But if someone drives a tank across that bridge and uses it to do something awful, that's outside the discipline, right?
Sure, look into "Software FMEA", alternatively look at Class 3 medical device software.
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E.g. An online forum being misused to abuse or mistreat people.
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An example I use is that last year, a woman's fitbit data led to her rape claim being dismissed & she got convicted
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but, it is possible to get a heart rate off a chicken breast with these devices. So, there is a problem.
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Foreseeing this might not lead to design changes, but might lead to better documentation, etc. This matters.
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Better documentation for Fitbit users? About what?
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Imagine a device could be used to testify against you. Wouldn't you want some trust that its data were correct?
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Sure. Though I'd hope the device's accuracy is something the attorney would have to prove.
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True story: GPS data cannot be used to get you out of a speeding ticket, but it can be used to link you to a crime.
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My understanding was that we're looking for ways to prevent non-obvious problems.
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Most medical device failures are non-obvious, but regardless it is a good starting point for discussion.
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Thanks! From quick look, FMEA seems focused on failure/bug prevention, not ethics. Is that right?
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So, FMEA is about calculating the effect of *the harm* and the probability of *the harm*. It's harm analysis.
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And medical device software has what I'd describe as "obvious" potential for causing harm.
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