Cyber Security, Data Breach, HIPAA / HITECH Enforcement, OCR HIPAA Audits, Settlements

Improper Disclosure of Research Participants’ PHI Results in $3.9 million HIPAA Settlement

Readers, please make sure you read all the way to the end because this article points out a significant part of the Corrective Action Plan in this settlement, and the previous one.

March 17, 2016

From the HHS Press Office

Improper Disclosure of Research Participants’ Protected Health Information Results in $3.9 million HIPAA Settlement

Feinstein Institute for Medical Research agreed to pay the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) $3.9 million to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules and will undertake a substantial corrective action plan to bring its operations into compliance. This case demonstrates OCR’s commitment to promoting the privacy and security protections so critical to build and maintain trust in health research.  Feinstein is a biomedical research institute that is organized as a New York not-for-profit corporation and is sponsored by Northwell Health, Inc., formerly known as North Shore Long Island Jewish Health System, a large health system headquartered in Manhasset, New York that is comprised of twenty one hospitals and over 450 patient facilities and physician practices.

OCR’s investigation began after Feinstein filed a breach report indicating that on September 2, 2012, a laptop computer containing the electronic protected health information (ePHI) of approximately 13,000 patients and research participants was stolen from an employee’s car.  The ePHI stored in the laptop included the names of research participants, dates of birth, addresses, social security numbers, diagnoses, laboratory results, medications, and medical information relating to potential participation in a research study.

OCR’s investigation discovered that Feinstein’s security management process was limited in scope, incomplete, and insufficient to address potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by the entity.  Further, Feinstein lacked policies and procedures for authorizing access to ePHI by its workforce members, failed to implement safeguards to restrict access to unauthorized users, and lacked policies and procedures to govern the receipt and removal of laptops that contained ePHI into and out of its facilities.  For electronic equipment procured outside of Feinstein’s standard acquisition process, Feinstein failed to implement proper mechanisms for safeguarding ePHI as required by the Security Rule.

“Research institutions subject to HIPAA must be held to the same compliance standards as all other HIPAA-covered entities,” said OCR Director Jocelyn Samuels.  “For individuals to trust in the research process and for patients to trust in those institutions, they must have some assurance that their information is kept private and secure.”

The resolution agreement may be found on the OCR website at

A notable and consistent theme present in the Corrective Action Plan (Appendix A) of both of the recent settlement agreements is the following section, “As a part of this process, [ENTITY] shall develop a complete inventory of all electronic equipment, data systems, and applications that contain or store [ENTITY] ePHI, including personally owned devices, if any, which will then be incorporated in its risk analysis.”  This is of significant note for two reasons:

  1. As consultants in the performance of risk analysis activities, we have seen that accurate inventory of data, systems, and applications is a Unicorn. It is both a beautiful thing, and non-existent.
  2. The requirement of the CAP includes personally owned devices which will then be incorporated into its risk analysis. Wow! This is a huge scope change for a risk analysis, and requires Physicians, APNs, Therapists, Executives, and others to allow their devices’ security to be assessed.

Hopefully the OCR will offer some clarification on this point either in presentations or through other methods as this small phrase in one sentence has huge implications!

Sponsored by: RISC Management and Consulting, LLC

Appendix A

Corrective Action Plan Between The Department Of Health And Human Services And The Feinstein Institute For Medical Research may be found on the OCR website at

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