Kusserow on Compliance: OCR enforcement update at the HCCA Compliance Institute

“OCR Enforcement Update” was the topic of the presentation by Iliana Peters, HHS Office for Civil Rights (OCR) Senior Adviser for HIPAA Compliance and Enforcement at the Health Care Compliance Association (HCCA) Compliance Institute. She provided an update on enforcement, current trends, and breach reporting statistics.  Peters stated that the OCR continues to receive and resolve complaints of Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191)  violations of an increasing number.  She cited that OCR has received 150,507 complaints to date, with 24,879 being resolved with corrective action measures or technical assistance.  At the rate of reports being received, the OCR is estimating receiving 17,000 complaints in 2017.  She said that this year OCR has placed a major priority on privacy issues and will be issuing guidance on this, ranging from social media privacy, certification of electronic health record technology, and the rationale for penalty assessment. She spoke about OCR’s Phase 2 audits that are underway, involving 166 covered entities (CEs) and 43 business associates (BAs). These audits are to ensure CEs’ and BAs’ compliance with the HIPAA Privacy, Security, and Breach Notification Rules that include mobile device compliance.  They address privacy, security, and breach notification audits. It is expected that among the results of this effort will be increases in  monetary penalties this year.  Phase 3 will follow the same general approach currently being used, which includes review of control rules for privacy protection, breach notification, and security management.

In her comments about what the OCR has learned from its audits and investigations, Peters made the point that most HIPAA breaches still commonly occur as a result of poor controls over systems containing protected health information (PHI). A particular vulnerability has been mobile devices, such as laptops computers, that failed to be properly protected with encryption and password.

OCR advice

 Peters provided in her slide presentation considerable advice as what CEs and BAs should do to prevent breaches and other HIPAA-related problems. CEs and BAs should:

  • ensure that changes in systems are updated or patched for HIPAA security;
  • determine what safeguards are in place;
  • review OCR guidance on ransomware and cloud computing;
  • conduct accurate and through assessments of potential PHI vulnerabilities;
  • review for proliferation of electronic PHI (ePHI) within an organization;
  • implement policies and procedures regarding appropriate access to ePHI;
  • establish controls to guard against unauthorized access;
  • implement policies concerning secure disposal of PHI and ePHI;
  • ensure disposal procedures for electronic devices or clearing, purging, or destruction;
  • screen appropriately everyone in the work area against the OIG’s List of Excluded Individuals and Entities (LEIE);
  • ensure departing employees’ access to PHI is revoked;
  • identify all ePHI created, maintained, received or transmitted by the organization;
  • review controls for PHI involving electronic health records (EHRs), billing systems, documents/spreadsheets, database systems, and all servers (web, fax, backup, Cloud, email, texting, etc.);
  • ensure security measures are sufficient to reduce risks and vulnerabilities;
  • investigate/resolve breaches or potential breaches identified in audits, evaluations, or reviews;
  • verify that corrective action measures were taken and controls are being followed;
  • ensure when transmitting ePHI that the information is encrypted;
  • ensure explicit policies and procedures for all controls implemented; and
  • review system patches, router and software, and anti-virus and malware software.

Expert tips to meet HIPAA compliance requirements

Carrie Kusserow, MA, CHC, CHPC, CCEP, is a HIPAA expert with over 20 years of compliance officer and consultant experience. She pointed out that the OCR finds that most HIPAA breaches still commonly occur as a result of poor or lapsed controls over systems with PHI.  She noted that Iliana Peters stated that the OCR often encounters situations where established internal controls were not followed; in many cases, discoveries of breaches within organizations were not promptly investigated.  Also, most of the breaches currently being reported involve mobile devices, specifically laptop computers, and a failure to properly encrypt and password protect PHI. Kusserow offered additional tips and suggestions to those offered in the OCR presentation, particularly as it relates to mobile devices.

  • Conduct a complete security risk analysis that addresses ePHI vulnerabilities.
  • Ensure the Code of Conduct covers reporting of HIPAA violations.
  • Validate effectiveness of internal controls, policies, and procedures.
  • Maintain an up-to-date list of BAs that includes contact information.
  • Ensure identified risks have been properly addressed with corrective action measures.
  • Develop corrective action plans to promptly address any weaknesses or breaches identified.
  • Follow the basics in prevention of information security risks and PHI breaches.
  • Ensure policies/procedures  govern receipt and removal of laptops containing ePHI.
  • Verify workforce member and user controls for gaining access to ePHI.
  • Verify laptops and other mobile devices are properly encrypted and password protected.
  • Implement safeguards to restrict access to unauthorized users.
  • Review adequacy of security processes to address potential ePHI risks and vulnerabilities.
  • Ensure the hotline is set up to receive HIPAA-related calls.
  • Verify that all BAs have signed business associate agreements.
  • Train the workforce on HIPAA policies/procedures, including reporting violations.
  • Investigate complaints, allegations, and reports of non-compliance promptly and thoroughly.
  • Engage outside experts to independently verify controls are adequate and being followed.

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.

