In a series of videos for the EJP RD’s Massive Open Online Course (MOOC) on “Innovative Therapies and Personalized Medicine for Rare Diseases“, led by CVBF, Dr. Stefano Benvenuti, Public Affairs Manager at Fondazione Telethon in Italy, stresses the importance of putting patients at the center of data collection and sharing efforts.

Dr. Benvenuti highlights that informed consent is a complex and crucial issue in data sharing environment. To respect patient wishes, he advocates for involving patient representatives in decision-making processes, ensuring data is used ethically and transparently, and emphasizing patient ownership of their data in line with the EU’s General Data Protection Regulation (GDPR).

Dr. Benvenuti provides insights into the management of patient data, addressing the challenges related to preserving patient identity. He explores the concepts of i anonymization, and pseudonymization as strategies to protect patient privacy while enabling valuable research.

He also discusses patients’ rights to access their own clinical data. He emphasizes the legal and ethical obligations of organizations to provide such access, while also illustrating the responsibility of patient associations to safeguard data privacy and empower patients.

“Patient-centricity should not be just a motto, but a guiding principle in rare disease research,” Dr.Benvenuti states. “By involving patients in governance, ensuring transparent data use, and respecting their rights, we can build the trust necessary to unlock the potential of data sharing for the benefit of the rare disease community.”

The EJP RD MOOC is available free of charge, for the new users of the platform, at https://www.futurelearn.com/courses/innovative-therapies-and-personalised-medicine-for-rare-diseases