5 ms·

Just FYI, the European Union made such projects illegal as of 26 May 2021. See Medical Devices Regulation (MDR) EU 2017/745: https://eur-lex.europa.eu/legal-con

Just FYI, the European Union made such projects illegal as of 26 May 2021. See Medical Devices Regulation (MDR) EU 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELE... Also, these projects were designed on purpose to circumvent or in some cases break the law, which is the wrong approach to medical device design. It's dangerous and designs kill, as you know. See this stipulation (and control/command + f = "commercial" in paper): 27) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; Also: 46) ‘investigational device’ means a device that is assessed in a clinical investigation Also: 1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, Also: (19) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device.

netr0ute 5y ago
Sad, Big Pharma strikes again.
- OJFord 5y ago
  Did people start sentences with 'Sad' like this before Trump's presidency? I don't know if it's a (an American) colloquialism I simply hadn't noticed prior to that, or a more personal quirk that caught on? I don't mean to single out you specifically, I keep noticing it now.
  - netr0ute 5y ago
    Trump is more associated with "SAD!" but with how many sad privacy/freedom violations there are nowadays, it could be because of that.
  - meowster 5y ago
    Yes, it's been used that way in American venacular for at least several decades.
    - OJFord 5y ago
      Thanks, it was an honest question, something I've noticed a few times and wondered about. I was going to say (did type) that I can't think of another word that's used in the same sort of declaratory way - but actually, as I wrote, it occurred to me that 'funny' is too. 'Funny, I just never noticed it with 'sad' until a few years ago.'
  - OneLeggedCat 5y ago
    It became a lot more common around 2015.
  - dTal 5y ago
    Let me put it this way. How linguistically innovative do you think Trump is?
monocasa 5y ago
Sure, I just have inside information into some of these systems (and enough inside knowledge to be scared of their lawyers enough to not name specifics). Therac style systemic implementation issues aren't uncommon. Think handle every failure mode by panicking the OS, and the hardware fails in the wrong direction for the patient without software control. IMO, yeah, community approaches might not be the ideal solution, but when it comes to my health it's the better of the two options I have (community that I can actually look at the implementation of vs. proprietary that I know has systemic regulatory issues and is a crap shoot on if it is actively killing people and the engineers who worked on it don't ever want it used on them). If it comes down to it I'm going to choose my health over legality every time.
- skybrian 5y ago
  A third option might be some kind software transparency scheme, where every change is publicly available and audited, with bug bounties. This could be done to keep the professionals on their toes without resorting to relying on random unvetted software. They could even take pull requests, as long as the company takes responsibility for them.
  - lupire 5y ago
    That's not an option; that's a dream.
- disabled 5y ago
  > Think handle every failure mode by panicking the OS, and the hardware fails in the wrong direction for the patient without software control. Thanks, I am aware of this. It's called a block diagram, and is standard safety design. See page 3: https://pdfserv.maximintegrated.com/en/an/AN4675.pdf https://pdfserv.maximintegrated.com/en/an/AN4675.pdf
  - monocasa 5y ago
    In case you're wondering why you're being downvoted, a block diagram isn't a standard safety design, nor really a safety design at all per se. It is simply a connection graph of subcomponents.

netr0ute 5y ago

Sad, Big Pharma strikes again.

OJFord 5y ago
Did people start sentences with 'Sad' like this before Trump's presidency? I don't know if it's a (an American) colloquialism I simply hadn't noticed prior to that, or a more personal quirk that caught on? I don't mean to single out you specifically, I keep noticing it now.
- netr0ute 5y ago
  Trump is more associated with "SAD!" but with how many sad privacy/freedom violations there are nowadays, it could be because of that.
- meowster 5y ago
  Yes, it's been used that way in American venacular for at least several decades.
  - OJFord 5y ago
    Thanks, it was an honest question, something I've noticed a few times and wondered about. I was going to say (did type) that I can't think of another word that's used in the same sort of declaratory way - but actually, as I wrote, it occurred to me that 'funny' is too. 'Funny, I just never noticed it with 'sad' until a few years ago.'
- OneLeggedCat 5y ago
  It became a lot more common around 2015.
- dTal 5y ago
  Let me put it this way. How linguistically innovative do you think Trump is?

monocasa 5y ago

Sure, I just have inside information into some of these systems (and enough inside knowledge to be scared of their lawyers enough to not name specifics). Therac style systemic implementation issues aren't uncommon. Think handle every failure mode by panicking the OS, and the hardware fails in the wrong direction for the patient without software control. IMO, yeah, community approaches might not be the ideal solution, but when it comes to my health it's the better of the two options I have (community that I can actually look at the implementation of vs. proprietary that I know has systemic regulatory issues and is a crap shoot on if it is actively killing people and the engineers who worked on it don't ever want it used on them). If it comes down to it I'm going to choose my health over legality every time.

skybrian 5y ago
A third option might be some kind software transparency scheme, where every change is publicly available and audited, with bug bounties. This could be done to keep the professionals on their toes without resorting to relying on random unvetted software. They could even take pull requests, as long as the company takes responsibility for them.
- lupire 5y ago
  That's not an option; that's a dream.
disabled 5y ago
> Think handle every failure mode by panicking the OS, and the hardware fails in the wrong direction for the patient without software control. Thanks, I am aware of this. It's called a block diagram, and is standard safety design. See page 3: https://pdfserv.maximintegrated.com/en/an/AN4675.pdf https://pdfserv.maximintegrated.com/en/an/AN4675.pdf
- monocasa 5y ago
  In case you're wondering why you're being downvoted, a block diagram isn't a standard safety design, nor really a safety design at all per se. It is simply a connection graph of subcomponents.