FDA: We Can't Scale To Regulate Mobile Health Apps

chicksdaddy writes Mobile health and wellness is one of the fastest growing categories of mobile apps. Already, apps exist that measure your blood pressure and take your pulse, jobs traditionally done by tried and true instruments like blood pressure cuffs and stethoscopes. If that sounds to you like the kind of thing the FDA should be vetting, don't hold your breath. A senior advisor to the U.S. Food and Drug Administration (FDA) has warned that the current process for approving medical devices couldn't possibly meet the challenge of policing mobile health and wellness apps and that, in most cases, the agency won't even try. Bakul Patel, and advisor to the FDA, said the Agency couldn't scale to police hundreds of new health and wellness apps released each month to online marketplaces like the iTunes AppStore and Google Play.

Comments

Charge what it costs to certify

[Anonymous Coward]

Just charge what it costs to certify that an application/ device does what it claims to do. I know it is a novel concept of fee for service, but things are far more transparent that way. If the federal government cannot keep up, then farm it out to private firms who are then audited by the Federal Government.

Re:Charge what it costs to certify

[Hungus]

In other words, provide no oversight at all while an "independent" firm rubber stamps all the industry's apps for a completely legal fee which ends up going to the executives of the fake company via bonuses, then let it fold and start up a new one.

Privatized enforcement is no enforcement. If it can't be overseen by the government it needs to either be banned. You can open up the question of if it needs to be regulated at all, but providing the illusion of safety and regulation when there is none is far worse.

Nowhere does the OP say that, you are jumping way down an argument and not providing your work in between. How I read the OP is that private contractors do the heavy lifting and then the FDA comes back in and audits the results. If you audit one in 3, then see a group fails to catch something so you audit their entire batch, that is still substantial oversight.

I also would be willing to jump in and say the FDA is overstepping what little role it should have and might be provided by the ICC (Article I, Section 8, Clause 3) and would even be willing to say that it may only regulate the actual commerce and not the actual products, however I think the OP is a step in the right direction.

Re:Charge what it costs to certify

[Rockoon]

Everything you said is unimportant because the FDA's purpose isnt supposed to be enforcing efficacy, only safety.

Somewhere along the way, however, some blind fool tools such as yourself got the FDA into the safety efficacy racket, and the thing that took a back seat because of it was in fact safety.


Let me quote you: "if it can't be overseen by the government it need to either be banned." Not only is this a grammatic fail, even if it was grammatically correct it would still just be a full blown blind call for complete Statism.

Re:Charge what it costs to certify

[AuMatar]

And I gave my reasoning. You can keep on to your infantile libertarian dreams, but a government agency is always more trustworthy than a private company- a government agency has at least some checks and balances and accountablility. A private agency has absolutely none, and is motivated solely by profits. Belief that they will actually do their job is asinine.

Private regulation is no regulation

Re:Charge what it costs to certify

[Bing Tsher E]

That is completely garbage. The Underwriter's Laboratory is a private for-profit organization and does a very good job of assuring fire and electrical safety for a huge sector of industry. When something is UL listed you can be certain it meets stringent safety standards.

Re:Charge what it costs to certify

[Rockoon]

Also to add:

The Kefauver Harris Amendment was inspired by the thalidomide tragedy that caused thousands of birth defects. However, the number of birth defects it caused in America was 0 because thalidomide was not approved yet by the FDA simply on the safety mandate. Thalidomide would have passed efficacy tests because it was, in fact, effective for more that a few purposes. So effective it was for so many purposes that Germany had lifted regulations and even started selling it over the counter.

Mandating efficacy is the backwards thinking of the Statist.

Re:Charge what it costs to certify

[sycodon]

Because INS, "Homeland" Security (What a freaking Totalitarian sounding name), and the TSA are doing such a bang up job.

Dickheads like you are the ones shutting down Lemonade stands run by six year olds because they don't "meet regulations".

Re:Charge what it costs to certify

[Goldsmith]

With medical devices efficacy and safety are very closely linked. If you're providing a product that monitors blood glucose and you do a poor job of it, your customer makes incorrect medical decisions that are potentially life threatening. The closer an app gets to providing such "actionable" information, the more likely it is that it requires FDA approval.

That said, this "can't be overseen" thing is silly. The FDA doesn't have the resources to oversee ALL smartphone health apps, they don't want to, and they shouldn't. There's no debate there. If the next generation of phones include electrocardiogram electrodes or a sophisticated spectrometer, the FDA is going to regulate the health software using those tools. That's really the news coming out of that FDA statement.

Re:Charge what it costs to certify

[Hungus]

Rather than simply make a quip, would you care to show a general trend of neglect in the pharmaceutical industry? While there are instances of abuse, the over all standards for pharmaceuticals in the US for safety is far better than what one would expect from your comment.

