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OPEN DEI is a collaborative and support action which is contributing to helping make every industry in Europe benefit fully from digital innovations.

OPEN DEI’s three main foci are on Open Source, Platforms and Pilots. The project uses several Digital Maturity assessment methods and tools to evaluate four areas of work: processes, monitoring and control, technologies, and organisation. Health and care is one of the various industries involved In the OPEN DEI project.

OPEN DEI now has the opportunity to work more intensively, with others, on a new CEN workshop agreement.

A CEN workshop agreement started its work in summer 2022

The European Committee for Standardization (CEN) organises workshop agreements. Each agreement is called a CEN Workshop Agreement (CWA). Starting up a CWA is an official recognition by one of the world’s top standardisation organisations that guidelines are needed on a particular topic.

This new workshop agreement recognises the work of multiple European research projects and large-scale pilots. The key topic is the data that is at the core of health and care. All these projects/pilots have found that they all need 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. OPEN DEI is one of them.

Hence, on 22 July 2022, OPEN DEI partners participated in a kick-off meeting of this new CWA. The aim was to start the process of defining a good practice guideline for obtaining the most suitable consent for the use of digital health innovations.

In receiving this acknowledgement, the OPEN DEI project’s work has been recognised as a de facto reference. This recognition can offer a first step towards the development of a potential standard.

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Content, motivation and intention of the guide

The guide aims to consolidate the learning and experience of several projects and large scale pilots regarding data subject consent (or some other lawful basis) for the development, piloting and evaluation of digital health innovations intended for use in the health and care sector.

The motivation for this guide emerged from the findings of multiple European projects and large-scale pilots. In many cases, the project and pilots could see the potential value for reusing the data they have collected later, after the end of their project. The re-use could even be for research questions that have not yet been identified. The projects/pilots therefore needed a multi-layered lawful basis, potentially a multi-layered consent.

What the projects/pilots found is that they are encountering similar problems and challenges. Therefore, they could benefit hugely by learning from each other. After some initial exchanges, it became clear that the body of projects collectively had accumulated useful learnings that could be shared with others to avoid them making the same mistakes or “reinventing the same wheels”.

The intention underpinning this future guide will be to help projects with obtaining the most appropriate consent for their needs, and with understanding the implications of the types of consent they have already obtained. It should make it easier for Research and Innovation (R&I) projects, as well as market participants outside of R&I projects, to consider what are the different topics that consent is needed for and how best to obtain it.

To learn more about this whole process, visit the OPEN DEI website.

OPEN DEI’s work provides a great link to the outcomes of the InteropEHRate project. To dig deeper into the topic of health data sharing for multiple purposes, attend the InteropEHRate Final Conference, taking place on 28 September 2022. Save the date or sign up now.


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