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by adunsulag 749 days ago
OpenEMR is an OSS practice management system and is certified for medical use by ONC in the USA. It has been deployed in the medical context in many jurisdictions in the USA. There are some government agencies / larger organizations that require 'sole-sourcing' which I think is what you are referring to, it varies by jurisdiction, but I've never heard of anything at the federal level and widespread state level that 'requires' this. If this was the case I doubt we'd have made it through the many times we've been certified.

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.
2 comments
Joel_Mckay 749 days ago
In general, up here the 3 relevant ISO certifications (around $45k to $80k each) that apply to e-record and diagnostic systems are required, or software cannot be legally purchased by the health authority. For many reasons, the e-record system software was written in partnership between a large telecom and Microsoft.

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

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nradov 748 days ago
It's kind of hilarious how some people with no real industry experience aren't able to do a simple search on the CHPL. Obviously, there's nothing illegal about using OpenEMR regardless of who wrote the code. And certification isn't even necessarily required. Providers who don't participate in certain federal or state programs are free to use non-certified software as long as they're able to comply with applicable interoperability and privacy/security regulations; regulatory compliance and enforcement for that stuff is at the provider organization level, not at the product level.
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Joel_Mckay 748 days ago
"there's nothing illegal about using OpenEMR regardless of who wrote the code"

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. =)

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