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Interesting, up north the ISO 13485 certification etc. is required to even deploy an App, as your phone would be considered a medical device under the rules if

Interesting, up north the ISO 13485 certification etc. is required to even deploy an App, as your phone would be considered a medical device under the rules if used for diagnostics and or reporting. Don't get me wrong, I am sure people have no issue paying the $84k each release cycle to be cleared as compliant. Notably, our health authority legally can't buy software without these certifications, and for the past 6 years only Microsoft offers a framework through their partner for the e-records exchange systems. There is zero "open" anything in this ecosystem, as commercial insurance won't cover mystery commits. Best of luck, =)

moneywoes 2y ago
Can you elaborate, aren’t there cheaper cloud based hosting solutions e.g. aws?
- Joel_Mckay 2y ago
  AWS is usually not compliant, and thus likely prohibited as well. Microsoft partnered with a large local telecom company to provide the NOC. It is 100% a monopoly, and thus why we left a competing firm a long time ago. =)
nradov 2y ago
I'm not sure what you mean by "mystery commits". Health plans are legally required to accept transactions that conform to CMS adopted standards. They don't know or care what software is used to generate those transactions. https://www.cms.gov/priorities/key-initiatives/burden-reduction/administrative-simplification/hipaa/adopted-standards-operating-rules https://www.cms.gov/priorities/key-initiatives/burden-reduct...
- Joel_Mckay 2y ago
  For regulatory reasons, the slicer.org team found out after the software was written... that it was illegal to deploy in a medical context within the US. The reason was you can't legally use software with patchwork origins and licenses to cobble together something where the authors are not able to be found/held liable for damages if they accidentally injure someone. If the data is not being used in _any_ way for patients diagnostics/e-record roles, than your team might get away with just clearing HIPAA rules in the US (not sure how each state would handle that exception.) You have been warned about the historical rules, but if something changed since I was last in that Circus... than I hope the project does well. It is always wise to talk with a local legal specialist to clear up current rules. I'd wager people had a billion reason$ to keep things as they were... =)
  - nradov 2y ago
    Wrong. Merely storing clinical data or providing it to clinicians who use it for diagnostics isn't sufficient for software to be considered an FDA regulated medical device. I have actually built such software and was careful to avoid adding any features that would make it a medical device. Open source software has being used legally by provider organizations for decades. Instead of remaining ignorant and spreading secondhand misinformation you can literally just go read the federal regulations and supplementary guidance. Or just ask the FDA for a formal opinion letter if you're in a gray area. This is basic stuff, not hard to find or understand.
    - Joel_Mckay 2y ago
      I too have written software for both Canada and the US markets. Don't YOLO this one kid. (the fact you didn't mention the 2 other common ISO standards I omitted on purpose, means you have not done your work properly for "years" as you put it.)
      - nradov 2y ago
        It's always disappointing to see such ignorance in HN comments like this. While there are some relevant technical standards cross listed with ISO, adherence to ISO standards isn't legally required for products like Metriport. Seriously buddy, you can just go read the FDA regulations instead of making a fool of yourself. But if you'd like to keep looking silly then feel free to have the last word.
        Joel_Mckay 2y ago
        It is ok to disagree kid (I often make mistakes), but asserting your locale's rules are somehow international is a nonsense argument for your own ego. I would recommend considering programs compatible with your obvious temperament: https://www.youtube.com/watch?v=XUAsU_zQVMo https://www.youtube.com/watch?v=XUAsU_zQVMo Feel free to append any additional off-topic nonsense below if it makes you feel better. I still like you. =3
  - 2y ago

moneywoes 2y ago

Can you elaborate, aren’t there cheaper cloud based hosting solutions e.g. aws?

Joel_Mckay 2y ago
AWS is usually not compliant, and thus likely prohibited as well. Microsoft partnered with a large local telecom company to provide the NOC. It is 100% a monopoly, and thus why we left a competing firm a long time ago. =)

nradov 2y ago

I'm not sure what you mean by "mystery commits". Health plans are legally required to accept transactions that conform to CMS adopted standards. They don't know or care what software is used to generate those transactions. https://www.cms.gov/priorities/key-initiatives/burden-reduction/administrative-simplification/hipaa/adopted-standards-operating-rules https://www.cms.gov/priorities/key-initiatives/burden-reduct...

Joel_Mckay 2y ago
For regulatory reasons, the slicer.org team found out after the software was written... that it was illegal to deploy in a medical context within the US. The reason was you can't legally use software with patchwork origins and licenses to cobble together something where the authors are not able to be found/held liable for damages if they accidentally injure someone. If the data is not being used in _any_ way for patients diagnostics/e-record roles, than your team might get away with just clearing HIPAA rules in the US (not sure how each state would handle that exception.) You have been warned about the historical rules, but if something changed since I was last in that Circus... than I hope the project does well. It is always wise to talk with a local legal specialist to clear up current rules. I'd wager people had a billion reason$ to keep things as they were... =)
- nradov 2y ago
  Wrong. Merely storing clinical data or providing it to clinicians who use it for diagnostics isn't sufficient for software to be considered an FDA regulated medical device. I have actually built such software and was careful to avoid adding any features that would make it a medical device. Open source software has being used legally by provider organizations for decades. Instead of remaining ignorant and spreading secondhand misinformation you can literally just go read the federal regulations and supplementary guidance. Or just ask the FDA for a formal opinion letter if you're in a gray area. This is basic stuff, not hard to find or understand.
  - Joel_Mckay 2y ago
    I too have written software for both Canada and the US markets. Don't YOLO this one kid. (the fact you didn't mention the 2 other common ISO standards I omitted on purpose, means you have not done your work properly for "years" as you put it.)
    - nradov 2y ago
      It's always disappointing to see such ignorance in HN comments like this. While there are some relevant technical standards cross listed with ISO, adherence to ISO standards isn't legally required for products like Metriport. Seriously buddy, you can just go read the FDA regulations instead of making a fool of yourself. But if you'd like to keep looking silly then feel free to have the last word.
      - Joel_Mckay 2y ago
        It is ok to disagree kid (I often make mistakes), but asserting your locale's rules are somehow international is a nonsense argument for your own ego. I would recommend considering programs compatible with your obvious temperament: https://www.youtube.com/watch?v=XUAsU_zQVMo https://www.youtube.com/watch?v=XUAsU_zQVMo Feel free to append any additional off-topic nonsense below if it makes you feel better. I still like you. =3
- 2y ago