CWA 17933 - Digital health innovations — Good practice guide for obtaining consent for the use of personal health information for research and innovations now published
Digital innovations in healthcare are still in development or in the evaluation process, which is why formal patient consent is required for all phases of their application, for example in pilot projects. CWA 17933 – Good practice guide for obtaining consent for the use of personal health information for research and innovations is supposed to help with this. More than 30 stakeholders from Europe contributed, among others, their experience from European H2020 health research projects (ADLIFE, InteropEHRate, KATY, PHArA-ON, SHAPES, SMART BEAR) and developed the content of the specification. This document describes which aspects should be considered when obtaining consent and what kind of consent is required in different situations, for example for future reuse of the data collected. It also outlines how ethical and data privacy protection requirements, formulation of consent forms, and the collection of consent by the ethics committee, if applicable, are to be considered. CWA 17933, financed by the European research project PHArA-ON, is now available for download (Link).