Since digital health innovations are still under development or within the evaluation process formal consent is usually needed for all stages of the development cycle. This CEN Workshop Agreement (CWA) defines a guideline for devising, obtaining and documenting the most suitable consent for the use of digital health innovations. The guideline describes which aspects should be considered when asking for consent. It specifies the appropriate consent for different situations and how it should be framed and transparently explained. This includes seeking consent for the future reuse of collected data for additional areas of research. The document establishes how to consider ethical and data protection requirements, the wording of consent forms and obtaining ethics committee approval where applicable. Further, this document focuses on how to handle the subjects access request or withdrawal during (formative and summative) technology evaluation trials. The aim is to support researchers to ensure that the appropriate ICF (informed consent form) elements are considered. This is necessary since the presently adopted consent procedures usually concern only the specific use of data for identified and therefore foreseen purposes and are often challenged to obtain data reuse consent in a suitable way.
This document does not cover the information security safeguards that should be adopted during the data processing.