Healthcare Compliance SOP¶

Purpose¶

To establish standardized procedures for maintaining compliance with Saudi healthcare regulations, including PDPL, CCHI requirements, and NPHIES standards, ensuring data protection and operational integrity.

Scope¶

This SOP applies to all BrainSAIT staff, healthcare clients, and system users handling protected health information (PHI) and participating in healthcare data processing.

Roles and Responsibilities¶

Definitions¶

• PDPL - Personal Data Protection Law of Saudi Arabia
• PHI - Protected Health Information
• CCHI - Council of Cooperative Health Insurance
• NPHIES - National Platform for Health Information Exchange
• Data Breach - Unauthorized access to personal data

Compliance Framework¶

Regulatory Requirements¶

PDPL Compliance¶

1. Lawful Processing
2. Valid legal basis required
3. Document processing purposes

4. Minimize data collection

5. Data Subject Rights

6. Access requests within 30 days
7. Rectification capabilities

8. Erasure procedures

9. Security Measures

10. Encryption requirements
11. Access controls

12. Audit logging

13. Breach Notification

14. SDAIA notification within 72 hours
15. Data subject notification if high risk
16. Incident documentation

CCHI Requirements¶

1. Insurance Processing
2. Accurate claim submission
3. Timely filing

4. Appeals procedures

5. Provider Compliance

6. Licensing verification
7. Network agreements
8. Quality standards

NPHIES Standards¶

1. Technical Compliance
2. FHIR R4 adherence
3. API security

4. Data validation

5. Operational Compliance

6. Transaction logging
7. Error handling
8. Performance standards

Step-by-Step Procedures¶

Procedure 1: Data Collection¶

Objective: Ensure lawful and minimal data collection

Steps:

1. Identify Purpose
2. Document processing purpose
3. Verify legal basis

4. Assess necessity

5. Obtain Consent (when required)

6. Clear, specific language
7. Arabic and English
8. Document consent receipt

9. Enable withdrawal

10. Collect Minimum Data

11. Only necessary fields
12. No excessive collection

13. Validate accuracy

14. Document Processing

15. Record in processing log
16. Link to legal basis
17. Note retention period

Procedure 2: Data Access Control¶

Objective: Restrict PHI access to authorized personnel

Steps:

1. Define Access Roles

   roles:
     clinical_user:
       access: [view_patient, edit_encounter]
     billing_user:
       access: [view_demographics, edit_claims]
     admin:
       access: [all_functions]
   

2. Implement Controls

3. Role-based access (RBAC)
4. Unique user IDs
5. Strong passwords

6. Multi-factor authentication

7. Review Access

8. Quarterly access reviews
9. Remove unnecessary access

10. Document changes

11. Monitor Usage

12. Log all PHI access
13. Alert on anomalies
14. Regular audit review

Procedure 3: Data Security¶

Objective: Protect PHI from unauthorized disclosure

Steps:

1. Encryption
2. At rest: AES-256
3. In transit: TLS 1.3

4. Key management via HSM

5. Network Security

6. Firewall configuration
7. Network segmentation

8. VPN for remote access

9. Endpoint Security

10. Antivirus/EDR
11. Patch management

12. Device encryption

13. Physical Security

14. Data center access controls
15. Visitor management
16. Clean desk policy

Procedure 4: Audit Logging¶

Objective: Maintain complete audit trail

Steps:

1. Configure Logging

   audit_events:
     - user_login
     - phi_access
     - data_export
     - configuration_change
     - failed_attempts
   

2. Protect Logs

3. Immutable storage
4. Access restricted

5. Integrity verification

6. Retain Logs

7. Minimum 7 years
8. Secure archival

9. Retrieval procedures

10. Review Logs

11. Daily automated alerts
12. Weekly manual review
13. Monthly compliance report

Procedure 5: Incident Response¶

Objective: Handle security incidents promptly

Steps:

1. Detection
2. Monitoring alerts
3. User reports

4. Third-party notification

5. Containment

6. Isolate affected systems
7. Preserve evidence

8. Prevent spread

9. Assessment

10. Determine scope
11. Identify affected data

12. Assess risk level

13. Notification

If personal data breach:

1. Remediation
2. Fix vulnerabilities
3. Update controls

4. Document lessons learned

5. Post-Incident

6. Complete incident report
7. Update procedures
8. Train staff

Procedure 6: Data Subject Requests¶

Objective: Fulfill data subject rights within legal timeframes

Steps:

1. Receive Request
2. Verify identity
3. Log request

4. Acknowledge receipt

5. Process Request

1. Respond
2. Provide clear response
3. Document completion
4. Retain proof

Procedure 7: Vendor Management¶

Objective: Ensure third-party compliance

Steps:

1. Assessment
2. Security questionnaire
3. Compliance verification

4. Risk evaluation

5. Contracting

6. Data processing agreement
7. Security requirements

8. Audit rights

9. Monitoring

10. Regular reviews
11. Incident communication

12. Performance tracking

13. Termination

14. Data return/deletion
15. Access revocation
16. Certificate of destruction

Training Requirements¶

Initial Training¶

• PDPL overview
• Security awareness
• Incident reporting
• Role-specific procedures

Annual Refresher¶

• Regulation updates
• Incident lessons
• Policy changes
• Practical exercises

Documentation¶

• Training records
• Competency assessments
• Acknowledgments

Monitoring and Metrics¶

Daily Monitoring¶

• Security alerts reviewed
• Access anomalies checked
• System health verified

Weekly Metrics¶

Monthly Reporting¶

• Compliance dashboard
• Incident summary
• Training status
• Risk assessment updates

Annual Review¶

• Full policy review
• Regulation updates
• Control effectiveness
• Improvement planning

KPIs¶

Escalation¶

Revision History¶

Related Documents¶

• HIPAA PDPL Alignment
• Security Guidelines
• Claim Submission SOP
• Master Glossary

Last updated: January 2025