&gt; possibly this has changed recently but I don&#x27;t think medical records software is subject to the same standards as medical device software (in Europe, at least).<p>That is indeed the case (medical record software not being classified as a medical device software product in Europe). However medical record software has been added to also be covered some ISO 80xxx standard. However in the USA medical record software is considered a class B or even class C medical product by the FDA, depending on if the software is used just for record keeping or actively used for therapy planning.