I beg to differ. Are you unaware of the 6+ year history of enforcement actions against the pharmaceutical giant Ranbaxy for gross violations of health and safety standards? http://www.reuters.com/article/2014/01/24/us-ranbaxy-ban-idUSBREA0N06Z20140124. And the FDA enforcements were only started after the pharma giant had been documented by private auditing firms as intentionally neglecting health and safety standards in their drug production processes. http://articles.economictimes.indiatimes.com/2013-05-28/news/39580238_1_ranbaxy-case-us-drug-regulator-paonta-sahib

That's 3 extra years that American health was at-risk because the pharmaceutical industry was allowed to rely on non-government, private safety inspectors.

You can 'beg to differ" all you want to, but you made my point for me with "FDA enforcements were only started after the pharma giant had been documented by private auditing firms".

In fact, I am well aware of that case and it was the specific case I had in mind when I mentioned the exception that proves the rule.

Re:Charge what it costs to certify

[AmiMoJo]

Efficacy and safety are often the same thing. If you have cancer and I tell you I have a miracle cure that only cost half as much as proper medical procedures and you decide to take it, you will die of cancer. If I tell you I have a miracle diet pill that lets you eat as much as you like, you will get fat.

Re:Charge what it costs to certify

[Bite The Pillow]

Mandating efficacy is the best defense against snake oil sales. Fear of lawsuits polices safety.

The only way to prove a drug safe is to have people use it for years, and see how many die or incur damage. It us better to take the health risk on effective medicine, instead of on snake oil, yes?

Personally, I think all new medicine should be on limited release for 10 years, only for those not helped by existing medicine. That limits exposure and effectively operates as phase 4 trial. But why take the risk if it doesn't do anything? Proving it works can be done in a month or two for most everything, but proving safety takes much longer.

Also, FDA does revoke approval for safety concerns, so it is not just ignoring safety.

FDA shouldn't even exist in the first place

[Anonymous Coward]

Nothing in the Constitution gives the federal government permission to have the FDA.

Shut it down.

Re: does it mean anything though?

[fustakrakich]

With the FDA infected with industry worms a lot of dangerous is given a chance, while less harmful substances are outright prohibited from even studying.

Re: does it mean anything though?

[Impy the Impiuos Imp]

I'll tell you what -- all it'll take is the FDA causing the delay for one year of a decent cancer or heart disease or diabetes drug, and boom! They've cost more lives than they will have saved since 1938.

Not medical grade instruments ...

[perpenso]

I expect these new mobile devices/apps coming onto the scene will be considered some sort of novelty devices by the FDA not medical devices. Like ancient digital watches.

The info they provide will be considered more trivia or a novelty than medical info. Much like ancient digital watches that could show a pulse, novelty info, not to be used for medical purposes. Or ancient digital watches that could show pressure, novelty info, not to be used for aircraft altitude or depth when scuba diving. I actually used one for scuba diving but it was secondary to my actual depth gauge made for scuba diving. It was surprisingly close. And when driving up to the mountains it will surprisingly close to the altitude markers along the highway, assuming I calibrated. I knew my altitude at home. And when diving, I was at sea level on the beach/boat. As reasonably accurate as it was, it was still a novelty device, or a last resorts back if my actual device failed.

Re:Not medical grade instruments ...

[rhsanborn]

Unfortunately, companies like Apple are developing services to aggregate health data from things like wifi BP cuffs, scales, activity trackers, pulse oximeters, etc. And, physicians and regulators are already looking at ways to integrate that information into a broader plan of care. So, regardless of it's novelty, it's going to be used for very real medical decisions. At the very least, there needs to be better education about the lack of oversight and the potential for wildly inaccurate data, and I don't get the feeling that's happening.

Good news

[jtwiegand]

This is a very good sign on the whole as it shows that out-innovating the regulatory state is not only possible, but actually happening right now. Our regulatory regime is stuck in the 19th century centralized command-and-control model, and it will stay there. Better to let it fail so that a useful and effective method of necessary oversight can come to replace our gilded age government with an information age government.

Re:So is an app food...

[TapeCutter]

Why is the government involved in devices? ... get Underwriter's Labs .... to certify it.

From the WP entry on UL - "UL is one of several companies approved to perform safety testing by the US federal agency Occupational Safety and Health Administration (OSHA)". If UL started handing out certs without doing the work then their license will be pulled and they will go out of business overnight.

Very few "free markets" spontaneously arise and prosper, the government creates them with the judicious use of regulation, the most basic of these regulations is property law, the saftey cert market is simply a more recent example. This is actuacully how things should work, the government defines a fair market for the public good via regulation of property and trade, business competes to implement the new market as efficiently as possible. Neither can do it alone due to self-interest getting in the way, which is why politicians and CEO's need to be kept at arms length from each other.