Recital 38

Self-certification of general purpose software

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.

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