Day 1: October 16th, 2024

13:00 – 14:00 – Registration Opening & Coffee Break

14:00 – 15:30 – Opening Plenary – Session 1 – Plenary 1 “Update on regulations” – Salle ORSAY

CNIL : AI Act + Biomedical Research Reference Methodologies EDPB : Updated anonymization guidance OTHER EU Authority

In France, CNIL has carried out a public consultation to improve its Reference Methodologies on biomedical research. It has also put in place a team dedicated to the use of Artificial Intelligence, a technology now widely used in healthcare and medical research.
At the EU level, the European Data Protection Board is working on new anonymisation and pseudonymisation guidelines
Several national authorities are working on updating their regulatory framework to prepare the implementation of the European Health Data Space

Learning objectives

Chair
Pierre-Yves Lastic
EFDPO
Paris, France

speaker 1
Aurore gaignon
CNIL
Paris, France

Speaker 2
Benedicte Illien
EMA
Amsterdam, netherland

Speaker 3
Sabine BrOScH
Ema, Data analytics
Vienna, Austria

15:30 – 16:00 – Coffee Break

16:00 – 17:30 – Workshops Sessions

16:00 – 17:30 Session 2 – Panel Discussion 1 – International Data Transfers – Salle ORSAY

This panel will be dedicated to exploring the challenges relating to the transfer of health data in general and in particular in the context of scientific research. The session will combine academic and practical considerations on transfer tools and transfer impact assessment.

These are the topics or questions we intend to address:

The challenges of implementing Standard Contractual Clauses, particularly the famous module 4 processor to Controller and the implications of the recent Dutch DPA decision sanctioning uber.
The European Commission has (finally) launched an initiative to update Standard Contractual Clauses (SCCs) for the transfer of personal data to third-country controllers and processors under the GDPR. Was it worth the wait?
The Challenges linked to the frame of data transfer within the complex processing chain of some clinical trials.
What place for the other data transfer tools and mechanisms such as BCRs ?
Reliance on Derogations for scientific research. Is it a viable option ?
Clarifying the purpose of the Transfer Impact Assessment and the implementation of supplementary measures for “problematic” countries.

Chair
Winnie Dongbou
MyData-Trust
Brussels, Belgium

Speaker 1
Sonia Cissé
Linklaters LLP
Paris, France

Speaker 2
adriana minovic
DPO, ERGOMED
serbia

Speaker 3
Teodora Lolava-Spinks
U-gent
Gent, Belgium

16:00 – 17:30 Session 3 – Workshop 1 – Tutorial : Certifications and codes of conduct – Salle Vendôme 5-6

This workshop aims to highlight:

• the practical implications of assessments for compliance with the GDPR and more specific related to privacy and transparency within the different areas of digital health.

• existing assessment and certification frameworks with focus on AI and Telemedicine

• feasible and criteria relevant for the DPO in order to harmonise the European assessment frameworks

Learning objectives

Chair
Christophe MAES
I-HD
Deinze, Belgium

Speaker 1
Yoanni MATSAKIS
Telemedicine, technologies
Boulogne billancourt, France

Speaker 2
Irène schlunder
TMF eV
berlin, germany

Speaker 3
NATHAN LEA
DPO, I-HD
GENT, BELGIUM

16:00 – 17:30 Session 4 – Workshop 2 – Training & Education – Salle Vendôme 1

This panel discussion will discuss the need for specific training and education for DPO and Privacy Officers working in healthcare and biomedical research:

What kind of education is needed for DPO and Privacy Officers involved in the processing of personal health data?
Should health data specific certification frameworks be developed?
How could an European training program for Health Data Protection look like?

Learning objectives