Medical Compliance Skill

Data Integrity Principles

No Soft Deletes on Clinical Data

Clinical data must never be "undeleted" - use explicit void flags instead.

// WRONG - Allows accidental restoration
treatment.destroy(); // Sets deletedAt, can be restored

// CORRECT - Explicit, auditable, non-reversible
treatment.update({
  isVoided: true,
  voidedBy: userId,
  voidedAt: new Date(),
  voidReason: 'Entered in error'
});
// Never "un-void" clinical data

Required Void Fields

All medical data tables should include:

• •is_voided (boolean) - Void flag
• •voided_by (UUID) - Who voided the record
• •voided_at (timestamp) - When voided
• •void_reason (text) - Why voided

Audit Logging Requirements

What to Log (Process Safety Focus)

• •WHO performed the action (userId)
• •WHAT action was performed (scan, insert, complete)
• •WHEN it happened (server timestamp)
• •WHICH resources were affected (applicatorId, treatmentId)

Audit Log Pattern

await ApplicatorAuditLog.create({
  applicatorId: applicator.id,
  action: 'STATUS_CHANGE',
  previousStatus: oldStatus,
  newStatus: newStatus,
  userId: req.user.id,
  timestamp: new Date(),
  details: JSON.stringify({ reason })
});

Retention

• •Audit logs must be retained for minimum 6 years (FDA 21 CFR Part 11)
• •Never delete audit logs in application code
• •Use database-level archival for old records

Treatment State Machine

SCHEDULED → ACTIVE → COMPLETED
    ↓          ↓
 CANCELLED  CANCELLED

Transition Rules

• •VALIDATE transitions before allowing
• •LOG all state changes
• •PREVENT invalid transitions (return 400 error)

const validTransitions = {
  'SCHEDULED': ['ACTIVE', 'CANCELLED'],
  'ACTIVE': ['COMPLETED', 'CANCELLED'],
  'COMPLETED': [], // Terminal
  'CANCELLED': [], // Terminal
};

if (!validTransitions[currentStatus].includes(newStatus)) {
  throw new Error(`Invalid transition: ${currentStatus} → ${newStatus}`);
}

Fail-Safe Principles

When Uncertain, BLOCK

• •ERP offline + no cache = BLOCK
• •ERP offline + stale cache (>24h) = BLOCK
• •Cannot verify expiry = BLOCK
• •Local says USED, ERP says available = BLOCK (trust local)

Never Fail-Open

Medical devices must never default to "allow" when verification fails.

// WRONG - Fail-open
if (!canVerify) {
  console.warn('Cannot verify, proceeding anyway');
  return true; // DANGEROUS
}

// CORRECT - Fail-closed
if (!canVerify) {
  throw new Error('SAFETY BLOCK: Cannot verify applicator');
}

Transaction Requirements

When to Use Transactions

• •Treatment status changes
• •Patient data modifications
• •Multi-step workflows
• •Any operation affecting multiple tables

Transaction Pattern

const transaction = await sequelize.transaction({
  isolationLevel: Transaction.ISOLATION_LEVELS.SERIALIZABLE
});
try {
  await Treatment.update({ status: 'COMPLETED' }, { transaction });
  await Activity.create({ ... }, { transaction });
  await transaction.commit();
} catch (error) {
  await transaction.rollback();
  throw error;
}

Pre-Commit Checklist

• • No soft deletes on clinical data (use is_voided)
• • Audit logging for all state changes
• • State transitions validated
• • Transactions used for multi-step operations
• • ERP offline = BLOCK (fail-safe)
• • Local DB checked BEFORE ERP for safety decisions