
Ask HN: Are there any healthcare software SMEs? - tixocloud
We want to leverage our platform within the healthcare space and need to understand the regulatory environment. Hoping to learn more about what we need to fix to be compliant.<p>Thanks in advance.
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verdverm
Have you talked with any stake holders in a hospital? They each tend to have
their own requirements for deployment. Most likely you will have to operate on
premise.

Beyond HIPAA, if you intend to recommend treatment, you need FDA approval.

I'm currently working on the DevOps for a competitor of yours, ML models in
the hospital, moving towards a marketplace and ecosystem. Fun stuff because in
some hospitals, you can't even get remote access. Everything installs from a
USB stick.

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tixocloud
Funny - looks like everyone is moving towards the same model (i.e. marketplace
and ecosystem) which is a logical step! Wonder what would happen if there are
too many marketplaces.

Effectively, I won't be recommending treatments but rather I'll be hosting ML
models from other researchers that might - I wonder if I can write a legal
clause that clears me from FDA approval.

It seems like IBM has a way of saying 'not FDA-cleared for diagnostic use':
[http://www.merge.com/Solutions/Cardiology/Merge-
Cardio.aspx](http://www.merge.com/Solutions/Cardiology/Merge-Cardio.aspx)

