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SAFETY BULLETIN Release Date: April 30, 2018SLICommunication #: T1801 Model Year(s): 20152019 Confidential and Proprietary VERSION: R03 (March 7, 2019) **Additional units added to the affected population,
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Safety-enhanced designhealthitgov - office is a process or system put in place to ensure that health IT products are designed with safety considerations.
Health IT developers and manufacturers are required to file safety-enhanced designhealthitgov - office for their products.
To fill out safety-enhanced designhealthitgov - office, developers and manufacturers must provide detailed information about how safety is considered in the design of their health IT products.
The purpose of safety-enhanced designhealthitgov - office is to ensure that health IT products are designed in a way that prioritizes patient safety.
Information reported on safety-enhanced designhealthitgov - office includes details on safety risks considered, design features implemented for safety, and any testing or evaluation conducted to ensure safety.
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