What is a Security Risk Analysis?

A HIPAA Security Risk Analysis identifies where electronic protected health information (ePHI) is stored, received, maintained, or transmitted and evaluates the potential risks and vulnerabilities that could compromise its confidentiality, integrity, or availability. Its purpose is to help covered entities and business associates understand their security gaps, determine the likelihood and impact of potential threats, and implement appropriate administrative, technical, and physical safeguards. This process is required under the HIPAA Security Rule (45 CFR §164.308(a)(1)(ii)(A)) and serves as the foundation for an organization’s risk management plan, ensuring that security measures are reasonable, appropriate, and properly documented to protect patient data and demonstrate compliance during audits or investigations.

The HIPAA Security Rule

The HIPAA Security Rule is divided into sections: Administrative Safeguards, Physical Safeguards, Technical Safeguards, Organizational Requirements, Policies, Procedures and Documentation Requirements. Each of these areas must be addressed during a risk analysis. A thorough risk analysis is more than just a scan of your IT network. 75% of the security rules are policies and procedures, only 25% covers the technical aspects.

HIPAA requires covered entities and business associates to assign a HIPAA Security Officer that will be responsible for creating, implementing, and enforcing the HIPAA security policies and procedures. This responsibility should not be taken lightly because it comes with requirements that must be followed under state and federal laws. Although this responsibility may be assigned to one person; it is everyone’s responsibility to safeguard patient information. In fact, criminal charges can be brought against anyone who violates HIPAA for monetary gain.

The HIPAA security officer may choose to form a team to assist with the risk analysis, this may include their IT vendor, a member from each department, and of course management.  Most organizations choose to work with a company that specializes in HIPAA security since it is difficult to uncover vulnerabilities that you did not know existed.

How Do I Perform a HIPAA Risk Analysis?

The risk analysis is the foundation of HIPAA compliance.

Identify, Evaluate, and Document

HIPAA requires organizations to:

• Identify where PHI is stored
• Identify systems that access PHI
• Identify risks and vulnerabilities
• Evaluate likelihood and impact of threats
• Document findings

This requirement is found under 45 CFR §164.308(a)(1)(ii)(A).

Without a documented risk analysis, an organization is not compliant.

Implement Risk Management Measures

After identifying risks, organizations must reduce them to reasonable and appropriate levels.

This includes:

• Encryption
• Access controls
• Secure backups
• Antivirus and malware protection
• Multi-factor authentication
• Policies and procedures

This requirement is under 45 CFR §164.308(a)(1)(ii)(B).

Establish Written Policies and Procedures

HIPAA requires written documentation explaining how the organization protects PHI.

Minimum required policies include:

• Access control policy
• Password policy
• Security incident response policy
• Breach notification policy
• Backup and disaster recovery policy
• Workforce security policy
• Device and media control policy

If policies are not documented, HIPAA considers them non-existent. It is recommended to follow the Security Standards Matrix (Appendix A of the Security Rule) to ensure all policies are implemented.

Train Workforce Members

HIPAA requires workforce training for all employees who access PHI.

Training must include:

• Privacy requirements
• Security procedures
• Password protection
• Phishing awareness
• Incident reporting procedures

Training must be documented and repeated periodically.

Requirement: 45 CFR §164.308(a)(5)

Prepare for Security Incidents and Breaches

Organizations must:

• Identify security incidents
• Document incidents
• Investigate incidents
• Notify affected individuals if required
• Report breaches to OCR when applicable

Requirement: 45 CFR §164.308(a)(6)

Execute Business Associate Agreements (BAAs)

Covered entities must sign Business Associate Agreements with all vendors that access PHI.

BAAs must define:

• Responsibilities
• OIG exclusions list
• Safeguards required
• Breach reporting requirements
• Permitted uses of PHI

Requirement: 45 CFR §164.308(b)

Without BAAs, sharing PHI is a HIPAA violation.

Protect Physical Access to Systems

Organizations must protect physical locations and devices containing PHI.

Examples include:

• Locking server rooms
• Securing workstations
• Locking file cabinets
• Securing laptops and mobile devices
• Limiting facility access

Requirement: 45 CFR §164.310

Implement Technical Safeguards

Technical safeguards protect electronic PHI.

These include:

• Encryption
• Secure transmission
• Access controls
• Audit controls
• Integrity controls

Requirement: 45 CFR §164.312

Control and Monitor Access to PHI

Organizations must ensure only authorized individuals access PHI.

This includes:

• Unique user IDs
• Password protection
• Role-based access
• Automatic logoff
• Audit logs

Requirement: 45 CFR §164.312(a)

Maintain Documentation

HIPAA requires documentation of all compliance activities, including:

• Risk analysis
• Policies and procedures
• Training records
• Incident reports
• Business associate agreements

Documentation must be retained for six years.

Requirement: 45 CFR §164.316(b)

Maintain Ongoing Compliance

HIPAA compliance is not a one-time task.

Organizations must:

• Update risk analysis periodically
• Review policies
• Update training
• Monitor systems
• Address new risks

Compliance must evolve as technology and operations change.

Summary:

The Core HIPAA Compliance Framework

Every HIPAA compliance program must include:

1. Risk analysis
2. Risk management
3. Written policies and procedures
4. Workforce training
5. Access controls
6. Physical safeguards
7. Technical safeguards
8. Business associate agreements
9. Incident response procedures
10. Ongoing monitoring and documentation

The Most Important Principle

HIPAA enforcement is documentation-based.

The Office for Civil Rights follows this standard:

If it is not documented, it does not exist.

Aris Medical Solutions helps medical practices and business associates understand HIPAA expectations and reduce risk- step by step.

Our HIPAA Keeper™ was designed to help organizations:

• Understand where they stand
• Organize required documentation
• Maintain compliance over time
• Be prepared if questions ever arise

Additionally, you will have a HIPAA security analyst to guide and assist you when you need help.

Click here to learn more how we can work together and get HIPAA compliant