Health software

Health software is wider than software as a medical device: it also covers wellness and care-delivery software that no regulation treats as a device. IEC 82304-1 applies to health software that runs on general computing platforms such as phones, PCs and the cloud.

software intended to be used specifically for managing, maintaining or improving health of individual persons, or the delivery of care Note 1 to entry: HEALTH SOFTWARE fully includes what is considered software as a medical device (see rationale in A.1). Note 2 to entry: The scope of this document refers to the subset of HEALTH SOFTWARE that is intended to run on general computing platforms.

IEC 82304-1:2016, clause 3.6