9 ms·

Very much in favour of open standards on principle, but is a few hundred EUR really an obstacle for any kind of serious medical startup?

by wk_end 6y ago

oauea 6y ago
It's not just one document. And you don't know what will be relevant before you buy them, because you won't know the contents!
- ballenf 6y ago
  ICD code licensing is highway robbery. I would guess most health tech startups also need those. And those prices look reasonable compared to drug database license costs. And the real killer is meaningful use certification. The whole field seems engineered to prevent competition. So while ISO costs are unjustifiable, they’re a pittance compared to other compliance costs that most in the field will encounter.
  - btilly 6y ago
    The whole field seems engineered to prevent competition. It is. After all it is not in the interests of anyone who is established in the field to make competition easy.
  - snuxoll 6y ago
    ICD-10-CM that you need in the US can be obtained from CMS free of charge. CPT is obnoxious, but you can also generally substitute HCPCS from CMS as well at no cost. Source: work for a medical billing company, have had to deal with this garbage before.
  - biofox 6y ago
    Not sure about licensing, but one important difference with ICD codes is that you can access them for free: https://icd.who.int/en https://icd.who.int/en
  - deleted 6y ago
    [deleted]
jtwaleson 6y ago
The fact that the content is copyrighted and can't be publicly discussed is the main issue.
- nl 6y ago
  That's not what copyright is at all. Copyright might restrict reposting parts, but nothing (except perhaps license agreements) restricts public discussion. You can see this by the fact that Wikipedia has complete details of the ISO date standard (as referenced in the parent tweet Tim replied to).
  - Natanael_L 6y ago
    This means every single thing must be very carefully rewritten. You can not cite every single sentence in the full document, you would have to mimic Wine and rewrite the entire thing until your lawyers aren't worried about getting sued anymore. And nobody's doing that. Most people aren't going to quote much anyway, which means the people who don't know what's referenced can't understand it because they have no context. Which brings us back to square one, you can't meaningfully discuss the content in public.
    - DaiPlusPlus 6y ago
      > Which brings us back to square one, you can't meaningfully discuss the content in public. Fair Use exception in the US, and I think that would be covered by Fair Dealing in the UK and similar countries.
      - Aerroon 6y ago
        That's an affirmative defense in the US though. That means you can still be sued and have to defend yourself in court.
        DaiPlusPlus 6y ago
        I guess the trick is to pirate a specific localized version of the standard from an ISO member country that doesn't care about IP rights enough to sue you... say... PRC?
unethical_ban 6y ago
When ISO is defacto law in some industries, I would argue that laws should not be paywalled.
- jrochkind1 6y ago
  Your comment reminds me of related thing, with building codes in the US. The Supreme Court recently ruled they could not be copyrighted, for the reasons you say, they are laws that need to be available. These codes are often produced by a single organization, "International Code Council", a non-profit somewhat analagous to ISO, which I believe sells them to governmental jurisidictions which adopt them as law, sometimes with some customizations or "choose A or B" choices. One of the parties to the lawsuits involved happens to be a Y Combinator funded company, "UpCodes". https://archinect.com/news/article/150195411/supreme-court-rules-that-building-codes-cannot-be-copyrighted https://archinect.com/news/article/150195411/supreme-court-r... https://www.constructiondive.com/news/construction-code-purveyor-calls-supreme-courts-ruling-that-annotated-code/577013/ https://www.constructiondive.com/news/construction-code-purv... https://techcrunch.com/2020/11/16/a-court-decision-in-favor-of-startup-upcodes-may-help-shape-open-access-to-the-law/ https://techcrunch.com/2020/11/16/a-court-decision-in-favor-... In the US, if there are any cases where an ISO code is mentioned in law as legally binding in some way, it's possible someone could try to challenge the ability to keep from sharing the relevant standard text freely. It's not exactly the same situation, but this supreme court decision provides a possible path anyway.
  - jsmith45 6y ago
    That is a severe overstatement. The Supreme Court ruled in Georgia vs public.resource.org, which was very much not about building codes. P.R.Org actually does have another ongoing lawsuit that is similar to UpCode's: American Society for Testing and Materials et al. v. Public.Resource.Org The UpCode ruling was at the district court level, and merely cited the ruling from Georgia vs public.resource.org. Until we get at least appellate level decisions on the copyrightability of enacted codes, I'm unlikely to feel satisfied.
    - 6y ago
edflsafoiewq 6y ago
Especially compared to the cost of reading and complying with them.
pretendgeneer 6y ago
The problem is not just a few hundred EUR if that standard is your core business, it's the 10's-100's that are roughly adjacent that if they were free you would just have on hand and use/adopt if it makes sense, but to have a price gatekeeper means you have to think about every single standard that might make sense to follow.
