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  • Originally posted by mSparks View Post
    That was a quote from the PDF I linked, CRA is only one of like 10 of the potentially relevant acts and they know they are broken (in the FUBAR sense not just the violation sense).
    Any device used in the context of a medical facility is probably classed as a medical device, even mobile phone apps (hence the google declarations), new regulation is also coming in for that, I was involved with various global agencies discussing assessment and recommendation of them back in October.
    e.g. Anything recording/monitoring any bio data would run into at least some of them. there is no one size fits all.
    you just have a missunterstanding what my brother does and what people like him do and what companies like him do. for example he has no "medical facility" because he is not a nurse in a Hospital.
    he is a outpatient nursing service​ means he goes to the people at home. nothing what you write exist in this business. there is no "medical device" this software EVER touch its not a hospital. these outpatient nursing services do very simple stuff what has all nothing to do with all of that stuff what need government regulation.

    see here we come to the root problem with government and law and people who do "I was involved with various global agencies discussing assessment and recommendation of them back in October."

    they do not unterstand that there is a market outside of hospital setting what is complete low-tech and low-risk and nothing of these rules and recommendations for laws and all makes sense there.

    a "even mobile phone apps" who would do "Anything recording/monitoring any bio data would run into at least some of them" nothing like this exist in this market field. nothing.

    there is not even a need to and my brother does not plan a app or software or device who do recording or monitoring of bio data what so ever. he just go to old peoples home and inject them some insuline and goes to the next house. the tools they are using in this field for example to measure blood-pressure are 100-200 years old. and they do not even have the need to update it to a blood-pressure with electric air pump.

    Originally posted by mSparks View Post
    Its expensive enough "just" when the world is simple and you are making computer games with no real world consequences.
    As soon as you get into the world when a < instead of a > can accidentally kill 50,000 people things change.
    Now if "old-people-nursing​" doesn't matter, and we are instead talking about something just as suitable for "children's basketballs" then sure, regulation is not an issue.
    i ask you why did all these regulations and all these regular verification of the medical control service​ did not discover any issues with regulations even if the standard in all aspects are the lowest you can imagine ?

    maybe you have a missunterstanding that there is a low-risk market outside of Hospital settings and well to be honest no one cares about this market its small its dirty work and well no one cares about this field to be honest.

    99% of all the regulations are clearly not for these old-people outpatient nursing services...

    explain to me if my brother does not write the billing by hand in libre office and then print it and sign it by hand now a software does it and print it and he has now paper checkts the data and sign it by hand what difference does it make in the sense of RISK ? the end result is paper he has to final check it anyway then he signs it.
    there is on risk.

    ok tell me where is the risk if people come to him with this 60€ form and he checks date signs it and send it to th the health insurance now people send him the form via email he print it and sign it and send it to health insuracne and newest development is that he makes video call to see the patient then he sign the form and send it to health insurance. in this case of this 60€ form he does not even nurse/care these people himself its the family members who do this.

    can you explain to me where is the risk ? i can not see a risk by the way its their trojan infected smartphone and whatsapp anyway to they have the risk already and of course no one cares (really)

    to you to serious and you can not imagine that in this nursing business low-risk stuff exist.

    lets say this 60€ form because of the software has an error... well my brother has to check manually anyway and then he does not sign the paper because of the error. RISK IS ZERO.
    Phantom circuit Sequence Reducer Dyslexia

    Comment


    • Originally posted by qarium View Post

      can you explain to me where is the risk ? i can not see a risk by the way its their trojan infected smartphone and whatsapp anyway to they have the risk already and of course no one cares (really)
      I think maybe you are missing the point of the regulations. Its all about liability and who bears responsibility if/when things go wrong.

      Absent all else, if something "real world" happens that causes harm the author of the software holds all liability, so if I wrote some software that say interacts with people with mental health problems, then something in the software triggers them to commit suicide, that is my fault- at the very least a civil liability for the rest of their expected lifes earnings, worst case it could be counted as criminal negligence and I could face manslaughter charges.

      regulations then shift that liability around or obsolete it or make it more concrete. not abiding by regulations = negligence = big fines and jail time when TSHTF.

