It's totally dependent on what you are doing. Sure, HIPAA / PHI concerns are the primary issues for people who generally make software for the medical space, but by "medical software" I mean software that FDA might classify as "software as a medical device" AKA FDA regulated software. If your software falls under this designation, as most diagnostic medical AI systems like Watson would, then your primary regulatory concern is the FDA and you are held to much more stringent software development requirements than someone that has to deal with some PHI concerns.
In this context, my bulk de-regulation comment is 100% correct, as the FDA has basically dictated almost everything in the space to be unregulated (all back office products, general wellness products, enforcement discretion products, MDDS, even CDS which almost certainly should be regulated). They have literally gutted Class 1. You basically have to be writing something that is going to provide a diagnosis or treatment plan, control an existing medical device remotely, or mimic an existing regulated medical device in functionality in order to be regulated now. Reasonable people weren't scared to enter the space because they might have to deal with PHI for HIPAA concerns, as it is well known how to do that at this stage; they were scared to enter because there was (and continues to be) some uncertainty as to how novel product classes will be regulated by FDA.
> Your concerns on the sales side also do not mention "RISK" even once. You don't speak even a little bit of our healthcare space. Those doctors want risk management. What happens if/when the software screws up? Whose fault is it that the software is literally response for killing patients?
All FDA regulated software is mandated to have robust risk management planning prior to approval (ie ISO 14971 compliance). Other than that, the vast majority of products that a patient will be interfacing with can't do them real harm if they are buggy. That is precisely why the FDA has chosen not to regulate them.
> You also don't mention what doctors care about: does it meet CMS regs? Does it meet state regs? Will I be able to submit my obscure XYZ state form? Will I be able to submit to BCBS, Aetna, Medicare? Will they accept? Etc etc. You will be writing custom software for customers all over, because the regulations that states and even cities like NYC might impose could be imposed on a single customer of yours only.
I don't mention doctor wants because doctors aren't the buyers most of the time. Payers are the buyers, hospitals are the buyers, or patients are the buyers. How many pieces of software that you know of are sold directly to the doctor?