olieidel 6y ago
It is: - You need to purchase multiple standards (at least 4). - In theory, you need to purchase a multi-user license if more than one person should be allowed to read the pdf in your company (hint: nobody purchases the multi-user license). - Every few years, new versions of the standards are released which you have to purchase. - Sometimes, you just purchase standards to realise that they're not applicable to your company. - The industry is riddled with shadiness: A German standards web shop offers a "standards flatrate" for a "great price" of e.g. 750 EUR for 10 standards. [1] - Getting off-topic, but more related shadiness: Your purchased PDFs are watermarked with your company name and full name of purchaser (!) in the footer of each page to prevent sharing. [1] https://www.beuth.de/de/regelwerke/normen-flatrates-im-ueberblick https://www.beuth.de/de/regelwerke/normen-flatrates-im-ueber...
- dataflow 6y ago
  > - In theory, you need to purchase a multi-user license if more than one person should be allowed to read the pdf in your company (hint: nobody purchases the multi-user license). How does the law treat this differently from a book? You can buy a book and then give or sell it to whomever you wish without any restrictions... how is this different?
  - grishka 6y ago
    When you try to compare digital downloads to physical media that isn't easy to copy, like books, most of the logic falls apart just like that. Then there's also another side to digital distribution, especially in entertainment — if you bought a (heavily DRM'ed) video game, or a movie, or a book, or something else, online, it's tied to your account. You can't lend whatever it is you bought to a friend like you absolutely could the same exact thing on a physical medium. You can't resell it either. You also rely on the mercy of the seller to not pull your access to the thing. Yet, even though it lacks this basic trait of a physical medium, sellers treat digital and physical as mostly the same thing.
    - dataflow 6y ago
      To clarify, I was comparing physical media against physical media. The standards are sold as physical copies. e.g., https://www.iso.org/standard/65464.html https://www.iso.org/standard/65464.html
burkaman 6y ago
It's a few hundred for one person, but buying it for your whole company is so expensive they won't even tell you the price: https://www.iso.org/terms-conditions-licence-agreement.html#Single-User https://www.iso.org/terms-conditions-licence-agreement.html#...
- Aerroon 6y ago
  If they charge that much, then perhaps we should choose not to use ISO standards whenever possible.
  - philihp 6y ago
    A better model is certification. Make the rules public, and when you want to sell your product, you must pay a standards agency to put their logo on your product.
    - krageon 6y ago
      You have to do that too. Well, you can never use their (the ISO) logo but you can use the logos provided by the certifying company to "prove" that you are certified. People don't abuse those logos because the companies in question have a lot of lawyers and will litigate relentlessly.
ska 6y ago
> but is a few hundred EUR really an obstacle for any kind of serious medical startup? No, it really isn't if they are serious, or even if they plan on being serious in the future. If you are shipping anything classified as a device, regulatory & QA work will typically involve multiple full time hires and/or equivalent consulting help by the time you file. Things are a bit leaner in SAAS only world, but still significant.
Galanwe 6y ago
Well standards are not just for companies, they are of interest to individuals too. For instance, the C++ specification is registered as an ISO standard, which means you have to either rely on free drafts, or pay for it...
rodgerd 6y ago
Startups: millions of dollars a year for AWS bills is just the price of doing business! Also startups: We can't afford a hundred dollar PDF uwu.
otabdeveloper4 6y ago
For a startup - probably not. But getting funding through finances for 'a few hundred EUR' in a largish company could be nearly impossible. It's not a thing that can go into your yearly budget and it's not attached to any project. You'll have to pay out of your own pocket for that.
yarcob 6y ago
The problem is that all these standards apply to large and small devices, and to software as well. I was once tangentially involved with an app that was basically a weight tracker. It was supposed to be a simple, reliable solutions for doctors to prescribe their patients, that allowed doctors to export data, and did not have annoying ads. Since doctors were supposed to prescribe the app, it had to be certified as a medical device. It was fortunately a self-certification process. But still the certification process was 10x more expensive than just the app development. The problem is that not every medical "startup" has multiple full time employees and millions in funding. Some are just a single doctor with a simple idea, and for them a few thousand dollar here and a few thousand dollar there quickly add up. The standards aren't their only expense.
rhizome 6y ago
To be sure, this entire thread is about principles, and while the costs may not be prohibitive, the title is "obstructs," not "prevents."

