Software Compliance Testing for HIPAA

Healthcare companies that store, process or transmit Electronic Protected Health Information (EPHI) are required to comply with the Health Insurance Portability and Accountability Act (HIPAA). HIPAA requirements apply to Protected Health Information (PHI) kept in electronic form known as EPHI (Electronic Protected Health Information). The HIPAA Security Rule covers 36 implementation specifications supported by 18 HIPAA Standards that protect the confidentiality, integrity and availability of individually identifiable health information.

Through our Software Compliance Testing service for HIPAA, we assess and test vendors’ software solutions to ensure they support HIPAA requirements. After a thorough evaluation, we feature these solutions on our website.

HIPAA Compliance Testing Controls

Compliance Testing for HIPAA relies on credible, objective testing controls based on the intent of HIPAA requirements. This approach incorporates insights from auditors perspective, and various specialists, including affected software vendors, developers, users, and industry groups, to align with organizational needs. The HIPAA compliance testing controls cover the following software controls categories:

Application and DevOps Security

The HIPAA Security Rule includes several standards and implementation specifications that are particularly relevant to application and DevOps:

Access Control (5.3.1): This standard mandates implementing technical policies and procedures to restrict access to ePHI to authorized users and software programs. Applications should incorporate access control mechanisms to enforce user authentication, authorization, and unique user identification.
Audit Controls (5.3.2): This standard requires implementing mechanisms to record and examine activity in information systems that contain or use ePHI. This is especially important for applications handling ePHI, where audit logs can help track data access, modifications, and potential security incidents.
Transmission Security (5.3.5): This standard mandates implementing security measures to protect ePHI during transmission over electronic networks. Secure communication protocols, such as TLS (Transport Layer Security), should be used to protect ePHI in transit between applications and systems.

Asset Inventory and Management

The HIPAA Security Rule emphasizes the importance of identifying and documenting all systems that house electronic protected health information (ePHI), including mobile devices, medical equipment, and Internet of Things (IoT) devices. This process aligns with the concept of asset inventory and management, crucial for understanding the organization’s technology assets that store or process sensitive data.

Awareness and Training

HIPAA requirements highlight the importance of a robust security awareness and training program for all workforce members, including training on recognizing and reporting malicious software, creating secure passwords, and understanding their roles in safeguarding ePHI. Regularly updating training content to reflect current threats and organizational policies is critical. For instance, training materials should encompass modern threats like phishing and ransomware and address the secure use of any new devices or technologies adopted by the organization.

Backup and Recovery

HIPAA requirements highlight the necessity of a data backup plan as a critical component of a comprehensive contingency plan. This plan should encompass procedures for data backup, storage, recovery, and testing to ensure the availability of ePHI during emergencies, including ransomware attacks.

Audit and Compliance Management

The HIPAA Security Rule mandates the implementation of audit controls. These controls involve mechanisms for recording and examining activity within information systems that handle ePHI. This data enables organizations to track access, detect security incidents, and demonstrate compliance with the Security Rule. Continuous monitoring of these audit logs and security incident tracking reports allows organizations to ensure the confidentiality, integrity, and availability of ePHI and maintain compliance with regulatory standards.

Data Security

Protecting ePHI from unauthorized access, use, disclosure, disruption, modification, or destruction is paramount. Implementing appropriate data security measures to address the risks identified through risk analysis is essential. These measures might include access controls, encryption, and data backup and recovery plans tailored to an organization’s specific needs and risk assessments.

Endpoint and Device Protection

Safeguarding workstations and electronic devices is crucial for maintaining the security of ePHI. Implementing policies and procedures for the proper use of workstations, electronic media, and the secure transfer, removal, disposal, and reuse of such media is essential to prevent unauthorized access and protect ePHI. These policies might encompass measures like requiring password protection on all devices storing ePHI, encrypting sensitive data on these devices, and deploying regular security updates. Organizations may also consider using anti-theft devices, physical privacy screens, or other safeguards to prevent unauthorized access to ePHI on devices, particularly mobile devices or those used for remote work.

