3 ms·

There’s no “might” here, in a device advertised as “92% accuracy”. This device _will_ give false results, almost certainly an overwhelmingly number of false res

by avalys 1y ago

There’s no “might” here, in a device advertised as “92% accuracy”. This device _will_ give false results, almost certainly an overwhelmingly number of false results relative to the actual heart attacks it detects. And those false results have real, guaranteed harm and cost as well. Both false positives and false negatives are harmful. False positives will send people to the hospital for no reason and divert resources from people with real emergencies - not to mention leaving them with a large ER bill to pay. False negatives will result in people with actual heart attacks dismissing their symptoms and dying.

vlovich123 1y ago
The counter is that people can build their own informed intuition about whether these things are helpful, particularly in coordination with their doctor and experience of using it. And a product is easier to improve and will improve more quickly if the company can easily bring updates and find investment that improve quality to product they have revenue for. I think the FDA safety margin for things like this should be more “this has no actual obvious harm to use, it has a plausible mechanism of action to help + isn’t fraudulently measuring what it claims to measure and its science backed. Something like this hits all the targets already.
ETH_start 1y ago
You’re basically saying "92% accurate" devices will cause harm, so let’s ban them outright. Even if the failure was death, we should allow it. It's a free country. We let consenting adults do all sorts of dangerous stuff — base jumps, do weird diets, drink alcohol, smoke, etc — yet somehow medical device regulation treats personal risk tolerance as if it’s off-limits. But the failure scenario is not death. It's an unnecessary hospital visit. And you STILL want it banned. If someone wants early heart-attack warnings at 92% accuracy, that should be their call. As for costs, a few thousand false alarms might clog ERs and bill wallets, but big deal. That’s the price of getting these things in the wild and learning what actually works. More wearables in real world situations equals massive real-world data, faster device improvement, economies of scale, and ultimately, over the long run, millions of prevented heart attacks — plus orders-of-magnitude lower costs down the road. I’d take a handful of extra ER visits any day if it speeds up innovation and saves lives.

by avalys 1y ago

vlovich123 1y ago

The counter is that people can build their own informed intuition about whether these things are helpful, particularly in coordination with their doctor and experience of using it. And a product is easier to improve and will improve more quickly if the company can easily bring updates and find investment that improve quality to product they have revenue for. I think the FDA safety margin for things like this should be more “this has no actual obvious harm to use, it has a plausible mechanism of action to help + isn’t fraudulently measuring what it claims to measure and its science backed. Something like this hits all the targets already.

ETH_start 1y ago

You’re basically saying "92% accurate" devices will cause harm, so let’s ban them outright. Even if the failure was death, we should allow it. It's a free country. We let consenting adults do all sorts of dangerous stuff — base jumps, do weird diets, drink alcohol, smoke, etc — yet somehow medical device regulation treats personal risk tolerance as if it’s off-limits. But the failure scenario is not death. It's an unnecessary hospital visit. And you STILL want it banned. If someone wants early heart-attack warnings at 92% accuracy, that should be their call. As for costs, a few thousand false alarms might clog ERs and bill wallets, but big deal. That’s the price of getting these things in the wild and learning what actually works. More wearables in real world situations equals massive real-world data, faster device improvement, economies of scale, and ultimately, over the long run, millions of prevented heart attacks — plus orders-of-magnitude lower costs down the road. I’d take a handful of extra ER visits any day if it speeds up innovation and saves lives.