What is HIPAA Certification?

August 7, 2024

Table of Contents:

1. Introduction
2. What is HIPAA Certification?
3. Who Needs HIPAA Certification?
4. Top Benefits of HIPAA Certification
5. HIPAA Certification Requirements
6. The HIPAA Certification Process Step-by-Step
7. What is the Cost of HIPAA Certification?
8. Maintaining Compliance After HIPAA Certification
9. HIPAA Training Requirements
10. HIPAA Enforcement and Penalties
11. Conclusion

Introduction 

HIPAA, or the Health Insurance Portability and Accountability Act, sets national standards for protecting sensitive patient health information. It applies to covered entities like healthcare providers, health plans, healthcare clearinghouses, as well as business associates.

HIPAA certification to a healthcare organization undergoing an independent audit to demonstrate compliance with HIPAA regulations. While HIPAA compliance is mandatory, certification is voluntary and indicates an organization’s commitment to safeguarding patient privacy. 

Let’s look at HIPAA certification and how to achieve it.

What is HIPAA Certification?

HIPAA certification refers to a healthcare entity’s process of demonstrating complete compliance with the Health Insurance Portability and Accountability Act (HIPAA).

HIPAA is a US federal law that provides strict regulations around the privacy and security of protected health information (PHI). To become fully HIPAA-approved, healthcare groups must adopt the full set of physical, administrative, and digital protections needed by the HIPAA Security Rule. An independent external auditor then audits the organization all HIPAA requirements.

If a healthcare entity is found to adequately protect and secure PHI as HIPAA mandates after this comprehensive audit, they are considered “HIPAA certified.”

Who Needs HIPAA Certification?

The following types of healthcare businesses must follow HIPAA rules when they make, view, store, or send protected health information. Because of this, they can greatly benefit from voluntarily obtaining HIPAA compliance certification to show that they are following the rules:

• Healthcare Providers: This includes doctors, dentists, hospitals, nursing homes, home health agencies, physical therapy clinics, mental health counsellors, and any other groups that treat people and get access to PHI.
• Health Insurers: Regarding health insurers, HIPAA rules apply to all of them. This includes private and public health insurers, company group health plans, government health plans like Medicare and Medicaid, Affordable Care Act health plans, COBRA plans, and Health Maintenance Organisations (HMOs).
• Healthcare Clearinghouses: These groups take nonstandard health information from sources and turn it into standard computer forms. Clearinghouses let insurance companies and providers handle health data automatically.
• Business Associate:As a business associate (BA), you can access or use protected health information (PHI) to provide services to a HIPAA-covered organisation. A billing company that looks over claims or an IT company that stores data are both examples of business partners.

Even though these organizations do not legally need to be HIPAA certified, it can greatly help them follow HIPAA’s complex privacy and security rules. The thorough checks and audits can find gaps in compliance and lower the risk of a costly data breach. HIPAA compliance Certification also shows patients, buyers, and partners that a company is dedicated to carefully protecting health information. 

Top Benefits of HIPAA Certification

There are several compelling benefits for healthcare organizations that undertake the process of independent third-party HIPAA compliance certification audits:

• Identifies weaknesses or gaps in compliance: Experienced assessors can pinpoint any issues or vulnerabilities in privacy or security controls that need remediation to fully meet HIPAA standards. This allows entities to improve compliance systematically across all required safeguards.
• Lowers risk of HIPAA violations: Rigorously implementing all of HIPAA’s required safeguards and controls substantially decreases the chances of a patient data breach or other HIPAA rule infractions.
• Avoids large HIPAA violation fines: Passing a  audit helps organizations avoid sizable HIPAA violation fines, which can exceed $100 per violation.
• Improves patient trust and satisfaction: When patients know their health records are secured as validated by HIPAA certification they will feel much more confident and satisfied with the healthcare provider.
• Provides a competitive advantage: Being HIPAA certified can distinguish an organization from others in the market as one that takes PHI privacy and security regulations very seriously.
• Supplements internal audits: Third-party assessors provide an objective external perspective to complement internal HIPAA audits.

Overall, the extensive review and verification processes involved in voluntary HIPAA certification audits can substantially improve compliance and reduce breach risks. While not mandatory, certification is considered a best practice.

Next, let’s review the actual requirements that healthcare entities must meet to pass a HIPAA certification audit.

Read also: What is Considered Protected Health Information Under HIPAA?

HIPAA Certification Requirements

To successfully become HIPAA certified, you need to follow some of most important requirements which include:

• HIPAA Security Officer: Assign a dedicated Security Officer to manage HIPAA compliance efforts. This person may also take on the responsibilities of the Privacy Officer.
• Risk Analysis: Conduct accurate and thorough risk analyses at least annually to identify any vulnerabilities that could potentially lead to improper disclosure or breaches of protected health information.
• HIPAA Policies: Maintain extensive written policies, procedures, and documentation for handling and safeguarding PHI in compliance with HIPAA standards.
• Employee Training: Provide comprehensive role-based HIPAA training certification to all workforce members on HIPAA regulations and the organization’s privacy and security policies. Training should be conducted at hire and annually.
• Physical Safeguards: Physically secure offices, facilities, and workstations that house PHI and limit physical access only to authorized personnel.
• Technical Safeguards: Implement various technical data protections required by HIPAA across infrastructure, applications, and devices. This includes encryption, multi-factor authentication, audit logging, and access controls.
• Business Associate Agreements: Have current and compliant BA agreements with all vendors that may access or use PHI to perform contracted services.

In addition to implementing all the above safeguards, the organization must permit an experienced, independent HIPAA auditor to review the HIPAA Security Rule.

Now, let’s walk through the typical HIPAA certification process and the steps involved.

