MASSDEVICE ON CALL — House Energy & Commerce Committee members are taking a closer look at the FDA following an October hack that exposed thousands of agency employee accounts, including some 5,000 for active users.
The FDA has until December 23 to product documents related to the breach, which tapped employee user-names, passwords, email addresses, phone numbers and more.
"The security breach of FDA’s gateway system not only compromised the security of personal identifiable information, but also compromised the protection of confidential business information and medical privacy information of patients enrolled in clinical trials," according to a committee letter addressed to FDA chief Dr. Margaret Hamburg. "To restore public confidence in the FDA’s information security, we request that you immediately obtain a 3rd-party audit from a qualified expert to assess and ensure the adequacy of FDA’s corrective actions taken in response to this incident."
The hack occurred on October 18, but the FDA didn’t inform industry or make the information public until November 8, lawmakers said. The committee gave the FDA until December 23 to respond to its letter and provide requested information.
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