"The Food and Drug Administration (FDA) is responsible for evaluating the risks of new devices and monitoring the safety and efficacy of those currently on market. However, the agency is unlikely to scrutinize the software operating on devices during any phase of the regulatory process unless a model that has already been surgically implanted repeatedly malfunctions or is recalled."
"Despite the crucial importance of these devices and the absence of comprehensive federal oversight, medical device software is considered the exclusive property of its manufacturers, meaning neither patients nor their doctors are permitted to access their IMD’s source code or test its security."
The SFLC concludes that transparency going forward is the only way to prevent people from being "Killed by code". Would you want windows mobile regulating your blood pressure?"
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