      How big? Servier chose the "get another safety guy" approach. that cost them half a billion dollars. (earlier link)

      The T&Cs of libreoffice shift all the liability to the user. Assuming your brother is paid for his work, he should have public liability insurance. All the risks of his business should have been assessed in getting that, anything he didnt declare wont be covered, and they wont pay.
      Originally posted by qarium View Post
      lets say this 60€ form because of the software has an error... well my brother has to check manually anyway and then he does not sign the paper because of the error. RISK IS ZERO.
      The risks are never zero, if the user/your brother had a reasonable expectation the software was checking the form for him, and something bad happens, the author of the software is liable (hence CRA open source exemptions) - how much they are liable for 100% depends on the consequences of the form ending up wrong.

      This is true if its old people or basketballs or post offices, health gets special attention because fuck ups like the UK Horizon scandal are incredibly easy when peoples health is involved, otoh if some software kills 1000 basketballs it wouldnt even be worth taking to court to find out whose fault it was.

      Comment


      • Originally posted by mSparks View Post
        I think maybe you are missing the point of the regulations. Its all about liability and who bears responsibility if/when things go wrong.
        Absent all else, if something "real world" happens that causes harm the author of the software holds all liability
        this is clearly wrong libreoffice is also software and holds no liability.
        as soon as the software only print letter and a person reads and controls it and sign the paper and stamp the paper then only the person who did sign and stamp it is liable.
        Libre-Office is best example its open-source software and has zero liability in this process.
        same with this software it is opensource software does same job as libre-office and has zero liability in this process.

        the person who sign the paper is liable.

        Originally posted by mSparks View Post
        , so if I wrote some software that say interacts with people with mental health problems, then something in the software triggers them to commit suicide, that is my fault- at the very least a civil liability for the rest of their expected lifes earnings, worst case it could be counted as criminal negligence and I could face manslaughter charges.
        just see the libre-office example it is opensource software and a hypothetical error cause a spelling mistake​
        on the printed paper and this results into a person with mental health problems commit suicide then what?
        i am pretty sure no one can make libre-office developers liable.

        a software who does the billing and print a paper is really just a tool like libre-office.
        a software who does this 60€ form is really just a tool like libre-office.

        but its sounds like you just disagree with me on that point.

        Originally posted by mSparks View Post
        regulations then shift that liability around or obsolete it or make it more concrete. not abiding by regulations = negligence = big fines and jail time when TSHTF.
        man its magic libre-office is open-source software and does all this and obviously​ not abiding any regulations...
        i am pretty sure the libre-office developers get big fines and jail time.

        Originally posted by mSparks View Post
        How big? Servier chose the "get another safety guy" approach. that cost them half a billion dollars. (earlier link)
        just tell me what kind of safety guy does the libre-office open-source software has?
        because with your interpretation of the law libre-office is clearly against the law.

        Originally posted by mSparks View Post
        The T&Cs of libreoffice shift all the liability to the user. Assuming your brother is paid for his work, he should have public liability insurance. All the risks of his business should have been assessed in getting that, anything he didnt declare wont be covered, and they wont pay.
        my brother does this business for over 25 years in his own company and before this he did this business in other companies.
        and my mother is in pension now and she worked 47 years in same business and something like you claim never happened and also does not exist.

        if this is possible: "The T&Cs of libreoffice shift all the liability to the user." then why it is not possible with the hypothetical other software ? what is the magic in libreoffice that the other software can not do same ?

        my brother does have all necessary public liability insurance and more.

        Originally posted by mSparks View Post
        The risks are never zero, if the user/your brother had a reasonable expectation the software was checking the form for him, and something bad happens, the author of the software is liable (hence CRA open source exemptions) - how much they are liable for 100% depends on the consequences of the form ending up wrong.
        its very simple why the risk for the developer is zero because the software never gets release and the developer does not deploy the software. by law source code is just human readable text and not a compiled software ready to run.

