Food, HEALTH/FOOD

Lessons For Users Of Medical Devices

Pay attention to policies and procedures or else could it be costly.

Photo Credit:  Richard B. Johnson - Lahey Clinic in Burlington, Massachusetts, USA.
Photo Credit: Richard B. Johnson – Lahey Clinic in Burlington, Massachusetts, USA.

Lahey Hospital and Medical Center (Lahey)  has agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules with the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR).

Lahey will pay $850,000 and will adopt a robust corrective action plan to correct deficiencies in its HIPAA compliance program.  Lahey is a nonprofit teaching hospital affiliated with Tufts Medical School, providing primary and specialty care in Burlington, Massachusetts.

Lahey notified OCR that a laptop was stolen from an unlocked treatment room during the overnight hours on August 11, 2011.  The laptop was on a stand that accompanied a portable CT scanner; the laptop operated the scanner and produced images for viewing through Lahey’s Radiology Information System and Picture Archiving and Communication System.  The laptop hard drive contained the protected health information (PHI) of 599 individuals.  Evidence obtained through OCR’s subsequent investigation indicated widespread non-compliance with the HIPAA rules, including:

  • Failure to conduct a thorough risk analysis of all of its ePHI;
  • Failure to physically safeguard a workstation that accessed ePHI;
  • Failure to implement and maintain policies and procedures regarding the safeguarding of ePHI maintained on workstations utilized in connection with diagnostic/laboratory equipment;
  • Lack of a unique user name for identifying and tracking user identity with respect to the workstation at issue in this incident;
  • Failure to implement procedures that recorded and examined activity in the workstation at issue in this incident; and
  • Impermissible disclosure of 599 individuals’ PHI.

“It is essential that covered entities apply appropriate protections to workstations associated with medical devices such as diagnostic or laboratory equipment,” said OCR Director Jocelyn Samuels. “Because these workstations often contain ePHI and are highly portable, such ePHI must be considered during an entity’s risk analysis, and entities must ensure that necessary safeguards that conform to HIPAA’s standards are in place.”

In addition to the $850,000 settlement, Lahey must address its history of noncompliance with the HIPAA Rules by providing OCR with a comprehensive, enterprise-wide risk analysis and corresponding risk management plan, as well as reporting certain events and providing evidence of compliance.

Readers Bureau

Edited by Jesus Chan

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