Kusserow on Compliance: New analysis of OCR reports found 1800 large breaches over 7 years

In presentation at the Health Care Compliance Association (HCCA) entitled “OCR Enforcement Update,” HHS Office for Civil Rights (OCR) Senior Adviser Iliana Peters reported that the OCR continues to receive and resolve complaints of Health Insurance Portability and Accountability Act (P.L. 104-191) (HIPAA) violations of an increasing number. To date, the OCR has received 150,507 complaints, with 24,879 being resolved with corrective action measures or technical assistance.  She estimated that the OCR will receive about 17,000 complaints in 2017.

A new study published in JAMA Internal Medicine found since 2009 that 1,798 “large data breaches” involving patient information since 2009 had been reported by health care providers to the OCR.  Out of that number, 216 hospitals reported 257 data breaches, while 33 hospitals were found to have experienced multiple data breaches.  Of 141 acute care hospitals reporting breaches, 52 were major academic medical centers.  These numbers are misleading in that they represent only a small fraction of the total number of breaches, as indicated by Peters.  The reason is that smaller breaches are not required to be reported, and many breaches may not have been voluntarily reported.  The need for increased vigilance and internal controls are needed.

Latest OCR resolution

The OCR announced a resolution agreement based on the lack of a security management process to safeguard electronic protected health information (ePHI). Metro Community Provider Network (MCPN), a federally-qualified health center (FQHC), has agreed to settle potential noncompliance with the HIPAA Privacy and Security Rules by paying $400,000 and implementing a corrective action plan. MCPN filed a breach report with the OCR indicating that a hacker accessed employees’ email accounts and obtained 3,200 individuals’ ePHI through a phishing incident. As with many of the reported large breaches, the OCR found that prior to the breach incident, there was no risk analysis to assess the risks and vulnerabilities in its ePHI environment and a corresponding failure to implement any associated risk management plans to address the risks and vulnerabilities identified in a risk analysis.

Reminder tips on HIPAA compliance

As a reminder, entities should perform the following recommended steps in order to comply with HIPAA.

  1. Perform a complete a security risk analysis that addresses ePHI vulnerabilities.
  2. Engage an outside expert to independently verify that Privacy/Security Officers are meeting obligations.
  3. Properly address identified risks with corrective action measures.
  4. Follow the basics in reviewing compliance for information security risks and PHI breaches.
  5. Verify that the Code of Conduct covers reporting HIPAA violations.
  6. Ensure that policies and procedures govern receipt and removal of laptops containing ePHI.
  7. Train the workforce on HIPAA policies and procedures, including reporting violations
  8. Ensure that all business associates (BAs) have signed BA agreements (BAAs), with contact information on file.
  9. Verify that controls cover gaining access to ePHI by workforce members and users.
  10. Encrypt and password protect all laptops and mobile devices.
  11. Implement safeguards to restrict access to unauthorized users.
  12. Validate effectiveness of internal controls, policies, and procedures
  13. Review adequacy of security processes to address potential ePHI risks and vulnerabilities.
  14. Ensure that a hotline is set up to receive HIPAA-related calls.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2017 Strategic Management Services, LLC. Published with permission.

Comments

  1. A clarification – Covered Entities are required to report every breach of Unsecured Protected Health Information to HHS/OCR. However, only a breach affecting 500 or more individuals is posted by HHS/OCR on its Breach Portal web site as directed by the 2009 HITECH Act amendment to the 1996 HIPAA statute. OCR is aware that many small breaches (affecting from 1 to 499 individuals) are not reported and announced an initiative to investigate smaller breaches more closely on August 18, 2016. Regional Offices are to identify and obtain corrective action to address entity and systemic noncompliance related to small breaches. In my opinion small breaches are not reported primarily because Covered Entities and Business Associates are not aware of the HIPAA Rule. And they do not realize the HIPAA Rules are easy to follow step-by-step when you know the steps.