It is 100% a monopoly, and thus why we left a competing firm a long time ago. =)
https://www.cms.gov/priorities/key-initiatives/burden-reduct...
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... =)
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.
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.)
I would recommend considering programs compatible with your obvious temperament:
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
I will mention that the certification process is expensive. It ranges in the 100K-250K range each time we go through it in fundraising and to go through the certification process.
slicer.org has their detailed story why "3D Slicer is NOT FDA approved", and its unfortunate given the transient nature of volumetric imaging data formats.
My point was this area is a mine-field of regulation. Generally, the above rules trip the instant a doctor uses something to diagnose or communicate patient data. Notably, the same software is deployed across provinces and states... but will obviously have different certification requirements in each locale.
Some people seem to get really rude over the most mundane details. =3
Indeed, in your area this may be true. However, the health authority can't legally purchase or use these projects without the ISO certs, and thus it is a moot point.
I think we will have to agree to disagree, as there are two truths here. And people seem to be getting emotional about their egos. =)
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, =)