Ask HN: Are there any healthcare software SMEs?
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.
Thanks in advance.
Thanks in advance.
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.
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