FDA Says It Monitored Staff Email as Part of Data Leak Investigation

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On Thursday, FDA said it began monitoring the personal emails of employees who expressed concern over medical device safety because it was conducting an internal probe into claims that confidential data also were being leaked to the public, the Washington Post reports (Nakashima/Rein, Washington Post, 2/9).

Background

Last month, six current and former FDA scientists and physicians filed a lawsuit alleging that FDA monitored their personal email after they warned congressional staffers that the agency approved medical devices that might pose risks to patients.

According to government documents gathered by the plaintiffs, FDA started intercepting personal Gmail communications between several of its employees and congressional staffers in January 2009 and continued the surveillance for two years. FDA also took screenshots of the employees' computer desktops and reviewed documents that they had saved on their hard drives.

The plaintiffs argued that FDA violated their constitutional right to privacy by checking their personal email accounts. They also argued that the information obtained by FDA contributed to the harassment or dismissal of the six employees.

Sen. Chuck Grassley (R-Iowa) recently sent a letter asking FDA Commissioner Margaret Hamburg to explain why the agency monitored the personal email of employees who expressed concern about medical device safety (iHealthBeat, 2/6).

Details of FDA's Response

In a statement, FDA spokesperson Erica Jefferson noted that the "targeted monitoring of email content of these individuals was not initiated until April 2010," when the agency learned about the alleged leaks.
She said, "Our monitoring was designed to determine whether confidential information had been inappropriately released."

She also noted that FDA employees are required to give consent to having their computer usage monitored when they log onto FDA's computer system (Washington Post, 2/9).


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