OCR shows no signs of slowing HIPAA enforcement

The HHS Office for Civil Rights (OCR) is on pace to have another record-breaking year for enforcement actions against covered entities (CEs) and business associates (BAs) accused of Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191) violations. As of February 13, 2017, it had already entered into two resolution agreements with CEs and imposed civil monetary penalties (CMPs) on another for only the third time in its history. Prior to 2016, the OCR had not entered into more than six resolution agreements with CEs or BAs in single year. As of December 2016, the OCR had entered into twice that number. As of February 13, 2016, the OCR had just imposed its second CMP, but had not yet entered into any resolution agreements.

The agency kicked off the year by entering into a $475,000 resolution agreement with Presence Health. Unlike past agreements that settled potential violations of the HIPAA Privacy and Security Rules, the Present Health resolution represented the OCR’s first agreement to resolve potential violations of the HIPAA Breach Notification Rule. Presence failed to notify the OCR, affected individuals, and the media that paper-based operating schedules containing the protected health information (PHI) of 836 individuals had gone missing in the statutorily-required 60-day timeline for breaches affecting more than 500 individuals; instead, it waited more than 100 days.

Eight days later, the OCR announced a $2.2 million resolution agreement with MAPFRE Life Insurance Company of Puerto Rico for Security Rule violations affecting the data of 2,209 individuals. The OCR determined that MAPFRE failed to perform a risk analysis, implement risk management plans, and encrypt data stored in removable storage media led to a breach caused when a thief stole a USB data storage device containing electronic PHI (ePHI).

In early February, the OCR announced that it had issued a final determination and imposed a $3.2 million CMP on Children’s Medical Center of Dallas due to a pattern of noncompliance with the Security rule. Children’s suffered a breach in 2010 due to the loss of an unencrypted, non-password-protected BlackBerry device containing the ePHI of 3,800 individuals.  It suffered a second breach in 2013; despite the first breach, Children’s had failed to encrypt a laptop containing the ePHI of 2,462 individuals that was later stolen. The agency determined that the CMP was merited based on Children’s failure to implement risk management plans, in contravention of prior recommendations to do so, and its failure to encrypt mobile devices, storage media, and workstations. The OCR also imposed CMPs against Lincare, Inc., a home health company, in 2016 and against Cignet Health in Prince George’s County, Maryland, in 2011.

The agency stepped up enforcement efforts in 2016, in part due to negative reports regarding its performance from the HHS OIG and the Government Accountability Office (GAO). It began the Phase 2 audit process, targeting both CEs and BAs, and announced its intention to allocate resources for the first time to investigate complaints of breaches affecting 500 individuals or fewer. It appears geared to continue, if not ramp up, its enforcement efforts, but the impact of newly appointed HHS Secretary Thomas E. Price, M.D.–who will appoint a new OCR director–remains to be seen. Price, a physician and former Congressional representative has historically opposed government regulatory activity of physicians. However, Adam H. Greene, Partner at Davis Wright Tremaine, suggests that, although Price the physician may dislike HIPAA, “his personal views will [not] necessarily lead to a significant change in enforcement.”


OCR thinks small to stop data breaches

Reports of breaches impacting the protected health information (PHI) of 500 or fewer individuals will be more widely investigated by the HHS Office for Civil Rights (OCR), beginning August 2016. Previously, the OCR’s regional offices investigated all breach reports involving the PHI of 500 or more individuals and only investigated smaller breaches when resources permitted the additional oversight. Under the new initiative, regional offices will retain discretion to investigate smaller breaches, but each office will increase investigative efforts to identify smaller breaches and obtain necessary corrective action.


Covered entities (CEs) under the Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191), are required to report breaches of PHI to affected individuals and the HHS Office for Civil Rights (OCR), consistent with the Breach Notification Rule; in instances of breaches involving at least 500 individuals, they must also notify the media. To decide which breach reports affecting fewer than 500 individuals will be investigated, the OCR plans to consider the following factors:

  • the size of the breach;
  • the presence of theft or improper disposal of unencrypted PHI;
  • unwanted intrusions into information technology IT systems (hacking); and
  • instances where numerous breach reports from a single entity raise similar issues.

Prior breaches

The OCR has already investigated some smaller breach reports, which have led to settlements. Those investigations include breaches resulting from a business associate’s failure to safeguard the PHI of skilled nursing facility residents, an insurance company’s failure to implement adequate PHI security measures, a medical center’s improper use of a data-sharing internet application, and the theft of two unencrypted laptops—one from a hospice provider and another from an employee’s car at a physical therapy center.

Other threats

Data breaches and cybersecurity threats of all kinds continue to plague the health care industry. For example, in July 2016, Banner Health experienced a breach of PHI and payment card data of 3.7 million patients, members, beneficiaries, and food and beverage outlet customers (see Banner Health breach potentially affects millions, Health Law Daily, August 4, 2016). Additionally, health systems are facing new threats, like ransomware, where hackers “kidnap” data and demand ransom payments for the data’s release (see Lawmakers, agencies raise specter of ransomware threats to cybersecurity, Health Law Daily, June 30, 2016).