Assurance of Software-Intensive Medical Devices : What About Mental Harm?

Interdisciplinary synergies are arising from the growing usage of software, e.g., between dependability assurance and mental health. In a context in which software-intensive medical devices are used for the treatment of mental illnesses such as schizophrenia, it is important to consider mental harm when dealing with and justifying system dependability. However, we are not aware of any publication on system assurance that has paid attention to mental harm in detail. This emerging idea should be considered for the success of the devices. We discuss why and how mental harm should be addressed for assurance of software-intensive medical devices, considering hazard and risk analysis, system compliance, dependability justification, and assurance evidence collection. We draw from prior more general work and from system examples for which mental health plays a major role.