Intelligent ecosystem to improve
the governance, the sharing,

and the re-use of health data for rare cancers

Ethical data governance

The deliverable “Ethical data governance and reuse incentivization approach” offers a first version of the data governance model for the IDEA4RC data ecosystem. It is based on the analysis of the ethical and legal requirements for the secondary use of health data within the European Union, from which a set of guidelines that fulfil the principles of Ethics by Design and by Defaults have been formulated.

The guidelines ensure adherence to ethical principles throughout the various phases of the project.

The proposed data governance model has also been informed by the analysis of the main barriers and incentives that the various stakeholders involved in IDEA4RC could face when collecting, sharing, and reusing health data on rare cancers.

“It is important to identify who are the stakeholders and which are their concerns in order to build the data governance model in a way that will inspire their trust and thus will encourage them to use the platform”, explains Vasiliki Tsiompanidou, legal researcher at the European Centre for Certification and Privacy and one of the leading authors of the deliverable.

The barriers and incentives have also led to the formulation of the Incentivisation and trust-building guidelines for data reuse”, which revolve around the idea of trust and articulates in guidelines on incentives, transparency and certification.

Ethical and legal requirements, risks and incentives are tightly related to one another. As an example, the EHDS, in its current formulation, requires the publication of the results obtained from data-reuse and potentially their active communication to the patients that contributed with their data. This addresses the ethical principle that the benefits of data should be widely shared across society, but at the same time it builds patient’s trust in the ecosystem encouraging patients to seek medical care from clinical centers that participate in data re-use platforms, such as IDEA4RC.

Given the nature and processes associated with ethical and legal compliance assessment and data governance, the information presented in this deliverable is expected to evolve during the project’s lifetime. The results of this evolution will be considered by deliverable 10.1 which will address relevant issues for post-project activities.