The main reason people aren't healthy has nothing to do with the medical system or regulation. It has everything to do with lifestyle. Technology will not help at all in that regard. The mobile-device generation will be less healthy and even more physically disconnected than the current one, which is a horrifying thought given how bad the state of affairs is right now.
Man is a physical animal, and movement will always beat analysis when it comes to improving health outcomes. We already know how to improve health, we choose not to do it.
And if the patient survives, but has a debilitating condition that was a side-effect of that risky drug, then claims he was going to survive anyway and now his life has a shattered quality because the doctor prescribed an drug that hadn't been fully cleared yet? It's not as black and white as you're painting it, and drugs are not always silver bullets that save your life and send you back to playing the violin like the virtuoso you once were.
Conversely, if you didn't have that regulation, you'd have medication with a much lower quality - more people dying, and more negative side-effects for the ones who survived. Plenty of drugs look promising at the outset, then turn out to have serious issues.
Kind of like supplements? http://www.nytimes.com/2013/11/05/science/herbal-supplements...
It's also about balancing incentives. If there were no such regulations whatsoever, you'd find yourself in a situation, where a patient with a mild cancer and a broken arm is potentially "terminally ill" and needs the New Risky Drug. It could degenerate to regular, systematic experimentation on humans in the guise of "doing everything we can".
I mean, yes, we don't want folks to die. Nor do we want folks making bad decisions based on information they don't understand. However, to say that it is just "people could die" ignores the fact that they have technology entering in vehicles and whatnot.
This was a huge problem we faced in Automotive. All big automotive companies are VERY cautious about safety, to what would seem like absurd levels.
The US will have to make do with their automobile deathtraps and continue to live suboptimal lifespans (35th worldwide) for a country with such a high GDP per capita (6th).
HIPAA laws protect patient rights very well. I think we are on the right track.
We do not even know how many people die every year because the increased cost of regulation and delayed time to market because of FDA.
We had to do a risk analysis review recently, and figured that unless you physically dropped one of our servers onto a patient you couldn't directly cause harm.
Anyways, you'd be a lot less concerned with regulation if you knew how brainfucked and unscientific the whole field of medicine seems to be--it's not as far along as you might expect/hope.
http://sunnyday.mit.edu/papers/therac.pdf
http://courses.cs.vt.edu/professionalism/Therac_25/Therac_1....
plenty of other reading: https://www.google.com/#q=therac-25
There is a difference between embedded systems or devices (pacemakers, imaging devices, etc.) and EMR/records/data mining software.
The regulations are all calibrated to defend against a Therac-25 (well, sort of) and seemingly not to deal with modern software development or deployment.
Dengue kills poor people but we've got dick pills when you can't get it up. The regulations are just part of it...
What did an MRI cost 20 years ago, what does it cost today? No competition, no Moore's law, and that's on the technology side...
Oh wait.
http://www.bloomberg.com/image/iFbqs_CCtc4k.png
The VA has asked for budget increases many times, but was denied by congress. The result is completely predictable.