Merit Career Development Blog | Entries from May 2014

$4.8 Million, Highest Fines Issued by HHS to Date

ePHI breach on internetMay 2014

The Department of Health and Human Services (HHS) entered into settlements totaling $4.8 million with New York-Presbyterian Hospital (NYP) and Columbia University Medical Center (CU) for failing to implement appropriate administrative and technical safeguards to secure the ePHI of approximately 6,800 patients[i]. This is HHS’ highest financial sanction issued to date as a part of breach settlement agreements, confirming its commitment to enforce HIPAA compliance.

Breach Report, Investigation and Findings


NYP and CU received a complaint from an individual who found confidential health information (ePHI) including status, vital signs, medications, and laboratory results of a deceased relative, a former NYP patient, on the Internet. The HIPAA regulations require such ePHI be maintained in secure systems and kept confidential. In accordance with HIPAA requirements, they submitted a joint report of the complaint to HHS dated September 27, 2010 resulting in an investigation by HHS’ Office of Civil Rights (OCR).

OCR’s investigation found that NYP and CU have a joint healthcare services arrangement wherein CU faculty members work as attending physicians at NYP. To support the services, NYP and CU operate a shared data network including firewalls administered by employees of both entities with shared links to NYP patient information systems.

OCR identified the breach to have occurred when a CU physician employed to develop applications for both entities attempted to de-activate a networked server containing NYP patient ePHI. Due to a lack of technical safeguards in place on the network, the de-activation attempt resulted in NYP ePHI becoming accessible to internet search engines.

OCR found that neither NYP nor CU could demonstrate that its servers were secure or contained software protections prior to the breach. OCR found an additional lack of administrative safeguards, specifically that neither entity had conducted a risk analysis to identify all systems with access to NYP’s ePHI or had a risk management plan in place to address potential hazards or threats to the security of its ePHI.

Finally, OCR found that NYP failed to implement its own technical safeguards including procedures for authorizing access to its databases and information access management processes. In addition to the financial sanctions, NYP and CU agreed to a corrective action plan requiring implementation of the administrative and technical safeguards and to monitor compliance with regular reports back to HHS.

Increased HHS Enforcement of HIPAA Compliance


This action gives notice to Covered Entities and Business Associates that HHS has heightened its enforcement efforts since the enactment of HITECH and the HIPAA Omnibus Rule.

It is imperative that a healthcare organization ensure that its workforce understands the privacy and security regulations, not just completes rote training programs, and recognizes the impact that non-compliance - from even one employee - can have on an organization.

The mandated HIPAA safeguards must be in place to identify risks and threats to ePHI and patient information systems, including insider threats from its own workforce. The safeguards must be regularly monitored through risk analysis as a part of a comprehensive risk management program.

[i] See http://www.hhs.gov/news/press/2014pres/05/20140507b.html

HIPAA Privacy and Security, Perfect Together

Privacy In this era of HIPAA enforcement, it is important to understand the fundamental role of the privacy regulations. Privacy outlines the big picture for compliance. Failing to understand and implement privacy's administrative, technical and physcial safeguards can be a costly miscalculation.

Privacy regulations have been in effect since 2003 and are updated regularly on the Department of Health and Human Services’ (HHS) website.

These regulations list compliance requirements for protected health information (PHI) in all formats (oral, paper or electronic). Security regulations are a subset of privacy limited to PHI in electronic format (ePHI). Privacy encompasses the big picture for compliant access, use, and disclosure of all PHI, including ePHI. Investing the staff, resources and time necessary to meaningfully implement privacy regulations is the entrée to compliance and a prudent business decision.

Prior to 2009, regulated organizations were primarily self-monitoring. The lack of outside accountability precipitated the major investment of staff and resources allocated for HIPAA compliance being directed towards building and supporting electronic health records systems. Fewer resources were dedicated to the less concrete, yet more comprehensive, role of privacy. Responsibility for patients’ and clients’ rights; uses and disclosures of PHI; role-based access issues; business associates; and other privacy issues were disbursed over many departments. This resulted in insufficient compliance, lax oversight and a high occurrence of violations.

HITECH’s enactment in 2009 refocused HIPAA enforcement on the privacy regulations.

HITECH mandates the implementation of complaint and breach report procedures, requires accountability for management of PHI, establishes higher sanctions for violations including a new category for willful neglect, and initiated a random audit program for an expanded list of regulated organizations by HHS’ Office of Civil Rights (OCR).

More federal and state regulatory agencies, including FTC and states’ attorney generals, now coordinate with HHS’ enforcement actions. Their websites regularly post results of enforcement actions as notice and guidance for regulated organizations. Most violations settle with corrective action plans (CAPs); some include fines tipping millions of dollars.

Many CAPs require hiring auditors to monitor and report to HHS on CAP compliance, particularly revising policies and procedures and workforce training programs (basic privacy administrative safeguards) over a period of years. As the following three cases from HHS’ website confirm, HHS is serious about privacy compliance.

Continue reading "HIPAA Privacy and Security, Perfect Together"