Very much in favour of open standards on principle, but is a few hundred EUR really an obstacle for any kind of serious medical startup?

by wk_end 6y ago

Very much in favour of open standards on principle, but is a few hundred EUR really an obstacle for any kind of serious medical startup?

oauea 6y ago

It's not just one document. And you don't know what will be relevant before you buy them, because you won't know the contents!

ballenf 6y ago
ICD code licensing is highway robbery. I would guess most health tech startups also need those. And those prices look reasonable compared to drug database license costs. And the real killer is meaningful use certification. The whole field seems engineered to prevent competition. So while ISO costs are unjustifiable, they’re a pittance compared to other compliance costs that most in the field will encounter.
- btilly 6y ago
  The whole field seems engineered to prevent competition. It is. After all it is not in the interests of anyone who is established in the field to make competition easy.
- snuxoll 6y ago
  ICD-10-CM that you need in the US can be obtained from CMS free of charge. CPT is obnoxious, but you can also generally substitute HCPCS from CMS as well at no cost. Source: work for a medical billing company, have had to deal with this garbage before.
- biofox 6y ago
  Not sure about licensing, but one important difference with ICD codes is that you can access them for free: https://icd.who.int/en https://icd.who.int/en
- deleted 6y ago
  [deleted]

jtwaleson 6y ago

The fact that the content is copyrighted and can't be publicly discussed is the main issue.

nl 6y ago
That's not what copyright is at all. Copyright might restrict reposting parts, but nothing (except perhaps license agreements) restricts public discussion. You can see this by the fact that Wikipedia has complete details of the ISO date standard (as referenced in the parent tweet Tim replied to).
- Natanael_L 6y ago
  This means every single thing must be very carefully rewritten. You can not cite every single sentence in the full document, you would have to mimic Wine and rewrite the entire thing until your lawyers aren't worried about getting sued anymore. And nobody's doing that. Most people aren't going to quote much anyway, which means the people who don't know what's referenced can't understand it because they have no context. Which brings us back to square one, you can't meaningfully discuss the content in public.
  - DaiPlusPlus 6y ago
    > Which brings us back to square one, you can't meaningfully discuss the content in public. Fair Use exception in the US, and I think that would be covered by Fair Dealing in the UK and similar countries.
    - Aerroon 6y ago
      That's an affirmative defense in the US though. That means you can still be sued and have to defend yourself in court.
      - DaiPlusPlus 6y ago
        I guess the trick is to pirate a specific localized version of the standard from an ISO member country that doesn't care about IP rights enough to sue you... say... PRC?

unethical_ban 6y ago

When ISO is defacto law in some industries, I would argue that laws should not be paywalled.

jrochkind1 6y ago
Your comment reminds me of related thing, with building codes in the US. The Supreme Court recently ruled they could not be copyrighted, for the reasons you say, they are laws that need to be available. These codes are often produced by a single organization, "International Code Council", a non-profit somewhat analagous to ISO, which I believe sells them to governmental jurisidictions which adopt them as law, sometimes with some customizations or "choose A or B" choices. One of the parties to the lawsuits involved happens to be a Y Combinator funded company, "UpCodes". https://archinect.com/news/article/150195411/supreme-court-rules-that-building-codes-cannot-be-copyrighted https://archinect.com/news/article/150195411/supreme-court-r... https://www.constructiondive.com/news/construction-code-purveyor-calls-supreme-courts-ruling-that-annotated-code/577013/ https://www.constructiondive.com/news/construction-code-purv... https://techcrunch.com/2020/11/16/a-court-decision-in-favor-of-startup-upcodes-may-help-shape-open-access-to-the-law/ https://techcrunch.com/2020/11/16/a-court-decision-in-favor-... In the US, if there are any cases where an ISO code is mentioned in law as legally binding in some way, it's possible someone could try to challenge the ability to keep from sharing the relevant standard text freely. It's not exactly the same situation, but this supreme court decision provides a possible path anyway.
- jsmith45 6y ago
  That is a severe overstatement. The Supreme Court ruled in Georgia vs public.resource.org, which was very much not about building codes. P.R.Org actually does have another ongoing lawsuit that is similar to UpCode's: American Society for Testing and Materials et al. v. Public.Resource.Org The UpCode ruling was at the district court level, and merely cited the ruling from Georgia vs public.resource.org. Until we get at least appellate level decisions on the copyrightability of enacted codes, I'm unlikely to feel satisfied.
  - 6y ago

edflsafoiewq 6y ago

Especially compared to the cost of reading and complying with them.

