A HITECH Guide to Information System Activity Reviews and Audit Logs

The Health Information Technology for Economic and Clinical Health (HITECH) Act intensified the enforcement of the HIPAA Security Rule’s technical safeguard requirements, making activities such as information system activity reviews and audit logging more critical than ever. 

Under 45 CFR § 164.308(a)(1)(ii)(D), covered entities and business associates must implement procedures to regularly review records of information system activity, including audit logs, access reports, and security incident tracking. HITECH’s higher penalties and broader breach notification requirements make consistent, thorough logging and review a practical necessity for compliance and risk mitigation.

For small healthcare practices, mastering these requirements ensures you can detect inappropriate access to ePHI, respond to potential incidents quickly, and demonstrate compliance during an OCR investigation or audit.

Understanding Information System Activity Reviews

An information system activity review is a structured, routine examination of system-generated records such as access logs, audit trails, and security alerts to verify compliance with security policies and detect anomalies that could signal a breach or attempted intrusion.

HIPAA and HITECH do not dictate specific tools or timeframes for these reviews, but OCR guidance emphasizes that the frequency should be based on your organization’s size, complexity, and risk profile.

Key objectives include:

• Monitoring access to ePHI for unauthorized activity

• Identifying unusual patterns that may indicate insider threats or external attacks

• Validating that system configurations and permissions remain appropriate

• Ensuring rapid incident detection and response

Audit logs record details of user activities within your systems, including:

• User identity and role

• Date, time, and type of access

• Resources accessed or modified

• Source IP address or device used

Effective audit logs provide the foundation for security investigations, compliance reporting, and breach determinations under HITECH’s burden of proof requirement in 45 CFR § 164.414(b).

Why This Matters Under HITECH

HITECH increased the stakes for failing to detect and respond to impermissible uses or disclosures of ePHI. Without proper logging and review, a practice may be unable to determine:

• Whether a breach occurred

• When the breach was discovered, which starts the 60-day notification clock

• Who accessed the data and what was viewed or altered

Inadequate logging has been cited in multiple OCR enforcement actions, often leading to corrective action plans and, in some cases, substantial monetary penalties.

A mid-sized internal medicine clinic took a proactive step by initiating monthly reviews of their electronic health record (EHR) audit logs as part of a newly implemented compliance program. Within just the first quarter, the compliance officer identified a troubling pattern: a medical assistant was accessing patient records outside of her assigned caseload. Upon further investigation, it was revealed that she had been viewing the records of several acquaintances without any legitimate work-related reason, constituting an impermissible disclosure under HIPAA.

Recognizing the severity of the issue, the clinic acted swiftly. The medical assistant faced immediate disciplinary action consistent with the clinic’s policies. The incident was reported in accordance with the HIPAA Breach Notification Rule, ensuring transparency with affected patients and regulatory bodies. In addition, the clinic revamped its workforce training to emphasize proper access protocols and the consequences of unauthorized PHI access.

The Office for Civil Rights (OCR) acknowledged and praised the clinic’s diligent monitoring efforts, highlighting that this early detection limited the scope of the breach and minimized potential harm. This case underscores the critical importance of regular EHR audit log reviews in identifying and preventing privacy violations before they develop into more serious compliance failures or reputational damage.

Lesson Learned: Consistent, systematic review of access logs is an essential practice for uncovering unauthorized PHI access early and protecting both patient privacy and your practice’s compliance standing.

Steps to Implement HITECH-Compliant Activity Reviews

Step 1: Identify Systems That Require Logging
Include EHR platforms, practice management systems, email servers, and any other application handling ePHI.

Step 2: Enable and Configure Audit Logging
Ensure that logs capture sufficient detail user IDs, timestamps, actions taken, and objects accessed.

Step 3: Define Review Frequency and Scope
Base this on your risk analysis; high-risk systems may require weekly or daily reviews.

Step 4: Assign Responsibility
Designate a compliance officer or security administrator to perform and document the reviews.

Step 5: Develop Incident Response Procedures
Ensure suspicious activity is promptly investigated, documented, and addressed.

Step 6: Retain Logs Securely
Maintain logs for at least six years to meet HIPAA documentation requirements, and store them in a secure, tamper-proof environment.

Step 7: Integrate With Your Risk Management Program,
Use review findings to update your risk analysis and improve security controls.

Pitfall 1: Enabling Logs Without Reviewing Them

Some practices enable audit logging but never check the records.

How to Avoid It: Establish a documented review schedule and follow it consistently.

Pitfall 2: Incomplete or Poorly Configured Logs

Logs that omit key details make investigations ineffective.

How to Avoid It: Test your logging configuration to ensure it captures required information for compliance and incident response.

Pitfall 3: Reviewing Too Infrequently

Annual or ad hoc reviews are insufficient for detecting timely threats.

How to Avoid It: Review logs regularly, at least monthly, or more often for high-risk systems.

Pitfall 4: Failing to Act on Findings

Identifying suspicious activity without investigating wastes the review process.

How to Avoid It: Tie reviews directly to your incident response plan to ensure timely action.

Pitfall 5: Storing Logs in an Insecure Location

If attackers can alter or delete logs, they can cover their tracks.

How to Avoid It: Store logs in a secure, access-controlled environment, ideally using write-once storage.

Pitfall 6: Overlooking Vendor-Managed Systems

If your EHR vendor hosts your system, you may assume they are performing reviews.

How to Avoid It: Verify and document the vendor’s logging and review practices in your business associate agreement.

Pitfall 7: Not Training Staff on Log Review Procedures

Without proper training, reviewers may miss critical signs of malicious activity.

How to Avoid It: Provide clear guidelines, examples, and ongoing education for those performing reviews.

Pitfall 8: Ignoring Legal and Regulatory Changes

Log retention and review requirements can change at the state or federal level.

How to Avoid It: Monitor for regulatory updates and adjust your policies accordingly.

1. HHS OCR – Security Rule: Administrative Safeguards

2. 45 CFR § 164.308 – Security Management Process

3. NIST Special Publication 800-92 – Guide to Computer Security Log Management

Information system activity reviews and audit logs are not just boxes to check for HIPAA or HITECH compliance, they form the backbone of a robust, proactive security program. These reviews give your practice critical visibility into how electronic protected health information (ePHI) is accessed and used daily. By consistently monitoring audit logs, you can quickly detect unusual or unauthorized activity, such as inappropriate access attempts or unusual data downloads, before they escalate into serious breaches.

Investigating anomalies is crucial to differentiate between benign errors and potential threats, enabling timely mitigation. Moreover, thorough documentation of your review procedures, findings, and corrective actions creates a clear compliance trail that can protect your practice during OCR audits or investigations.

With HITECH’s increased focus on enforcement, demonstrating a systematic, documented approach to audit log management shows your commitment to safeguarding patient data. It’s an essential practice that not only helps reduce the risk of costly breaches and penalties but also builds patient trust by maintaining the integrity and confidentiality of their health information.

Next Steps for Your Practice:

• Enable comprehensive logging across all systems handling ePHI

• Establish and document a regular review schedule

• Train staff to recognize and respond to suspicious activity

• Securely store logs for required retention periods

• Include log review findings in your risk analysis updates

When implemented effectively, these measures not only fulfill regulatory obligations but also provide the visibility needed to protect patient information and maintain trust.

Boosting compliance resilience requires more than policies alone. A compliance automation solution can streamline processes, simplify record-keeping, and deliver continuous risk assessments, helping you stay audit-ready and avoid compliance pitfalls.