        "if the user/your brother had a reasonable expectation the software was checking the form for him,"

        i talked with my brother about this many times and something like this does not exist if he sign a paper he by law is forced to check what text on the paper he is signing. there by my point of view is zero chance that a libre-office software author is made liable for an error on the paper my brother signed.

        can you show me just one court case about such a claim? i am sure you can show zero court case.

        it would be a very insane court case.

        Originally posted by mSparks View Post
        This is true if its old people or basketballs or post offices, health gets special attention because fuck ups like the UK Horizon scandal are incredibly easy when peoples health is involved, otoh if some software kills 1000 basketballs it wouldnt even be worth taking to court to find out whose fault it was.
        i told you to make software who automatically does job/ask and then send this automatically to the health insurance is impossible to do.
        but any software like libre-office who just result in print a paper and people then read the paper and check it manually by reading it and then sign the paper such cases are risk free.
        keep in mind the expensive billing software in this field of profession has functionality to send it to the health insurance directly such a functionality would trigger all the stuff you talk about.

        but a software who just print a paper like libre office is simple in comparison. simple in the meaning of less regulations.

        Phantom circuit Sequence Reducer Dyslexia

        Comment


        • Originally posted by qarium View Post
          this is clearly wrong libreoffice is also software and holds no liability.
          They absolutely do.
          But you dont pay for it, so all the stuff that comes with that doesn't apply.
          They transfer all their liability to the user in the terms and conditions "to the extent applicable by law" - by using the software you personally accept liability for their mistakes.

          As soon as you pay for something for a specific purpose it needs to be fit for that purpose and the "manufacturer" (author of software) is liable for any consequences of it not being.

          if that purpose is connected to health (or aviation) then pretty much everything is heavily regulated paid or free.

          Comment


          • Originally posted by mSparks View Post
            They absolutely do.
            But you dont pay for it, so all the stuff that comes with that doesn't apply.
            They transfer all their liability to the user in the terms and conditions "to the extent applicable by law" - by using the software you personally accept liability for their mistakes.
            As soon as you pay for something for a specific purpose it needs to be fit for that purpose and the "manufacturer" (author of software) is liable for any consequences of it not being.
            if that purpose is connected to health (or aviation) then pretty much everything is heavily regulated paid or free.
            the point is no one want to do anything what is a software you pay for.
            like libre-office i talk about software you do not pay for.

            "They transfer all their liability to the user in the terms and conditions "to the extent applicable by law" - by using the software you personally accept liability for their mistakes"

            what is wrong in doing exactly this ?

            "As soon as you pay for something for a specific purpose it needs to be fit for that purpose and the "manufacturer" (author of software) is liable for any consequences of it not being."

            there is a reason why i want open-source software that is free to use.

            "if that purpose is connected to health (or aviation) then pretty much everything is heavily regulated paid or free."

            not everything is a hospital setting who you need to follow all these health regulations.
            the 2 examples i did make what is relevant for my brother has nothing to do with something risky or dangerous means there is not the case that 50 000 people die only because of this.
            and it is clear for me that you need to follow any rule and regulation for something risky who people can die.
            also you make it look like anyone does not want to follow law and rules and regulation but this is clearly not the case.

            you make it look like it is impossible to develop open-source software in this field.. and this is clearly nonsense.
            Phantom circuit Sequence Reducer Dyslexia

            Comment


            • Originally posted by qarium View Post

              what is wrong in doing exactly this ?
              Nothing is wrong with doing this - you just cannot do it for anything that has a purpose specifically in health or aviation. Either the software has been approved for use or the user is (potentially) committing a crime if they use it in a commercial/healthcare setting - this will possibly be one of the reasons they farm the work out to your brother instead of doing it themselves.
              Originally posted by qarium View Post
              there is a reason why i want open-source software that is free to use.
              Sure, but, generally open source software is open source either because it has little value any more, and the cost of maintaining it exceeds the income industry can get from selling it, or because the authors enjoy what they are doing, in both cases development is funded through a service model.
              Originally posted by qarium View Post
              also you make it look like anyone does not want to follow law and rules and regulation but this is clearly not the case.
              most of the regulations are things that should be done anyway, It's more that so far all I've heard is surprise that no one wants to fund standing on the street handing out free ipads to anyone who walks by.

