CEN Workshop Agreement on 'Digital health innovations – Good practice guide for obtaining user consent for personal health information'

The motivation for this Workshop came from multiple European research projects and large-scale pilots that found that they were all needing to identify the most suitable lawful basis for collecting and processing personal health data for the development, deployment, testing and evaluation of digital health innovations. This CWA aims to combine the experience of various R&I projects regarding this topic in a best practice guide on how to obtain user consent for personal health information.

The planned CEN Workshop Agreement (CWA) will define a guideline for obtaining the most suitable consent for the use of digital health innovations. The guideline will describe which aspects should be considered when asking for consent. It will also cover the usability of a consent form especially regarding the patient-friendly presentation of informed consent choices. Another aspect of this CWA will focus on how to handle the subject’s access requests or withdrawal during a pilot evaluation. The CWA is of particular use for R&I and is also of interest for market participants outside of R&I projects as to consider the different topics that consent is needed for.


The proposal of the workshop is the European Institute for Innovation through Health Data, and the secretariat holder of this workshop is DIN, the German Institute for Standardization.


The kick-off meeting will be held on Friday, 22nd July 2022, from 11:00 – 16:00 as a virtual meeting.

The Workshop participation will be open to all interested parties. Interested parties can submit comments on the draft Project Plan via the 'Commenting form' (see below) until 15th July 2022 and to register to the workshop by sending an email to the workshop secretary Ms Madlen SCHMUDDE.1


Download the documents:

1Applications for participating in the Workshop and comments on the project plan that are not received by the deadline do not need to be taken into consideration. Once constituted, the Workshop will decide whether or not to consider the comments received in good time.


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