Theranos happened because the founders chose to lie. Plenty of laws were violated there. Medical regulation is not to blame. Investor hubris is.

Oh, sure! But the primary purpose of regulatory enforcement is to catch people lying, and Holmes was pretty effective at exploiting the weak points in the regulatory regime to avoid that detection.

What? Holmes (allegedly) misled people that were willing accomplices in being misled. There wasn't a regulatory failure, just investors that did not do their homework.

So beyond the investors, Theranos injured quite a lot of real people. They were actually doing blood tests, which largely did not work. With different regulation, some of this might have been averted (in particular, if the FDA was responsible for diagnostic labs, that might have helped).

Frankly, dodgy companies screw over the people unwise enough to invest in them every day. Theranos was unusual in that it also directly screwed over members of the public.

> while medicines and medical devices deployed to hospitals and homes are heavily regulated in the US, medical labs are not

Relatively speaking, this is as it should be. There are ways to cope with arbitrarily-convincingly fake lab reports (most generically, do multiple tests and compare them), whereas there's not a procedural fix for your X-ray machines occasionally going THERAC. Those measures generally aren't actually in place, but they should be anyway to cope with eg human error.

But the regulations actually in place on both patient-proximate and lab-based equipment are insufficiently stringent. (Annoyingly, they're also gratuitously burdensome.)

Medical labs are heavily regulated. Theranos mislead inspectors by not showing them their entire lab.

Well, 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.

(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)