I'm curious, why "rightly"? I use all kinds of assistive devices. You probably know them by the names "metal tongs", "gloves", "ice axes", "crampons", "shoes", and so on.
I can see regulation as soon as you are penetrating the body - screwing something in, surgery to make an attachment point, and so on, but otherwise? Don't make people's lives even harder because you think you can think and make decisions better than they can.
Possibly I am using a jargon term that you aren't familiar with - assistive devices have a special meaning in this kind of context. They are designed and marketed to give renewed function or rehabilitation to someone with some impairment (http://en.wikipedia.org/wiki/Assistive_technology).
I'm making generalisations that may extend beyond this particular device for this particular user because its an entire field that isn't well serving its users at the present time. Implementation far lags technology because business and operations models don't exist to promote the development of these technologies. The kind of approach article is suggesting is promising, but not a complete solution.
The reason why regulation is needed is that the people making/designing/marketing the device have by doing so made an appeal that they are an expert.
Often, failure of these devices have far higher consequences than failure of typical consumer devices (maybe ice axes and crampons are also in this category!). Its the same reason why doctors need to be licensed to practice, whether it be for open heart surgery or to diagnose someone with a runny nose.
Probably assistive devices (and medical technologies in general) are over-regulated now, but that doesn't mean the solution is no regulation.
I'm familiar with the term. My argument is that the fact that device X is fixing an impairment should not make a difference vs a device that augments me. Tongs let me flip things on the grill without burning myself. If everyone but me had fireproof skin then that would be an 'assistive device', yes? My rock climbing shoes give me grip on the rock - is that not correcting an an impairment in some sense? I use stools to correct for my relatively short height - people fall off stools every day. Shall we require stools to cost $20K, complete with stabilization arms, railings, and a safety harness? My keyboard & mouse bothers my carpal tunnel. Would you like to have to pay $10K (say) for a keyboard? Artifical legs can cost over $100K, yet people get by hobbling around using a stick for support. IMO, it's madness to regulate at this level.
I agree that there is gray area, but these are people with very real needs that are finally being addressed in a cost effective way ($2000 or less!). There is a world of difference between open heart surgery and uninvasively strapping something on the end of my arm.
So how much regulatory tax would you think is acceptable to add to a $50 hand? A few thousand?
How about a simple disclaimer - not to be used in safety critical applications - and let people have their $50 hand? When people start selling hands with bigger promises that have more grave consequences, dial up the regulation on those.
Ice axes and crampons are generally certified by the UIAA [1], but this certification is not legally binding -- it's just that consumers won't buy products that aren't UIAA-certified.
Yes. I mentioned climbing on purpose, because of the standards. In reality, you can go to the hardware store and buy things like bolts and rings, and people do that. Others buy certified versions, which is probably a bit smarter. But in the end it is personal responsibility. And the certification is not that onerous. I can buy a locking biner for $15 or so dollars, a sling for $5, a very high tech rope for $150, shoes for $60, and so on. I have no doubt economy of scale is working here - more carabiners are made and sold vs prosthetic arms. But in the end I have a lot of choice - I can use $5 cheapo sunglasses at altitude, or spend $300 for high end versions. I can spend $100 for a benchmade knife, or $3 at Walmart. My life, my risks,my choice.
In the end it doesn't matter much if my prosthetic finger breaks - I'll just print a new one. Could I get a rash if I use PVC plastic vs some bioplastic? Sure,but I can also get a rash from the $5 sneakers from Walmart. Is medical grade stainless going to be better than something I get from Home Depot? I would imagine so, but I buy all my metal from Home Depot and the like, and I have yet to suffer any real consequences from that. I have a stiff neck from the $10 pillow from BB&B - shall I buy a $3800 orthopedic, medical grade, hypoallergenic pillow? Nah.
I can see regulation as soon as you are penetrating the body - screwing something in, surgery to make an attachment point, and so on, but otherwise? Don't make people's lives even harder because you think you can think and make decisions better than they can.