Same thing for the Theranos scandal. Financial regulators have done better for the safety of the patients than the FDA!
Other regulators in the world are worst sadly. The European framework is a mess - stuck in between 2 revisions of their dogma and in the hand of Notified Bodies which are running a private business of setting up the benchmark of safety and efficacy for health-tech, without any accountability mechanism in place.
I could go for hours on that.
Note that there are great people and initiative too (there's one coming up at the FDA on 14 OCT).
These institutions are sadly not "fit" for the upcoming intelligence explosion. Everyone is asking for more regulation of AI but we need to learn how to be efficient at regulating fast!!
Theranos is interesting because they modelled themselves after the startup world. And in this world being less than truthful (fradulent ?) with customers and investors is not only accepted but often encouraged. YC itself has often promoted this "fake it until you make it" approach.
As an example, Musk has promised robotaxis and FSD for years which if delivered would have a massive impact on Tesla's stock performance. And yet he has never been taken to task and likely never will.
But he's also clearly working towards delivering those things. This isn't Theranos-like at all. FSD is a real thing, and it's not a stretch to see it becoming Robo-taxis. What would you take him to task on? The timings? That's not a startup thing... every company has delays on timings: Apple, Boeing, Sony... the entire car industry....
> yet he has never been taken to task and likely never will.
They are not comparable at all. Diagnostics is a life-or-death issue. Any "faking" employed there should automatically lead to a capital sentence for everyone involved. Look at how the Chinese dealt with the milk-powder adulteration scandal of 2008.
> Same thing for the Theranos scandal. Financial regulators have done better for the safety of the patients than the FDA!
I have no idea why you think that. The FDA looked into Theranos in 2014-2015 and by 2015 had shut down everything but their herpes test. In 2012, when they started signing deals, Theranos was still claiming they were only performing research and development, so the FDA wouldn't get involved then. If a big company wants to invest in your startup with promises of future delivery of healthcare, how is that the FDA's responsibility?
They have been "looking" since 2012 - and between 2012 and 2015 did - in effect - nothing else than looking. They did not shut down anything - Theranos pulled back when the FDA requested a change of classification from I to II.
When you have the auditing power of the FDA, you should have the ability to do better than request a "change of classification" in 3 years when you have so much evidence of fraud.
Same thing for the Theranos scandal. Financial regulators have done better for the safety of the patients than the FDA!
Other regulators in the world are worst sadly. The European framework is a mess - stuck in between 2 revisions of their dogma and in the hand of Notified Bodies which are running a private business of setting up the benchmark of safety and efficacy for health-tech, without any accountability mechanism in place.
I could go for hours on that.
Note that there are great people and initiative too (there's one coming up at the FDA on 14 OCT).
These institutions are sadly not "fit" for the upcoming intelligence explosion. Everyone is asking for more regulation of AI but we need to learn how to be efficient at regulating fast!!
https://youtu.be/tFxLoqbLj6I