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Medical labs are heavily regulated. Theranos mislead inspectors by not showing them their entire lab.
by whatshisface 5y ago
Medical labs are heavily regulated. Theranos mislead inspectors by not showing them their entire lab.
- rsynnott 5y agoWell, depends on how you define ‘heavily’. Theranos did hide a lab, but even beyond that they were depending on rules that allowed novel tests with very minimal oversight, provided they were done in a lab rather than in the field.
- rsynnott 5y ago(Also, the regulator was presumably aware that Theranos made proprietary medical devices; it said so on their website. So, when they were shown a lab full of Siemens stuff, they should probably have asked about that. The problem here was really hiding in plain sight, and a competent, sufficiently empowered regulator would have caught it)