A Preliminary Study of a Probabilistic Risk-based Approach for Ambient Intelligence Healthcare Systems

The Ambient Intelligence (AmI) paradigm applied to the healthcare sector is a promising solution to develop software-based systems capable of supporting medical procedures and activities carried out in a close, high-regulated, and complex healthcare environment. An AmI Healthcare System (AmI-HS) which may impact on the health and life of its users (i.e. doctors, caregivers, patients, etc.) is considered as a Medical Device (MDs), and thus subject to pass through a cumbersome risk-based regulatory process which evaluates and certifies the system safety before it is put on the market. Thus, a human-centred risk analysis is of paramount importance to establish the safety level of an AmI-HS.