Re:Theranos Voids Two Years of Edison Blood-Test Results
by tacos on Wednesday May 18, 2016 @09:56PM
(#11727410)
This is an Epic Fuck Up that will be discussed for decades in legal, technology, VC, and startup circles. It makes it effectively impossible for a non-established player to innovate in the space for at least 5 years. Additional regulations will hinder innovation for far longer. People will go to jail.
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Re:Theranos Voids Two Years of Edison Blood-Test Results
by seehafer on Wednesday May 18, 2016 @10:00PM
(#11727428)
Ironically Holmes might end up getting her wish about all Lab Developed Tests (LDTs) needing to go through FDA approval in addition to CLIA certification, which cover the operation of a lab, not the design and validation of the machines in the lab.
Re:Theranos Voids Two Years of Edison Blood-Test Results
by eitally on Thursday May 19, 2016 @11:44AM
(#11731062)
This series of events will create a business case for the ages, one that MBA students will read right after they study the J&J Tylenol crisis of 1982 (http://www.ou.edu/deptcomm/dodjcc/groups/02C2/Johnson%20&%20...)
Re:Theranos Voids Two Years of Edison Blood-Test Results
by kosmic_k on Wednesday May 18, 2016 @11:57PM
(#11727854)
I am not familiar with the actual laws involved in this kind of case. If it were proven that a Theranos tests harmed a patient and that Theranos willingly obscured the accuracy data to regulars could Holmes be held criminally liable?
Re:Theranos Voids Two Years of Edison Blood-Test Results
by tacos on Thursday May 19, 2016 @02:59AM
(#11728539)
That would likely fall under a civil statute. But criminal fraud seems likely. I'd be willing to take a bet on even more trivial matters like falsification of evidence once things started to go south ("it's the coverup, not the crime"). Investigated properly this will probably blow up the FDA too.