Improper disclosure of research participants’ protected health information results in $3.9 million HIPAA settlement

There’s a follow-up to a breach I first noted on this blog in 2012 when Feinstein Institute for Medical Research issued a press release about a laptop stolen from a programmer’s car. Now HHS has issued a press release of its own:

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 and corrective action plan may be found on the OCR
website at

To learn more about non-discrimination and health information privacy laws,
your civil rights, and privacy rights in health care and human service
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