“One could imagine applying regulations to a simple calculator app with an algorithm that gives an exact result, but it seems like the proposed regulation also would also apply to diagnostic software that deals with thousands of diseases.
Such software responds differently depending on which of thousands of findings a physician chooses to enter. One could never test all combinations, and although the diagnosis models can be excellent, I’ve never heard anyone claim they are perfect. Is the FDA really proposing to require each version of diagnostic software to get putatively exhaustive testing before release? This is not really possible, and not even close to possible in fields in which the knowledge changes very rapidly.”
Article
David E Williams, HealthWorks Collective, 24 July 2011
