Recital 38

While EHR systems specifically intended by the manufacturer to be used for processing one or more specific categories of electronic health data should be subject to mandatory self-certification, software for general purposes should not be considered to be an EHR system, even when used in a healthcare setting, and should therefore not be required to comply with this Regulation. That covers cases such as text-processing software used for writing reports that would then become part of written electronic health records, general-purpose middleware, or database management software that is used as part of data storage solutions.