I've worked in MRI AI both in academic and non-academic centers, including technology that has received 510K clearance.
I admit it sounds pedantic, but I'm not discussing IRB *exemptions* that are sometimes required by an institution nor am I discussing BAAs. I was specifically talking about the specific IRB applications (which I've submitted and signed before) that the blog author was talking about. Yes, HIPAA and other state and local regulations also govern what you can and cannot do with the data, but that's not what I argued.
Sorta off topic but the FDA doesn't care so much about SAR unless you're directly programming the MR machine's pulse sequence. If you're just doing quantification of some brain structure for monitoring a biomarker, they're primarily concerned if your product 1) matches an existing prerequisite and 2) functionality that your product achieves performance that you say it does. That is why the marketing around most of the early DL / AI based radiology startups were focused on language for "study prioritization" rather than more specific claims.
I admit it sounds pedantic, but I'm not discussing IRB *exemptions* that are sometimes required by an institution nor am I discussing BAAs. I was specifically talking about the specific IRB applications (which I've submitted and signed before) that the blog author was talking about. Yes, HIPAA and other state and local regulations also govern what you can and cannot do with the data, but that's not what I argued.
Sorta off topic but the FDA doesn't care so much about SAR unless you're directly programming the MR machine's pulse sequence. If you're just doing quantification of some brain structure for monitoring a biomarker, they're primarily concerned if your product 1) matches an existing prerequisite and 2) functionality that your product achieves performance that you say it does. That is why the marketing around most of the early DL / AI based radiology startups were focused on language for "study prioritization" rather than more specific claims.