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In June 2023, CEN – the European Committee for Standardization – published a final version of its guide on patient consent for use in research and innovation projects. The guide’s full title is “Digital health innovations - Good practice guide for obtaining consent for the use of personal health information for research and innovations”. It is formally known as CWA 19933 2023 (E).

The guide has materialised thanks to the active collaboration among several Large Scale Pilot Projects in the Health and Care Cluster, and coordinated by the PHArA-ON project. Several large-scale pilots were involved in the endeavour. They include ADLIFE, InteropEHRate, SHAPES, SMART BEAR, as well as around a dozen other institutions and individuals.


The guide has been developed as a good practice guide. It is intended to help organisations and scientific associations performing research to develop and evaluate digital health innovations to obtain the most appropriate consent needed from individuals (whenever they are piloting and evaluating digital health innovations or conducting research). It was developed through an earlier period of commentary and constructive criticism.

Exciting for the future, it is expected that this guide will be used as a reference document by future research projects. As a result of its use, the overall efficiency of the privacy and security strategy of European projects should be improved significantly.

The guide is available for download here. (It can be downloaded only from the CEN downloadable area.)

Further resources



  • Enabling effective secondary use of health data in Europe: specific recommendations for a potential optout mechanism for the EHDS 06 June 2023 EHTEL & multiple stakeholders PDF*

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