28 Jun Pharaon-led guide for obtaining consent on personal health information published (CWA 17933)

Digital health innovations are still in the development or evaluation process. Thus, when they are used, for example in pilot projects, formal patient consent is required for all phases of development.

The CEN Workshop Agreement (CWA) 17933 – Good practice guide for obtaining consent for the use of personal health information for research and innovations aims to remedy this situation. A CEN Workshop Agreement (CWA) is a reference document from the European Committee for Standardization (CEN) but is not an official standard from the member organizations. More than 30 stakeholders from Europe have contributed amongst other their experience from European Horizon 2020 research projects in the health sector (ADLIFE, InteropEHRate, KATY, PHARAON, SHAPES, SMART BEAR) and developed the content of the specification. The document describes what aspects should be considered when obtaining informed consent and what consent is needed in different situations, such as for future reuse of the data collected. It also outlines how to consider ethical and privacy requirements, formulation of consent forms, and obtaining ethics committee approval, where applicable.

You can download the guide here: CEN Workshop Agreement 17933 Digital health innovations – Good practice guide for obtaining consent for the use of personal health information for research and innovations