Framework for clinical trial participants data reutilisation for a fully transparent and ethical ecosystem

Challenge

For it to be competitive, the medical field tends to be data-consuming. It is therefore indispensable to think of the European data protection regulatory frameworks as a catalyst, rather than a hinderer, for innovation. FACILITATE is a project that reimagines the dynamic of medical data processing by giving the data subjects transparency and control over the utilization of their data while granting reliable material for medical innovation.

FACILITATE will last 4 years and will participate in the extended Pilot on Open Research Data of Horizon 2020. Its strategy represents a unique and innovative opportunity for medicines drug development and regulation to better understand the clinics of diseases, and to evaluate the effectiveness of products in the healthcare system.

Objectives

By putting patients at the center of decision-making regarding their data, FACILITATE will allow stakeholders to balance regulatory and ethical frameworks with the need for high-quality, exploitable medical data. FACILITATE aims to define clear mechanisms for data subjects to allow the re-use of their data in accordance with European data protection regulations.

Including the patient in the decision-making is a reaffirmation of the principles of the GDPR and is a gateway to an ethical and compliant gathering, use and reuse of medical data.  To achieve this, FACILITATE will couple flexible and multi-purpose medical data with a consent-powered GDPR compliance.

Our Role

Privanova intervenes in FACILITATE to guarantee its business exploitation and sustainability. Privanova leads the consortium’s efforts on WP7, thus ensuring that the outputs of the project can be exploited in a realistic, efficient way. Privanova outlines and assesses the steps needed to implement the project’s results by identifying go-to-market strategies and optimizing the business plan.

With expertise in EU Ethics Appraisal Process, leadership of Ethics Advisory Boards for EU-funded projects, information security and privacy and data protection, Privanova brings a myriad of experience to the project. Our involvement in similar project of interest to the international healthcare community such as AI4HEALTHSEC and DIGICARE4YOU will also directly benefit the FACILITATE project.

As part of WP2, we also put our expertise at the service of the project by contributing to the implementation of adequate standards regarding privacy, data protection and ethics compliance.

This project has received funding from the European Union’s Horizon 2020 research and Innovation programme under grant agreement N°101034366. All information on this website reflects only the authors’ view. The Agency and the Commission are not responsible for any use that may be made of the information this website contains.