Protecting patient data is one of the main responsibilities of healthcare organizations, especially in light of the Health Insurance Portability and Accountability Act (HIPAA) Omnibus Rule enacted in 2013. This rule significantly expanded the requirements for safeguarding patient privacy and data security. Complying with the HIPAA Omnibus Rule is not just a legal obligation but also essential for maintaining trust with patients and avoiding costly penalties.
In this blog, we will explore the key aspects of the Omnibus Rule and provide guidance on assessing and enhancing your organization's compliance posture.
What Is the Omnibus Rule?
The HIPAA Omnibus Rule took effect March 26, 2013, and comprises a comprehensive set of modifications to the HIPAA Privacy, Security, and Enforcement Rules. Affiliated with the Health Information Technology for Economic and Clinical Health (HITECH) Act, the Omnibus Rule implements many of the privacy, security, and enforcement provisions outlined in the Act. The primary purpose of the Omnibus Rule includes all of the following:
- Enhanced Privacy Protections
- Expanded Coverage
- Increased Penalties for Non-Compliance
- Breach Notification Rule Modification
- Enhanced Individual Rights
- Genetic Information Protections
Impact of the Omnibus Rule on Covered Entities
Business Associates and Business Associate Agreements
The Omnibus Rule impacts covered entities by expanding the definition of "business associates" to include entities that create, receive, maintain, or transmit protected health information (PHI) on behalf of a covered entity.
This change requires covered entities to update their Business Associate Agreements (BAAs) to ensure compliance with the new requirements. Covered entities must revise their Notice of Privacy Practices (NPP) to reflect the changes brought about by the Omnibus Rule, including informing patients of their rights and how their information is protected.
Penalties and HIPAA Breach Notification
The Omnibus Rule also increased penalties for HIPAA violations and revised breach notification rules, incentivizing entities to adhere to the updated regulations to avoid costly fines and reputational damage. Under the revised breach notification rules, covered entities must notify affected individuals, the Department of Health and Human Services (HHS), and, in some cases, the media of any breaches of unsecured PHI.
Specific Compliance Challenges for Different Organizations
Healthcare Provider Compliance
Healthcare providers face unique challenges in complying with the Omnibus Rule. They must ensure that all BAAs with their business associates are updated to include the new requirements and that they adequately train all of their staff on the changes. Providers must also update their NPPs and make them available to patients, which can be a time-consuming and resource-intensive process.
Health Plan Compliance
The Omnibus Rule explicitly mentions healthcare plans as covered entities, so they are expected to be in compliance with the rule’s standards. This includes health insurance companies, clearinghouses, and government-sponsored programs like Medicare, Medicaid, and veterans and military programs.
Health Plan Marketing
Any use of PHI for marketing or fundraising must comply with the new regulations, which may require significant changes to their current practices. Covered entities must obtain individual authorization for certain marketing communications and provide an opt-out mechanism for fundraising communications.
Strategies for Achieving Omnibus Rule Compliance
- Distribute specified HIPAA policies and procedures to all staff members.
- Ensure all staff members read and attest to the implemented HIPAA policies and procedures.
- Document staff attestations to prove the distribution of HIPAA rules.
- Maintain documentation for annual reviews of HIPAA policies and procedures.
Training:
- Provide basic HIPAA compliance training to all staff members.
- Ensure all staff members complete HIPAA training for employees.
- Maintain documentation of staff training.
Compliance Officer:
- Designate a staff member as the HIPAA Compliance, Privacy, or Security Officer as the law requires.
Business Associates
- Identify all business associates as defined under HIPAA rules.
- Identify all associates who may receive, transmit, maintain, process, or access ePHI.
- Execute a Business Associate Agreement (Business Associate Contract) with each identified Business Associate.
- Audit Business Associates to ensure their compliance with HIPAA rules.
- Maintain written reports to demonstrate due diligence regarding Business Associates.
Incident Management
- Implement a management system to handle security incidents or breaches.
- Establish systems to track and manage investigations of incidents that impact the security of PHI.
- Ensure thorough investigation of each incident.
- Generate reports of all breaches and incidents, regardless of their severity.
Additional Strategies
- Conduct regular risk assessments to identify potential vulnerabilities and gaps in HIPAA compliance.
- Develop and maintain a comprehensive risk management plan to address identified risks.
- Implement technical, physical, and administrative safeguards to protect PHI.
- Regularly review and update HIPAA policies and procedures to ensure ongoing compliance.
- Provide ongoing training and education to staff members to reinforce best practices for HIPAA compliance.
- Establish a process for timely notification of breaches to affected individuals, the Department of Health and Human Services (HHS), and the media, as required by HIPAA regulations.
Ensuring compliance with the HIPAA Omnibus Rule can be a complex and challenging process for healthcare providers, health plans, and their business associates. To help your organization navigate these requirements and maintain ongoing compliance, consider investing in comprehensive HIPAA training for your staff.
HIPAA Exams offers compliance training courseware specifically designed for healthcare workers. Our "HIPAA for Health Care Workers" training course covers essential topics, including the Omnibus Rule, and provides the knowledge and tools needed to protect patient privacy and secure protected health information (PHI).
By prioritizing staff education and implementing the strategies outlined in this article, your organization can confidently meet the challenges of the HIPAA Omnibus Rule and demonstrate a strong commitment to safeguarding patient data. Take the first step towards a culture of compliance by visiting HIPAAexams.com today and exploring our comprehensive HIPAA training solutions.
