This deliverable report examines the outcomes of the REACH research project with regard to data privacy and data security, associated with Task T7.5. This document gives an overview of our analyses involving ethics and privacy concerns in terms of the individual touchpoints and shows how these findings guided the project towards the determination of the medical purpose and intended use – cornerstones to on the path to market entry. In addition, we provide a brief overview of how the guidelines regarding data protection and encryption influenced the technical design and implementation of project components. Furthermore, we provide an update on the management of legal implications (and the implications resulting from this for system requirements and business strategy) of the use of machine learning and artificial intelligence in the context of REACH solutions, incorporating an external expert opinion. Finally, this deliverable report contains a summary of our approach towards risk governance and standardization in this regard: our work in REACH on privacy and security schemata, culminated in a CEN Workshop Agreement (guideline) that generalizes REACH outcomes and makes them accessible and usable beyond the REACH consortium.     «

This deliverable report examines the outcomes of the REACH research project with regard to data privacy and data security, associated with Task T7.5. This document gives an overview of our analyses involving ethics and privacy concerns in terms of the individual touchpoints and shows how these findings guided the project towards the determination of the medical purpose and intended use – cornerstones to on the path to market entry. In addition, we provide a brief overview of how the guidelines r...    »