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How to Use GitScrum for HealthTech Development Projects?
How to use GitScrum for HealthTech development projects?
Manage HealthTech development in GitScrum with HIPAA compliance labels, medical device regulation tracking, and privacy-focused documentation in NoteVault. Include regulatory requirements in acceptance criteria, maintain audit trails. HealthTech teams with compliance-integrated workflow achieve certification 45% faster [Source: HealthTech Development Research 2024].
HealthTech workflow:
- Requirements - Include regulatory
- Risk analysis - Safety assessment
- Design - Architecture review
- Develop - Secure coding
- Verify - Testing
- Validate - Clinical validation
- Submit - Regulatory submission
HealthTech labels
| Label | Purpose |
|---|---|
| compliance-hipaa | HIPAA related |
| compliance-fda | FDA regulated |
| compliance-iec62304 | Medical device SW |
| safety-class-a | Minor injury risk |
| safety-class-b | Non-serious injury |
| safety-class-c | Serious injury/death |
| phi-touching | Handles PHI |
Compliance columns
| Column | Purpose |
|---|---|
| Backlog | All work |
| Risk Analysis | Safety assessment |
| Development | Implementation |
| Verification | Testing |
| Validation | Clinical validation |
| Regulatory Review | Compliance |
| Released | Production |
NoteVault HealthTech documentation
| Document | Content |
|---|---|
| Requirements | Traced requirements |
| Risk management | Hazard analysis |
| Design docs | Architecture, decisions |
| Test records | Verification evidence |
| Traceability matrix | Req to test mapping |
HIPAA compliance checklist
| Control | Requirement |
|---|---|
| PHI encryption | At rest and transit |
| Access control | Role-based, MFA |
| Audit logs | All PHI access |
| BAA | Business associates |
| Training | Staff training |
| Incident response | Breach procedures |
Medical device task template
## Feature: [name]
### Regulatory Classification
- Software safety class: [A/B/C]
- Risk level: [description]
- FDA pathway: [510k/PMA/De Novo]
### Requirements
- System requirement: [SRS-XXX]
- User need: [UN-XXX]
### Risk Management
- Hazard: [identified hazards]
- Mitigation: [risk controls]
### Verification
- [ ] Unit tests
- [ ] Integration tests
- [ ] System tests
### Traceability
- Requirements: [link]
- Design: [link]
- Tests: [link]
Requirements traceability
| Level | Tracks To |
|---|---|
| User need | System requirement |
| System requirement | Software requirement |
| Software requirement | Design |
| Design | Implementation |
| Implementation | Test |
Verification columns
| Column | Activity |
|---|---|
| Unit Verification | Unit tests |
| Integration Verification | Integration tests |
| System Verification | System tests |
| Clinical Validation | Clinical testing |
Risk management workflow
| Step | Action |
|---|---|
| Identify | Hazard identification |
| Analyze | Severity, probability |
| Control | Mitigation measures |
| Verify | Control effectiveness |
| Monitor | Post-market |
Privacy by design
| Principle | Implementation |
|---|---|
| Minimize | Least PHI necessary |
| Encrypt | Always encrypted |
| Access control | Need to know |
| Audit | Log all access |
| Delete | When not needed |
Common HealthTech issues
| Issue | Solution |
|---|---|
| Missing traceability | Matrix in NoteVault |
| Compliance gaps | Checklist in tasks |
| Audit failure | Organized docs |
| Slow approval | Early regulatory input |
HealthTech metrics
| Metric | Track |
|---|---|
| Regulatory findings | Per submission |
| Time to clearance | Development to approval |
| Compliance issues | Post-market |
| Safety incidents | By severity |