Perform HIPAA Omnibus Rule Assessment using eAuditor
The HIPAA Omnibus Rule is a 2013 update to the Health Insurance Portability and Accountability Act (HIPAA) that strengthens patient privacy protections, expands compliance requirements for business associates, and increases penalties for violations.
Performing a HIPAA Omnibus Rule Assessment using eAuditor ensures compliance with enhanced HIPAA regulations, protects patient data, and minimizes legal risks. This assessment helps organizations evaluate business associate agreements, breach notification protocols, patient rights, and data security practices.
Preparation Stage
Objective:
Define the assessment scope, select an appropriate checklist, and review HIPAA Omnibus Rule requirements.
- Select an Inspection Template:
- Use or customize an eAuditor checklist covering business associate compliance, breach notifications, patient rights, and security practices.
- Define the Scope:
- Assess compliance for covered entities (healthcare providers, insurers) and business associates (IT vendors, cloud storage, billing services).
- Review HIPAA Omnibus Rule Updates:
- Understand expanded liability, breach notification rules, patient rights, and penalty structures.
On-Site Data Collection (Assessment Execution)
Objective:
Evaluate compliance with HIPAA Omnibus Rule provisions.
2.1 Business Associate Compliance
- Business Associate Agreements (BAAs):
- Are valid BAAs signed with all vendors handling PHI?
- Do BAAs include data protection responsibilities and liability clauses?
- Are third-party security measures reviewed regularly?
- Business Associate Risk Management:
- Are business associates aware of their HIPAA obligations?
- Is there evidence of security policies and staff training?
2.2 Breach Notification Compliance
- Incident Response & Reporting:
- Are breach detection systems in place?
- Are breaches reported within 60 days unless proven low-risk?
- Risk Assessment Documentation:
- Does the organization assess breaches using the HIPAA Omnibus four-factor test?
- Is there a clear breach notification process for affected individuals, HHS, and media (if required)?
2.3 Patient Rights Compliance
- Access to Medical Records:
- Can patients request electronic copies of their health records?
- Are patient records provided within 30 days of request?
- Request for Restricted Disclosures:
- Can patients restrict PHI disclosures to insurers if they pay out-of-pocket?
- Are processes in place to honor these restrictions?
2.4 Marketing & Fundraising Restrictions
- Patient Authorization for Marketing:
- Is written patient consent obtained before using PHI for marketing purposes?
- Are fundraising opt-out options clearly communicated to patients?
2.5 Security & Privacy Measures
- PHI Protection:
- Are data security measures (encryption, access controls, firewalls) in place?
- Are staff trained in handling PHI and preventing unauthorized disclosures?
- HIPAA Training & Policy Updates:
- Have employees received updated training on the HIPAA Omnibus Rule?
- Are internal HIPAA policies regularly reviewed and updated?
Inspection Report Generation
Objective:
Summarize findings, identify compliance gaps, and document corrective actions.
- Automated Report Generation:
- eAuditor compiles inspection data into a detailed report with compliance scores, evidence, and flagged issues.
- Export & Share Reports:
- Generate reports in PDF or Excel and share them with compliance officers and management.
Follow-up and Corrective Actions
Objective:
Address compliance gaps and strengthen HIPAA adherence.
- Assign Corrective Actions:
- If issues are found (e.g., missing BAAs, improper breach handling), assign tasks to responsible personnel.
- Monitor Progress:
- Track corrective actions in eAuditor and schedule follow-up audits if needed.
Continuous Improvement
Objective:
Enhance compliance with ongoing assessments and staff training.
- Review Recurring Issues:
- Identify patterns in breach handling, business associate compliance, and patient rights implementation.
- Strengthen Training Programs:
- Implement HIPAA refresher training for staff and vendors.
- Schedule Regular HIPAA Audits:
- Conduct quarterly or annual assessments to maintain compliance.
Conclusion
Performing a HIPAA Omnibus Rule Assessment using eAuditor ensures stronger PHI protection, improved business associate oversight, and compliance with breach notification requirements. Regular assessments help reduce risks, enhance security measures, and maintain regulatory compliance in healthcare organizations.