The Steps to HIPAA Compliance

If your organization comes into contact with Protected Health Information (PHI), it needs to comply with HIPAA. Noncompliance puts covered entities and business associates at risk of large fines and lawsuits. HIPAA is a complex law with a broad scope and detailed regulations, which can make achieving and maintaining compliance feel like a daunting task. In this article, we’ll detail the steps to HIPAA compliance organizations can follow to simplify the process.

1. Understand HIPAA Requirements

To comply with HIPAA, businesses must first understand what the law requires. HIPAA standards are built on essentially three rules:

• The Privacy Rule dictates when and how PHI can be used and disclosed. It establishes patients’ rights to control how their health data is used. It also gives patients the ability to access their health records and request that errors be fixed.
• The Security Rule sets the minimum security standards to protect the integrity, confidentiality, and availability of all electronic Protected Health Information (ePHI). 
• The Breach Notification Rule requires the notification of affected individuals, the HHS Secretary, and potentially the media when a breach occurs.

Organizations must also know that the following data types qualify as PHI:

• Personal identifiers: Name, address, date of birth, phone number, email address, social security number, medical record number
• Health information: Diagnosis, treatment, test results, prescription information, medical history
• Financial information: Health insurance status, payment information
• Geolocation data: Street address, city, state
• Biometric identifiers: Fingerprints, voice prints
• Device identifiers: Medical device serial numbers, wearable device data

To help with this foundational knowledge, businesses can designate a compliance officer or team to interpret regulations and guide the implementation of required policies and safeguards.

2. Conduct a Risk Assessment

HIPAA requires covered entities and business associates to conduct an annual HIPAA risk assessment. A risk assessment is critical to identifying the risks and vulnerabilities to the confidentiality, integrity, and availability of PHI. Use the results as a roadmap for prioritizing security improvements and ensuring compliance measures align with organizational needs.

Read our Performing a HIPAA Security Risk Assessment blog for a step-by-step guide.

3. Develop and Implement HIPAA Policies and Procedures

Once risks are identified, it’s time to develop formal policies and procedures that meet HIPAA requirements. These should address data access, use, and disclosure, as well as breach reporting and workforce training. Customize policies to the organization’s specific workflows and technologies; copying templates is not a recipe for success.

Document all policies and procedures. Communicate requirements to all staff and stakeholders and have them acknowledge these requirements.

4. Implement Technical and Physical Safeguards

HIPAA’s Security Rule requires technical safeguards to protect ePHI. Examples of technical safeguards include:

• Apply role-based access controls to limit PHI access
• Encrypt data at rest and in transit
• Log access requests
• Use secure communication channels (e.g., encrypted email or portals) for PHI sharing
• Regularly update and patch systems to prevent vulnerabilities

HIPAA requires that organizations limit physical access to systems, facilities, and devices containing PHI. Common physical safeguards include:

• Entry controls to buildings and offices
• Securing server rooms
• Disposal procedures for hardware or paper records that contain patient information
• Physical locks and tracking tools for physical assets like laptops
• Visitor management protocols

5. Train the Workforce

Human error is the biggest vulnerability to PHI, making HIPAA training an essential step. Every member of the workforce must understand how HIPAA applies to their role. Training should cover proper handling of PHI, reporting suspicious activity, and avoiding common mistakes like discussing patient information in public areas. HIPAA training is required for “each new member of the workforce within a reasonable period of time after the person joins the covered entity’s workforce,” and when “functions are affected by a material change in policies or procedures.”

6. Establish an Incident Response and Breach Notification Plan

HIPAA mandates that organizations have a clear process in place to detect, respond to, and report breaches of PHI. Organizations must have a well-defined incident response plan that defines roles, responsibilities, and workflows so people know what actions they need to take if a data breach occurs. Also, conduct annual tabletop exercises to test the effectiveness of your incident response plan. The breach notification policies and procedures should detail how and when they will communicate with the HHS Secretary, individuals impacted by the breach, and the media.

7. Validate Third-party Compliance

Organizations need to verify what third-party vendors have access to PHI on their behalf, such as cloud providers, billing companies, or transcription services. Under HIPAA, a covered entity or business associate can be held liable for a vendor’s security lapse.

Effective vendor monitoring involves conducting due diligence before onboarding, such as reviewing security certifications, compliance attestations, and references. It also requires executing a Business Associate Agreement (BAA) that clearly outlines HIPAA responsibilities. Ongoing oversight can be achieved through periodic audits, security questionnaires, and reviewing incident reports to ensure vendors maintain compliance.

8. Monitor, Audit, and Continuously Improve

HIPAA compliance is an ongoing effort. Organizations must regularly monitor their compliance program, conduct internal audits, and implement corrective actions when needed. Effective audits will enable businesses to account for new threats, regulatory updates, and operational changes faster. Continuous improvement is what ensures HIPAA compliance remains effective, resilient, and integrated into the organization’s culture of protecting patient privacy.

CompliancePoint has a team of experts focused on helping healthcare organizations comply with all aspects of HIPAA. Contact us at connect@compliancepoint.com to learn more about our services.