The HealthSec Blog

A recent analysis of OCR’s enforcement activity reveals key trends that healthcare organizations should consider when evaluating their HIPAA compliance efforts. While the likelihood of an enforcement action remains low—OCR has taken action against only 0.001% of regulated entities—those that do face scrutiny often encounter significant penalties and drawn-out investigations.

Key Takeaways from 2024 OCR Enforcement Actions

• Risk Analysis is a Top Priority: OCR’s most frequently cited violation involved inadequate risk analysis, appearing in 13 out of 20 cases. This aligns with OCR’s Risk Analysis Initiative, launched in late 2024, which aims to drive better compliance with HIPAA Security Rule requirements. Organizations should ensure their risk assessments are current, comprehensive, and well-documented to avoid penalties.
• Access Requests Matter: OCR issued enforcement actions in five cases where covered entities failed to provide timely access to patient records. This reinforces the importance of adhering to Right of Access requirements, even for seemingly minor delays.
• Investigations Take Time: The average timeline from complaint to resolution spanned 57 months, with some cases stretching beyond seven years. Settlements typically resolve faster than civil monetary penalties, taking 52 months on average compared to 66 months for adjudicated cases.
• Security Rule Enforcement Dominates: Of the 20 enforcement actions, 15 involved HIPAA’s Security Rule, highlighting OCR’s continued focus on cybersecurity compliance, risk management, and incident response.
• Ransomware and Unauthorized Disclosures Drive Scrutiny: The top enforcement triggers included: Ransomware attacks (8 cases), Unauthorized disclosures (5 cases), Access violations (5 cases), Credential stuffing and third-party business associate breaches also made the list.

Settlements vs. Civil Monetary Penalties

OCR generally prefers settlements over civil monetary penalties (CMPs):

• 13 of the 20 cases were resolved through settlements.
• 7 cases resulted in CMPs.
• Organizations that settled paid an average of $437,545, while those that faced penalties paid $535,466 on average—about 18% more.
• The median penalty was $240,000, while the median settlement was $90,000, reflecting the impact of one outlier settlement of $3 million.

What This Means for Covered Entities and Business Associates

• Risk assessments should be a top compliance priority. If your risk analysis is outdated or incomplete, OCR may view it as a red flag.
• Don’t ignore access requests. Even a single delayed request can trigger an enforcement action.
• Expect lengthy investigations. Once OCR initiates an inquiry, the resolution could take years, requiring significant time, legal fees, and compliance resources.
• Proactively address security gaps. The Security Rule remains a primary focus, particularly regarding ransomware, unauthorized access, and system activity reviews.

OCR’s Risk Analysis Initiative appears poised to follow in the footsteps of its 2019 Right of Access Initiative, which resulted in nearly 50 enforcement actions over five years. As a result, covered entities and business associates should expect heightened scrutiny in this area moving forward.

For organizations looking to stay ahead of OCR enforcement trends, regular security assessments, comprehensive training programs, and strict adherence to access and disclosure policies are critical steps toward compliance.

Source: JDSupra.com