Duration: 2 hours Prerequisites: Project management fundamentals Session Type: Methodology and Practice

• Apply agile methodologies effectively in healthcare contexts
• Manage regulatory workflows and clinical validation requirements
• Coordinate with diverse healthcare stakeholders and timelines
• Balance clinical needs with technical constraints and project timelines

• Patient Safety Requirements: Zero tolerance for errors affecting patient care
• 24/7 Operations: Systems must maintain availability during implementations
• Regulatory Compliance: FDA, HIPAA, and other regulatory approval processes
• Clinical Validation: Medical staff must validate system functionality
• Stakeholder Complexity: Physicians, nurses, administrators, patients, regulators

• Clinical Workflow Disruption: Changes affecting patient care delivery
• Data Migration: Maintaining data integrity during system transitions
• Integration Complexity: Connecting with multiple existing systems
• User Adoption: Ensuring clinical staff embrace new technology
• Regulatory Approval: Meeting compliance requirements and validation needs

• Sprint Planning: Include clinical validation time in sprint estimates
• Daily Standups: Accommodate clinical staff schedules and availability
• Sprint Reviews: Include clinical stakeholders and patient safety validation
• Retrospectives: Focus on clinical workflow improvements and safety

As a [clinical role],
I want [functionality]
So that [patient care benefit/safety improvement]

Example:
As an Emergency Department physician,
I want real-time allergy alerts when ordering medications
So that I can prevent allergic reactions and improve patient safety

• Functional requirements met and tested
• Clinical validation completed by medical staff
• Security and privacy requirements verified
• Regulatory compliance confirmed
• Documentation updated (clinical and technical)
• Training materials created and validated
• Go-live support plan prepared

• Pre-Submission Meetings: Early FDA engagement for medical device software
• 510(k) Submissions: Demonstrating substantial equivalence to existing devices
• De Novo Pathway: For novel medical device software classifications
• Quality Management System: Design controls and risk management processes

• Privacy Impact Assessments: Evaluating patient data protection requirements
• Security Risk Assessments: Identifying and mitigating security vulnerabilities
• Business Associate Agreements: Managing third-party vendor compliance
• Breach Response Planning: Preparing for potential security incidents

• Clinical Evidence: Demonstrating safety and effectiveness
• Usability Testing: Ensuring clinical workflow integration
• Risk Analysis: Identifying and mitigating clinical risks
• Post-Market Surveillance: Monitoring real-world performance

• Physicians: Focus on clinical efficiency and patient outcomes
• Nurses: Emphasize workflow integration and documentation burden
• Pharmacists: Concentrate on medication safety and inventory management
• Laboratory Staff: Prioritize accuracy and turnaround time
• Radiology: Focus on image quality and diagnostic workflow

• C-Suite Executives: ROI, strategic alignment, competitive advantage
• Department Managers: Operational efficiency and resource optimization
• Quality Officers: Patient safety and regulatory compliance
• Finance: Budget management and cost control
• Legal/Compliance: Risk management and regulatory adherence

• Clinical Rounds: Participate in existing clinical meetings
• Medical Staff Committees: Present to organized medical staff
• Executive Briefings: Regular updates to senior leadership
• Departmental Meetings: Tailored updates for specific user groups
• Training Sessions: Combine communication with education

• Clinical Needs Assessment: Identify patient care improvement opportunities
• Regulatory Review: Assess compliance and approval requirements
• Stakeholder Analysis: Map all affected parties and their interests
• Risk Assessment: Identify clinical, technical, and regulatory risks
• Business Case: Demonstrate ROI and patient care benefits

• Clinical Workflow Analysis: Current state assessment and future design
• Regulatory Strategy: Approval pathway and compliance requirements
• Training Plan: Clinical education and competency development
• Go-Live Strategy: Minimizing disruption to patient care
• Support Plan: Post-implementation assistance and optimization

• Clinical Validation: Ongoing testing with medical staff
• Risk Monitoring: Tracking clinical and technical risks
• Regulatory Compliance: Maintaining approval requirements
• Change Management: Managing scope changes with clinical impact
• Quality Assurance: Ensuring patient safety throughout development

• Clinical Outcomes Assessment: Measuring patient care improvements
• User Adoption Monitoring: Tracking clinical staff engagement
• Performance Optimization: Continuous improvement based on usage data
• Regulatory Reporting: Ongoing compliance and surveillance
• Lessons Learned: Documenting insights for future projects

• Limited Availability: Clinical staff have patient care priorities
• Shift Schedules: Accommodating 24/7 healthcare operations
• Seasonal Variations: Holiday schedules and vacation coverage
• Emergency Response: Adjusting for unexpected clinical demands
• Training Time: Balancing education with patient care responsibilities

• System Downtime Windows: Scheduling maintenance during low-usage periods
• Testing Environments: Providing realistic test data and scenarios
• Integration Timeline: Coordinating with multiple system vendors
• Security Reviews: Allowing time for comprehensive security assessments
• Performance Testing: Load testing during peak usage scenarios

Scenario: Implementing medication reconciliation module

• Create healthcare-specific user stories
• Plan sprints with clinical validation time
• Identify clinical stakeholders for each story
• Design acceptance criteria including safety requirements

Scenario: Medical device software requiring FDA approval

• Map regulatory milestones and dependencies
• Plan clinical validation activities
• Schedule stakeholder reviews and approvals
• Create risk mitigation strategies

Scenario: EHR system upgrade in active hospital

• Design phased rollout strategy
• Plan training and support coverage
• Create fallback procedures for critical issues
• Develop communication plan for all stakeholders

• Include clinical stakeholders from project inception
• Plan for extended validation and testing phases
• Budget for clinical training and adoption support
• Prepare comprehensive risk management strategies
• Design flexible timelines accommodating clinical needs

• Maintain regular communication with clinical stakeholders
• Monitor clinical workflow impact continuously
• Address patient safety concerns immediately
• Provide adequate training and support resources
• Document all decisions and changes thoroughly

• Monitor clinical outcomes and system performance
• Continue stakeholder engagement and feedback collection
• Plan for ongoing system optimization and updates
• Maintain regulatory compliance and reporting
• Prepare for future upgrades and enhancements

• Healthcare IT projects require specialized project management approaches
• Patient safety must be the top priority throughout the project lifecycle
• Clinical validation and regulatory compliance add complexity and time
• Stakeholder management is more complex due to diverse healthcare roles
• Agile methodologies can be adapted effectively for healthcare contexts
• Post-implementation support and optimization are critical for success

• Project Planning: Microsoft Project, Smartsheet, Jira
• Collaboration: Microsoft Teams, Slack, Confluence
• Risk Management: Risk registers, mitigation tracking tools
• Document Management: SharePoint, Google Workspace, Box
• Compliance Tracking: Regulatory compliance management systems

Session 12 will explore advanced analytics and predictive modeling in healthcare, including the 71% of hospitals using EHR-integrated AI models and applications in population health management.