A lot of the regulation has allowed people to die when there was a chance they would have lived without it. Regulations on advertising and OTC drugs are absolutely needed, but stopping a doctor from prescribing a risky drug to a terminally ill patient who will die without it anyway is counterproductive.
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.
stopping a doctor from prescribing a risky drug to a terminally ill patient who will die without it anyway is counterproductive.
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.
> stopping a doctor from prescribing a risky drug to a terminally ill patient who will die without it anyway is counterproductive.
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".
The regulations more exist to keep you from getting people discriminated against.
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.
The first time a Google car crashes and Google lawyers have to sit across from a now paralyzed child on the witness stand, Google will quickly think twice about the Vehicle market.
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 rest of the world will welcome the Google car with open arms.
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).
This is the USA, it's about 40-50 years behind even my country (the UK) on discrimination-related law and practice, and law related to societal issues in general. One could argue that this is just the set of trade-offs that the US has made for itself, but the real-world results are looking grim.
Obama has done great things with healthcare. If Congress was not so deadlocked, he would have done more. So far, he got rid of the denial of service due to preexisting conditions. He started a government run program, which will greatly reduce prices in the long term.
HIPAA laws protect patient rights very well. I think we are on the right track.
The reference to HIPAA and how it restricts things they'd like to do with health information -- and the fact that Goolge is investing in Calico, which is more about health technology -- suggests that the concern is more with the regulations that are designed to prevent financial fraud, exploitation of health information for scams and discrimination purposes, etc., that affect the market for health information technology, and less about the kind of regulations that are designed around the safety of health care technology.
Right, but unless you fuck up pretty badly software is not going to kill a patient directly (barring, say, pacemaker software).
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.
Yeah, I'm familiar with that--note again that that was a combination of hardware and software, and that the perhaps leading cause of actual damage was the omission of a mechanical safety interlock that existed on earlier models; with that interlock, the buggy software wouldn't have mattered.
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.
