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GenPRES Roadmap

Vision

GenPRES aims to be the leading open-source medication decision support system for pediatric care, providing safe, accurate, and evidence-based dosing calculations that reduce medication errors and improve patient outcomes.

Current Status (v2.0 Development)

🚧 Active Development - Moving toward production-ready release

Current Phase: Foundation Building & Documentation

  • Core libraries implemented (GenSolver, GenUnits, GenOrder, GenForm)
  • SAFE Stack architecture in place
  • MDR compliance documentation in progress
  • Test coverage expanding

Release Schedule

v2.0.0 - Production Release (Target: Q4 2026)

First production-ready release with MDR compliance and clinical validation.

Status: In Development

Major Milestones:

  • 12 structured workshops (see Architecture and Timeline)
  • Complete MDR documentation package
  • Clinical validation studies
  • Regulatory compliance verification
  • Production deployment infrastructure

Development Phases

Phase 1: Foundation & Governance (Q1 2026)

Workshop W1-W3

  • ✅ W1: Project Structure & Governance (In Progress)

    • Community health files
    • Governance model
    • Quality gates
    • CI/CD foundation

  • ⏳ W2: Core Architecture Review

    • Domain model validation
    • Constraint solver optimization
    • Unit of measure framework
    • Performance benchmarking

  • ⏳ W3: Requirements & Traceability

    • Requirements review and validation
    • Traceability matrix completion
    • Test coverage analysis
    • Gap identification

Phase 2: Clinical Validation (Q2 2026)

Workshop W4-W6

  • ⏳ W4: Clinical Scenarios & Testing

    • Expand scenario coverage
    • Clinical accuracy validation
    • Literature review
    • Expert consultation

  • ⏳ W5: Risk Management

    • Complete hazard analysis
    • Risk control implementation
    • Residual risk assessment
    • Safety testing

  • ⏳ W6: Usability Engineering

    • Usability testing
    • User interface refinement
    • Critical task analysis
    • User documentation

Phase 3: Integration & Interfaces (Q3 2026)

Workshop W7-W9

  • ⏳ W7: FHIR/HL7 Integration

    • Interface implementation
    • EHR integration testing
    • Interoperability validation
    • Integration documentation

  • ⏳ W8: Data Management

    • Resource management
    • Data versioning
    • Update procedures
    • Data validation

  • ⏳ W9: Security & Privacy

    • Security hardening
    • GDPR compliance
    • Audit logging
    • Penetration testing

Phase 4: Production Readiness (Q4 2026)

Workshop W10-W12

  • ⏳ W10: Performance & Scalability

    • Load testing
    • Performance optimization
    • Scaling infrastructure
    • Monitoring setup

  • ⏳ W11: Deployment & Operations

    • Deployment automation
    • Operations procedures
    • Backup/recovery
    • Support processes

  • ⏳ W12: Documentation & Training

    • User documentation
    • Training materials
    • Administrator guides
    • Release preparation

Feature Roadmap

v2.1.0 - Enhanced Clinical Features (Target: Q1 2027)

Focus: Expanded clinical capabilities

  • Additional medication categories
    • Antibiotics dosing
    • Pain management protocols
    • Emergency medications
  • Enhanced chemotherapy support
    • Body surface area calculations
    • Cycle management
    • Dose adjustments
  • Renal dosing adjustments
    • GFR-based adjustments
    • Renal function monitoring
    • Dialysis protocols
  • Drug interaction checking
    • Basic interaction database
    • Severity classification
    • Clinical recommendations

v2.2.0 - Advanced Calculations (Target: Q2 2027)

Focus: Sophisticated dosing algorithms

  • Pharmacokinetic modeling
    • Vancomycin dosing
    • Aminoglycoside dosing
    • Population PK models
  • Therapeutic drug monitoring
    • Level interpretation
    • Dose adjustment recommendations
    • Sampling time optimization
  • Weight-based protocols
    • Ideal body weight calculations
    • Adjusted body weight
    • Obesity dosing guidelines

v2.3.0 - Workflow Integration (Target: Q3 2027)

Focus: Clinical workflow optimization

  • Order sets and protocols
    • Pre-defined order sets
    • Protocol templates
    • Customization capability
  • Clinical decision support rules
    • Age-appropriate dosing
    • Weight-based alerts
    • Renal function alerts
  • Enhanced reporting
    • Dose calculation reports
    • Audit trail reports
    • Utilization statistics

v3.0.0 - AI/ML Integration (Target: 2028)

Focus: Machine learning enhancements

  • Predictive dosing recommendations
    • Historical outcome analysis
    • Patient-specific predictions
    • Continuous learning
  • Natural language processing
    • Order entry via natural language
    • Documentation analysis
    • Literature mining
  • Anomaly detection
    • Unusual dosing patterns
    • Potential errors
    • Safety alerts

Long-Term Vision (2028+)

Research & Development

  • Integration with pharmacogenomics data
  • Real-world evidence collection
  • Outcomes research platform
  • International expansion (localization)

Platform Expansion

  • Mobile applications (iOS/Android)
  • Wearable device integration
  • Home care support
  • Patient/family engagement tools

Ecosystem Development

  • Plugin architecture for extensions
  • Third-party integrations
  • API marketplace
  • Community contributions

How to Influence the Roadmap

We welcome community input on our roadmap:

  1. Feature Requests: Create a GitHub Discussion in the Ideas category
  2. Clinical Needs: Share use cases and clinical scenarios
  3. Partnerships: Contact us about collaboration opportunities
  4. Contributions: Implement features and submit pull requests

Priority Considerations

Features are prioritized based on:

  • Patient Safety Impact: Direct impact on medication safety
  • Clinical Need: Frequency and urgency of clinical scenarios
  • Evidence Base: Available literature and guidelines
  • Regulatory Compliance: MDR and regulatory requirements
  • Resource Availability: Development capacity and expertise
  • Community Interest: User requests and contributions

Versioning Strategy

We follow Semantic Versioning:

  • Major (x.0.0): Breaking changes, major features, architectural changes
  • Minor (2.x.0): New features, non-breaking enhancements
  • Patch (2.0.x): Bug fixes, security patches, minor improvements

Release Cadence

  • Major releases: Annually or as needed
  • Minor releases: Quarterly
  • Patch releases: As needed (especially for critical bugs)

Development Principles

Our roadmap is guided by:

  1. Safety First: Patient safety is paramount in all decisions
  2. Evidence-Based: Grounded in clinical literature and guidelines
  3. Quality Over Speed: Thorough validation before release
  4. Community-Driven: Responsive to user needs and feedback
  5. Regulatory Compliance: Maintain MDR and quality standards
  6. Open & Transparent: Public roadmap and decision-making

Dependencies & Risks

Key Dependencies

  • .NET ecosystem and SAFE Stack stability
  • Clinical advisory board availability
  • Regulatory landscape changes
  • Resource and funding availability

Known Risks

  • Regulatory approval timelines
  • Clinical validation complexity
  • Resource constraints
  • Technical debt management

Mitigation Strategies

  • Incremental delivery approach
  • Early regulatory engagement
  • Strong testing and validation
  • Active community building

Detailed Planning

For detailed workshop planning and task breakdown, see:

Get Involved

Want to contribute to GenPRES development?

  • Developers: See CONTRIBUTING.md
  • Clinicians: Share scenarios in GitHub Discussions
  • Researchers: Collaborate on validation studies
  • Organizations: Contact us about partnerships

Questions?

Document Version: 1.1 Last Updated: 2026-02-28 Next Review: 2026-05-28

For the most up-to-date information, see the project GitHub repository.