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Their use of the term "reverse engineering" is perhaps not ideal. If they were taking apart and studying the hardware inside competitors' machines, then that w
by rleigh 5y ago
Their use of the term "reverse engineering" is perhaps not ideal.
If they were taking apart and studying the hardware inside competitors' machines, then that would not have been a problem. It's something which many companies do. But they would not be using this for patient testing, they would use it as input to product development and engineering.
Theranos were modifying the machines to operate outside their design parameters. Medical diagnostic equipment is validated at great expense to operate within given parameters to give a diagnostic result which is known to be accurate with a very high probability. They are carefully calibrated and tested to guarantee the accuracy of every test. Tampering with them makes them invalidated and destroys any guarantee of diagnostic result accuracy. The FDA approval for the equipment is only valid if they are operated as intended.
- kragen 5y agoAgreed. My concern is precisely with this conflation of Theranos's negligent misconduct with the exercise of the fundamental rights which allow us to fix our cars (if you fix your car without a shop manual, you're doing reverse engineering --- and both Chilton and Haynes do reverse engineering to write their shop manuals), fix our laptops (see Louis Rossmann), uncover Microsoft's dirty tricks to break competitors' software (reverse-engineering was crucial to the antitrust trial), preserve our information (both PDF and Word formats were reverse engineered before they were opened), use IBM-compatible PCs (the clone industry was able to launch because Phoenix reverse engineered the BIOS and wrote a cleanroom clone), and generally do anything with a manufactured device that the manufacturer didn't intend. For this reason there are carve-outs in copyright law where something is illegal except when done for the purpose of reverse engineering; for example, in the US, you have Sega v. Accolade.