SOUP stands for software of unknown pedigree or provenance and in Healthcare it is extremly common in most of the autonomous regions in Spain. It represents “in house” home-made software for the health care control and EHR of the various autonomous communities. One of the common characteristics is that has never pass any official national based or EU based quality control system or the requirements for type I Medical Devices.
For that software it is essential to control risks and fails to assure a minimum quality control following IEC-62304 software control cicle 3rd Edition and ISO 14971 Risk management for Medical Devices together with ISO 13485 of Quality management that should be certified as a first step to get the CE-mark in the EU. And finally we do not have to forget patient security norms,
How many of our “in house” software for patient control and EHR do fulfill those norms?
Who is at a National level responsible for it?
Now with the Apps controling or selfcontroling healthcare regulation requirements have increase. FDA have controlled in the States.
Who is going to control it in Spain?