              If your brother really wants it open source, all he needs do is write a blog post describing exactly what he does and who he does it for, and the Chinese will probably offer it to them for $1 an hour in a few weeks.

              Last edited by mSparks; 22 May 2024, 05:35 PM.

              Comment


              • Originally posted by mSparks View Post
                Nothing is wrong with doing this - you just cannot do it for anything that has a purpose specifically in health or aviation. Either the software has been approved for use or the user is (potentially) committing a crime if they use it in a commercial/healthcare setting - this will possibly be one of the reasons they farm the work out to your brother instead of doing it themselves.​

                yes of course my brother has only job because they source out the work for my brother because they do not want to do the job. its a dirty job no one want to do it.
                but keep in mind my mother was PDL leader position in a very big Diakanie nursing station for 47 years.
                and my brother does it for 25 years in his own company.
                and in all these years cases like you claim literally do not exist in real world. theoretically it is like you say but in the real world statistically it does not exist. really not. such cases if they happen are big in the media.

                Originally posted by mSparks View Post
                Sure, but, generally open source software is open source either because it has little value any more, and the cost of maintaining it exceeds the income industry can get from selling it, or because the authors enjoy what they are doing, in both cases development is funded through a service model.​
                yes exactly we want a service model similar to the DATEV cooperative​

                DATEV is not software you can buy on the free market it is a cooperative modell you need to be tax lawyer and become member. means these members then finance these service model to finance the open-source development.

                Originally posted by mSparks View Post
                most of the regulations are things that should be done anyway, It's more that so far all I've heard is surprise that no one wants to fund standing on the street handing out free ipads to anyone who walks by.


                even only the existence of such a open-source project would flood my brother with customers because he is already flooded with customers who want this 60€ form.
                again keep in mind my brother does not have to make money with the software the only existence of such a software would already make him money. even such a project without a existing software would make him money. just see it as a PR stunt its the cheapest PR you can get.

                Originally posted by mSparks View Post
                If your brother really wants it open source, all he needs do is write a blog post describing exactly what he does and who he does it for, and the Chinese will probably offer it to them for $1 an hour in a few weeks.
                we have close contact with chinese people and they tell us otherwise they say developers earn in china nearly as much as they earn here because its already a global market. also to even give these chinese work is impossible task for people like my brother means you need expert who then hand over the work to the chinese.

                Phantom circuit Sequence Reducer Dyslexia

                Comment


                • Originally posted by qarium View Post

                  DATEV is not software you can buy on the free market it is a cooperative modell you need to be tax lawyer and become member. means these members then finance these service model to finance the open-source development.
                  Yes, opportunities, but as many such groups already exist in healthcare as their are silos. MSLs, CROs, Medical Managers (software in nursing homes), Originators, H&W, patient organisations etc etc.
                  We have a partnership with Ericsson (who did a lot of Europe's eHealth systems) and work with/for a dozen or so more similar accros the EU and globally, hence the link to clininote - there is absolutely an acute shortage of developers - even more so in healthcare where everything is heavily regulated, its a rapidly growing and expanding market and very far from "nothing".

                  If you/your brother want something specific in nursing space that is GPL, you are almost certainly going to need to learn to write it yourselves, because no one else is going to be giving such valuable code away for free, you are as good as asking why you cant find a street corner with someone handing out free new shiney iPads they don't want any more to anyone passing by.

