# Risk & Issue Register

**Project:** HAD Digital  
**Version:** 1.0.0  
**Date:** 2026-09-05  
**Owner:** Dr Kais Aldabbagh

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## Risks

| ID | Risk | Likelihood | Impact | Mitigation | Owner | Status |
|----|------|------------|--------|------------|-------|--------|
| RSK-001 | Regulatory (SaMD qualification) | High | High | Engage regulatory counsel before pilot | Dr Aldabbagh | Open |
| RSK-002 | Data security breach | Medium | High | Implement MFA, encryption, HDS hosting | Technical Lead | Open |
| RSK-003 | Low adoption by clinicians | Medium | Medium | User testing, iterative design | Dr Aldabbagh | Open |
| RSK-004 | Data quality (patient self-report) | Medium | Medium | Clinician confirmation for Grade >= 2 | Dr Aldabbagh | Open |
| RSK-005 | IP protection | Low | High | Anteriority filing, NDAs | Dr Aldabbagh | Open |

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## Issues

| ID | Issue | Impact | Owner | Status | Resolution |
|----|-------|--------|-------|--------|------------|
| ISS-001 | None identified yet | - | - | - | - |

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## Decisions

| ID | Decision | Options Considered | Rationale | Date | Owner |
|----|----------|-------------------|-----------|------|-------|
| DEC-001 | Use SQLite for MVP | PostgreSQL, MySQL, SQLite | Zero-config, portable, file-based | 2026-09-05 | Technical Lead |
| DEC-002 | Use Python standard library | Flask, Django, FastAPI | Zero external dependencies | 2026-09-05 | Technical Lead |
| DEC-003 | Use PyInstaller for .exe | cx_Freeze, Nuitka, py2exe | Well-documented, reliable | 2026-09-05 | Technical Lead |

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