Hipaa Security Rule Declaration - Medtronic Prostiva 8930 Guía Para El Usuario

8930EN_7.fm 12/17/10 2:44 pm
UCxxxxxx EN
7 x 9 inches (178 mm x 229 mm)

HIPAA Security Rule Declaration

MA07445A008 Rev X
Introduction
The following information describes for Medtronic's customers in
the United States (U.S.) the use and security of electronic
protected health information (ePHI). The ePHI is defined in the
Health Insurance Portability and Accountability Act, or HIPAA,
Security Rule, 45 C.F.R. 165.514.
This information is intended to assist U.S. customers in
safeguarding ePHI and complying with the requirements of the
rule and other applicable requirements.
This information is not intended as a comprehensive or
exhaustive list of issues and recommendations. Your
organization's particular needs and security requirements may
call for additional actions and controls than those stated here.
Each organization must reach its own decisions on how to
implement appropriate safeguards, and this information is
intended to assist but not control that process.
Model 8930 RF Generator
The Model 8930 RF Generator maintains within its memory data
collected on a specific patient during the current procedure, but
the data is not associated with any personally identifiable patient
information. As the device does not store any personally
identifiable patient information (no ePHI), it is not directly affected
by the HIPAA Security Rule.
The only safeguard recommended is to appropriately protect the
confidentiality of any data downloaded or printed from the device
in the same manner as any other medical record, particularly after
any patient identifier (such as a patient name or record label) has
been added to the data or printout.
Supplemental Information
Troubleshooting Checklist
2010-12 8930 System User Guide English
Medtronic Confidential
CRMRef_R06
113