                  Comment


                  • Originally posted by mSparks View Post
                    Yes, opportunities, but as many such groups already exist in healthcare as their are silos. MSLs, CROs, Medical Managers (software in nursing homes), Originators, H&W, patient organisations etc etc.
                    We have a partnership with Ericsson (who did a lot of Europe's eHealth systems) and work with/for a dozen or so more similar accros the EU and globally, hence the link to clininote - there is absolutely an acute shortage of developers - even more so in healthcare where everything is heavily regulated, its a rapidly growing and expanding market and very far from "nothing".
                    If you/your brother want something specific in nursing space that is GPL, you are almost certainly going to need to learn to write it yourselves, because no one else is going to be giving such valuable code away for free, you are as good as asking why you cant find a street corner with someone handing out free new shiney iPads they don't want any more to anyone passing by.
                    why do you think that anyone expect that anyone give away valuable code away for free ?

                    "nothing"

                    again you mix up other branches of the healthcare industry with that specific part.
                    of course there is software for hospitals or doctors.

                    "there is absolutely an acute shortage of developers"

                    right. but is doing anyone anything about that ? i think clearly not the case.
                    in germany they clearly scare people away from doing a computer science university degree.
                    this starts with teaching "democracy" in the math class instead of mathematics.
                    this also starts with spam people with mandatory useless stuff to get their highest school degree to block them to even enter a university to do a computer science degree. without the highest school degree full of spam they do not allow you do enter the university. and so one and so one.

                    my opinion is they should allow a minimalist school degree with only nessesary school topics like only english+mathematics to not scare away people with spam like lies in the history classes.

                    but even if you are able to enter the university they spam you with nonsense in my point of view everything about closed-source and proprietary stuff like CUDA is also spam. its spam because its not in the interest of the students to learn this.

                    "If you/your brother want something specific in nursing space that is GPL, you are almost certainly going to need to learn to write it yourselves"

                    i am working no that part and i also give people i know books in that field to also learn and do that.

                    Phantom circuit Sequence Reducer Dyslexia

                    Comment


                    • Originally posted by qarium View Post

                      why do you think that anyone expect that anyone give away valuable code away for free ?


                      You said

                      Originally posted by qarium View Post
                      we want Guerrilla warfare style open source do-it-yourself​ software with zero liability for anyone.

                      That necessitates the author of that source code, source code worth orders of magnitude more than the expensive software it creates, give away for free that source code.

                      Originally posted by qarium View Post
                      again you mix up other branches of the healthcare industry with that specific part.
                      of course there is software for hospitals or doctors.
                      Obviously, because code is code, code doesn't care if it automatically landing a 747 at Heathrow airport with 400 passengers on board, keeping a heart beating, or automatically filling in a form for a lawyer or a nursing home. Its all the same signals and logic; a stream of 0s and 1s in, being converted to a different stream of 0s and 1s out.

                      Originally posted by qarium View Post
                      "there is absolutely an acute shortage of developers"

                      right. but is doing anyone anything about that ? i think clearly not the case.
                      in germany they clearly scare people away from doing a computer science university degree.
                      this starts with teaching "democracy" in the math class instead of mathematics.
                      this also starts with spam people with mandatory useless stuff to get their highest school degree to block them to even enter a university to do a computer science degree. without the highest school degree full of spam they do not allow you do enter the university. and so one and so one.

                      my opinion is they should allow a minimalist school degree with only nessesary school topics like only english+mathematics to not scare away people with spam like lies in the history classes.

                      but even if you are able to enter the university they spam you with nonsense in my point of view everything about closed-source and proprietary stuff like CUDA is also spam. its spam because its not in the interest of the students to learn this.

                      "If you/your brother want something specific in nursing space that is GPL, you are almost certainly going to need to learn to write it yourselves"

                      i am working no that part and i also give people i know books in that field to also learn and do that.
                      A whole other "can of worms".

                      We have been growing by taking students directly out of faculty, generally engineering or pharmacy, and train them in house, no one teaches what we need even at masters level. Also been sending quite a few talented people off on PHDs recently, it's a whole new era.

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