CEN Workshop: Digital Health Innovations - Good practice guide for obtaining user consent for personal health innovation

Project Details


The CEN Workshop Agreement (CWA) will define a guideline for obtaining the most suitable consent for the use of digital health innovations, including evaluations, pilots and trials. 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.
Effective start/end date15/07/202215/07/2023

Collaborative partners

  • The European Institute for Innovation through Health Data (Project partner) (lead)
  • German Institute for Standardization (Project partner)
  • Department of Technology, Management and Economics
  • University of Vienna (Project partner)
  • University of Florence (Project partner)
  • University of Warwick (Project partner)
  • University of the Basque Country (Project partner)
  • National and Kapodistrian University of Athens (Project partner)
  • Stelar Security Technology Law Research UG (Project partner)
  • Kronikgune Institute for Health Services Research (Project partner)
  • Maynooth University (Project partner)
  • Medicines Optimisation Innovation Centre (Project partner)
  • University of Beira Interior

UN Sustainable Development Goals

In 2015, UN member states agreed to 17 global Sustainable Development Goals (SDGs) to end poverty, protect the planet and ensure prosperity for all. This project contributes towards the following SDG(s):

  • SDG 3 - Good Health and Well-being
  • SDG 9 - Industry, Innovation, and Infrastructure


  • digital health innovation
  • user consent
  • health innovation


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