This work was carried out under a CEN Workshop Agreement to develop a good practice guide to help organisations and scientific associations performing research to develop and evaluate digital health innovations to obtain the most appropriate consent that they need from individuals when piloting and evaluating digital health innovations or conducting research The working group included representatives from five large H2020 projects namely ADLIFE (Grant agreement No.875209), InteroperEHRate (Grant agreement No.826106), KATY (Grant agreement(No 1010167453),OPEN DEI(Grant No. 857065) PHArA-ON (Grant agreement No.857188) SMART BEAR(Grant agreement No.857172) and SHAPES (Grant agreement No.857172)

The group was led by Dipak Kalra from the European Institute for Innovation through Health Data and from DIN research and transfer Madlen Schmudde

There are an ever-increasing number of digital health innovations being developed evaluated deployed and used and thus a growing area for research and product development clearly requiring testing before they can be finally approved for use. In this scenario it is difficult to know what kinds of consent are required in the digital innovation field, what permissions are necessary from individuals and how it can be framed and transparently explained. It was identified that there were four key aspects of consent that needed to be covered in the guide as follows:

Care Intervention: In case the research involves possible changes to care or treatment, or change clinician behaviour, which would require human ethics approval

Using a novel digital health tool: In the situation where patient care is not changed but the methods for collecting data, delivering data or interacting between actors is changed

Collecting data to study the research innovation: This case includes any evaluation data and sharing among partners potentially across borders, outside EU etc.

The downstream reuse of collected data: This is potentially research that might not be anticipated at the time the consent was expected and possibly sharing the data with parties and countries that were not anticipated

In terms of scope therefore the guide covers these key elements describing which aspects should be considered when seeking consent specifying what is appropriate for different situations including its framing and transparent explanation It also establishes how to consider both ethical and data protection arrangements, consent form wording and obtaining ethical approval where required. In addition, the document deals with how to handle subjects access requests, or withdrawal during evaluation trials.

The ultimate aim of the guide is to support researchers/innovators to ensure that all appropriate consent elements are considered including the future unforeseen purposes where data may wish to be reused.

The document does not cover the information security safeguards that should be adopted during the data processing.