The HIPAA Certification Process Step-by-Step

If you want to certify your healthcare organization’s HIPAA compliance through a third-party assessment, here are the key steps involved:

1. Conduct Internal HIPAA Risk Analyses and Audits: Begin by performing risk analyses and internal audits across the organization to identify any areas not yet compliant with HIPAA requirements. This will uncover any gaps needing remediation.
2. Remediate Any Gaps or Compliance Issues: Using the results of the risk analysis, implement any missing physical, administrative, or technical safeguards needed to comply fully with all HIPAA regulations. Priority should be given to fixes that reduce the greatest risks.
3. Formally Appoint HIPAA Privacy and Security Officers: Designate one or more qualified individuals to serve as the Privacy and Security Officers responsible for managing the HIPAA compliance program. Equip them with HIPAA training and tools to fulfill their roles.
4. Review and Update HIPAA Policies and Procedures: Closely review and update all policies, plans, and protocols related to HIPAA privacy, security, breach notification, and other relevant areas to ensure they reflect current regulations and best practices.
5. Provide Organization-Wide HIPAA Training. Deliver comprehensive HIPAA education and HIPAA training certification to all employees and staff (including C-suite leadership) tailored to their job roles. This empowers them to comply with HIPAA in their day-to-day responsibilities.
6. Contract with a Qualified HIPAA Auditor: Research qualified firms or consultants experienced in HIPAA auditing and compliance. Select one to perform an exhaustive independent certification audit.
7. Make Any Changes Needed to Remediate Issues: If any compliance gaps or vulnerabilities are identified during the audit, make any necessary changes to policies, training, documentation, or systems.
8. Obtain HIPAA Certification: After successfully passing the audit and demonstrating full compliance with all HIPAA regulations, the auditor will issue you an official .

Be aware that HIPAA certification represents compliance at a point in time. Maintaining compliance requires ongoing vigilance. Let’s look at costs next.

What is the Cost of HIPAA Certification?

The costs involved in undergoing comprehensive independent third-party HIPAA certification can vary widely based on these key factors:

• The overall size of the healthcare entity (number of employees, locations, etc.)
• The complexity of their IT systems environment and data landscape
• The amount of protected health information requires safeguards
• The number of business associates that require HIPAA contract reviews
• The degree of staff needing HIPAA training certification

Maintaining Compliance After HIPAA Certification

It is extremely important for healthcare entities to understand that HIPAA certification reflects compliance at a distinct point in time only. To remain continuously compliant in the months and years after certification, organizations must take actions like:

• Conduct Updated Risk Analyses : Perform new risk analyses at least annually to identify any new risks that need mitigation to maintain compliance as conditions change.
• Provide Ongoing HIPAA Training: Deliver refresher HIPAA privacy and security training to all staff at least yearly to reinforce their understanding of policies.
• Monitor for Unusual Activity: Monitor systems housing PHI daily for any anomalous activity that could indicate a breach attempt or cyber attack.
• Review Policies and Procedures: Periodically review and update all HIPAA policies, procedures, and documentation as regulations evolve or the business changes.
• Obtain Recertification: Schedule new third-party HIPAA certification audits every 2-3 years to re-validate sustained compliance.
• Test Incident Response: Conduct tabletop exercises to test the organization’s incident response plan for different breach scenarios. Update plans accordingly.

By taking these steps, healthcare groups can maintain compliance long after initial HIPAA certification is achieved.

HIPAA Training Requirements

One of the key requirements of both the HIPAA Privacy and Security Rules is providing ongoing training to all employees on HIPAA regulations and the organization’s compliance policies. Such HIPAA training certification must be provided:

• At Hire: All new hires who will have any exposure to protected health information must receive HIPAA training.
• Annually: Annual refresher training is required for all existing workforce members to reinforce HIPAA policies.
• When Policies Change: Additional training limited to policy changes may be warranted if procedures are updated.
• Upon Role Changes: Employees changing roles may require new training tailored to their new duties.

At a minimum, HIPAA training should cover:

• Definition of PHI
• Patient privacy rights
• Permitted uses and disclosures of PHI
• Proper handling of PHI
• Safeguarding PHI confidentiality
• Identifying and reporting breaches

Documentation of HIPAA training certification should be maintained for 6 years.

Read also: The HIPAA Minimum Necessary Rule Standard

HIPAA Enforcement and Penalties

The Office for Civil Rights (OCR) under the Department of Health and Human Services (HHS) implements HIPAA rules. If the OCR gets a report regarding a possible HIPAA violation or breach, it may start an investigation by reviewing the healthcare entity’s compliance with Privacy, Security, and Breach rules. If violations are found, the OCR may apply stiff civil monetary penalties.  

Some key HIPAA penalties include:

Civil Penalties

Civil penalties are typically financial in nature and are categorized into four tiers based on the level of culpability. These range from relatively minor fines for unknowing violations to substantial penalties for willful neglect.

Criminal Penalties

Criminal penalties, on the other hand, involve both fines and potential imprisonment. They are divided into three levels, with increasing severity based on the intent behind the violation and the potential harm caused.

In addition to HIPAA penalties, breaches resulting from non-compliance can cause healthcare organizations significant financial losses and reputational damage.

HIPAA Compliance: Your Roadmap to Success

While the HIPAA rules may seem complicated, this guide has hopefully simplified some key aspects around certification and compliance. The thorough monitoring and external approval processes involved with optional HIPAA certification can improve compliance, avoid leaks, and show a dedication to PHI security.

However, truly keeping compliance takes non-stop monitoring through strong training, policies, risk management, and system defenses well beyond any licensing event. By spending properly in compliance, training, and evaluations, healthcare companies can keep health data safe and avoid stiff HIPAA fines. If you have additional questions about HIPAA certification, cprcare has many additional safety tools available.