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[Sergio Toews <aluminio AT dipaga.com.ar>]

A una paciente cardíaca le negaron inspeccionar el software que maneja su marcapasos. Hay antecedentes de fatalidades por fallas de ese software y otros.
En EEUU, la FDA, si bien hace pruebas de años sobre medicamentos nuevos potencialmente peligrosos, aprueba el equipamiento médico SIN inspeccionarlo :

>>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.<<

Nota completa aquí.

S!