Identity Management and Access Control

The principle of ‘minimum necessary’ access to ePHI should be enforced, granting access only to authorized individuals based on their roles. Implement both physical and technical access controls to limit access to facilities, workstations, and ePHI. This includes using unique user identification, emergency access procedures, automatic logoff, and encryption and decryption mechanisms to control and authenticate access.

Incident Response

Having incident response procedures is crucial. Entities must be prepared to identify, respond to, and document security incidents, including those involving malware like ransomware.

Logging and Threat Detection

Employ mechanisms to record and examine system activity in information systems handling ePHI. Regularly reviewing audit logs, access reports, and security incident tracking reports can help detect and respond to security violations. This includes monitoring log-in attempts and reporting any discrepancies to ensure only authorized access to ePHI is permitted.

Network Security

Implementing technical security measures to protect ePHI transmitted over electronic networks is essential. Encrypting ePHI during transmission can prevent unauthorized access. The Security Rule does not mandate specific technologies but requires covered entities to assess their network security risks and implement reasonable and appropriate safeguards.

Posture and Vulnerability Management

Conducting accurate and thorough risk analysis is essential. It helps identify potential risks and vulnerabilities to ePHI, including those related to outdated firmware on network devices. Regularly assessing the security measures in place and updating them as needed is crucial for maintaining a strong security posture.

Risk Assessment and Management

HIPAA requirements place significant emphasis on risk analysis and risk management as the foundation for complying with the HIPAA Security. It is an ongoing process that involves:

Evaluating the likelihood and impact of potential risks to ePHI.
Implementing and documenting appropriate security measures to address those risks.
Regularly reviewing and updating security measures to maintain continuous, reasonable, and appropriate protection of ePHI as the environment changes.
Developing and implementing a risk management plan that outlines risk tolerance, security measures, and implementation priorities.

Evaluating and maintaining the effectiveness of implemented security measures over time.

Software Bill Of Materials (SBOM)

HIPAA requirements do not mention the SBOM.

Zero Trust Network Access

While HIPAA requirements do not explicitly mention Zero Trust Network Access (ZTNA), they emphasize the importance of strong access controls and risk management for protecting electronic protected health information (ePHI). Based on these principles, some insights aligning HIPAA with ZTNA concepts can be derived:

Principle of Least Privilege: The HIPAA Security Rule emphasizes limiting access to ePHI based on roles and job functions, reflecting the principle of least privilege, a core concept of ZTNA. Covered entities are required to implement policies and procedures for authorizing access, ensuring only authorized individuals and systems can access specific information.
Continuous Verification: HIPAA requirements stress the importance of continuous evaluation of security measures to address evolving threats and vulnerabilities. This aligns with the ZTNA concept of continuous verification, where trust is not assumed but continuously assessed.
Microsegmentation: While not explicitly mentioned, the principle of microsegmentation in ZTNA, where access is granted to specific applications or resources rather than broad network access, aligns with HIPAA’s focus on limiting access to ePHI. Covered entities are encouraged to implement technical safeguards like network segmentation to restrict access to systems containing ePHI.
Risk-Based Approach: HIPAA’s security standards are flexible and scalable, requiring covered entities to implement safeguards based on their risk assessments. This aligns with ZTNA’s core principle of a risk-based approach to security.

HIPAA requirements highlight resources like the NIST publications, including NIST SP 800-66, which provide guidance on implementing HIPAA security standards. These resources may contain more information about ZTNA and its relevance to HIPAA compliance, which you might want to verify independently.

Continuous Evaluation Process

Compliance Labs has developed the compliance continuous testing process as a fundamental aspect of the HIPAA compliance testing controls. The continuous evaluation process will monitor new cybersecurity regulations and standards compliance requirements or frameworks best practices and update testing criteria to drive software compliance effectiveness and quality.