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Comment by wintorez | Hacker News Reader

May I ask why is it a huge deal?

With FDA clearance you're allowed to brand and advertise your product as a "medical device". Also, without FDA approval, you have to be very careful about certain terms you use to describe your product's features. For example, without FDA approval, you cannot say your device "monitors" falls. You can only say it "tracks" falls. There are several other limitations because the FDA doesn't want you making these types of medical claims to customers unless the FDA has approved them.

Source: I worked on a fall detection app for the Apple Watch last year.

With a prescription you’ll be able to use HSA/Flex Spending or insurance to buy one.

That's fucking brilliant. Tesla, are you listening? I want the car to be an FDA approved monitoring device.

It seems like that could be possible, even without a prescription. I can buy any number of non-prescription things with my HSA now. Obviously this seems a little different than say a blood glucose testing device. Next year they will probably amend it with a "*excluding Apple Watch"

Why would an insurance company care about what you do with your HSA/Flex account. They aren't out of any money.

The IRS might care since they are the ones who enforce the rules surrounding their use, not your insurance company...

I took the parent post as implying that the insurance company would try to exclude purchasing the Apple Watch.

Sorry that was not clear (and this response is late). I know my HSA admin limits use of those funds for medically approved things only. I assume based on rules that the government created. I am just speculating that they may have to start dealing with devices like this which have a dual purpose, mostly not medical.

"This feature has received clearance from the US Food and Drug Administration, meaning it can be used as a medical device — a move that is part of Apple’s increasing push to brand the watch as more than a fitness device." - https://www.theverge.com/2018/9/12/17850660/apple-watch-seri...

It is not easy to get any FDA approval. Companies go bankrupt after spending millions and still don't get approved.

When you have more money than the government that’s no so much of a problem.

Yes, Apple is excluded from that statement. The company which had a budget of $1 billion for their new headquarters and end up spending $5b :-)

And have that still be a rounding error on their balance sheet. :-)

Technically Apple has more money than some governments, it's nowhere near the US Government's: Apple's entire assets could pay for under 18 months of net interest on the public debt (263bn in 2017).

The US has negative money, they are in debt. I have more money than the US.

Maybe you can make an offer to buy the US with 30% of your net worth. Then resell to a hedge fond.

I don’t think I have the patience to deal with the ‘deal maker’ in chief, sorry. I’ve heard he’s got quite a lot of experience with bankruptcies though so he might have new ideas to deal with all that debt the US has been taking on lately.

The US has assets to cover its debts in spades. Nobody would give them money for free if they didn't.

And the debt is owned at ~50% by the government itself or the Fed and ~20% by various non-federal investors (pensions, mutual funds, local governments, individuals) with the rest being owned by various non-US entities.

The U.S. federal government can accumulate only debt, it cannot accumulate savings. Why? Because any surplus it generates is stored in Treasury bonds, which are also counted as debt.

Things are different for the federal government. It's an institution of last resort, so the normal ways of thinking about personal finance don't apply. It can't open a "savings account" anywhere, because every other institution on Earth is smaller and less reliable.

It's a 510k "clearance", not an "approval". It's relatively cheap and all you have to do is show your thing (ECG in this case) is effectively the same as other similar devices (older ECGs) for medical purposes.

Was looking for this in the comments.

The ambiguity there is abused by many companies on the fringes of consumer health and cosmetic products.

> A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval

Didn't theranos get FDA approval too.

They have different types of approval based on the risks involved. Some are a lot easier to obtain.

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