unusual user and system behavior
• Threat Intelligence: Automated threat detection and response
• Predictive Security: Anticipating and preventing security incidents
• Automated Response: Reducing incident response time and human error

• Identity Verification: Multi-factor authentication and identity management
• Device Security: Endpoint protection and device compliance
• Network Security: Micro-segmentation and encrypted communications
• Application Security: Secure application development and deployment

• Shared Responsibility Model: Understanding cloud provider vs. customer responsibilities
• Data Residency: Managing data location and sovereignty requirements
• Configuration Management: Maintaining secure cloud service configurations
• Monitoring and Logging: Comprehensive visibility into cloud environments

Scenario: New telemedicine platform implementation

• Identify potential security risks and vulnerabilities
• Assess impact and likelihood of various threats
• Recommend risk mitigation strategies
• Develop security requirements for the project

Scenario: HMIS system upgrade with new data sharing capabilities

• Review HIPAA Security Rule requirements
• Identify compliance gaps and risks
• Develop compliance action plan
• Create business associate agreement requirements

Scenario: Ransomware attack affecting EHR system

• Develop incident response timeline and actions
• Identify key stakeholders and communication requirements
• Plan business continuity measures
• Design recovery and restoration strategy

• Include security requirements from project inception
• Identify regulatory and compliance requirements
• Assess third-party vendor security practices
• Plan for security testing and validation

• Define security and privacy requirements explicitly
• Consider security implications of functional requirements
• Include audit and monitoring requirements
• Plan for incident response and business continuity

• Participate in security testing and validation
• Review security configurations and settings
• Validate compliance with security requirements
• Document security controls and procedures

• Monitor security metrics and indicators
• Participate in security reviews and assessments
• Support incident response activities
• Contribute to continuous security improvement

• Healthcare cybersecurity threats are increasing in frequency and sophistication
• Regulatory compliance is a minimum baseline, not a complete security strategy
• Security must be integrated into all phases of digital health projects
• Incident response planning is essential for business continuity and patient safety
• Business analysts play a critical role in balancing security requirements with operational needs

• Risk Assessment Frameworks: NIST Cybersecurity Framework, ISO 27001
• Compliance Tools: HIPAA compliance checklists, security assessment templates
• Security Training: SANS Institute, (ISC)² certification programs
• Threat Intelligence: Healthcare security bulletins and alerts
• Vendor Assessment: Security questionnaires and audit checklists

Session 10 will focus on change management and user adoption strategies for digital transformation in healthcare settings, including overcoming resistance and measuring adoption success.