Killed by Code: Software Transparency in Implantable Medical Devices
source: http://www.softwarefreedom.org/resources/2010/transparent-medical-devices.html
Software is an integral component of a range of devices that perform critical, lifesaving functions and basic daily tasks. As patients grow more reliant on computerized devices, the dependability of software is a life-or-death issue. The need to address software vulnerability is especially pressing for Implantable Medical Devices (IMDs), which are commonly used by millions of patients to treat chronic heart conditions, epilepsy, diabetes, obesity, and even depression.
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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.
[...]
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.
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- groups:
- Tech, Technology
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- tags:
- Technology, Medicine, Open Source, proprietary, 2 more
