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This requirement is documented in the 2013 HIPAA Omnibus Rule which updated the language from the original 2003 HIPAA Security Rule. Protecting medical devices and the regulated information stored on them is the responsibility of the CISO. Depending on the severity, OCR may be obliged to investigate how the organization is protecting the security of patient information. This leads to a higher risk of unauthorized individuals gaining access to patient information stored on medical devices, which is a HIPAA violation.īoth security events listed above should trigger a mandatory compliance evaluation which could result in a reportable breach to the Office for Civil Rights (OCR). In addition, many medical devices do not require user ID and passwords for access and those that do, may still have the factory default settings.
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Facility managers and security officers need only to periodically review the “Could Not Locate” (CNL) list to gain an understanding of the complexity of the problem and estimate the annual financial loss to the organization. As such, the responsibility for protecting these devices is typically diffused, resulting in a lack of individual accountability if they go missing or are accessed by unauthorized individuals. Medical devices are not typically assigned to an individual, but rather to the clinical engineering department or perhaps, a care unit. This creates the potential for a responsibility gap and can lead to the loss of sensitive information when a device goes missing. This myopic view sometimes overlooked the fact that PHI is stored in medical devices which are located throughout a hospital or clinic. Until recently, the Chief Information Security Officer or CISO (as many HIPAA Security Officers are known by) has stayed inside their comfort zones, focusing primarily on securing servers and workstations. The regulation extends the scope of their job into areas that have typically been outside of the traditional “IT space.” Not only are they required to protect all information technology (IT) systems that store sensitive information, but they are also required by HIPAA regulations to have oversight of physical protections for electronic equipment that also can create, store, or dispose of protected health information or PHI. Hospital’s HIPAA security officers have a tough job.