A tamper-proof audit and control system for the doctor in the loop.

The "doctor in the loop" is a new paradigm in information-driven medicine, picturing the doctor as authority inside a loop supplying an expert system with information on actual patients, treatment results, and possible additional (side-)effects, including general information in order to enhance data-driven medical science, as well as giving back treatment advice to the doctor himself. While this approach can be very beneficial for new medical approaches like P4 medicine (personal, predictive, preventive, and participatory), it also relies heavily on the authenticity of the data and thus increases the need for secure and reliable databases. In this paper, we propose a solution in order to protect the doctor in the loop against responsibility derived from manipulated data, thus enabling this new paradigm to gain acceptance in the medical community. This work is an extension of the conference paper  Kieseberg et al. (Brain Informatics and Health, 2015), which includes extensions to the original concept.