This course aims to provide an overview of how personal data protection affects the healthcare sector, from legal frameworks to current challenges.

Module I will provide you with the basic principles of personal data protection under the GDPR in the healthcare environment and the key insights of the Clinical Trials Regulation, which came into force in 2022.

Module II will provide a deep dive into the upcoming new European Health Data Space regulation, and all the challenges and opportunities facing the healthcare sector with regards to data protection.

In particular, the recent challenges faced, the complexities of data protection in clinical trials and research, the ways protecting patients’ privacy.

Furthermore, all the open questions that remains with the implementation of the Artificial Intelligence in the Healthcare sector will be open to discussion.

What you will learn

Module I:

• A refresher of the basic GDPR principles of data protection in relation to the healthcare sector
• GDPR obligations – transparency, records of processing activities and documentation system, international data flows in EU and global multi-centre
• Clinical Trials Regulation and the GDPR – the relations and prevalence between the two disciplines, with a focus on consent to treatment and to data processing
• Risk assessments and the DPIA – methodology and operational phases, data protection by design and default in the health research process, interactions with individuals data protection notice and consent, data subjects’ rights
• Interactions with third parties – roles of actors in the GDPR and healthcare sector: data controllers, data processors, data subjects, DPOs, sponsors, CROs, CRAs, investigators, monitors, laboratory, ethical

Module II:

• Regulation on the European Health Data Space – explanation of the proposal, how it revolutionises the potential of health data, how it will benefit citizens, how it will benefit researchers on the one side and the critique by the EDPB/EDPS on the other side.

  Next steps and key insights regarding its

• How the patients’ rights can be protected under the new common data
• The right to data portability and its configuration in the European Health Data
• Tools to manage health data from a technical
• Artificial Intelligence in the Healthcare Sector – state of the art of artificial intelligence and its applications in the Healthcare

Course methodology

We believe that practical know-how is the key to effective learning.

This course therefore includes:

• Individual preparation for the course – you are invited to bring along any information about the mission, vision, values and data protection framework and governance within your organisation for case study;
• Group and individual assignments; including case
• An interactive approach: the module’s structure will give you the opportunity to ask questions and share and discuss experiences, knowledge, needs and challenges with the trainers and other participants;