Thursday, September 27, 2012

GAO issues long-awaited report on medical device security

Today, the U.S. Government Accountability Office (GAO) issued a set of recommendations to improve the information security of certain medical devices.

Congressional lawmakers who requested the GAO review issued the following response.  In August 2011, the lawmakers had asked GAO to investigate the topic.

In April 2011, I submitted a document on software issues for the medical device approval process at a Senate hearing on "A delicate balance: FDA and the reform of the medical device approval process."  The document raises questions about how to improve the trustworthiness of medical device software.  A more in-depth survey on trustworthy medical device software was commissioned in 2010-2011 by the Institute of Medicine for a panel investigating the FDA 510(k) clearance process.

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