ESR eHealth and Informatics Subcommittee Session

ESR eHealth 4 - What the radiologist needs to know about EU regulations: AI Act, EHDS and more

February 26, 13:00 - 14:30 CET

5 min
Chairperson's introduction
Daniel Pinto Dos Santos, Frankfurt / Germany
15 min
The EU AI Act: helpful protection or the end of innovation?
Kicky Gerhilde van Leeuwen, De Bilt / Netherlands
  1. To learn about how medical AI software is classified by the AI Act.
  2. To appreciate the requirements for datasets and generalisability as defined in the AI Act.
  3. To understand how the regulations of the AI Act will impact the AI software market in the EU.
15 min
The EHDS: what can we expect of it and when?
Carla Meeuwis, Arnhem / Netherlands
  1. To learn about the general envisioned structure of the European Health Data Space.
  2. To appreciate the potential benefits of the EHDS for primary and secondary use of healthcare data.
  3. To discuss the future timeline of EHDS rollout and implementation throughout Europe.
15 min
Post-market surveillance: how is it done and what needs to change?
Nilaykumar Patel, Vienna / Austria
  1. To learn about the general concepts of post-market surveillance with regard to medical devices.
  2. To appreciate the particularities of post-market surveillance for medical AI software.
  3. To discuss what radiologists can do to facilitate post-market surveillance in their institutions.
15 min
The business of data: who can share which data and at what price?
Martin J. Willemink, San Diego / United States
  1. To learn about the need for data and where data is currently being sourced from for medical AI software.
  2. To appreciate how EU regulations (EHDS, GDPR, etc.) affect which data can be shared for AI development.
  3. To understand if and how institutions can contribute their data to EU projects or share it with industry.
25 min
Panel discussion: Regulations: are they a benefit or only a challenge?