3 ms·

Compliance review? Like HIPAA? Or are you referring to FDA approval? As someone with a chronic medical condition, my experience is that software approved by

by jnovek 3y ago

Compliance review? Like HIPAA? Or are you referring to FDA approval? As someone with a chronic medical condition, my experience is that software approved by the FDA are often prohibitively expensive (they are considered medical devices) and not covered by insurance.

jacquesm 3y ago
The key indeed is that they can be considered medical devices, and medical devices are a regulated class of devices (depending on where you live these can have all kinds of compliance requirements imposed on them). Compliance is expensive, difficult and tends to constrain what you can do with your data. So companies that want to side-step compliance will work hard to avoid being labeled a medical device. Whether your insurance covers the costs or not is yet another aspect, typically if your insurance company isn't going to reimburse you for an app that is classed as a medical device they definitely aren't going to reimburse you for other kinds of apps that are not approved. Note that not all software only applications in the medical domain are immediately considered medical devices, the line is a pretty fine one. If you plan on putting out an app that has medical implications you should research this properly to avoid running afoul of the regulators (which isn't a very good way to start your relationship).
- jnovek 3y ago
  > if your insurance company isn't going to reimburse you for an app that is classed as a medical device they definitely aren't going to reimburse you for other kinds of apps that are not approved. Insurance companies are loathe to cover even FDA approved _physical_ devices. Insurance is enthusiastic to classify such things -- even treatments that are decades old -- as experimental. The only devices that are a shoe-in are things with widespread adoption like CPAP or pacemakers. If your condition is uncommon, you'll be paying out of pocket. That wipes FDA approved apps off the map for most of us. Meanwhile, the app store is full of apps the claim to provide relief for various conditions for just $14.99/mo. Some of them are even actually effective. I'm definitely not arguing that this state of affairs is a good thing, but it is pragmatic reality for those of us with chronic conditions. Unless we have truly fantastic insurance or loads of income (things that are often mutually exclusive with chronic conditions), we are priced out of the tools that are most trustworthy.
  - jacquesm 3y ago
    This is a failure of health care systems. The degree to which healthcare has been made into a differentiating factor between the haves and have nots is astounding (to me, at least). You'd think the first thing a developed country would do is to ensure that healthcare was universal and completely free, instead it is used as a source of income because health is 'priceless'. It bothers me tremendously but I don't see what I could realistically do about it.

by jnovek 3y ago

jacquesm 3y ago

The key indeed is that they can be considered medical devices, and medical devices are a regulated class of devices (depending on where you live these can have all kinds of compliance requirements imposed on them). Compliance is expensive, difficult and tends to constrain what you can do with your data. So companies that want to side-step compliance will work hard to avoid being labeled a medical device. Whether your insurance covers the costs or not is yet another aspect, typically if your insurance company isn't going to reimburse you for an app that is classed as a medical device they definitely aren't going to reimburse you for other kinds of apps that are not approved. Note that not all software only applications in the medical domain are immediately considered medical devices, the line is a pretty fine one. If you plan on putting out an app that has medical implications you should research this properly to avoid running afoul of the regulators (which isn't a very good way to start your relationship).

jnovek 3y ago
> if your insurance company isn't going to reimburse you for an app that is classed as a medical device they definitely aren't going to reimburse you for other kinds of apps that are not approved. Insurance companies are loathe to cover even FDA approved _physical_ devices. Insurance is enthusiastic to classify such things -- even treatments that are decades old -- as experimental. The only devices that are a shoe-in are things with widespread adoption like CPAP or pacemakers. If your condition is uncommon, you'll be paying out of pocket. That wipes FDA approved apps off the map for most of us. Meanwhile, the app store is full of apps the claim to provide relief for various conditions for just $14.99/mo. Some of them are even actually effective. I'm definitely not arguing that this state of affairs is a good thing, but it is pragmatic reality for those of us with chronic conditions. Unless we have truly fantastic insurance or loads of income (things that are often mutually exclusive with chronic conditions), we are priced out of the tools that are most trustworthy.
- jacquesm 3y ago
  This is a failure of health care systems. The degree to which healthcare has been made into a differentiating factor between the haves and have nots is astounding (to me, at least). You'd think the first thing a developed country would do is to ensure that healthcare was universal and completely free, instead it is used as a source of income because health is 'priceless'. It bothers me tremendously but I don't see what I could realistically do about it.