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by unsrsly
1832 days ago
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There's a lot to unpack here! In the USA, the ABR regulates human radiologists via board certification. Medical technology is traditionally regulated by the 510K, PMA, and de novo pathways at the FDA. Of course, these products still have to demonstrate value in order for major stakeholders (hospitals, radiology practices) to purchase them. And using these products does not absolve the ordering doctor, the radiologist, or the hospital of legal liability for misdiagnosis. In fact, IANAL and this is a somewhat novel area of the law, but any AI product that functions as a drop-in replacement for a radiologist might be held liable for misdiagnosis that leads to harm. These liabilities could become quite large for a product deployed at scale (a single misdiagnosis causing death can lead to a settlement in excess of 10 million dollars). In summary, there's quite a bit more to the issue than simple "gatekeeping." It might be appealing to blame radiologists for these issues, but there's a much larger system at work that's designed to ensure quality and safety for patients. This is not AdTech - lives are at stake and people can get hurt. Now, this definitely comes with a cost to innovation, but it's going to take more than just a few MD's to reinvent the economics and law of computers practicing medicine on people. |
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My experience with getting a sonogram was that the sonogram wasn't that expensive, but getting it read was hugely expensive. I understand that there are issues of liability, but it's really frustrating that I'm saddled with a high deductible healthcare plan where access to useful medical stuff is stuck behind 3-4 digit costs. Want antibiotics, inhalers, ADHD meds - all of which are pretty cheap in generic form? Pay $100 to the doctor for the privilege. People have very little agency in this system.
I guess at the end of the day I'd like to see open data (I'm able to get the images/data from all kinds of scans & diagnostics), and some kind of transparent system for submitting my data for diagnosis or analysis. There may be caveats & waivers, but I'd be willing to pay $10 to an AI service to tell me "You definitely need to consult with a radiologist based on the data presented" before I pay a radiologist orders of magnitude more to tell me that everything looks OK.