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

[Inga Goddijn]

http://www.hhs.gov/about/news/2016/03/17/improper-disclosure-research-participants-protected-health-information-results-in-hipaa-settlement.html

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
http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/Feinstein/index.html
<http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/feinstein/index.html>
.

To learn more about non-discrimination and health information privacy laws,
your civil rights, and privacy rights in health care and human service
settings, and to find information on filing a complaint, visit us at
www.hhs.gov/hipaa <http://www.hhs.gov/hipaa/index.html>.
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