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, which are commonly used by millions of patients to treat chronic heart conditions, epilepsy, diabetes, obesity, and even depression.
The software on these devices performs life-sustaining functions, such as cardiac pacing and defibrillation, drug delivery, and insulin administration. It is also responsible for monitoring, recording, and storing private patient information, communicating wirelessly with other computers, and responding to changes in doctors’ orders.
The Food and Drug Administration 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.
From The Software Freedom Law Center
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