pretendgeneer 6y ago

The problem is not just a few hundred EUR if that standard is your core business, it's the 10's-100's that are roughly adjacent that if they were free you would just have on hand and use/adopt if it makes sense, but to have a price gatekeeper means you have to think about every single standard that might make sense to follow.

olieidel 6y ago

It is: - You need to purchase multiple standards (at least 4). - In theory, you need to purchase a multi-user license if more than one person should be allowed to read the pdf in your company (hint: nobody purchases the multi-user license). - Every few years, new versions of the standards are released which you have to purchase. - Sometimes, you just purchase standards to realise that they're not applicable to your company. - The industry is riddled with shadiness: A German standards web shop offers a "standards flatrate" for a "great price" of e.g. 750 EUR for 10 standards. [1] - Getting off-topic, but more related shadiness: Your purchased PDFs are watermarked with your company name and full name of purchaser (!) in the footer of each page to prevent sharing. [1] https://www.beuth.de/de/regelwerke/normen-flatrates-im-ueberblick https://www.beuth.de/de/regelwerke/normen-flatrates-im-ueber...

dataflow 6y ago
> - In theory, you need to purchase a multi-user license if more than one person should be allowed to read the pdf in your company (hint: nobody purchases the multi-user license). How does the law treat this differently from a book? You can buy a book and then give or sell it to whomever you wish without any restrictions... how is this different?
- grishka 6y ago
  When you try to compare digital downloads to physical media that isn't easy to copy, like books, most of the logic falls apart just like that. Then there's also another side to digital distribution, especially in entertainment — if you bought a (heavily DRM'ed) video game, or a movie, or a book, or something else, online, it's tied to your account. You can't lend whatever it is you bought to a friend like you absolutely could the same exact thing on a physical medium. You can't resell it either. You also rely on the mercy of the seller to not pull your access to the thing. Yet, even though it lacks this basic trait of a physical medium, sellers treat digital and physical as mostly the same thing.
  - dataflow 6y ago
    To clarify, I was comparing physical media against physical media. The standards are sold as physical copies. e.g., https://www.iso.org/standard/65464.html https://www.iso.org/standard/65464.html

burkaman 6y ago

It's a few hundred for one person, but buying it for your whole company is so expensive they won't even tell you the price: https://www.iso.org/terms-conditions-licence-agreement.html#Single-User https://www.iso.org/terms-conditions-licence-agreement.html#...

Aerroon 6y ago
If they charge that much, then perhaps we should choose not to use ISO standards whenever possible.
- philihp 6y ago
  A better model is certification. Make the rules public, and when you want to sell your product, you must pay a standards agency to put their logo on your product.
  - krageon 6y ago
    You have to do that too. Well, you can never use their (the ISO) logo but you can use the logos provided by the certifying company to "prove" that you are certified. People don't abuse those logos because the companies in question have a lot of lawyers and will litigate relentlessly.

ska 6y ago

> but is a few hundred EUR really an obstacle for any kind of serious medical startup? No, it really isn't if they are serious, or even if they plan on being serious in the future. If you are shipping anything classified as a device, regulatory & QA work will typically involve multiple full time hires and/or equivalent consulting help by the time you file. Things are a bit leaner in SAAS only world, but still significant.

Galanwe 6y ago

Well standards are not just for companies, they are of interest to individuals too. For instance, the C++ specification is registered as an ISO standard, which means you have to either rely on free drafts, or pay for it...

rodgerd 6y ago

Startups: millions of dollars a year for AWS bills is just the price of doing business! Also startups: We can't afford a hundred dollar PDF uwu.

otabdeveloper4 6y ago

For a startup - probably not. But getting funding through finances for 'a few hundred EUR' in a largish company could be nearly impossible. It's not a thing that can go into your yearly budget and it's not attached to any project. You'll have to pay out of your own pocket for that.

yarcob 6y ago

The problem is that all these standards apply to large and small devices, and to software as well. I was once tangentially involved with an app that was basically a weight tracker. It was supposed to be a simple, reliable solutions for doctors to prescribe their patients, that allowed doctors to export data, and did not have annoying ads. Since doctors were supposed to prescribe the app, it had to be certified as a medical device. It was fortunately a self-certification process. But still the certification process was 10x more expensive than just the app development. The problem is that not every medical "startup" has multiple full time employees and millions in funding. Some are just a single doctor with a simple idea, and for them a few thousand dollar here and a few thousand dollar there quickly add up. The standards aren't their only expense.

rhizome 6y ago

To be sure, this entire thread is about principles, and while the costs may not be prohibitive, the title is "obstructs," not "prevents."